RecruitingEarly Phase 1NCT06120881

Precision Dosing of Metformin in Youth With T2D

Pilot Study of Precision Dosing of Metformin in Youth With Type 2 Diabetes (PRECISE_T2D)

Sponsor

University of California, San Francisco

Enrollment

20 participants

Start Date

Apr 25, 2024

Study Type

INTERVENTIONAL

Conditions

Type 2 Diabetes

Summary

The purpose of this study to compare the typically prescribed dose of metformin (1000mg twice a day) with a higher dose of metformin (1350mg twice a day).

Eligibility

Min Age: 10 YearsMax Age: 21 Years

Plain Language Summary

Simplified for easier understanding

This study focuses on finding the right dose of metformin — a common diabetes drug — for children and teenagers with type 2 diabetes. Researchers will use continuous glucose monitors (CGMs, small sensors worn on the body) to track blood sugar patterns and help personalize dosing. **You may be eligible if...** - You are 10–21 years old - You have been diagnosed with type 2 diabetes by a doctor - You are currently taking regular metformin (not the extended-release version) - Your diabetes medication has been stable for at least 2 weeks - You are able to wear a CGM for 6 weeks and follow study procedures - You speak English or Spanish **You may NOT be eligible if...** - You have positive pancreatic autoantibodies (which would suggest type 1 diabetes) - You have known kidney or liver disease - You have a significant mental health condition or developmental delay that would make it hard to participate independently Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGMetformin

Participants will receive either 2700mg of metformin/day (1350mg twice a day) or 2000mg of metformin/day (1000mg twice a day, standard of care). The study intervention will be blinded to the participants as they will receive the same number of pills (4 pills of the same size) regardless of whether they are in the intervention arm or control arm .