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Clinical Trial Details

Trial ID: L6068
Source ID: NCT06120881
Associated Drug: Metformin
Title: Precision Dosing of Metformin in Youth With T2D
Acronym: PRECISE_T2D
Status: RECRUITING
Study Results: NO
Results:
Conditions: Type 2 Diabetes
Interventions: DRUG: Metformin
Outcome Measures: Primary: Acceptability of Higher Metformin Dose measured with the Acceptability of Intervention Measure (AIM), The perception that a higher dose of Metformin is agreeable or satisfactory measured with the 4-item Acceptability of Intervention Measure (AIM). A 4-item measure of perceived intervention acceptability. Items are measured on a 5-point Likert scale (Completely Disagree-Completely Agree). Score is calculated mean. The greater the score, the better the acceptability., Measured at 3 months|Feasibility of Higher Metformin Dose measured with the Feasibility of Intervention Measure (FIM), The extent to which a higher dose Metformin study can be successfully carried out measured with 4-item Feasibility of Intervention Measure (FIM). A 4-item instrument to assess perceived intervention feasibility. Items are measured on a 5-point Likert scale (Completely Disagree-Completely Agree). Score is calculated mean. The greater the score, the better the feasibility., Measured at 3 months | Secondary: Glycemic Change, Change in serum HbA1C at 3 months adjusted for the baseline value youth with T2D on higher dose of metformin compared to standard dose, Baseline (0) to 3 months|Time in target glucose range, Time spent in target glucose range of 70 to 180 mg/dL, Baseline (0) to 3 months|Time above high glucose range, Percent of readings and time \>250 mg/dL, Baseline (0) to 3 months|Time above glucose range, Percent of readings and time 181-250 mg/dL, Baseline (0) to 3 months|Time in glucose range, Percent of readings and time 70-180 mg/dL, Baseline (0) to 3 months|Time below glucose range, Percent of readings and time 54-69 mg/dL, Baseline (0) to 3 months|Time below low glucose range, Percent of readings and time \<54 mg/dl, Baseline (0) to 3 months|Glucose management indicator, Continuous glucose monitoring (CGM) metric that indicates average blood glucose. Glucose Management Indicator (GMI) approximates the laboratory A1C level expected based on average glucose measured using CGM values. Average glucose is derived from 14 or more days of CGM readings., Baseline (0) to 3 months|Co-efficient of variation of glucose, CGM metric that measures variability in CGM values, Baseline (0) to 3 months
Sponsor/Collaborators: Sponsor: University of California, San Francisco | Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Gender: ALL
Age: CHILD, ADULT
Phases: EARLY_PHASE1
Enrollment: 20
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-04-25
Completion Date: 2026-12-31
Results First Posted:
Last Update Posted: 2025-03-30
Locations: UCSF Benioff Children's Hospital Oakland, Pediatric Diabetes Clinic, Oakland, California, 94609, United States|UCSF Benioff Children's Hospital San Francisco, Madison Clinic for Pediatric Diabetes, San Francisco, California, 94158, United States
URL: https://clinicaltrials.gov/show/NCT06120881