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Clinical Trial Details

Trial ID: L2991
Source ID: NCT05614089
Associated Drug: Insulin Glargine
Title: Human Versus Analogue Insulin for Youth With Type 1 Diabetes in Low-Resource Settings
Acronym: HumAn-1
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 1|Type 1 Diabetes
Interventions: DRUG: Insulin Glargine|DRUG: NPH or premixed 70/30 (human insulin)
Outcome Measures: Primary: Time-in-serious hypoglycemia, % spent less than 54mg/dl, averaged across all daily measures averaged across two CGM sensors, 6 months after randomization|Time-in-range (TIR), % between 70 and 180mg/dl inclusive, averaged across two CGM sensors, 6 months after randomization | Secondary: Time-in-hypoglycemia, % spent less than 70mg/dl, 6 months after randomization|Time-above-range, % spent greater than 180mg/dl, 6 months after randomization|Nocturnal hypoglycemic events, Number of events (defined as \>=15mins in duration \< 70mg/dl) between 1200 and 0600, 6 months after randomization|Glycemic control (HbA1c), Mean HbA1c lab result, baseline, 3, 6, 9 and 12 months after randomization|Rate of severe hypoglycemic events, Events requiring the assistance of an external third party person, 6 months after randomization|Rate of Diabetic Ketoacidosis, Hospitalization or Emergency Room Visit with primary diagnosis of Diabetic Ketoacidosis. This will be measured by self-report and confirmed through review of hospital records, 6 months after randomization|Quality of Life (e.g. PedsQL Pediatric Quality of Life Inventory), The PedsQLTM 3.2 Diabetes Module is composed of 33 items comprising 5 dimensions for ages 8- 45 years. Items are scaled on a 5-point scale from 0 (never) to 4 (almost always). Scores are transformed on a scale range from 0 to 100. The total score is the sum of all the items over the number of items answered on all scales., Baseline and at 6 and 12 months after randomization
Sponsor/Collaborators: Sponsor: Jing Luo | Collaborators: The Leona M. and Harry B. Helmsley Charitable Trust
Gender: ALL
Age: CHILD, ADULT
Phases: PHASE4
Enrollment: 400
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2023-03-15
Completion Date: 2025-03-19
Results First Posted:
Last Update Posted: 2025-04-06
Locations: BIRDEM Hospital, Dhaka, Bangladesh|Bugando Medical Center, Mwanza, Tanzania|Sekou-Toure Hospital, Mwanza, Tanzania
URL: https://clinicaltrials.gov/show/NCT05614089