[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"diabetes-dm\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:diabetes-dm":29},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,37,0,25,[9,50,87,122,156,183,212,234,290,318,342,376,404,434,463,518,541,572,605,632,657,679,704,728,766],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":25,"conditions":26,"keywords":33,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":4},"100652794","an-innovative-proprioceptive-instrument-for-upper-extremities-100652794",false,"NCT07779928","An Innovative Proprioceptive Instrument for Upper Extremities","Development, Validation, and Clinical Application of an Innovative Proprioceptive Instrument for Upper Extremities: PropArm-PosiMoF (PropArm)","1. Healthy Young Adults:\n\n   Inclusion Criteria:\n   * (1) Age between 20 and 29 years,\n   * (2) Right-hand dominance, and\n   * (3) Ability to understand three consecutive verbal instructions.\n\n   Exclusion Criteria:\n   * (1) Currently a student or faculty member of the Department of Occupational Therapy at National Cheng Kung University, or a staff member of the Department of Physical Medicine and Rehabilitation, National Cheng Kung University Hospital,\n   * (2) History of surgery on the right upper limb,\n   * (3) Presence of neuromusculoskeletal disorders that may affect sensory or motor function of the right upper limb, such as stroke or shoulder impingement syndrome, and\n   * (4) Uncorrected hearing problems, such as hearing loss.\n2. Healthy Adults:\n\n   Inclusion Criteria:\n   * (1) Age between 30 to 39, 40 to 49, or 50 to 59 years,\n   * (2) Right-hand dominance, and\n   * (3) Ability to understand three consecutive verbal instructions.\n\n   Exclusion Criteria:\n   * (1) Currently a student or faculty member of the Department of Occupational Therapy at National Cheng Kung University, or a staff member of the Department of Physical Medicine and Rehabilitation, National Cheng Kung University Hospital,\n   * (2) History of surgery on the right upper limb,\n   * (3) Presence of neuromusculoskeletal disorders that may affect sensory or motor function of the right upper limb, such as stroke or shoulder impingement syndrome, and\n   * (4) Uncorrected hearing problems, such as hearing loss.\n3. Healthy Older Adults:\n\n   Inclusion Criteria:\n   * (1) Age between 60 to 69, 70 to 79, or 80 to 89 years,\n   * (2) Right-hand dominance, and\n   * (3) Ability to understand three consecutive verbal instructions.\n\n   Exclusion Criteria:\n   * (1) Score below the 5th percentile on the Color Trails Test-Chinese Version (CTT-C),\n   * (2) Currently a student or faculty member of the Department of Occupational Therapy at National Cheng Kung University, or a staff member of the Department of Physical Medicine and Rehabilitation, National Cheng Kung University Hospital,\n   * (3) History of surgery on the right upper limb,\n   * (4) Presence of neuromusculoskeletal disorders that may affect sensory or motor function of the right upper limb, such as stroke or shoulder impingement syndrome, and\n   * (5) Uncorrected hearing problems, such as hearing loss.\n4. Stroke:\n\n   Inclusion Criteria:\n   * (1) Age between 20 and 89 years,\n   * (2) Right-hemispheric hemorrhagic or ischemic stroke with lesions involving proprioceptive pathways or the primary somatosensory cortex, potentially resulting in difficulties with body position, movement, or force perception, or with fine tactile perception (e.g., localization, two-point discrimination, object recognition),\n   * (3) Right-hand dominance, and\n   * (4) Ability to understand three consecutive verbal instructions.\n\n   Exclusion Criteria:\n   * (1) Score below the 5th percentile on the Color Trails Test-Chinese Version (CTT-C),\n   * (2) Upper limb still in acute pain stage,\n   * (3) Muscle tone severe enough to affect right upper limb movement (e.g., score ≥ 1+ on the Modified Ashworth Scale),\n   * (4) Uncorrected hearing problems, such as hearing loss.\n5. Shoulder Impingement Syndrome:\n\n   Inclusion Criteria:\n   * (1) Age between 20 and 89 years,\n   * (2) Diagnosis of shoulder impingement syndrome in the right upper limb,\n   * (3) Right-hand dominance, and\n   * (4) Ability to understand three consecutive verbal instructions.\n\n   Exclusion Criteria:\n   * (1) Score below the 5th percentile on the Color Trails Test-Chinese Version (CTT-C),\n   * (2) Upper limb still in acute pain stage,\n   * (3) Uncorrected hearing problems, such as hearing loss.\n6. Diabetes (DM):\n\nInclusion Criteria:\n\n* (1) Age between 20 and 89 years,\n* (2) Diagnosis of diabetes mellitus by a specialist physician, based on one of the following:\n\n  1. Fasting plasma glucose (FPG) ≥ 126 mg\u002FdL or 7.0 mmol\u002FL;\n  2. Hemoglobin A1C (HbA1c) ≥ 6.5%;\n  3. Plasma glucose ≥ 200 mg\u002FdL or 11.1 mmol\u002FL at 2 hours during an oral glucose tolerance test (OGTT);\n  4. Presence of hyperglycemia symptoms (polyphagia, polyuria, polydipsia, and unexplained weight loss) with a random plasma glucose ≥ 200 mg\u002FdL.\n\nDiagnosis of diabetes is confirmed if any two of items (a-c) are met, or if any one of them remains positive on repeat testing; fulfillment of item (d) alone is also sufficient for diagnosis.\n\n* (3) Right-hand dominance, and\n* (4) Ability to understand three consecutive verbal instructions.\n\nExclusion Criteria:\n\n* (1) Score below the 5th percentile on the Color Trails Test-Chinese Version (CTT-C),\n* (2) History of surgery on the right upper limb,\n* (3) Presence of other neuromusculoskeletal disorders that may affect sensory or motor function of the right upper limb, and\n* (4) Current skin infection, and\n* (5) Uncorrected hearing problems, such as hearing loss.",true,"ALL","20 Years","89 Years",{"count":22,"type":23},280,"ESTIMATED","OBSERVATIONAL","This study aimed to develop and validate an innovative proprioceptive assessment instrument for the upper extremities, the PropArm-PosiMoF (PropArm). This observational study was conducted in three stages. The first stage focused on the development and validation of PropArm, including test-retest reliability, concurrent validity, and convergent validity. The second stage established age norms and cut-off points in healthy adults. In the final stage, PropArm was applied to patients with proprioceptive impairments (stroke, shoulder impingement syndrome, and diabetes mellitus patients) to examine its diagnostic accuracy and clinical applicability.",[27,28,29,30,31,32],"Stroke","Shoulder Impingement Syndrome","Diabetes (DM)","Healthy Young Adults","Healthy Adults","Healthy Older Adults",[34,35,36,37],"Proprioception","Upper Extremities","Instrument","Psychometric Properties","NOT_YET_RECRUITING","2026-08-18",{"date":41,"type":42},"2026-08-21","ACTUAL",{"date":44,"type":23},"2026-09-01",{"date":46,"type":23},"2027-12-31",{"name":48,"class":49},"National Cheng-Kung University Hospital","OTHER",{"id":51,"slug":52,"hasResults":12,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":12,"sex":18,"minAge":58,"maxAge":59,"enrollmentInfo":60,"targetDuration":4,"studyType":62,"phases":63,"briefSummary":65,"conditions":66,"keywords":72,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":4},"100652068","a-prospective-multicenter-study-evaluating-the-metabolic-effects-of-pulsendo-therapy-in-adults-with-type-2-diabetes-100652068","NCT07768631","Study Evaluating the Metabolic Effects of pulsENDO Therapy in Adults With Type 2 Diabetes","A Prospective, Multicenter, Randomized, Sham-Controlled Study Evaluating the Metabolic Effects of pulsENDO Therapy in Adults With Type 2 Diabetes (pULSENDO Study)","pulsENDO","Inclusion Criteria:\n\n1. 22- 75 years of age, inclusive.\n2. T2D diagnosis for at least 6 months.\n3. HbA1c of 7.5-10.5%, inclusive, for participants on 1-3 GLMs or or if on 4 glucose-lowering medications must have HbA1c between 7.5% - 9.0%, inclusive.\n4. BMI 27-40 kg\u002Fm2, inclusive.\n5. On 1-4 non-insulin glucose lowering medications, with no changes in medication or dosing for at least 12 weeks prior to the baseline visit\n6. If on lipid-lowering medications, the medication stable for at least 12 weeks .\n7. Individualized metabolic surgery (IMS) score ≤ 115.\n8. Weight stability (≤5% weight change) for at least 12 weeks\n9. Agree not to donate blood during participation in the study.\n10. Women of childbearing potential must not be pregnant and using an acceptable method of contraception throughout the study.\n11. Willing and able to comply with study visits and study requirements.\n12. Understand and able to provide written informed consent.\n\nExclusion Criteria:\n\n1. Diagnosed with type 1 diabetes.\n2. History of diabetic ketoacidosis or hyperosmolar nonketotic coma.\n3. Fasting serum C-peptide \\\u003C1 ng\u002FmL (333pmol\u002Fl).\n4. Current use of insulin, or previous use of any types of insulin for \\>1 month at any time (except for treatment of gestational diabetes) in last 2 years.\n5. Hypoglycemic unawareness.\n6. History of ≥1 severe hypoglycemia episode in past 6 months\n7. Discontinuation of a GLP-1 or a GLP-1\u002FGIP dual-agonist within 6 months of the screening visit following at least one month of treatment.\n8. Known autoimmune disease\n9. Previous GI surgery that has changed GI anatomy\n10. Known history of a structural or functional disorder of the upper GI tract that may impede passage of the device through the upper GI tract or increase risk of tissue damage during an endoscopic procedure\n11. History of gastroparesis.\n12. Acute gastrointestinal illness in the last 7 days.\n13. Known history of inflammatory disease (e.g. Crohn's disease, ulcerative colitis, inflammatory bowel disease), radiation enteritis or other chronic inflammatory disorders of the bowel.\n14. History of chronic or acute pancreatitis.\n15. Active hepatitis or active liver disease, or alanine aminotransferase (ALT) level \\>3.0 times the upper limit of normal (ULN)\n16. Unable to discontinue non-steroidal anti-inflammatory drugs (NSAIDs) from treatment through 4 weeks following the procedure.\n17. Use of systemic glucocorticoids for more than 10 consecutive days within 12 weeks\n18. Use of medications known to affect GI motility (e.g. metoclopramide\u002F Reglan)\n19. Current use of weight loss medications or other weight loss medications including over-the-counter \\[OTC\\] medications or have discontinued weight loss medications within 6 months.\n20. Participation in any structured weight loss program or endoscopic weight loss intervention within 6 months.\n21. Persistent anemia, defined as hemoglobin \\\u003C10 g\u002FdL.\n22. Known history of hemoglobinopathy, hemolytic anemia or sickle cell anemia, or any other traits of hemoglobin abnormalities known to interfere with the measurement of HbA1c.\n23. History of blood donation or transfusion within 3 months.\n24. Unstable or paroxysmal cardiac arrhythmia.\n25. Any of the following cardiovascular conditions within 6-months prior to screening visit: acute myocardial infarction, unstable angina, cerebrovascular accident (stroke), hospitalization due to congestive heart failure, or history of other significant cardiovascular disease\n26. Heart failure\u002Fvalvular disease: NYHA Class III or IV heart failure, or clinically significant valvular heart disease associated with symptoms or increased procedural\u002Fanesthesia risk\n27. Estimated glomerular filtration rate (eGFR) ≤ 45 ml\u002Fmin\u002F1.73m2\n28. Known immunocompromised status, including but not limited to individuals who have undergone organ transplantation, chemotherapy, or radiotherapy within the past 12 months, who have clinically significant leukopenia, who are positive for the human immunodeficiency virus (HIV) or whose immune status makes the participant a poor candidate for clinical trial participation in the opinion of the investigator.\n29. History of secondary hypothyroidism or inadequately controlled primary hypothyroidism\n30. Presence of any implanted electronic devices that cannot be turned off during the procedure\n31. Presence of duodenal or biliary stents.\n32. Not a candidate for upper GI endoscopy or general anesthesia.\n33. Active illicit substance abuse or alcoholism (\\>2 drinks\u002Fday regularly).\n34. Active malignancy within the last 5 years (excluding non-melanoma skin cancers).\n35. Women who are breastfeeding.\n36. Participating in another ongoing clinical trial of an investigational drug or device.\n37. Current or history within the past 12 months of binge eating disorder, bulimia nervosa, anorexia nervosa, or night eating syndrome.\n38. Clinically significant psychiatric illness, defined as any of the following: (a) psychiatric hospitalization within the past 24 months; (b) a history of suicide attempt, or active suicidal ideation within the past 24 months; or (c) a diagnosis of schizophrenia, other psychotic disorder, or bipolar disorder that is not clinically stable on current management\n39. Critically ill or has a life expectancy \\\u003C5 years.\n40. Are investigator site personnel directly affiliated with this study and\u002For their immediate family member. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted.\n\n    Additional exclusion criteria to be evaluated during the screening process:\n41. HbA1c \\\u003C 7.5% or \\> 10.5% at baseline visit.\n42. Uncontrolled hyperglycemia with a glucose level \\>270 mg\u002Fdl (\\>15 mmol\u002FL) after an overnight fast or \\>360 mg\u002Fdl (\\>20 mmol\u002Fl) in a randomly performed measurement that is confirmed by a second measurement (not on the same day) between screening and baseline visit.\n43. Active systemic infection, febrile illness, or antibiotic use within 4 weeks of the Baseline visit.\n44. Vaccination within 14 days of the Baseline visit.\n45. Any severe hypoglycemic event since the screening visit.\n46. Poorly controlled hypertension, as evidenced by a mean of 3 separate blood pressure measurements \\>180 mmHg (systolic) or \\>100 mmHg (diastolic)\n47. Women of child-bearing potential with a positive urine pregnancy test at baseline visit.\n48. LA Grade C or greater esophagitis on endoscopy.\n49. Abnormalities of the GI tract preventing endoscopic access to the duodenum.\n50. Anatomic abnormalities in the duodenum or proximal jejunum that would preclude the completion of the treatment procedure, including tortuous anatomy.\n51. Endoscopic observation of upper gastrointestinal abnormalities such as ulcers, polyps in the area to be treated, varices, strictures, congenital or intestinal telangiectasia.\n52. Any other anatomical or endoscopic abnormalities\u002Fcharacteristics that, in the opinion of the investigator, would preclude safe use of the investigational device or procedure.","22 Years","75 Years",{"count":61,"type":23},320,"INTERVENTIONAL",[64],"NA","This is a prospective, multicenter, randomized, double-blind, sham-controlled, adaptive study evaluating the pulsENDO system in individuals with type 2 diabetes (T2D) inadequately controlled on non-insulin glucose-lowering medications (GLMs). The primary objective of this study is to demonstrate that pulsENDO therapy is superior to sham control for improving glycemic control in adults with type 2 diabetes.",[67,68,29,69,70,71],"Diabetes Type 2","Diabetes","Weight Change","Glycemic Control","Glycemic Control for Diabetes Mellitus",[73,74,75,76,77],"blinded","multicenter","randomized","doudenal regeneration","type 2 diabetes","2026-08-14",{"date":39,"type":42},{"date":81,"type":23},"2027-01-01",{"date":83,"type":23},"2030-11-01",{"name":85,"class":86},"Endogenex, Inc.","INDUSTRY",{"id":88,"slug":89,"hasResults":12,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":93,"eligibilityCriteria":94,"healthyVolunteers":12,"sex":18,"minAge":95,"maxAge":4,"enrollmentInfo":96,"targetDuration":4,"studyType":62,"phases":98,"briefSummary":99,"conditions":100,"keywords":107,"overallStatus":112,"whyStopped":4,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":121},"100628559","integrating-new-skills-into-diabetes-education-with-cgm-100628559","NCT07463209","Integrating New Skills Into Diabetes Education With CGM","Integrating New Skills Into Diabetes Education With CGM (INSIDE-CGM): An Individualized CGM Integration Program for Older Adults With Diabetes","INSIDE-CGM","Participant Inclusion Criteria:\n\n* Adults 65 years and older at time of consent\n* Actively receiving care at a UNC Health or UNC Physicians Network clinic (defined as 2 or more visits in primary care, family medicine, internal medicine, geriatrics, or endocrinology clinics within the past 365 days). Locality for care is defined as receiving care within a 90-mile radius of UNC Main Hospital on Manning Drive in Chapel Hill, NC.\n* Using any insulin at least once daily\n* No continuous glucose monitor (CGM) use within the previous 365 days\n* Willing to use a smartphone to access glucose readings using CGM phone app\n* Fluent in English\n\nParticipant Exclusion Criteria:\n\n* Clinical diagnosis of dementia, assessed through chart review and self-report on screening visit (cognitive impairment that is mild and not considered sufficient for diagnosis of dementia is acceptable)\n* Currently receiving dialysis, assessed through chart review and self-report on screening visit\n* Extreme visual or hearing impairment that would impair ability to use real-time CGM or attend and participate in an in-person or virtual group intervention session, assessed at screening visit\n* The presence of a significant medical or psychiatric condition or use of a medication that in the judgment of the investigator may affect completion of any aspect of the protocol, or is likely to be associated with life expectancy of \\\u003C1 year, assessed at screening visit\n* Unavailable for 6-week study duration (such as planned surgery or procedure, planned vacation, etc.) or unwilling to comply with study procedures\n* Not fluent in English\n* Unable to consent to recording of sessions\n\nCare Partner Inclusion Criteria:\n\n* Live in the same household as the study participant\n* Age 18 years or older\n* Fluent in English\n* Be willing to attend sessions alongside the study participant and learn how they can better support their partner participant to manage diabetes\n* Consent to recording of sessions","65 Years",{"count":97,"type":23},144,[64],"This study is designed to test the preliminary efficacy of a three-stage continuous glucose monitor (CGM) integration program for older adults who are taking insulin. This study will learn if a three-stage CGM integration program (\"intervention\") that includes sessions focused on CGM technology skills, data skills, and lifestyle skills impacts CGM wear-time, glycemic metrics, and participant-reported outcomes, compared to two standard CGM training approaches (\"comparators\").\n\nFollowing a screening visit and baseline data collection, participants will be randomized to either the intervention or one of the two comparator arms for 6 weeks. The intervention involves three educational sessions over 4 weeks. The first session will be in-person and subsequent sessions will be virtual. Participants in the intervention may receive 1-2 additional individualized training sessions to review CGM skills. The first comparator (Comparator 1) will receive a one-time clinic-based CGM training. The second comparator (Comparator 2) will be provided with a comprehensive informational pamphlet about CGM. All participants will complete outcomes data collection at 6 weeks.\n\nThe study will also explore participant experiences through a series of semi-structured interviews with a subset of purposively selected participants and their care partners to identify opportunities for scaling the intervention to a broader population. An extension phase of the study will evaluate long-term CGM use and associated outcomes 3- and 6-months post-intervention.\n\nLastly, we will run an additional small sub-study where consented care partners of participants will attend the intervention or comparator sessions alongside the study participant and provide care partner-specific data.",[101,29,102,103,104,105,106],"Insulin Dependent Diabetes","Diabetes (Insulin-requiring, Type 1 or Type 2)","Diabetes Education","Diabetes Care","Type 1 Diabetes (T1D)","Type 2 Diabetes Mellitus (T2DM)",[108,68,109,110,111,103],"Continuous Glucose Monitor","Insulin Dependent","Older Adults (65 years and older)","CGM","RECRUITING","2026-08-12",{"date":78,"type":42},{"date":116,"type":42},"2026-08-11",{"date":118,"type":23},"2028-06",{"name":120,"class":49},"University of North Carolina, Chapel Hill",1,{"id":123,"slug":124,"hasResults":12,"nctId":125,"briefTitle":126,"officialTitle":127,"acronym":128,"eligibilityCriteria":129,"healthyVolunteers":12,"sex":18,"minAge":130,"maxAge":131,"enrollmentInfo":132,"targetDuration":4,"studyType":62,"phases":134,"briefSummary":136,"conditions":137,"keywords":144,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":149,"startDateStruct":150,"completionDateStruct":152,"leadSponsor":154,"locationsCount":4},"100643950","early-phase-1-team-based-shared-decision-making-program-in-cardiovascular-kidney-metabolic-health-100643950","NCT07662616","Team-Based Shared Decision-Making Program in Cardiovascular-Kidney-Metabolic Health","Feasibility and Efficacy Pilot of a Team-Based Shared Decision-Making Program in Cardiovascular-Kidney-Metabolic Health, Medication Adherence, and Cardiovascular Health","SDM in CKM","Inclusion Criteria:\n\n* Are adults aged 30 to 79 years (to use PREVENT equations to calculate 10- and 30-year risk estimates for total CVD),\n* Are in stage 2 CKM: the presence of metabolic risk factors (hypertension \\[stages 1 and 2\\], hypertriglyceridemia \\[≥135 mg\u002FdL\\], diabetes, Metabolic Equivalents (MetS)\\*) and\u002For Chronic Kidney Disease (CKD) \\[moderate- to high-risk CKD which are stages 1-3 CKD\\]), and\n* Receive primary care at Johns Hopkins Community Physicians (JHCP).\n* Access to smart phone or tablet to use app.\n\nExclusion Criteria:\n\n* Have diagnosis of CVD,\n* Stage 4-5 CKD, kidney failure, or on dialysis\n* Have a serious medical condition such as cancer;\n* On or planning to start Glucagon-like peptide-1 (GLP-1) receptor agonists in next 6 months;\n* Have cognitive impairment;\n* Are currently involved in other programs on improving LE8; or\n* Unwillingness to provide informed consent\n* Unable to speak, read, or communicate in English.","30 Years","79 Years",{"count":133,"type":23},94,[135],"EARLY_PHASE1","The investigators are proposing a new team-based shared decision-making (SDM) program. The goal of this study is to see whether this program is practical and whether it may help adults with cardiometabolic risk factors and cardiovascular-kidney-metabolic syndrome. The investigators will enroll adults from a primary care clinic in Maryland. People in the intervention group will take part in the 6-month program in addition to usual care. People in the control group will receive usual care only.",[138,29,139,140,141,142,143],"Hypertension (HTN)","Hyperlipidaemia","Kidney Disease","Obesity","Cardiovascular-kidney-metabolic (CKM)","Overweight",[145,146,147,148],"shared decision-making","Cardiovascular-kidney-metabolic","Behavioral counseling","Team-based care",{"date":113,"type":42},{"date":151,"type":23},"2026-09-10",{"date":153,"type":23},"2028-06-30",{"name":155,"class":49},"Johns Hopkins University",{"id":157,"slug":158,"hasResults":12,"nctId":159,"briefTitle":160,"officialTitle":161,"acronym":4,"eligibilityCriteria":162,"healthyVolunteers":12,"sex":18,"minAge":163,"maxAge":4,"enrollmentInfo":164,"targetDuration":4,"studyType":62,"phases":166,"briefSummary":167,"conditions":168,"keywords":170,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":175,"lastUpdatePostDateStruct":176,"startDateStruct":177,"completionDateStruct":179,"leadSponsor":181,"locationsCount":4},"100651198","pilot-rct-of-a-chinese-medicine-diabetes-education-programme-100651198","NCT07758413","Pilot RCT of a Chinese Medicine Diabetes Education Programme","Development and Pilot Test of a Chinese Medicine Diabetes Education Program 中醫糖尿病個人管理教育方案建構及初步試驗","Inclusion Criteria:\n\n* Adults aged 18 years or above\n* Diagnosed with type 2 diabetes mellitus\n* Able to understand and communicate in Cantonese, and able to read Chinese\n* Willing and able to provide written informed consent\n* Able to attend the education sessions at the designated venues\n\nExclusion Criteria:\n\n* Severe cognitive impairment that would prevent meaningful participation in group education\n* Acute or unstable medical conditions, or serious chronic illnesses currently under active treatment (e.g., ongoing cancer treatment), that may preclude safe participation in group activities\n* Currently participating in another structured diabetes education research programme\n* Pregnancy","18 Years",{"count":165,"type":23},40,[64],"The goal of this clinical trial is to learn if a Chinese medicine diabetes education programme is feasible and acceptable, and to explore its preliminary effects on self-management, for adults with type 2 diabetes in Hong Kong. The main questions it aims to answer are:\n\n1. Is the Chinese medicine diabetes education programme feasible to deliver in a community setting (recruitment, retention and adherence)?\n2. Is the programme acceptable to participants?\n3. Does the programme show early signals of improving diabetes management self-efficacy and related outcomes?\n\nResearchers will compare the Chinese medicine education programme to usual care to see if the programme is feasible, acceptable and shows preliminary benefits.\n\nParticipants will:\n\n1. Be randomly assigned to either a 4-week Chinese medicine diabetes education programme (four group sessions, total 4-6 hours) or usual care\n2. Complete assessments at baseline, after the programme, and at 2-month follow-up.\n3. Attend a focus group interview at the end of the study (selected participants)\n\nOutcome assessors will be blinded to group allocation.",[29,169],"Medicine, Chinese Traditional",[171,172,173,174],"Diabetes Mellitus","patient education","self-management","medicine, chinese traditional","2026-08-06",{"date":116,"type":42},{"date":178,"type":23},"2026-07-30",{"date":180,"type":23},"2027-02-28",{"name":182,"class":49},"The Hong Kong Polytechnic University",{"id":184,"slug":185,"hasResults":12,"nctId":186,"briefTitle":187,"officialTitle":187,"acronym":188,"eligibilityCriteria":189,"healthyVolunteers":17,"sex":18,"minAge":163,"maxAge":190,"enrollmentInfo":191,"targetDuration":4,"studyType":62,"phases":192,"briefSummary":195,"conditions":196,"keywords":197,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":203,"lastUpdatePostDateStruct":204,"startDateStruct":206,"completionDateStruct":208,"leadSponsor":210,"locationsCount":121},"100616082","phase-1-studies-of-insulin-and-glucagon-action-in-the-liver-100616082","NCT07300982","Studies of Insulin and Glucagon Action in the Liver","SIGNAL","Inclusion Criteria:\n\n* Healthy adults age 18-45 years\n* Body Mass Index (BMI) \\\u003C 27.0 kg\u002Fm²\n* Fasting plasma glucose ≤ 95 mg\u002FdL or HbA1c ≤ 5.8% as measured at screening visit\n\nExclusion Criteria:\n\n* Active medical disease: e.g. active infectious, inflammatory, neurodegenerative or mental health disorders\n* No personal history of diabetes or pancreatitis\n* No personal history of cardiac, gastrointestinal, renal or liver disease\n* No history of diabetes among any first-degree family members\n* Renal insufficiency (eGFR \\\u003C 60 mL\u002Fkg\u002Fmin)\n* Anemia (hematocrit \\\u003C 34%) as measured at screening visit\n* Pregnant females\n* Consumption of daily medications that alter glucose metabolism of GI function (glucocorticoids, psychotropics, narcotics, metoclopramide)","45 Years",{"count":165,"type":23},[193,194],"PHASE1","PHASE2","This study examines how glucagon works to regulate glucose metabolism, based on new findings that suggest glucagon signaling in the liver has more than one role, and that these multiple roles can be opposing in nature. Understanding this biology provides an opportunity to develop new generations of glucagon-based drugs that target specific pathways, making them more effective at controlling blood glucose.\n\nParticipants will complete paired, 5-hour hyperinsulinemic glucose clamp visits in which they receive either glucagon or saline infusions while blood glucose is maintained and frequent blood samples are collected. The primary focus is whether coordinated glucagon and insulin signaling enhances hepatic insulin sensitivity.",[29],[198,199,200,201,202],"Glucose metabolism","Hepatic insulin sensitivity","Glucagon","Insulin","hepatic glucose production","2026-08-03",{"date":205,"type":42},"2026-08-05",{"date":207,"type":23},"2026-10",{"date":209,"type":23},"2029-12",{"name":211,"class":49},"Duke University",{"id":213,"slug":214,"hasResults":12,"nctId":215,"briefTitle":216,"officialTitle":216,"acronym":217,"eligibilityCriteria":218,"healthyVolunteers":12,"sex":18,"minAge":219,"maxAge":4,"enrollmentInfo":220,"targetDuration":4,"studyType":62,"phases":222,"briefSummary":223,"conditions":224,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":226,"lastUpdatePostDateStruct":227,"startDateStruct":229,"completionDateStruct":230,"leadSponsor":232,"locationsCount":4},"100649405","voice-activated-and-touchscreen-controlled-smart-speaker-intervention-for-older-adults-with-poorly-controlled-type-2-diabetes-100649405","NCT07734259","Voice-activated and Touchscreen-controlled Smart Speaker Intervention for Older Adults With Poorly Controlled Type 2 Diabetes","VATC-SS","Inclusion Criteria:\n\n* 1\\) Aged 50 and older; 2) clinical diagnosis of poorly controlled type 2 diabetes, defined as HbA1C greater than or equal to 8% at the screening visit; 3) willing to install and use the VATC-SS for the 3 months of the study.\n\nExclusion Criteria:\n\n* 1\\) Mental confusion at screening assessment suggesting significant dementia; 2) alcohol or drug abuse\u002Fdependency at screening assessment; 3) active psychosis or acute mental disorder at screening assessment.","50 Years",{"count":221,"type":23},30,[64],"This is a pre-post pilot study that will test the feasibility and acceptability of a health educator delivered diabetes education and skills training intervention using a voice-activated, touch screen controlled, smart speaker. We will enroll 30 adults aged 50 and older with poorly controlled type 2 diabetes as defined by a hemoglobin A1C of 8% in the study.",[68,29,225],"Type 2 Diabetes","2026-07-24",{"date":228,"type":42},"2026-07-29",{"date":44,"type":23},{"date":231,"type":23},"2028-03-30",{"name":233,"class":49},"Medical College of Wisconsin",{"id":235,"slug":236,"hasResults":12,"nctId":237,"briefTitle":238,"officialTitle":238,"acronym":4,"eligibilityCriteria":239,"healthyVolunteers":12,"sex":18,"minAge":163,"maxAge":4,"enrollmentInfo":240,"targetDuration":242,"studyType":24,"phases":4,"briefSummary":243,"conditions":244,"keywords":246,"overallStatus":112,"whyStopped":4,"lastUpdateSubmitDate":282,"lastUpdatePostDateStruct":283,"startDateStruct":284,"completionDateStruct":286,"leadSponsor":288,"locationsCount":121},"100645611","determination-of-resistance-training-status-for-patients-on-glucagon-like-peptide-1-receptor-agonists-100645611","NCT07702461","Determination of Resistance Training Status for Patients on Glucagon-Like Peptide-1 Receptor Agonists","Inclusion Criteria:\n\n* Adult aged 18 years or older\n* Currently taking a GLP-1 receptor agonist medication\n* On the GLP-1 receptor agonist for at least 3 months\n* Using the GLP-1 receptor agonist for type 2 diabetes, overweight or obesity, and\u002For weight management (self-reported)\n* Stable GLP-1 receptor agonist dose for the past 4 to 8 weeks\n* Able to read and respond to the survey in English\n* Willing and able to provide informed consent electronically\n\nExclusion Criteria:\n\n* Currently or planning to become pregnant\n* Planned bariatric surgery within the next 3 months\n* Recent bariatric surgery (within the past 3 months) or other conditions that substantially alter resistance training capacity (e.g., advanced cancer cachexia, severe mobility-limiting conditions)\n* Unable to read or respond to the survey in English",{"count":241,"type":23},300,"1 Day","This study examines how adults who take a GLP-1 receptor agonist medication (such as semaglutide \\[Ozempic, Wegovy, Rybelsus\\], liraglutide \\[Saxenda, Victoza\\], or tirzepatide \\[Mounjaro, Zepbound\\]) perform resistance (strength) training before and after starting their medication.\n\nGLP-1 medications are being prescribed more and more often to help people manage type 2 diabetes and lose weight. These medications work well, but a known side effect is that people can lose lean (muscle) tissue along with fat. Losing muscle can make it harder to move, do everyday tasks, and stay strong as we age. Resistance training, things like lifting weights, using resistance bands, or doing push-ups and squats, is the most effective way to keep and build muscle. Yet most adults in the United States do not meet the recommended amount of resistance training, and very little is known about the resistance training habits of people who take GLP-1 medications.\n\nThe purpose of this research is to systematically collect information from adults using GLP-1 medications so we can better understand: how often they do resistance training before and after starting the medication; what their sessions look like (frequency, duration, intensity, muscle groups); whether their resistance training is linked to how strong they feel and how well they can carry out daily activities; and what makes resistance training easier or harder while on a GLP-1 medication.\n\nFindings will help doctors, dietitians, exercise professionals, and researchers design better guidance and interventions to protect muscle mass, physical function, and quality of life in people using GLP-1 medications.\n\nWho can join: Adults 18 years or older who are currently taking a GLP-1 receptor agonist medication for type 2 diabetes, overweight or obesity, or weight management, and who have been on the medication for at least three months at a stable dose. Participants must be able to read and respond to the survey in English. People who are pregnant or planning bariatric surgery within the next three months are not eligible.\n\nWhat participants will do: The study is a single, anonymous, online survey. Interested individuals click the survey link, review a short consent page, and indicate their willingness to participate. Eligible participants then answer questions about their background, current health, GLP-1 medication and dose, resistance training habits before and after starting the medication, self-reported strength and function, and things that make resistance training easier or harder. There are no in-person visits, no exercise tests, and no blood draws.\n\nHow long it takes: About 10 minutes total, in one online session. There is no follow-up after the survey and no compensation is offered.\n\nData privacy: The survey is anonymous. No names, email addresses, or IP addresses are collected or linked to responses. The survey runs on Qualtrics, a secure, institution-approved platform hosted on Ohio State University servers.\n\nThe research team hopes to enroll up to 200-300 adults across the United States.",[245,29],"Obesity & Overweight",[247,248,249,250,251,252,253,254,255,256,257,258,259,260,261,262,263,264,265,266,267,268,269,270,271,272,273,274,275,276,277,278,279,280,281],"GLP-1","GLP-1 Receptor Agonist","GLP-1RA","Semaglutide","Liraglutide","Tirzepatide","Ozempic","Wegovy","Rybelsus","Mounjaro","Zepbound","Saxenda","Victoza","Muscle-strenghtening Exercise","MSEQ","Lean body mass","Sarcopenia","Muscle Preservation","Weight Loss","Weight Management","Resistance Training","Strength Training","Weightlifting","Exercise","Physical Activity","Body weight exercise","Pilates","Holistic Exercise","Physical Function","Activities of Daily Living","Quality of Life","Health Related Quality of Life","Glucagon-Like Peptide-1","Glucagon-Like Peptide-1 Receptor Agonist","Weight Loss Medication","2026-07-23",{"date":226,"type":42},{"date":285,"type":42},"2026-06-12",{"date":287,"type":23},"2027-01",{"name":289,"class":49},"Ohio State University",{"id":291,"slug":292,"hasResults":12,"nctId":293,"briefTitle":294,"officialTitle":295,"acronym":4,"eligibilityCriteria":296,"healthyVolunteers":12,"sex":18,"minAge":163,"maxAge":59,"enrollmentInfo":297,"targetDuration":4,"studyType":62,"phases":299,"briefSummary":300,"conditions":301,"keywords":304,"overallStatus":112,"whyStopped":4,"lastUpdateSubmitDate":309,"lastUpdatePostDateStruct":310,"startDateStruct":311,"completionDateStruct":313,"leadSponsor":315,"locationsCount":317},"100617337","the-ntu-jo-smart-study-100617337","NCT07317310","The NTU JO-SMART Study","Effects of the NTU-JO Smart Program for People With Knee Osteoarthritis and Obesity: a Multicenter Pragmatic Randomized Controlled Trial","Inclusion Criteria:\n\n* Age: 18 to 75 years.\n* Obesity status: body mass index (BMI) ≥ 27 kg\u002Fm², consistent with the obesity definition defined by the Health Promotion Administration, Ministry of Health and Welfare, Taiwan.\n* Diagnosis of KOA in at least one knee according to the American College of Rheumatology (ACR) criteria, with a Kellgren-Lawrence (KL) grade of 1, 2, or 3.\n* Symptomatic disease: defined as a WOMAC pain subscale score (range 0-20) greater than 4 at screening.\n* Sedentary lifestyle: defined as less than 30 minutes of physical activity per week for the past 6 months.\n* Informed consent: willing and able to provide written informed consent and comply with all longitudinal study procedures.\n* Comorbid status: participants may be included regardless of a baseline diagnosis of T2D or CKD. Stratified randomization and subgroup analyses will be conducted based on these baseline conditions.\n\nExclusion Criteria:\n\n* KL grade 4 KOA in either knee.\n* Diagnosis of inflammatory arthritis, such as rheumatoid arthritis or psoriatic arthritis.\n* Knee arthroscopy within the past 3 months or previous surgical history of TKA.\n* Recent receipt of intra-articular injections (e.g., corticosteroids, hyaluronic acid) within the past 3 months.\n* Documented history of osteoporotic fracture in hospital or cloud-based medical records.\n* Type 1 diabetes.\n* Presence of conditions precluding safe participation in an exercise program, such as unstable cardiovascular disease or severe neurological disorders.\n* Participation in another interventional clinical trial within the past 3 months.\n* Engagement in dietary regimens likely to cause significant weight change (e.g., intermittent fasting, such as the 16:8 time-restricted eating) within 1 month prior to trial initiation.\n* Use of any FDA-approved weight-loss medications (e.g., semaglutide, tirzepatide) within 3 months prior to trial initiation.\n* History of any form of surgical treatment for weight loss.\n* Current use of lithium or antipsychotics at a dose equivalent to olanzapine \\>20 mg\u002Fday.\n* Pregnant or breastfeeding women, or women of childbearing potential without adequate contraception.\n* Current malignancy (within the validity period of a catastrophic illness certificate), or any other clinical condition deemed unsuitable for participation by the investigator (investigator discretion).\n* Inability to use smart devices or telecommunication tools due to severe visual\u002Fhearing impairment or lack of internet access.",{"count":298,"type":23},312,[64],"This study recruits patients with coexisting obesity and knee osteoarthritis (KOA) to implement the NTU-JO Smart Program, an innovative intervention integrating AI-assisted community-based exercise with continuous glucose monitoring (CGM). The primary objective is to investigate whether this intervention can improve glycemic control in this comorbid population. Other outcome measures include the risk of total knee arthroplasty (TKA), body weight changes, pain intensity scores, bone mineral density (BMD), cognitive function, as well as the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and Patient-Reported Outcomes Measurement Information System (PROMIS) scores, which reflect the patients' overall functional status. The project also sought to explore the long-term association of the NTU-JO Smart Program with the development of type 2 diabetes (T2D) and major renal events, thereby facilitating patient-centered early treatment.",[302,29,245,303],"Knee Osteoarthristis","Chronic Kidney Disease",[68,305,306,307,270,308],"Chronic kidney disease","Knee osteoarthristis","obesity","continuous glucose monitoring","2026-07-22",{"date":226,"type":42},{"date":312,"type":23},"2026-08-01",{"date":314,"type":23},"2035-07-31",{"name":316,"class":49},"National Taiwan University Hospital",2,{"id":319,"slug":320,"hasResults":12,"nctId":321,"briefTitle":322,"officialTitle":323,"acronym":4,"eligibilityCriteria":324,"healthyVolunteers":12,"sex":18,"minAge":325,"maxAge":326,"enrollmentInfo":327,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":329,"conditions":330,"keywords":4,"overallStatus":112,"whyStopped":4,"lastUpdateSubmitDate":333,"lastUpdatePostDateStruct":334,"startDateStruct":335,"completionDateStruct":337,"leadSponsor":339,"locationsCount":341},"100645041","minimed-fit-payload-wear-pediatric-study-100645041","NCT07675161","MiniMed Fit Payload Wear Pediatric Study","CIP361: MiniMed Fit Payload Wear Pediatric Study","Inclusion Criteria:\n\n* Participants with insulin-requiring diabetes\n* Participants 7-17 years of age\n* Participant and parent\u002Fguardian\u002Flegally authorized representative are able and willing to sign informed consent\u002Fassent\n\nExclusion Criteria:\n\n* Participants who report known skin sensitivity or allergy to polycarbonate or pressure-sensitive adhesives, e.g., medical device adhesives, band-aids, other acrylic-containing adhesives.\n* Participants with any skin condition in the area where device placement (e.g., irritation, rash, infection) could occur, per participant report.\n* Participants who are pregnant (per self-report) at initial screening. If a participant becomes pregnant during the study, the site will follow procedures for study withdrawal.","7 Years","17 Years",{"count":328,"type":23},100,"The purpose of this study is to assess MiniMed Fit Payload adhesive components in different wear locations over a 7-day period to support development of the future commercialized patch pump in participants 7-17 years of age.",[29,102,331,332],"Diabetes in Children","Diabetes in Adolescence","2026-07-20",{"date":309,"type":42},{"date":336,"type":42},"2026-06-25",{"date":338,"type":23},"2026-12",{"name":340,"class":86},"Medtronic MiniMed, Inc.",5,{"id":343,"slug":344,"hasResults":12,"nctId":345,"briefTitle":346,"officialTitle":347,"acronym":348,"eligibilityCriteria":349,"healthyVolunteers":17,"sex":18,"minAge":350,"maxAge":351,"enrollmentInfo":352,"targetDuration":4,"studyType":62,"phases":354,"briefSummary":355,"conditions":356,"keywords":359,"overallStatus":112,"whyStopped":4,"lastUpdateSubmitDate":368,"lastUpdatePostDateStruct":369,"startDateStruct":370,"completionDateStruct":372,"leadSponsor":374,"locationsCount":121},"100638053","evaluating-glucose-control-using-a-next-generation-aid-algorithm-in-individuals-with-t1d-100638053","NCT07593625","Evaluating Glucose Control Using a Next-Generation AID Algorithm in Individuals With T1D","Evaluation Glucose Control Using a Next-Generation Automated Insulin Delivery Algorithm in Individuals With Type 1 Diabetes: EVOLUTION T1D","EVOLUTIONT1D","Inclusion Criteria:\n\n* Age at time of consent 2-70 years (inclusive)\n* Type 1 diabetes diagnosis for at least 6 months, for those aged 8-70 years, or 3 months for those aged 2-7 years, based on Investigator assessment\n* Basal\u002FBolus insulin delivery via multiple daily injections or insulin pump with or without automation\n* Willing to use the following types of U-100 insulin during the study: Humalog U-100, Novorapid or their generic equivalents\n* Deemed appropriate for pump therapy per Investigator's assessment considering previous history of severe hypoglycemic and hyperglycemic events, and other comorbidities\n* If using noninsulin glucose-lowering medications or weight reduction medications, dose has been stable for 6-weeks prior to screening; and participant is willing to not change the dose unless required for safety purposes.\n* Investigator has confidence that the participant can safely operate all study devices and can adhere to the protocol\n* Willing to wear the system continuously throughout the study\n* Willing and able to sign the Informed Consent Form (ICF) or has a parent\u002Fguardian willing and able to sign the ICF. Assent will be obtained from participants per local regulatory requirements\n* Able to read and understand English\n* If of childbearing potential, willing and able to have pregnancy testing\n\nExclusion Criteria:\n\n* Any medical condition, which in the opinion of the Investigator, would put the participant at an unacceptable safety risk. This may include untreated malignancy, unstable cardiac disease, unstable or end-stage renal disease, unstable proliferative retinopathy, unstable psychiatric conditions such as eating disorders, drug or alcohol abuse.\n* Current or known history of coronary artery disease that is not stable with medical management, including unstable angina, or a history of myocardial infarction, percutaneous coronary intervention, coronary artery bypass grafting, or arrhythmias requiring intervention within the 12 months prior to screening\n* Any planned surgery during the study which could be considered major in the opinion of the Investigator\n* History of more than 1 severe hypoglycaemia in the past 6 months. Severe hypoglycaemia is defined as an event that requires the assistance of another person due to altered consciousness, and requires another person to actively administer carbohydrate, glucagon, or other resuscitative actions\n* History of more than 1 diabetic ketoacidosis (DKA) in the past 6 months, unrelated to an intercurrent illness; kinked, dislodged, or occluded cannula; or initial diabetes diagnosis Unable to tolerate adhesive tape or has any unresolved skin condition that could impact sensor or pump placement\n* Blood disorder or dyscrasia within 3 months prior to screening, which in the Investigator's opinion could interfere with determination of HbA1c\n* Use of hydroxyurea\n* Plans to receive blood transfusion over the course of the study\n* Has taken systemic corticosteroids (oral or injectable) within 4 weeks or has had a local steroid injection (intraarticular, epidural) within 1 week prior to screening or plans to take oral or injectable steroids during the study\n* Use of non-insulin glucose-lowering medication or weight loss medications other than metformin and\u002For GLP1, in the 4 weeks prior to screening. Participants taking metformin and\u002For GLP1 should remain on a steady dose without dose increases during study participation\n* Pregnant or lactating, or is of childbearing potential and not using an acceptable form of birth control (acceptable forms of contraception include abstinence, barrier methods such as condoms, hormonal contraceptives, intrauterine device, surgical sterilisation such as tubal ligation or hysterectomy, or vasectomised partner); childbearing potential means that menstruation has started, and the participant is not surgically sterile or greater than 12 months post-menopausal).\n* In the past 30-days, has participated in a clinical study using any investigational drug or any investigational device that in the opinion of the investigator may have therapeutic impact on their diabetes management. Additionally, may not intend to participate in any other interventional clinical study during this study period\n* Unable to follow clinical protocol for the duration of the study or is otherwise deemed unacceptable to participate in the study per the Investigator's clinical judgment\n* Participant is an employee of Insulet, an Investigator or a member of Investigator's study team, or immediate family member of any of the aforementioned","2 Years","70 Years",{"count":353,"type":23},80,[64],"Feasibility study to evaluate the safety and feasibility of Omnipod automated insulin delivery algorithms in individuals with type 1 diabetes. This study will enroll up to 80 participants to have a minimum of 48 participants to initiate the use of Omnipod. The study will include hotel and outpatient evaluation periods.",[357,358,29],"Type 1 Diabetes","Type 1 Diabetes Mellitus",[357,360,361,362,363,364,365,366,367],"T1D","Omnipod","Omnipod M","Automated Insulin Delivery System","AID","fully closed loop","FCL","Omnipod S","2026-07-17",{"date":333,"type":42},{"date":371,"type":42},"2026-05-25",{"date":373,"type":23},"2027-02-01",{"name":375,"class":86},"Insulet Corporation",{"id":377,"slug":378,"hasResults":12,"nctId":379,"briefTitle":380,"officialTitle":381,"acronym":382,"eligibilityCriteria":383,"healthyVolunteers":17,"sex":18,"minAge":163,"maxAge":4,"enrollmentInfo":384,"targetDuration":4,"studyType":62,"phases":385,"briefSummary":386,"conditions":387,"keywords":391,"overallStatus":112,"whyStopped":4,"lastUpdateSubmitDate":396,"lastUpdatePostDateStruct":397,"startDateStruct":399,"completionDateStruct":401,"leadSponsor":402,"locationsCount":121},"100635720","empowering-faith-based-communities-to-provide-personalized-diabetes-self-management-education-and-support-dsmes-in-the-magic-city-100635720","NCT07556354","Empowering Faith-based Communities to Provide Personalized Diabetes Self-management Education and Support (DSMES) in the Magic City","Empowering Faith-based Communities to Provide Personalized Diabetes Self-management Education and Support (DSMES) in the Magic City: A Pilot Study","MCPILOTDSMES","Inclusion Criteria:\n\n* Have a prior diabetes (Type 1, Type 2, or Gestational) or prediabetes diagnosis\n* Are aged 18 or older\n* Live in Jefferson County, Alabama\n* Have never participated in a DSMES program\n\nExclusion Criteria:\n\n* Not a resident of Jefferson County, Alabama\n* Completed a DSMES program",{"count":221,"type":23},[64],"In this study, individuals living with diabetes in the Birmingham area will participate in a free, 3-month DSMES program hosted by MedsPLUS Consulting, a local independent pharmacy and wellness center, at a local faith-based organization. DSMES sessions meet twice a month and typically address topics including physical activity, nutrition, coping, and reducing risk and complications. Prior to beginning the program, participants will complete a questionnaire that assesses diabetes self-management behaviors (such as diet, physical activity, and medication adherence) and diabetes knowledge. Additionally, they will participate in a biometric screening where clinical data such as blood A1C, blood pressure, blood cholesterol, and BMI are collected. This data will also be collected again after the completion of the program. In this program, participants will be assigned a community health worker who will contact them outside of scheduled DSMES sessions to provide support. Participants will also be randomly assigned to one of two cohorts, the Traditional cohort and the Remote Patient Monitoring (RPM) cohort. The traditional cohort will use paper trackers to track blood pressure and blood sugar outside of DSMES sessions while the RPM cohort will utilize an RPM platform to track this data.",[388,389,69,390,103,29],"Blood Cholesterol","Blood Pressure Monitoring","BMI",[392,393,394,395],"dsmes","diabetes education","faith based intervention","remote patient monitoring","2026-07-14",{"date":398,"type":42},"2026-07-15",{"date":400,"type":23},"2026-07",{"date":207,"type":23},{"name":403,"class":49},"University of Alabama at Birmingham",{"id":405,"slug":406,"hasResults":12,"nctId":407,"briefTitle":408,"officialTitle":409,"acronym":410,"eligibilityCriteria":411,"healthyVolunteers":12,"sex":18,"minAge":163,"maxAge":4,"enrollmentInfo":412,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":414,"conditions":415,"keywords":419,"overallStatus":112,"whyStopped":4,"lastUpdateSubmitDate":427,"lastUpdatePostDateStruct":428,"startDateStruct":429,"completionDateStruct":431,"leadSponsor":432,"locationsCount":121},"100624978","validation-of-hemoglobin-a1c-in-patients-with-inflammatory-arthritis-treated-with-sulfasalazine-100624978","NCT07416656","Validation of Hemoglobin A1c in Patients With Inflammatory Arthritis Treated With Sulfasalazine","How Can We Prevent the Underdiagnosis of Diabetes and the Undertreatment of Known Diabetes in Patients With Inflammatory Arthritis Treated With Sulfasalazine?","DIA2SULFA","Inclusion Criteria:\n\n* Age ≥18 years\n* Treatment with sulfasalazine for at least 2 months prior to inclusion\n* Inflammatory arthritis diagnosis (Reumatoid Arthritis, Reaktive Arthritis, Axial spa, Psoriatic spondylitis, and Juvenil artrit)\n* HbA1c ≥38 mmol\u002Fmol obtained at least 2 months after sulfasalazine initiation OR a diabetes mellitus diagnosis (Type 1 diabetes mellitus, Type 2 diabetes mellitus, Malnutrition-related diabetes mellitus, Other specified diabetes mellitus (andre specificerede former for diabetes), and Unspecified diabetes mellitus (uspecificeret diabetes))\n* Can communicate in Danish\n* Informed consent including permission to upload glucose data and study ID to the Libreview Platform.\n\nExclusion Criteria:\n\n* Systemic treatment or local injections with glucocorticoids within the previous 2 months or planned within the following 4 weeks\n* Clinical conditions interfering with the interpretation of HbA1c expect for sulfasalazine alterations in red cell lifespan (etc. Dapson treatment)\n* Allergy towards the adhesive used in the CGM\n* Considered ineligible for participating (e.g. patients without decision-making capacity, , malignancy, terminal illness, ect.)",{"count":413,"type":23},75,"The purpose of this study is to examine whether the blood test Hemoglobin A1c (HbA1c) gives an accurate picture of blood glucose levels in patients with inflammatory arthritis who are treated with sulfasalazine. HbA1c is widely used to diagnose and monitor diabetes, but sulfasalazine can shorten red blood cell lifespan and thereby lower HbA1c values independently of actual glucose levels.\n\nThis may lead to underdiagnosis of diabetes in patients who develop diabetes during sulfasalazine treatment, and to undertreatment in patients with known diabetes due to falsely reassuring HbA1c values.\n\nThe study aims to answer two main questions:\n\n1. How many patients treated with sulfasalazine have undiagnosed diabetes despite having HbA1c values below the diagnostic threshold?\n2. Does HbA1c underestimate actual glucose levels when compared with continuous glucose monitoring (CGM) in patients with sulfasalazine-treated inflammatory arthritis, both in those with known diabetes and those that are not diagnosed with diabetes but have borderline HbA1c values (≥ 38 mmol\u002Fmol)?",[416,29,417,358,418],"Inflammatory Arthritis","Rheumatoid Arthritis (RA)","Type 2 Diabetes (T2DM)",[420,421,422,423,111,225,68,424,425,357,426],"Validation of HbA1c","Sulfasalazine","Salazopyrin","Continuous glucose monitoring","Hemoglobin A1c","HbA1c","Fasting blood glucose","2026-06-22",{"date":336,"type":42},{"date":430,"type":42},"2026-03-10",{"date":207,"type":23},{"name":433,"class":49},"Klavs Würgler Hansen",{"id":435,"slug":436,"hasResults":12,"nctId":437,"briefTitle":438,"officialTitle":439,"acronym":4,"eligibilityCriteria":440,"healthyVolunteers":12,"sex":18,"minAge":441,"maxAge":442,"enrollmentInfo":443,"targetDuration":4,"studyType":62,"phases":445,"briefSummary":446,"conditions":447,"keywords":450,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":454,"lastUpdatePostDateStruct":455,"startDateStruct":457,"completionDateStruct":459,"leadSponsor":461,"locationsCount":4},"100614494","moxie-self-management-and-education-support-program-100614494","NCT07280325","Moxie Self-Management and Education Support Program","Moxie: A Self-management Education and Support Program Using Advertising Principles to Reduce Rehospitalization for Cardiovascular-related Illnesses","Inclusion Criteria:\n\nEligible participants will be adults aged 40-85 years who are being discharged to their home from general internal medicine or family medicine inpatient services (hospitalist) in one of 10 Alberta acute care facilities, whose admitting diagnosis was diabetes, coronary artery disease, heart failure, chronic kidney disease, or hypertension (see appendix for list of inclusion diagnoses).\n\nExclusion Criteria:\n\nIndividuals who live at the same address\u002Fhousehold as a person who is already in the study and\u002For those discharged from hospitals to continuing care facilities, rehabilitation facilities or another hospital will not be eligible to take part in the study. Individuals whose goals of care at the time of discharge from acute care were oriented towards comfort (i.e. C1 or C2 Goals of Care) will not be eligible to take part in the study. Individuals with markers indicating lack of competency\u002Fcapacity in their inpatient ConnectCare record such as anything but full capacity on the medical record (i.e. \"incapacitated\" or \"needs review\"), or presence of an alternative decision maker, agent, or legal guardian listed on the medical record.","40 Years","85 Years",{"count":444,"type":23},9000,[64],"Health education and self-management support are key facilitators of health behaviours. Moxie is a mixed media, self-management, education and support program for Albertans living with cardiovascular-related chronic conditions. Moxie is built upon our previous work within the ACCESS study (2015-21, n=4761), a RCT that previously tested the Moxie intervention in Alberta. Results demonstrated that MOXIE reduced the rate of hospitalizations (notably for hypertension, angina, hyper\u002Fhypoglycemia, heart failure decompensation, and acute kidney complications) by 34% in a population of low-income seniors living with cardiovascular-related chronic conditions.\n\nHowever, before Moxie can be effectively implemented province-wide, another trial is necessary to determine whether benefits can be observed in a larger cohort of patients with cardiovascular-related chronic conditions recruited immediately after hospital discharge (n=9000). Furthermore, the effectiveness of the two components of the ACCESS trial intervention will be assessed individually:\n\n(a) The Moxie Program, a tailored health and disease education component developed by a user-experience-centric design process incorporating patients, behavioural scientists, disease specialists, health system administrators and marketing\u002Fadvertising professionals; and (b) the facilitated relay of clinical information to healthcare providers (letters).\n\nThe trial is designed as a 2x2 factorial pragmatic, individual-level randomized pragmatic trial of these different interventions. This would yield the following groups:\n\n1. Moxie SMES Program\n2. Facilitated Relay\n3. Moxie SMES Program and Facilitated Relay\n4. True control\n\nSelf-management education and support (SMES) intervention: This includes weekly physical mailers sent directly to patients' homes throughout the study containing information about chronic conditions, medication use, diet, physical activity, smoking cessation, and self-management\u002Fwellness principles. These messages will be refined by the social impact creative design partner and reviewed by clinicians and patients to ensure clinical safety and appropriate tone. Weekly mailers will encourage participants to enroll and consent to participate in the digital program by scanning a QR code or accessing a website where they will sign up for their own personalized Moxie mobile health app, complete a digital consent form and opt-in for electronic delivery of Moxie messages.\n\nFacilitated relay intervention: Participants allocated to this intervention will receive letters by mail, one addressed to them, one to their primary care provider, and one to their pharmacist. The letters will not be sent to their primary care provider directly; rather, they will be sent to patients who will be encouraged to take them to their primary care provider and pharmacist should they decide to do so. We hope this will empower patients to start discussions with their healthcare providers. This also supports patient autonomy by enabling patients to decide whether they want to take them to their provider or not. If for whatever reason they do not feel that this is going to be beneficial or of interest, they are not required to do so. The letter would contain a note to the patient's healthcare provider stating that their patient is at-risk of cardiovascular disease and that evidence has shown that the pharmacotherapy is effective in improving outcomes for patients similar to the participant.\n\nThe primary outcome is readmission for cardiovascular-specific ambulatory care-sensitive conditions (ACSC) based on the most responsible diagnosis listed in CIHI Discharge Abstract Database-(DAD), using established algorithms within 12 months from randomization. This outcome includes all repeat admissions in the study period as recorded in the health record. This outcome is a count variable. We will calculate and compare each intervention arm's mean number and distribution of hospitalizations.",[303,29,448,27,449],"Heart Disease","Chronic Disease",[451,452,453],"Chronic Disease Self-Management","Pragmatic Trial","Chronic Disease Education","2026-05-08",{"date":456,"type":42},"2026-05-11",{"date":458,"type":23},"2026-06-01",{"date":460,"type":23},"2029-12-31",{"name":462,"class":49},"University of Calgary",{"id":464,"slug":465,"hasResults":12,"nctId":466,"briefTitle":467,"officialTitle":468,"acronym":469,"eligibilityCriteria":470,"healthyVolunteers":12,"sex":18,"minAge":163,"maxAge":4,"enrollmentInfo":471,"targetDuration":472,"studyType":24,"phases":4,"briefSummary":473,"conditions":474,"keywords":487,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":509,"lastUpdatePostDateStruct":510,"startDateStruct":512,"completionDateStruct":514,"leadSponsor":516,"locationsCount":121},"100636568","cartiz-registry-cartilage-arthropathy-and-imaging-under-tirzepatide-in-zone-stratified-cohorts---a-four-institute-mexican-observational-registry-100636568","NCT07567378","CARTIZ Registry: Cartilage, Arthropathy and Imaging Under Tirzepatide in Zone-stratified Cohorts - A Four-Institute Mexican Observational Registry","Cartilage, Arthropathy and Imaging Under Tirzepatide in Zone-stratified Cohorts (CARTIZ): A Prospective Observational Multi-Institutional Registry of the VAT-Articular-Cardiac-Aging Axis in Adults Exposed to Tirzepatide in Mexico, With Quantitative Knee Cartilage T2 Mapping, Cardiac CT Epicardial Adipose Tissue Radiomic Phenotyping, HLA Stratification, Longitudinal Multi-Frequency Bioimpedance Body Composition, and a Prespecified Surgical Tissue Acquisition Subcohort","CARTIZ","Inclusion Criteria:\n\n* 1\\. Age ≥18 years at the time of informed consent. 2. Currently receiving tirzepatide under an independent clinical indication (type 2 diabetes, insulin resistance, obesity with or without associated metabolic disease, renal protection, metabolic hypertension, or associated off-label metabolic use) prescribed by the treating physician independently of the registry.\n\n  3\\. Presence of at least one objectively documented musculoskeletal manifestation - current or historical - defined as any of: (i) inflammatory arthralgia affecting one or more joints with clinical, imaging, or serological support; (ii) CASPAR-positive psoriatic arthritis; (iii) radiographically documented knee osteoarthritis; (iv) enthesitis on physical examination or ultrasound; (v) documented inflammatory arthropathy of the spine or peripheral joints with a specialist diagnosis.\n\n  4\\. For the retrospective-prospective component: availability of clinical documentation of articular state prior to tirzepatide initiation in the patient's medical record. Documentation may include physical examination notes, imaging, laboratory values, or specialist consultation notes.\n\n  5\\. Signed informed consent for registry enrolment, longitudinal serum biobanking, HLA typing at INCMNSZ, quantitative knee MRI with T2 mapping at Ci3M UAM-Iztapalapa at Week 0 and Week 52, non-contrast cardiac CT at INCar at Week 0 and Week 52, multi-frequency bioelectrical impedance analysis at Universidad La Salle México at six timepoints, and (where applicable) medical record review. Each attestation is consented modularly within a single document.\n\n  6\\. Clinical plan to continue tirzepatide for at least 52 weeks from registry Week 0, based on the treating physician's evaluation of current clinical indication. Discontinuation during follow-up is captured as an outcome variable and does not remove the patient from the registry.\n\n  7\\. Capacity to attend scheduled follow-up visits and to undergo bilateral knee MRI at Ci3M (without severe claustrophobia requiring sedation, without absolute contraindication to MRI - see Exclusion 6) and non-contrast cardiac CT at INCar (without uncontrolled arrhythmia precluding ECG-gated imaging of diagnostic quality).\n\nFor the Surgical Tissue Subcohort (Cohort 3) only - additional criteria applied at the time of subcohort enrolment:\n\n8s. Scheduled clinically indicated cardiac surgery at the Instituto Nacional de Cardiología Ignacio Chávez (coronary artery bypass grafting, valve replacement, or combined procedures) during registry follow-up.\n\n9s. Specific additional informed consent for intraoperative collection of epicardial adipose tissue fragments.\n\nExclusion Criteria:\n\n* 1\\. Initiation or modification of a biologic disease-modifying antirheumatic drug (biologic DMARD) or JAK inhibitor within the 12 weeks prior to Week 0, or clinically anticipated initiation or modification during the first 12 weeks of follow-up. Washout may permit re-screening.\n\n  2\\. Major joint surgery within the 3 months prior to Week 0, or planned major joint surgery within the 12 months following Week 0, involving any joint scheduled for evaluation in the registry.\n\n  3\\. Intra-articular corticosteroid or hyaluronic acid injection within the 6 weeks prior to baseline biospecimen collection in any joint. Patients beyond the 6-week washout are eligible.\n\n  4\\. Active malignancy, with the exception of adequately treated non-melanoma skin carcinoma. History of malignancy in remission ≥5 years is permitted at the discretion of the treating investigator.\n\n  5\\. Current pregnancy, lactation, or planned pregnancy within the 12-month observation period.\n\n  6\\. Absolute contraindication to MRI, including non-MRI-compatible cardiac pacemaker or implanted defibrillator, ferromagnetic intracranial vascular clips, non-documented non-MRI-compatible cochlear implants, or other contraindication per the local MRI safety protocol.\n\n  7\\. Systemic rheumatologic disease other than psoriatic arthritis or osteoarthritis requiring active immunomodulation, specifically: seropositive rheumatoid arthritis on biologic therapy, active systemic lupus erythematosus on immunomodulation, active vasculitis on immunosuppression, or other systemic disease whose treatment confounds the inflammatory axis the registry is designed to characterize.\n\n  8\\. Inability to provide informed consent (cognitive impairment, language barrier not resolvable with site interpreter, or other incapacity to understand the protocol), or anticipated inability to complete the 52-week follow-up.\n\nFor the Surgical Tissue Subcohort (Cohort 3) only - additional exclusions:\n\n9s. Prior major cardiac surgery resulting in extensive pericardial adhesions that preclude safe intraoperative EAT fragment collection, as assessed by the operating cardiac surgeon.\n\n10s. Emergency cardiac surgery precluding the specific informed consent process.",{"count":221,"type":23},"52 Weeks","CARTIZ is a prospective observational clinical registry of adults in Mexico receiving tirzepatide (a dual GLP-1\u002FGIP receptor agonist) under an independent clinical indication - typically type 2 diabetes, insulin resistance, obesity, renal protection, metabolic hypertension, or associated off-label metabolic use. The registry is entirely observational: CARTIZ does not initiate, modify, interrupt, or supply tirzepatide, and does not dictate dose, route, or duration. All pharmacological exposure decisions are made by the treating physician independently of study participation. The registry is operationalized through a four-institute architecture integrating three Mexican National Institutes of Health and one national imaging laboratory. Core 1 (Knee Cartilage Imaging, Ci3M UAM-Iztapalapa) performs bilateral 3T MRI with quantitative T2 mapping at Week 0 and Week 52. Core 2 (Cardiac Imaging, Instituto Nacional de Cardiología Ignacio Chávez) performs non-contrast cardiac computed tomography for radiomic phenotyping of epicardial adipose tissue at Week 0 and Week 52 under cardiovascular Co-Principal Investigator Dr. Erick Alexánderson Rosas. Core 3 (HLA Typing, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Transplant Department) performs Class I and Class II HLA typing by PCR-SSO Reverse Luminex. Core 4 (Body Composition, Universidad La Salle México) performs multi-frequency bioelectrical impedance analysis (seca mBCA) at six longitudinal timepoints capturing visceral adipose tissue trajectory, phase-angle trajectory, appendicular skeletal muscle mass, and hydration ratios at zero marginal cost. The registry enrolls n=30 patients across three clinical sites with identical protocol (IMSS Clínica Río Magdalena, INCMNSZ outpatient clinic, and a private practice site in Mexico City), generating 60 evaluable knees and 30 paired cardiac CT studies. The primary co-endpoints address a mechanistic question no other tirzepatide study is positioned to answer: whether the articular response to tirzepatide in inflammatory arthropathy precedes and mechanistically precedes weight loss, through formal mediation analysis of Week-4 ACR20 response via high-sensitivity C-reactive protein, SERPINB2, and dipeptidyl peptidase-4 activity, restricted to the Mechanistic Analysis Set of patients with tirzepatide exposure ≤16 weeks at Week 0 and delta-BMI \\\u003C1.0 kg\u002Fm² through Week 4. A prespecified Surgical Tissue Subcohort is declared at initial registration to establish public scientific priority on direct human epicardial adipose tissue transcriptomic characterization under dual GIP\u002FGLP-1 receptor agonism. Subcohort participants who undergo clinically indicated cardiac surgery at INCar during follow-up (coronary artery bypass grafting, valve replacement, or combined procedures) are invited to provide specific additional informed consent for collection of epicardial adipose tissue fragments routinely excised during operative access and otherwise discarded as surgical waste. Operational launch is contingent on separate INCar tissue-specific approvals and will proceed via PRS record amendment when ready",[475,476,477,29,106,478,479,480,481,482,483,484,485,263,486],"Psoriatic Arthritis","Osteoarthitis","Knee","Obesity (Disorder)","Insulin Resistance Syndrome","Metabolic Syndrome","Heart Failure","Preserved Ejection Fraction","Coronary Artery Disease","Atrial Fibrillation (AF)","Non Alcholic Fatty Liver Disease","Pericardium",[252,488,489,490,491,492,493,494,495,496,497,498,499,500,501,502,503,504,505,506,507,508],"Dual GIP\u002FGLP-1 receptor agonist","Multi-nutrient-stimulated hormones","Psoriatic arthritis","Inflammatory arthropathy","ACR20","Cartilage T2 mapping","Quantitative knee MRI","Epicardial adipose tissue","Cardiac CT radiomics","Fat Attenuation Index","HLA typing","Visceral adipose tissue","Phase angle","seca mBCA","Bioelectrical impedance analysis","Mediation analysis","Weight-independent effect","Off-label exposure","Mexican registry","Epicardial adipose transcriptomics","Single-nucleus RNA sequencing","2026-05-07",{"date":511,"type":42},"2026-05-12",{"date":513,"type":23},"2026-05",{"date":515,"type":23},"2029-05",{"name":517,"class":49},"JULIO GRANADOS MONTIEL",{"id":519,"slug":520,"hasResults":12,"nctId":521,"briefTitle":522,"officialTitle":522,"acronym":4,"eligibilityCriteria":523,"healthyVolunteers":12,"sex":18,"minAge":163,"maxAge":524,"enrollmentInfo":525,"targetDuration":4,"studyType":62,"phases":527,"briefSummary":528,"conditions":529,"keywords":530,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":532,"lastUpdatePostDateStruct":533,"startDateStruct":535,"completionDateStruct":537,"leadSponsor":539,"locationsCount":121},"100609994","continuous-glucose-monitors-cgms-and-readmission-rates-100609994","NCT07221812","Continuous Glucose Monitors (CGMs) and Readmission Rates","Inclusion Criteria:\n\n1. ≥18 years of age\n2. Patients with diabetes who are anticipated to be treated with any type of insulin after hospital discharge and with or without non-insulin medications (excluding those who are expected to be treated with correctional-sliding scale insulin regimens only\n3. Uncontrolled glycemic control, defined as hyperglycemia with HbA1c ≥8%\n\nExclusion Criteria:\n\n1. Patients with diabetes who are anticipated to be treated with diet only, any combination of non-insulin antidiabetic drugs only, sliding scale correctional insulins (with or without non-insulin medications) after hospital discharge.\n2. Patients at the time of screening on insulin pumps or CGMs\n3. Pregnant patients\n4. Patients with extensive skin disease or allergies that preclude wearing the CGM sensor\n5. Patients without current access of (or who are unable to obtain) a smartphone device and internet\n6. Patients who have end-stage renal disease requiring dialysis\n7. Patients with significant psychiatric illness or any other condition which by investigator decision makes the subject incapable of understanding the objectives and potential consequences of the study\n8. taking hydroxyurea\n9. Employed by, or having immediate family members employed by Dexcom, or having a direct supervisor at place of employment who is also directly involved in conducting the clinical trial (as a study investigator, coordinator, etc.); or having a first-degree relative who is directly involved in conducting the clinical trial","90 Years",{"count":526,"type":23},120,[64],"Among the diffident groups of patients, those with chronic and severe medical conditions are more likely to be readmitted to the hospital. It is not surprising therefore that patients with diabetes have high readmission rates. Patients with diabetes have 40% higher re-hospitalization rates compared with those patients without diabetes, with 30-day readmission rates reported to range between 14% and 26%. It should be noted that almost 30% of the patients with diabetes are experiencing two or more hospital admissions per year, accounting for more than 50% of total hospitalizations and hospital health care costs. This research application will evaluate whether the initiation of Continuous Glucose Monitor (CGM) devices at the time of hospital discharge will lead to better glucose control and health outcomes compared to the use of \"finger sticks\" Point of Care (POC) following hospital discharge among patients with diabetes. This study will be a two arm (Real Time CGM vs POC) single center RCT at the Baltimore VA Medical Center. One hundred and twenty individuals will be recruited and randomly assigned (1:1) to either Real Time CGM or to POC following hospital discharge. All subjects will be followed from for 3 months post hospital discharge.",[29],[531],"Continuous Glucose Monitors","2026-04-27",{"date":534,"type":42},"2026-04-29",{"date":536,"type":23},"2026-06-18",{"date":538,"type":23},"2028-06-17",{"name":540,"class":49},"University of Maryland, Baltimore",{"id":542,"slug":543,"hasResults":12,"nctId":544,"briefTitle":545,"officialTitle":546,"acronym":4,"eligibilityCriteria":547,"healthyVolunteers":17,"sex":18,"minAge":130,"maxAge":4,"enrollmentInfo":548,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":549,"conditions":550,"keywords":555,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":563,"lastUpdatePostDateStruct":564,"startDateStruct":566,"completionDateStruct":568,"leadSponsor":570,"locationsCount":121},"100631593","validation-of-remote-photoplethysmography-rppg-derived-cardiovascular-parameters-against-standard-clinical-measurements-and-risk-scores-in-a-community-100631593","NCT07502703","Validation of Remote Photoplethysmography (rPPG)-Derived Cardiovascular Parameters Against Standard Clinical Measurements and Risk Scores in a Community","Validation of Remote Photoplethysmography (rPPG)-Derived Cardiovascular Parameters Against Standard Clinical Measurements and Risk Scores in a Community-Based Population in Semanan, Jakarta","Inclusion Criteria:\n\n1. Adults aged ≥30 years\n2. Willing to participate and provide informed consent\n3. Able to undergo face scan, clinical examination, and laboratory testing\n\nExclusion Criteria:\n\n1. Facial abnormalities interfering with rPPG signal acquisition\n2. Inability to remain still during measurement\n3. Severe clinical instability\n4. Incomplete key variables",{"count":241,"type":23},"The goal of this observational study is to evaluate whether a contactless camera-based technology, called remote photoplethysmography (rPPG), can accurately measure cardiovascular parameters and estimate cardiovascular risk in adults aged 30 years and older living in a community setting in Semanan, Jakarta. This study aims to determine if rPPG can be used as a simple and accessible tool for early cardiovascular screening.\n\nThe main questions it aims to answer are:\n\n1. Do cardiovascular parameters measured using rPPG (such as blood pressure, heart rate, and cardiac workload) agree with standard clinical measurements?\n2. Do cardiovascular risk estimates generated by rPPG (such as ASCVD risk and Framingham heart age) correspond to risk calculations obtained using conventional clinical and laboratory methods?\n\nResearchers will compare results obtained from rPPG-based facial video scans with results from standard medical assessments, including blood pressure measurements, heart rate evaluation, and laboratory tests for cholesterol levels, to determine the level of agreement and accuracy.\n\nParticipants will:\n\n1. Undergo a short facial video scan (approximately 30-60 seconds) using an rPPG-based system\n2. Receive standard clinical assessments, including blood pressure and heart rate measurements\n3. Provide basic health information (such as age, sex, smoking status, and treatment history) Undergo simple laboratory testing for cholesterol levels\n\nThis study is expected to help determine whether rPPG can be used as a reliable, non-invasive, and scalable screening tool for cardiovascular risk in community and primary healthcare settings.",[551,552,553,448,554,29],"Dyslipidemia","Angina (Stable)","Coronary Artery Disease (CAD)","Hypertension",[556,557,558,559,560,561,562],"remote photoplethysmography","rPPG","cardiovascular risk","ASCVD","Framingham score","digital health","screening tool","2026-04-15",{"date":565,"type":42},"2026-04-20",{"date":567,"type":23},"2026-04-23",{"date":569,"type":23},"2026-12-30",{"name":571,"class":49},"Tarumanagara University",{"id":573,"slug":574,"hasResults":12,"nctId":575,"briefTitle":576,"officialTitle":577,"acronym":4,"eligibilityCriteria":578,"healthyVolunteers":17,"sex":18,"minAge":163,"maxAge":4,"enrollmentInfo":579,"targetDuration":242,"studyType":24,"phases":4,"briefSummary":581,"conditions":582,"keywords":591,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":563,"lastUpdatePostDateStruct":599,"startDateStruct":600,"completionDateStruct":602,"leadSponsor":604,"locationsCount":4},"100630769","development-and-multicenter-validation-of-an-ai-based-remote-photoplethysmography-rppg-facial-scan-for-multimodal-health-assessment-100630769","NCT07491978","Development and Multicenter Validation of an AI-Based Remote Photoplethysmography (rPPG) Facial Scan for Multimodal Health Assessment","Development and Multicenter Validation of an AI-Based Remote Photoplethysmography (rPPG) Facial Scan for Multimodal Health Assessment: Agreement With Clinical, Laboratory, and Psychological Parameters in an Urban Population","Inclusion Criteria:\n\n1. Adults aged ≥18 years.\n2. Able and willing to provide written informed consent.\n3. Able to comply with study procedures, including face scan, physical examination, blood sampling, and questionnaire completion.\n4. Clinically stable at the time of assessment.\n\nExclusion Criteria:\n\n1. Facial conditions affecting the region of interest (ROI), such as injury, deformity, or impaired circulation, that may interfere with rPPG signal acquisition.\n2. Presence of facial tattoos or coverings that obstruct optical signal detection.\n3. Inability to remain still or comply with measurement procedures during data acquisition.\n4. Severe medical conditions that preclude safe participation, as judged by the investigator.\n5. Incomplete data or withdrawal of consent during the study.\n\n   \\-",{"count":580,"type":23},1000,"The goal of this observational study is to learn if a non-contact facial scan using artificial intelligence (AI) can be used to check health status in adults living in urban areas such as Jakarta. The facial scan uses a method called remote photoplethysmography (rPPG), which measures small changes in blood flow from the face using a camera.\n\nThe main questions this study aims to answer are:\n\n1. How close are the results from the facial scan to standard medical measurements, such as heart rate, breathing rate, blood pressure, and oxygen levels?\n2. Can the facial scan estimate other health indicators, such as blood sugar, lipid profile, HbA1c, and hemoglobin levels?\n3. Is there a relationship between the facial scan results and mental health, such as stress, anxiety, and depression?\n\nParticipants will take part in several simple and mostly non-invasive procedures:\n\n1. Answer questionnaires about their mental health and daily habits\n2. Have basic health checks, such as blood pressure, heart rate, and body measurements\n3. Provide a blood sample for laboratory testing\n4. Complete a facial scan using a camera for about 1 to 3 minutes\n\nResearchers will compare the results from the facial scan with standard clinical and laboratory tests to see how well the technology works.\n\nThis study may help develop a simple and accessible screening tool that can be used for early detection of health risks. It may also support the use of digital health and telemedicine in community and clinical settings.",[480,554,29,583,559,584,585,586,245,587,588,589,590],"Tachycardia","Depression Disorder","Anxiety","Stress (Psychology)","Cardiometabolic Risk Factors","Cardiometabolic Health Indicators","Sleep","Wellness",[556,557,592,593,594,595,596,597,598,562],"artificial intelligence","digital biomarker","telemedicine","vital signs","cardiometabolic risk","machine learning","facial scan",{"date":565,"type":42},{"date":601,"type":23},"2026-04-24",{"date":603,"type":23},"2027-03-30",{"name":571,"class":49},{"id":606,"slug":607,"hasResults":12,"nctId":608,"briefTitle":609,"officialTitle":610,"acronym":4,"eligibilityCriteria":611,"healthyVolunteers":17,"sex":18,"minAge":163,"maxAge":4,"enrollmentInfo":612,"targetDuration":4,"studyType":62,"phases":613,"briefSummary":614,"conditions":615,"keywords":618,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":624,"lastUpdatePostDateStruct":625,"startDateStruct":627,"completionDateStruct":629,"leadSponsor":630,"locationsCount":121},"100625534","effect-of-a-low-calorie-mct-rich-traditional-minangkabau-diet-on-obese-individuals-100625534","NCT07423884","Effect of a Low-Calorie MCT-Rich Traditional Minangkabau Diet on Obese Individuals","The Effect of a Low-Calorie Diet Rich in Medium-Chain Triglycerides Based on Traditional Minangkabau Foods on Lipid Profile, Leptin Levels, and DNA Methylation of the Leptin Gene Promoter in Individuals With Obesity","Inclusion Criteria:\n\n* Administrative staff of the Faculty of Medicine and the Faculty of Public Health, Andalas University, Padang, with obesity defined as a body mass index (BMI) ≥ 25 kg\u002Fm².\n* Willing to participate in the study by providing written informed consent.\n* Participants with obesity classified as Metabolically Unhealthy Obese (MUHO)\n\nExclusion Criteria:\n\n* Did not come and could not be found at the time of research data collection\n* Unable to follow the dietary arrangements as set\n* Taking anti-diabetic or anti-lipid drugs\n* Use of contraceptives or hormonal drugs\n* In the treatment of radiotherapy or chemotherapyi\n* Participants with obesity classified as Metabolically Healthy Obese (MHO)",{"count":165,"type":23},[64],"This study aims to investigate the effect of a low-calorie diet rich in medium-chain triglycerides (MCTs) based on traditional Minangkabau foods on metabolic biomarkers in individuals with obesity. The traditional Minangkabau foods used in this study consist primarily of coconut milk-based dishes, which contain coconut oil as a natural source of MCTs. The metabolic biomarkers assessed include body mass index (BMI), waist circumference, systolic and diastolic blood pressure, body fat percentage, fasting blood glucose levels, lipid profile, leptin concentrations, and DNA methylation of the leptin gene promoter. Based on these metabolic biomarker measurements, participants will be classified into metabolic obesity phenotypes, namely metabolically healthy obesity (MHO) and metabolically unhealthy obesity (MUHO). The researchers hypothesize that the provision of a low-calorie, MCT-rich diet based on traditional Minangkabau foods will have a significant effect on metabolic biomarkers and metabolic status in individuals with obesity.",[616,551,29,617,141],"Metabolically Unhealty Obese","Resistance, Insulin",[619,620,621,622,623],"Low-calorie diet rich in medium-chain triglycerides","Traditional Minangkabau foods","Coconut oil","Metabolic biomarkers","Anthropometric parameters","2026-04-08",{"date":626,"type":42},"2026-04-13",{"date":628,"type":23},"2026-04",{"date":400,"type":23},{"name":631,"class":49},"Andalas University",{"id":633,"slug":634,"hasResults":12,"nctId":635,"briefTitle":636,"officialTitle":637,"acronym":638,"eligibilityCriteria":639,"healthyVolunteers":12,"sex":18,"minAge":163,"maxAge":4,"enrollmentInfo":640,"targetDuration":4,"studyType":62,"phases":642,"briefSummary":643,"conditions":644,"keywords":645,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":650,"lastUpdatePostDateStruct":651,"startDateStruct":652,"completionDateStruct":653,"leadSponsor":655,"locationsCount":121},"100632591","digital-discharge-planning-to-improve-self-management-in-patients-with-diabetes-mellitus-100632591","NCT07515677","Digital Discharge Planning to Improve Self-Management in Patients With Diabetes Mellitus","Effectiveness of a Digital Discharge Planning Intervention to Improve Self-Management in Patients With Diabetes Mellitus: A Randomized Controlled Trial","DDP-DM","Inclusion Criteria:\n\n* Patients diagnosed with diabetes mellitus.\n* Age 18 years or older.\n* Hospitalized patients who are preparing for discharge.\n* Able to use a smartphone and access the mobile application.\n* Willing to participate and provide informed consent.\n\nExclusion Criteria:\n\n* Patients with severe complications requiring intensive care.\n* Patients with cognitive impairment or severe mental illness that may interfere with participation.\n* Patients who are unable to operate a smartphone or mobile application.\n* Patients who decline to participate in the study.",{"count":641,"type":23},78,[64],"Diabetes mellitus is a chronic disease that requires continuous self-management to prevent complications and hospital readmissions. However, discharge planning in many hospitals is often delivered verbally and lacks structured follow-up after patients return home, which may lead to poor self-management behaviors.\n\nThis study aims to evaluate the effectiveness of a digital discharge planning intervention delivered through a mobile application to improve self-management among patients with diabetes mellitus after hospital discharge. The intervention is based on the Chronic Care Model and includes educational materials, reminders, and monitoring tools related to seven dimensions of diabetes self-management.\n\nA randomized controlled trial with a parallel-group design will be conducted among patients with diabetes mellitus. Participants in the intervention group will receive digital discharge planning through a mobile application for 90 days after discharge, while the control group will receive standard discharge planning provided by the hospital. Primary outcomes include patient self-management behavior, while secondary outcomes include glycemic control and hospital readmission within 90 days.",[29],[646,647,648,649],"Diabetes Self-Management","Digital Health Intervention","Discharge Planning","Mobile Health","2026-04-06",{"date":626,"type":42},{"date":563,"type":23},{"date":654,"type":23},"2026-11-30",{"name":656,"class":49},"Universitas Muhammadiyah Surakarta",{"id":658,"slug":659,"hasResults":12,"nctId":660,"briefTitle":661,"officialTitle":662,"acronym":663,"eligibilityCriteria":664,"healthyVolunteers":12,"sex":18,"minAge":163,"maxAge":4,"enrollmentInfo":665,"targetDuration":4,"studyType":62,"phases":667,"briefSummary":668,"conditions":669,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":672,"lastUpdatePostDateStruct":673,"startDateStruct":674,"completionDateStruct":675,"leadSponsor":677,"locationsCount":4},"100632225","cgm-in-acute-ischemic-stroke-100632225","NCT07510919","CGM in Acute Ischemic Stroke","Continuous Glucose Monitoring for Enhanced Management of Hyperglycemia in Persons With Type 2 Diabetes Undergoing Endovascular Therapy for Acute Ischemic Stroke: a Randomized Controlled Trial.","SENSTROKE","Inclusion Criteria:\n\n* Age ≥18 years\n* Acute ischemic stroke treated with endovascular therapy (EVT)\n* Type 2 diabetes mellitus, defined as one of the following:\n* documented diagnosis of type 2 diabetes mellitus\n* use of glucose-lowering medication\n* admission plasma glucose ≥11.1 mmol\u002FL\n* HbA1c ≥48 mmol\u002Fmol (≥6.5%)\n\nExclusion Criteria:\n\n* Current pregnancy\n* Extensive skin infections or dermatological conditions at the intended sensor site\n* Medical situations known to interfere with CGM accuracy, including:\n* Hypotension defined as a systolic blood pressure \\\u003C100 mmHg at 30 and 60 minutes after admission\n* Dialysis treatment\n* Estimated glomerular filtration rate (eGFR) \\\u003C15 mL\u002Fmin\u002F1.73 m²\n* Use of medications known to interfere with CGM accuracy, including:\n* Acetaminophen \\>4 g\u002Fday\n* Dopamine\n* High-dose vitamin C (ascorbic acid)\n* Hydroxyurea \u002F hydroxycarbamide\n* Clinically relevant pancreatic disease\n* Systemic glucocorticoid therapy with a prednisone-equivalent dose \\>5 mg\u002Fday\n* Expected admission to an intensive care unit (ICU)",{"count":666,"type":23},82,[64],"The goal of this randomized clinical trial is to evaluate whether continuous glucose monitoring (CGM) can be used to guide glucose management in patients with type 2 diabetes who are admitted with an acute ischemic stroke and undergo endovascular therapy. Hyperglycemia frequently occurs during hospitalization in stroke and is associated with worse neurological and clinical outcomes. In current clinical practice, glucose levels are monitored using intermittent point-of-care testing (POCT) with finger-prick measurements, which may miss clinically relevant glucose fluctuations. CGM provides continuous glucose measurements and may allow earlier detection of hyperglycemia and more timely glucose management.\n\nThis study is designed as a non-inferiority randomized controlled trial comparing CGM-guided glucose management with standard POCT-guided glucose management. The primary objective is to determine whether CGM-guided glucose management is non-inferior to POCT-guided management in terms of percentage time spent in hyperglycemia (glucose \\>10 mmol\u002FL) during the first 72 hours of hospitalization.\n\nResearchers will compare CGM-guided glucose management to POCT-guided glucose management to evaluate whether CGM can be used as an alternative strategy to guide glucose control in hospitalized stroke patients.\n\nParticipants will:\n\n* Be randomly assigned to either CGM-guided glucose management or standard POCT-guided glucose management\n* Have their glucose levels continuously monitored (blinded in the POCT-guided group) during hospitalization\n* Receive glucose management according to the assigned monitoring strategy, based on the hospital insulin protocol",[670,29,67,671,27],"Acute Ischemic Stroke","Hyperglycemia","2026-03-31",{"date":650,"type":42},{"date":628,"type":23},{"date":676,"type":23},"2028-08",{"name":678,"class":49},"Isala",{"id":680,"slug":681,"hasResults":12,"nctId":682,"briefTitle":683,"officialTitle":683,"acronym":4,"eligibilityCriteria":684,"healthyVolunteers":12,"sex":18,"minAge":130,"maxAge":4,"enrollmentInfo":685,"targetDuration":4,"studyType":62,"phases":687,"briefSummary":688,"conditions":689,"keywords":690,"overallStatus":112,"whyStopped":4,"lastUpdateSubmitDate":696,"lastUpdatePostDateStruct":697,"startDateStruct":698,"completionDateStruct":700,"leadSponsor":702,"locationsCount":121},"100626168","community-health-workers-led-integrated-management-of-hypertension-and-diabetes-in-nepal-100626168","NCT07432126","Community Health Workers Led Integrated Management of Hypertension and Diabetes in Nepal","Inclusion Criteria:\n\n* 30 years or older\n* have a high blood pressure of 140\u002F90 mmHg or under hypertension medication\n* have a high blood sugar of 6.5% or more (hba1c) or under diabetes medication are able to provide informed consent\n\nExclusion Criteria:\n\n* any form of disabilities limiting participation in the study\n* severe illness requiring bed rest, and\n* pregnant women, due to their special health needs.",{"count":686,"type":23},398,[64],"Hypertension (HTN) and diabetes mellitus are significant global public health challenges, contributing to 13.5% of premature deaths, 54% of incident strokes, and 47% of coronary heart disease cases (HTN), and increasing risks of cardiovascular diseases, kidney failure, and other complications (diabetes). In Nepal, HTN prevalence is 24.5% and diabetes affects 5.8% of adults (2019 Nepal STEPS Survey), with many cases undiagnosed or poorly managed, and an estimated 60% co-morbidity among diabetic individuals. Nepal's Package of Essential Non-Communicable Diseases (PEN), implemented since 2017, targets both conditions, but multi-level barriers limit its facility-based effectiveness. This study addresses the need for cost-effective, evidence-based strategies for HTN and diabetes management in low-resource settings, focusing on marginalized populations. It proposes a Type II hybrid implementation-effectiveness study with two objectives: (1) evaluate implementation outcomes (reach, adoption, implementation, maintenance) of the Female Community Health Volunteers (FCHVs)-led integrated HTN and diabetes management using the RE-AIM framework; (2) assess effectiveness compared to facility-based PEN on systolic blood pressure and fasting blood sugar at 12 months. FCHVs will deliver integrated health education, form peer groups, and coordinate care. Using a mixed-method approach, the study involves a cluster randomized controlled trial with participants, collecting quantitative data on implementation, supplemented by in-depth interviews (8-16 patients) and focus group discussions (2 FGDs with FCHVs), with qualitative tracking logs. The intervention adapts a prior FCHV-led HTN trial to integrate diabetes management. FCHVs will receive 3-day training on screening, counseling, BP and blood sugar monitoring, and referrals for both conditions. Mass screening will identify HTN and diabetes cases, forming monthly FCHV groups for lifestyle counseling, BP, and glucose tracking, with family involvement. Monthly referrals will link uncontrolled cases to facilities. This aims to enhance integrated HTN and diabetes management, fostering community engagement and healthcare coordination, with findings to inform scalable NCD strategies in Nepal.",[138,29],[691,692,693,694,695],"disease management","hypertension","diabetes","community health workers","intervention","2026-03-07",{"date":430,"type":42},{"date":699,"type":42},"2025-12-14",{"date":701,"type":23},"2027-11",{"name":703,"class":49},"Kathmandu University School of Medical Sciences",{"id":705,"slug":706,"hasResults":12,"nctId":707,"briefTitle":708,"officialTitle":709,"acronym":710,"eligibilityCriteria":711,"healthyVolunteers":12,"sex":18,"minAge":163,"maxAge":4,"enrollmentInfo":712,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":714,"conditions":715,"keywords":716,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":720,"lastUpdatePostDateStruct":721,"startDateStruct":723,"completionDateStruct":725,"leadSponsor":726,"locationsCount":4},"100625576","real-world-canadian-retrospective-study-evaluating-longitudinal-semaglutide-use-on-cardio-kidney-metabolic-outcomes-100625576","NCT07424430","Real-world Canadian Retrospective Study Evaluating Longitudinal Semaglutide Use on Cardio-Kidney-Metabolic Outcomes","Real-world Canadian Retrospective Study Evaluating Longitudinal SEMAglutide Use on Cardio-Kidney-Metabolic Outcomes","SEMA-CKM","Inclusion Criteria:\n\nT2D Cohort:\n\n* A clinical diagnosis of T2D ≥ 1 year\n* HbA1c ≥ 6.5% (pre-index date)\n* Initiated semaglutide or other AHA(s) before January 1st, 2023\\*\n* Seen by an LMC endocrinologist in the last 18 months as of the query date\n* ≥ one HbA1c value up to 6 months (+ 90 days) prior to index date\n* Informed data consent for their medical record data to be used for research purposes\n\nObesity Cohort:\n\n* 18 years or older\n* BMI ≥ 27 kg\u002Fm2\n* HbA1c \\\u003C 6.5% (pre-index date)\n* Initiated semaglutide before January 1st, 2023\\*\n* Seen by an LMC endocrinologist in the last 18 months as of the query date\n* ≥ one HbA1c value up to 6 months (± 90 days) prior to index date\n* Informed data consent for their medical record data to be used for research purposes\n\nExclusion Criteria:\n\n* Clinical diagnosis of type 1 diabetes\u002Flatent autoimmune diabetes in adults (LADA)\n* Clinical diagnosis of T2D (obesity cohort only)\n* Are pregnant at the time of semaglutide or other AHA initiation or became pregnant during follow-up period\n* Documented history or family history of medullary thyroid carcinoma\n* Participation in a research study with an Investigational Product\n* eGFR \\\u003C 15 mL\u002Fmin\u002F1.73m2 at index date\n* Use of non-semaglutide GLP-1-based medication for more than 6 months after the index date (T2D sema cohort and obesity sema cohort)\n* Use of other AHA for more than 6 months after the index date within the first year of semaglutide use (T2D sema cohort and obesity sema cohort)",{"count":713,"type":23},400,"The goal of this study is to better understand the real-world effectiveness of semaglutide use on cardio-kidney-metabolic outcomes among adults with T2D and adults with obesity (without diabetes mellitus). This is a retrospective longitudinal analysis using the LMC Diabetes Registry. The primary outcome of the study is to evaluate the change in HbA1c between baseline to 3 years of follow-up among adults with T2D who initiated semaglutide compared to adults with T2D who initiated other AHAs, including sulfonylurea, dipeptidyl peptidase-4 inhibitors, and sodium-glucose cotransporter-2 inhibitors.",[29,225,478],[717,718,719,425],"semaglutide","T2D","AHA","2026-02-13",{"date":722,"type":42},"2026-02-20",{"date":724,"type":23},"2026-03",{"date":513,"type":23},{"name":727,"class":49},"LMC Diabetes & Endocrinology Ltd.",{"id":729,"slug":730,"hasResults":12,"nctId":731,"briefTitle":732,"officialTitle":733,"acronym":4,"eligibilityCriteria":734,"healthyVolunteers":12,"sex":18,"minAge":163,"maxAge":4,"enrollmentInfo":735,"targetDuration":4,"studyType":62,"phases":737,"briefSummary":738,"conditions":739,"keywords":743,"overallStatus":112,"whyStopped":4,"lastUpdateSubmitDate":758,"lastUpdatePostDateStruct":759,"startDateStruct":761,"completionDateStruct":763,"leadSponsor":764,"locationsCount":121},"100605835","phase-1-phase-1-trial-of-arginine-hydrochloride-for-the-management-of-diabetic-ketoacidosis-in-type-2-diabetes-100605835","NCT07167693","Phase 1 Trial of Arginine Hydrochloride for the Management of Diabetic Ketoacidosis in Type 2 Diabetes","Phase 1 Randomized Clinical Trial of Arginine Hydrochloride Administration to Reduce Duration of Diabetic Ketoacidosis in Patients With Type 2 Diabetes","Inclusion Criteria:\n\n* Age \\>17 years.\n* Unscheduled presentation to a participating emergency department with hyperglycemia (serum glucose \\>250 mg\u002FdL) and significant ketonemia consistent with DKA, defined as laboratory serum\u002Fplasma β-hydroxybutyrate (BHB) \\>20 mg\u002FdL (≈≥1.9 mmol\u002FL).\n\nNote: point-of-care capillary BHB ≥1.5 mmol\u002FL and\u002For breath acetone ≥0.01% may be used for screening while confirmatory labs are pending; if confirmatory BHB ≤20 mg\u002FdL, the participant is a screen failure.\n\n* Clinical phenotype consistent with ketosis-prone type 2 diabetes (no known prior diagnosis of type 1 diabetes).\n* Able to provide written informed consent and comply with study procedures in the ED.\n\nExclusion Criteria:\n\n* Current renal replacement therapy for chronic kidney disease (hemodialysis or peritoneal dialysis).\n* Known history of type 1 diabetes mellitus or known GAD65 autoantibody positivity.\n* Diagnosed cirrhosis\u002Fadvanced chronic liver disease.\n* Pregnancy (known pregnancy or positive test at screening).\n* Known allergy or hypersensitivity to arginine or its components.\n* Features of at least moderate acute alcohol intoxication at screening, per treating team.",{"count":736,"type":23},60,[193,194],"Diabetic ketoacidosis (DKA) is increasingly recognized in adults with \"ketone-prone\" type 2 diabetes. In many of these patients, the pancreas can still make insulin but becomes temporarily \"stunned\" during severe, prolonged high blood sugar. Arginine is a naturally occurring amino acid that can trigger the pancreas to release its own insulin when glucose is high. It is FDA-approved for other uses and has been given intravenously for decades with a strong safety record. Whether a single arginine infusion given early during DKA can safely boost the body's insulin and speed recovery has not been tested.\n\nThis randomized, double-blind, placebo-controlled, phase 1\u002F2 trial will enroll 60 adults who present to one of four Detroit-area emergency departments with DKA consistent with ketone-prone type 2 diabetes (high glucose and significant ketones). Participants will receive standard DKA care ordered by their clinicians. In addition, under blinded conditions they will receive either arginine hydrochloride 30 grams (in 300 mL) or placebo (normal saline), infused intravenously over 30 minutes as early as feasible after DKA is recognized.\n\nThe main question is whether arginine increases endogenous (self-made) insulin soon after infusion. We will measure C-peptide (a marker released in equal amounts with insulin) and glucose at 10, 30, and 90 minutes after the start of the infusion and calculate the C-peptide\u002Fglucose ratio. Secondary measures include the rate of ketone (β-hydroxybutyrate) clearance and the total insulin dose required in the first 24 hours. Additional blood tests will examine arginine and related amino acids, and a small sample of platelets will be used to explore mitochondrial function. Safety will be closely monitored during and after the infusion, and participants will be contacted at 90 days to assess for any delayed problems.\n\nPotential risks include temporary flushing, nausea, or headache; the infusion can be stopped at any time if needed. Potential benefits include faster resolution of ketosis and reduced insulin needs, but benefits cannot be guaranteed for individual participants.",[29,740,741,742],"Diabetic Ketoacidosis","Ketosis Prone Diabetes","Hyperglycaemia (Diabetic)",[744,745,746,747,748,749,750,751,752,753,754,755,756,757],"Arginine hydrochloride","Arginine","R-Gene 10","Insulin secretagogue","Endogenous insulin secretion","C-peptide","C-peptide to glucose ratio","Type 2 ketosis-prone diabetes (T2KPD)","Flatbush diabetes","Ketosis-prone diabetes (KPD)","Hyperglycemic crisis","Nitric oxide (NO)","Global arginine bioavailability ratio (GABR)","Mitochondrial function","2026-02-09",{"date":760,"type":42},"2026-02-12",{"date":762,"type":42},"2025-12-19",{"date":46,"type":23},{"name":765,"class":49},"David K Carroll",{"id":767,"slug":768,"hasResults":12,"nctId":769,"briefTitle":770,"officialTitle":771,"acronym":4,"eligibilityCriteria":772,"healthyVolunteers":12,"sex":18,"minAge":163,"maxAge":4,"enrollmentInfo":773,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":775,"conditions":776,"keywords":778,"overallStatus":112,"whyStopped":4,"lastUpdateSubmitDate":758,"lastUpdatePostDateStruct":780,"startDateStruct":781,"completionDateStruct":783,"leadSponsor":785,"locationsCount":121},"100565986","a-prospective-multicenter-clinical-study-intracoronary-near-infrared-spectroscopy-and-optical-coherence-tomography-for-evaluating-coronary-vulnerable-plaque-in-patients-with-diabetes-100565986","NCT06649305","A Prospective Multicenter Clinical Study： IntracOronary neaR-Infrared Spectroscopy and OptIcal Coherence Tomography for Evaluating Coronary vulNerable Plaque in Patients With diabeTes","A Prospective Multicenter Clinical Study：IntracOnary neaR-Infrared Spectroscopy and OptIcal Coherence Tomography for Evaluating Coronary vulNerable Plaque in Patients With diabeTes","Inclusion Criteria:\n\n1. 18 years old or older, gender is not limited\n2. Patients with diabetes who require an OCT examination or treatment under OCT guidance (diabetes definition: active treatment with insulin or oral hypoglycemic agents at admission). For patients with diabetes who are treated with diet only, abnormal fasting blood sugar (\\>7 mmol\u002Fl), blood sugar \\>11.1 mmol\u002Fl at any time, or abnormal glucose tolerance tests based on World Health Organization standards need to be recorded.\n3. Be able to understand the purpose of clinical research, voluntarily participate can complete the observation as required and sign the informed consent form\n\n5: Lesion stenosis greater than or equal to 50% without interventional treatment\n\n6: The diameter of the blood vessel in the diseased segment is greater than or equal to 2.5 mm\n\nExclusion Criteria:\n\n* 1: Severe coagulation dysfunction (APTT greater than 3 times the upper limit of the normal range)\n\n  2: Severe hemodynamic disorder or shock that cannot be corrected\n\n  3: Patients with renal impairment（eGFR\\\u003C30 mL\u002Fmin\u002F1.73m2）\n\n  4: Severe symptoms of heart failure (NYHA III and above) or left ventricular ejection fraction \\\u003C30%\n\n  5: The presence or suspected presence of infective endocarditis or systemic active infection\n\n  6: Patients with refractory ventricular arrhythmias who have previously undergone coronary bypass transplantation (CABG) or plan to undergo CABG during the study\n\n  7: Patients with serious concurrent diseases such as advanced cancer have a life expectancy of less than 24 months\n\n  8: Pregnant or lactating women, have a family plan within 24 months or are unwilling to take effective contraceptive measures\n\n  9: The target vessel has severe calcification or severe tortuosity, which cannot be examined by OCT\n\n  10: Have participated in other clinical trials or are participating in other drug\u002Fdevice clinical trials within 3 months prior to enrollment and have not met the primary endpoint\n\n  11: Investigators believe that those who are unnecessary for OCT or not suitable for inclusion in this trial.\n\n  12: There are multiple lesions in the same blood vessel, and the non-target lesion distance requiring treatment vascular segment is less than 5mm",{"count":774,"type":23},1516,"To evaluate the correlation between maxLCBI4mm\u002FFCTmin(a new index of lipid plaque based on NIRS-OCT technology) and fiber cap thickness , and the prognosis of patients, providing a new quantitative index for early, accurate and comprehensive identification of vulnerable plaques, and exploring preventive measures for adverse events such as cardiac death and recurrent myocardial infarction caused by vulnerable plaques, so as to improve the long-term prognosis of patients.",[777,29],"Coronary Heart Disease (CHD)",[779],"near-infrared spectroscopy",{"date":760,"type":42},{"date":782,"type":42},"2024-10-30",{"date":784,"type":23},"2027-09-30",{"name":786,"class":49},"Shanghai Zhongshan Hospital"]