[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hypoglycemia-diabetic\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hypoglycemia-diabetic":31},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,53,96,127,152,174],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":32,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":43,"startDateStruct":46,"completionDateStruct":48,"leadSponsor":50,"locationsCount":4},"100650187","the-bright-study-device-name-halo-system-100650187",false,"NCT07745998","The BRIGHT Study (Device Name: HALO System)","The BRIGHT Study, an Open Label, Single-arm, Interventional, Multicenter, Prospective Study of the Diagnostic Feasibility of the HALO System, Designed to Evaluate the Safety and Performance of the HALO SYSTEM in Subjects With Diabetes Mellitus","Inclusion Criteria:\n\n* Willing to sign an informed consent form\n* Age ≥ 18 years\n* Willing to comply to study protocol requirements (study visits with frequent venous blood sampling and deliberate insulin, glucose, ketone and lactate challenges)\n* Willing to charge the SENSOR on daily basis\n* Willing not to insert their standard CGM and\u002For insulin pump in and around the SENSOR implant site (± radius 5 cm)\\[TS\\| XR1.1\\] Diagnosed with type 1 diabetes mellitus according to the World Health Organization criteria, for at least 12 months prior to screening, on CSII therapy\n\nExclusion Criteria:\n\n* Known allergy to polydimethylsiloxane (PDMS)\n* A contraindication to undergo challenging tests (i.e., ischemic heart disease, epilepsy, panhypopituitarism, hypoadrenalism, untreated hypothyroidism)\n* History of hepatitis C or HIV or other disease transmissible by blood\n* A condition requiring or likely to require magnetic resonance imaging during the study duration\n* Female participants who are pregnant, planning on becoming pregnant or nursing\n* Coagulation disorder, wound healing and bleeding disorder or taking anticoagulant medication (oral anticoagulants; antiplatelets (such as aspirin, ticagrelor are allowed).\n* Anemia identified by a haemoglobin \\\u003C14 g\u002FdL for men or \\\u003C12 g\u002FdL for women\n* The presence of any other active implanted device\n* The presence of any other CGM sensor\u002Fpump located in the lower abdomen (other location is acceptable)\n* Waist circumference of \\>120 cm\n* Any disorder, which in the investigator's opinion might jeopardise participants' safety or compliance with the protocol.","ALL","18 Years",{"count":19,"type":20},12,"ESTIMATED","INTERVENTIONAL",[23],"NA","The purpose of the BRIGHT study is to evaluate safety and performance of the HALO SYSTEM in subjects with diabetes mellitus. The primary objectives of this clinical investigation are 1) the evaluation of sensor's performance by demonstrating sensor's accuracy and stability and 2) to confirm safe implantation of the Sensor and safety of the device during implantation.",[26,27,28,29,30,31],"Diabetes Mellitus - Type 1","Diabetes Mellitus - Type 2","Diabetes Mellitus","Ketoacidosis, Diabetic","Hyperglycaemia (Diabetic)","Hypoglycemia (Diabetic)",[33,34,35,36,37,38,39,40],"CMM","CGM","Diabetes mellitus - type 1","Diabetes mellitus - type 2","ketoacidosis, diabetic","continuous multi-metabolite monitoring","hyperglycaemia (diabetic)","hypoglycaemia (diabetic)","NOT_YET_RECRUITING","2026-08-03",{"date":44,"type":45},"2026-08-04","ACTUAL",{"date":47,"type":20},"2026-12",{"date":49,"type":20},"2027-06",{"name":51,"class":52},"Indigo Diabetes NV","INDUSTRY",{"id":54,"slug":55,"hasResults":11,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":59,"eligibilityCriteria":60,"healthyVolunteers":11,"sex":16,"minAge":61,"maxAge":62,"enrollmentInfo":63,"targetDuration":4,"studyType":21,"phases":65,"briefSummary":66,"conditions":67,"keywords":71,"overallStatus":84,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":95},"100648700","glycoquest-an-ai-adaptive-cgm-integrated-serious-game-for-pediatric-type-1-diabetes-100648700","NCT07726680","GlycoQuest: An AI-Adaptive CGM-Integrated Serious Game for Pediatric Type 1 Diabetes","GlycoQuest: Glycemic and Psychosocial Outcomes of a CGM-Integrated, AI-Adaptive Serious Game Digital Therapeutic in Newly Diagnosed Pediatric Type 1 Diabetes: A Parallel-Group Randomized Controlled Trial","GlycoQuest","Inclusion Criteria:\n\n* Child or adolescent aged 6 to 17 years at enrollment.\n* Diagnosis of type 1 diabetes confirmed by a pediatric endocrinologist according to standard clinical criteria.\n* Type 1 diabetes diagnosed within the previous 3 months.\n* Primary caregiver aged 18 years or older willing to participate as part of a parent-child dyad.\n* Current use of continuous glucose monitoring or willingness to initiate CGM as part of standard diabetes care.\n* Household access to a compatible smartphone or tablet, or willingness to use a study-provided device if available.\n* Ability of child and caregiver to engage with study procedures and digital intervention content.\n* Caregiver able to provide written informed consent.\n* Child able to provide age-appropriate assent.\n\nExclusion Criteria:\n\n* Type 1 diabetes diagnosed more than 3 months before enrollment.\n* Concurrent participation in another intensive diabetes behavioral intervention trial.\n* Significant developmental, intellectual, visual, motor, or psychiatric condition that, in the opinion of the clinical team, would preclude meaningful engagement with the digital game interface or study procedures.\n* Acute psychiatric instability or safety concern requiring urgent specialist intervention.\n* Planned transfer to a different diabetes care provider within 6 months.\n* Absence of internet access that cannot be addressed by study support.","6 Years","17 Years",{"count":64,"type":20},110,[23],"Type 1 diabetes diagnosed in childhood requires rapid acquisition of complex self-management skills while children and caregivers are also adapting emotionally and socially to a chronic condition. Standard diabetes education is often delivered early after diagnosis, is information intensive, and is not usually personalized to real-time glucose patterns, emotional state, child developmental stage, or family communication needs.\n\nThis study will evaluate GlycoQuest, an AI-adaptive, continuous glucose monitoring-integrated serious game digital therapeutic for children and adolescents newly diagnosed with type 1 diabetes and their primary caregivers. GlycoQuest uses CGM-linked gameplay, a glucose-responsive digital avatar, AI-personalized learning pathways, parent-child collaborative modules, adaptive hypoglycemia and insulin decision simulations, and psychosocial adaptation content addressing diabetes distress, fear of hypoglycemia, stigma, illness acceptance, and autonomy transition.\n\nThis randomized controlled trial will enroll 110 parent-child dyads. Children aged 6 to 17 years with type 1 diabetes diagnosed within the previous 3 months will be randomized 1:1 to GlycoQuest plus standard care or enhanced digital psychoeducation plus standard care. The intervention period will be 6 months, with follow-up to 8 months. The co-primary outcomes are change in CGM-derived time in range, defined as 70 to 180 mg\u002FdL, and child diabetes distress at 8 months. Secondary outcomes include time below range, glycemic variability, HbA1c, severe hypoglycemia, diabetic ketoacidosis readmissions, insulin omission, quality of life, fear of hypoglycemia, parental stress, diabetes family conflict, self-efficacy, engagement, and implementation outcomes.",[68,69,31,70],"Type 1 Diabetes Mellitus (T1DM)","Diabetes Distress","Family Conflict",[72,73,74,75,76,77,69,78,79,80,81,82,83],"Type 1 Diabetes","Pediatric Diabetes","Continuous Glucose Monitoring","Digital Therapeutic","Serious Game","Artificial Intelligence","Fear of Hypoglycemia","Family-Centered Care","Behavioral Medicine","Time in Range","Self-Efficacy","Implementation Science","RECRUITING","2026-07-21",{"date":87,"type":45},"2026-07-24",{"date":89,"type":45},"2026-06-01",{"date":91,"type":20},"2026-11-30",{"name":93,"class":94},"Shifa International Hospital","OTHER",1,{"id":97,"slug":98,"hasResults":11,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":4,"eligibilityCriteria":102,"healthyVolunteers":11,"sex":16,"minAge":103,"maxAge":104,"enrollmentInfo":105,"targetDuration":4,"studyType":21,"phases":107,"briefSummary":108,"conditions":109,"keywords":112,"overallStatus":84,"whyStopped":4,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":95},"100646081","miniaturized-breath-based-sensor-for-the-detection-of-hypo--and-hyperglycemia-100646081","NCT07696273","Miniaturized Breath-based Sensor for the Detection of Hypo- and Hyperglycemia","Miniaturized Smart Sensor Device for the Detection of Hypo- and Hyperglycemic Events in Persons Diagnosed With Diabetes","Inclusion Criteria:\n\n* Who are diagnosed with T1D or T2D.\n* Who are between 7-25 years of age.\n* That use a Dexcom (G6 or G7) CGM device.\n* That have an established working CGM for at least 12 hours.\n* That are willing to share their CGM data for the study duration.\n* That are willing and able to fill up a breath collection bag.\n* That are attending a diabetes camp in the state of Indiana.\n\nExclusion Criteria:\n\n* That are smokers or who live with someone who smokes in their vicinity (including prior to attending camp).\n* That have a condition or abnormality other than T1D\u002FT2D that in the opinion of the Investigators would compromise the safety of the subject or the quality of the data.\n* That have symptoms or recently been diagnosed with an upper respiratory illness including COVID-19 (or other viral\u002Fbacterial infections).\n* That follow a \"ketogenic diet\".\n* That are unable or unwilling to cooperate with either of the sample collection modes.","7 Years","25 Years",{"count":106,"type":20},40,[23],"The purpose of this study is to determine whether an array of biosensors can noninvasively identify hyperglycemic or hypoglycemic events in persons diagnosed with diabetes through noninvasive detection of volatile organic compounds (VOCs) in exhaled breath.",[110,111,31],"Diabetes","Hyperglycemia",[113,114,115,116,117],"Exhaled Breath Analysis","Volatile Organic Compounds (VOCs)","Metal Oxide Sensors","Gas Chromatography","Mass Spectrometry","2026-07-04",{"date":120,"type":45},"2026-07-10",{"date":122,"type":45},"2026-05-31",{"date":124,"type":20},"2027-10-01",{"name":126,"class":94},"Indiana University",{"id":128,"slug":129,"hasResults":11,"nctId":130,"briefTitle":131,"officialTitle":132,"acronym":133,"eligibilityCriteria":134,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":135,"targetDuration":4,"studyType":21,"phases":137,"briefSummary":138,"conditions":139,"keywords":141,"overallStatus":84,"whyStopped":4,"lastUpdateSubmitDate":143,"lastUpdatePostDateStruct":144,"startDateStruct":146,"completionDateStruct":148,"leadSponsor":150,"locationsCount":95},"100600210","personalized-hypoglycemia-outpatient-treatment---a-feasibility-study-100600210","NCT07094529","Personalized Hypoglycemia Outpatient Treatment - a Feasibility Study","The Feasibility of Personalized Hypoglycemia Outpatient Treatment for People Living With Type 2 Diabetes Mellitus","PHOT","Inclusion Criteria:\n\n* In order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n  1. Consent provided\n  2. Age \\>= 18 years.\n  3. Diagnosed as type 2 diabetes mellitus.\n  4. Type 2 diabetes medications include at least one of the following for at least one month prior to entering the study: sulfonylurea or insulin of any type.\n\nExclusion Criteria:\n\n* An individual who meets any of the following criteria will be excluded from participation in this study:\n\n  1. Diagnosed as another form of diabetes mellitus.\n  2. Has a history of hypoglycemia unawareness.\n  3. Had a hypoglycemia event, defined as capillary blood glucose \\\u003C 3.9 mmol\u002FL within 24 hours prior to the study visit booking time.",{"count":136,"type":20},120,[23],"This study will offer two study interventions designed to bring on a mild low blood sugar (capillary blood glucose result 3.0 to 3.8 mmol\u002FL), in order to study the effectiveness of each study participant's personal choice of treatment and first recheck time.\n\nThe two study interventions that the participant can choose to complete (one or both interventions).\n\nBased on each participant's own experience with hypoglycemia treatment or their preferences, the participant can choose one of 4 simple carbohydrate treatment quantities, and choose one of 4 capillary blood glucose recheck times.",[140,31],"Type 2 Diabetes (T2DM)",[142],"hypoglycemia","2025-07-23",{"date":145,"type":45},"2025-07-30",{"date":147,"type":45},"2025-07-21",{"date":149,"type":20},"2027-06-30",{"name":151,"class":94},"Ottawa Hospital Research Institute",{"id":153,"slug":154,"hasResults":11,"nctId":155,"briefTitle":156,"officialTitle":157,"acronym":158,"eligibilityCriteria":159,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":160,"targetDuration":4,"studyType":21,"phases":162,"briefSummary":163,"conditions":164,"keywords":4,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":165,"lastUpdatePostDateStruct":166,"startDateStruct":168,"completionDateStruct":170,"leadSponsor":172,"locationsCount":4},"100597253","comparing-blood-glucose-control-intraoperative-between-insulin-drip-vs-insulin-boluses-will-provide-valuable-information-on-the-optimal-method-for-achieving-blood-glucose-control-intraoperatively-100597253","NCT07056088","Comparing Blood Glucose Control Intraoperative Between Insulin Drip vs. Insulin Boluses Will Provide Valuable Information on the Optimal Method for Achieving Blood Glucose Control Intraoperatively.","A Randomized Controlled Trial Comparing Blood Glucose Control Intraoperative Between Insulin Drip vs. Insulin Boluses","RANDOM-IB","Inclusion Criteria:\n\n* All adult patients (above 18 y of age undergoing Cardiac surgery with preoperative blood glucose level (80 -180 mg\u002FdL)\n* Patient with History of diabetes and those taking antidiabetics medications.\n\nExclusion Criteria:\n\n* Patients with known allergy or insulin intolerance.\n* Patients with severe hepatic Dysfunction.\n* Patient with History of hypoglycemic events in the past 6 month prior to surgery.",{"count":161,"type":20},384,[23],"Cardiac surgery patients often experience elevated blood glucose levels, which can lead to poor surgical outcomes and increased postoperative complications. Therefore, tight blood glucose control during surgery is important. Currently, there is no consensus on the best method for blood glucose control during cardiac surgery. This proposal aims to perform a randomized controlled trial to compare blood glucose control intraoperatively using an insulin drip versus insulin boluses. The primary objective of the study is to compare blood glucose control intraoperatively between patients who receive insulin drip and patients who receive insulin boluses during adult cardiac surgery. This study will be a randomized controlled trial in which adult patients undergoing cardiac surgery will be randomized into two groups: insulin drip and insulin boluses. Patients with a history of diabetes or those currently taking antidiabetic medications will be included in the study. This randomized controlled trial will provide valuable information on the optimal method for achieving blood glucose control intraoperatively. The results of this study may help improve patient outcomes and reduce the incidence of postoperative complications.",[31],"2025-07-03",{"date":167,"type":45},"2025-07-09",{"date":169,"type":20},"2025-07",{"date":171,"type":20},"2029-08",{"name":173,"class":94},"King Faisal Specialist Hospital & Research Center",{"id":175,"slug":176,"hasResults":11,"nctId":177,"briefTitle":178,"officialTitle":179,"acronym":180,"eligibilityCriteria":181,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":182,"enrollmentInfo":183,"targetDuration":4,"studyType":21,"phases":185,"briefSummary":186,"conditions":187,"keywords":189,"overallStatus":84,"whyStopped":4,"lastUpdateSubmitDate":198,"lastUpdatePostDateStruct":199,"startDateStruct":201,"completionDateStruct":203,"leadSponsor":205,"locationsCount":207},"100552468","continuous-bloodsugar-monitoring-system-with-a-sensor-compared-to-fingerstick-bloodsugar-monitoring-100552468","NCT06473480","Continuous Bloodsugar Monitoring System With a Sensor Compared to Fingerstick Bloodsugar Monitoring","Continuous GLUCOse Monitoring System With a SENSor Compared to Fingerstick Glucose Monitoring in Surgical Wards (GLUCOSENS)","GLUCOSENS","Inclusion Criteria:\n\n* Hospitalized patients (≥ 18 years old) in surgical wards\n* Glucose measurements at least 4 times (OUH) and 3 times (SUH) daily for at least three days, prescribed by surgeon\n* Expected hospitalization for at least three days\n* Communicates in Danish\n* Signed a declaration of consent to study participation\n* At risk of hypo- and hyperglycemia (with or without a diabetes diagnosis)\n* Specific for substudy 4 inclusion criteria as above with the following add on: Patients being treated with insulin at discharge and patients residing within the OUH admission area.\n\nExclusion Criteria:\n\n* Cognitively impaired patients\n* Indication for glucose monitoring solely because of parenteral nutrition treatment\n* Patients admitted with a CGMS\n* Patients from the point-of-care fingerstick capillary glucose monitoring group cannot be included in the continuous glucose monitoring system group\n\nEligibility criteria solely for substudy 7\n\nInclusion Criteria:\n\n* Nursing staff with at least one month of experience with both point-of-care fingerstick capillary glucose monitoring and continuous glucose monitoring system and are registered nurses or certified nursing assistants","110 Years",{"count":184,"type":20},329,[23],"This clinical trial aims to compare a continuous glucose monitoring system with traditional fingerstick blood glucose monitoring. The study focuses on adult patients in general surgical wards who need regular blood glucose checks due to the risk of low or high blood sugar levels.\n\nThe goal is to learn if using a continuous glucose monitoring system is better than fingerstick monitoring in managing glucose levels, preventing complications, improving patient satisfaction and experience, reducing nursing staff workload, and improving nursing staff' experience. The study also compares the accuracy of glucose readings from the continuous glucose monitoring system with those from fingerstick tests and blood samples.\n\nThe hypothesis is that CGMS is accurate and effective for monitoring glucose levels in surgical patients. This could lead to better blood sugar control, fewer complications, shorter hospital stays, and improved experiences for both patients and nursing staff.",[28,31,188,111],"Hypoglycemia Night",[190,191,192,193,194,195,196,197],"Blood glucose monitoring","point-of-care fingerstick capillary glucose monitoring","continuous glucose monitoring system","Patient satisfaction","Patient experience","Nursing staff's workload","Nursing staff's experience","accuracy","2025-03-31",{"date":200,"type":45},"2025-04-03",{"date":202,"type":45},"2024-06-26",{"date":204,"type":20},"2025-12-31",{"name":206,"class":94},"Odense University Hospital",2]