[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100651260":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":35,"centralContacts":40,"locations":45,"responsibleParty":47,"collaborators":51,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":61,"eligibilityCriteria":62,"healthyVolunteers":57,"sex":63,"minAge":64,"maxAge":65,"enrollmentInfo":66,"targetDuration":45,"studyType":69,"phases":70,"briefSummary":73,"conditions":74,"keywords":78,"overallStatus":86,"whyStopped":45,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":45},{"fullName":5,"class":6},"Shifa International Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Pre-emptive NPH Insulin Pathway","EXPERIMENTAL","Participants will receive three subcutaneous doses of human NPH insulin beginning within 30 minutes after intra-articular triamcinolone acetonide injection and repeated approximately 24 and 48 hours later. The initial dose is 0.10 units\u002Fkg, maximum 16 units. Subsequent doses are modified according to prespecified capillary-glucose and hypoglycaemia criteria. Participants will continue stable background diabetes medication and receive blinded continuous glucose monitoring, scheduled capillary glucose testing, safety contacts and the common rescue pathway.",[13],"Drug: Insulin Isophane Human, NPH, Pre-emptive Algorithm",{"label":15,"type":16,"description":17,"interventionNames":18},"Usual Reactive Diabetes Management","ACTIVE_COMPARATOR","Participants will continue stable background diabetes medication without pre-emptive NPH insulin. They will receive blinded continuous glucose monitoring, the same scheduled capillary glucose testing, safety instructions, study contacts and common rescue pathway as the experimental group. Additional non-emergency medication changes may be made by the treating diabetes clinician when clinically necessary and will be documented.",[19],"Drug: Triamcinolone Acetonide Knee Injection",[21,29],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Insulin Isophane Human, NPH, Pre-emptive Algorithm","Human NPH insulin U-100 will be administered subcutaneously within 30 minutes after the knee injection at 0.10 units\u002Fkg actual body weight, rounded to the nearest whole unit, maximum 16 units. Doses are repeated approximately 24 and 48 hours later. For doses 2 and 3, predose glucose below 90 mg\u002FdL requires withholding; 90 to 109 mg\u002FdL requires 50% of the initial dose; 110 to 180 mg\u002FdL requires 100%; 181 to 250 mg\u002FdL requires 120%; and above 250 mg\u002FdL requires 120%, maximum 20 units, plus clinician contact. Any glucose below 54 mg\u002FdL or level 3 hypoglycaemia permanently discontinues study NPH.",[9],[27,28],"Human NPH Insulin","Neutral Protamine Hagedorn Insulin",{"type":22,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"Triamcinolone Acetonide Knee Injection","A single 1 mL intra-articular injection of triamcinolone acetonide crystalline suspension 40 mg\u002FmL, total dose 40 mg, will be administered into one index knee using a standardised landmark-guided procedure. Up to 2 mL lidocaine 1% without epinephrine may be used for skin and subcutaneous anaesthesia but will not be mixed with or injected into the joint. No repeat or additional injected corticosteroid is permitted through day 7.",[15],[34],"Triamcinolone Acetonide Crystalline Suspension",[36],{"name":37,"affiliation":38,"role":39},"Saima Abbass, MD, PhD","Shifa hospital","STUDY_DIRECTOR",[41],{"name":42,"role":43,"phone":44,"phoneExt":45,"email":46},"Nadia Hussain, MD, PhD","CONTACT","0505440153",null,"nadia.hussain@aau.ac.ae",{"type":48,"investigatorFullName":49,"investigatorTitle":50,"investigatorAffiliation":5,"oldNameTitle":45,"oldOrganization":45},"PRINCIPAL_INVESTIGATOR","Saima Abass Tahammal","Medical Director Endocrinology",[52],{"name":53,"class":54},"Al Ain University","UNKNOWN","100651260","phase-1-pre-emptive-insulin-to-prevent-high-glucose-after-a-knee-steroid-injection-in-adults-with-type-2-diabetes-100651260",false,"NCT07757464","Pre-emptive Insulin to Prevent High Glucose After a Knee Steroid Injection in Adults With Type 2 Diabetes","A Phase 2 Randomized Trial of Pre-emptive NPH Insulin Versus Usual Reactive Diabetes Management for Preventing Hyperglycaemia After Intra-articular Triamcinolone Acetonide Injection in Adults With Type 2 Diabetes and Knee Osteoarthritis","PREVENT-SIH","Inclusion Criteria:\n\n* Age 40 to 80 years at consent.\n* Documented diagnosis of type 2 diabetes for at least 6 months.\n* HbA1c from 6.5% through 9.0% measured within 30 days before randomisation.\n* Symptomatic osteoarthritis of one knee for which the treating clinician has independently determined that an intra-articular corticosteroid injection is clinically indicated.\n* Planned administration of one intra-articular injection of triamcinolone acetonide crystalline suspension 40 mg into the index knee.\n* Diabetes managed without insulin, sulfonylureas or meglitinides.\n* Permitted glucose-lowering medications at stable doses for at least 30 days before randomisation.\n* Estimated glomerular filtration rate at least 45 mL\u002Fmin\u002F1.73 m² within 60 days before randomisation.\n* Capillary glucose from 90 through 250 mg\u002FdL immediately before the injection.\n* Ability and willingness to perform scheduled capillary glucose testing, administer or receive subcutaneous insulin if assigned, follow hypoglycaemia instructions and remain contactable through day 7.\n* Ability to wear the study continuous glucose monitoring device and provide informed consent.\n\nExclusion Criteria:\n\n* Type 1 diabetes, latent autoimmune diabetes in adults, pancreatogenic diabetes or another specific diabetes type requiring insulin.\n* Current basal, prandial, premixed or pump insulin treatment.\n* Current sulfonylurea or meglitinide treatment.\n* HbA1c below 6.5% or above 9.0%.\n* Capillary glucose below 90 mg\u002FdL or above 250 mg\u002FdL immediately before injection.\n* Fasting glucose above 250 mg\u002FdL, random glucose above 300 mg\u002FdL, clinically significant ketonaemia or hyperglycaemia requiring immediate treatment during screening.\n* Estimated glomerular filtration rate below 45 mL\u002Fmin\u002F1.73 m².\n* Severe hepatic impairment or another condition expected to materially alter insulin clearance or hypoglycaemia risk.\n* Level 3 hypoglycaemia requiring third-party assistance during the previous 6 months.\n* Documented impaired awareness of hypoglycaemia.\n* Pregnancy, planned pregnancy during study participation or breastfeeding.\n* Oral, intravenous or intramuscular corticosteroid use within 30 days before the study injection.\n* Any intra-articular, epidural, periarticular or soft-tissue corticosteroid injection within 30 days before the study injection.\n* Planned additional systemic or injected corticosteroid exposure before the day-7 assessment.\n* Acute febrile illness, active systemic infection or acute deterioration in health at screening or injection.\n* Suspected septic arthritis, infection over the injection site, prosthetic index knee, uncontrolled bleeding disorder or another contraindication to knee injection.\n* Known allergy or clinically significant hypersensitivity to triamcinolone acetonide, human NPH insulin, insulin aspart, protamine, lidocaine or required excipients.\n* Known allergy to continuous glucose monitoring adhesive or a skin condition preventing sensor use.\n* Cognitive, visual, physical or social limitation that would prevent safe glucose testing, insulin administration, hypoglycaemia treatment or study contact.\n* Participation in another interventional study likely to affect glucose or corticosteroid response.\n* Any condition that, in the investigator's documented judgement, makes participation unsafe for a reason not otherwise captured above.","ALL","40 Years","80 Years",{"count":67,"type":68},125,"ESTIMATED","INTERVENTIONAL",[71,72],"PHASE1","PHASE2","Steroid injections used to treat painful joints can temporarily increase glucose levels in people with type 2 diabetes. This study will test whether a short course of pre-emptive neutral protamine Hagedorn, NPH, insulin can reduce high glucose after a standard corticosteroid injection into the knee.\n\nAdults with type 2 diabetes who are scheduled to receive one intra-articular injection of triamcinolone acetonide 40 mg for knee osteoarthritis will be randomly assigned to one of two groups. The experimental group will receive a prespecified NPH insulin regimen beginning immediately after the injection and continuing for three doses. The comparison group will continue usual reactive diabetes management without pre-emptive NPH insulin.\n\nBoth groups will use blinded continuous glucose monitoring and scheduled capillary glucose testing. The main outcome is the percentage of continuous glucose monitoring time above 180 mg\u002FdL during the first 72 hours after the corticosteroid injection. Hypoglycaemia, rescue treatment, healthcare contacts, treatment burden, acceptability and adverse events will also be assessed.",[75,76,77],"Diabetes Mellitus, Type 2","Hyperglycemia Due to Type 2 Diabetes Mellitus","Osteoarthritis, Knee",[79,80,81,82,83,84,85],"Steroid-induced hyperglycaemia","Glucocorticoid-induced hyperglycaemia","Intra-articular corticosteroid injection","Triamcinolone acetonide","NPH insulin","Continuous glucose monitoring","Knee osteoarthritis","NOT_YET_RECRUITING","2026-08-05",{"date":89,"type":90},"2026-08-11","ACTUAL",{"date":92,"type":68},"2026-08-10",{"date":94,"type":68},"2027-01-30",{"name":5,"class":6}]