RightFit
RecruitingEarly Phase 1

Precision Dosing of Metformin in Youth With T2D

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
10 Years to 21 Years
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study compares the usual metformin dose of 1,000 mg twice a day with a higher dose of 1,350 mg twice a day. It is for young people ages 10–21 with type 2 diabetes who take regular metformin.

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).

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Are 10–21 years old.
  • Were diagnosed with type 2 diabetes by a health care provider at least 1 month ago.
  • Have had no medicines added or stopped for 2 weeks before screening, and no insulin dose change greater than 20%.
  • Take regular metformin, not the extended-release form.
  • Can wear a continuous glucose monitor (CGM), a device that tracks blood sugar, for a total of 6 weeks.
  • Speak English or Spanish.
  • Are willing to follow study advice and steps. You and your parent or guardian are willing to attend all required training sessions.
  • You and/or your parent or guardian can and will sign the required forms to agree to join.

Who can't join

  • Test positive for pancreatic autoantibodies, which are immune proteins that target cells in the pancreas.
  • Have a known history of ongoing kidney or liver disease.
  • Have a known serious mental illness or delay in development that makes it hard to complete study tasks on your own.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Age 10-21 years * Provider diagnosis of T2D * Stable medication regimen for 2 weeks before screening visit (No addition or removal of medications and no more than 20% change in insulin dose) * ≥ 1 month from T2D diagnosis * Taking regular metformin (not extended-release formula) * Ability to wear CGM for a total of 6 weeks while in the study. * English or Spanish speakers. * Willing to abide by recommendations and study procedures. * Willing and able to sign the Informed Consent Form (ICF) and/or has a parent or guardian willing and able to sign the ICF. * Participant and parent(s)/guardian(s) willingness to participate in all training sessions as directed by study staff. Written informed consent (and assent when applicable) obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study. Exclusion Criteria: * Pancreatic autoantibody positivity (GAD-65, insulin, IA-2, ICA 512, Zn-T8). * Known history of ongoing renal or hepatic disease. * Known history of significant mental illness or developmental delay impacting the ability to complete study activities independently.

Study sites (2)

CA