Effects of Metformin and Automated Insulin Delivery on Youth with Type 1 Diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the impact of metformin and an automated insulin delivery system on renal vascular resistance, insulin sensitivity, and cardiometabolic function in youth aged 12-25 with type 1 diabetes. The study aims to understand how these interventions can improve kidney and cardiovascular outcomes, given the complexities of type 1 diabetes that extend beyond insulin deficiency. Participants will be monitored for changes in their health metrics while receiving either metformin or a placebo alongside their usual insulin regimen.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* T1D and using an automated insulin delivery system or multiple daily insulin injections/manual insulin pump plus continuous glucose monitor for \> 6 months
* Age 12-25 years
* Use of an automated insulin delivery system or multiple daily insulin injections plus a continuous glucose monitor or an insulin pump in manual mode plus a continuous glucose monitor for \> 6 months
* Hemoglobin A1c \< 11%
* No recent episodes of diabetic ketoacidosis (DKA) or hyperglycemic hyperosmolar syndrome (HHS) (within 30 days)
* Pubertal (Tanner stage ≥ 2)
* Weight \> 54 kg and BMI \> 5th percentile for age and sex

Exclusion Criteria:

* Blood pressure \> 140/90 mm Hg
* Hemoglobin \< 9 g/dL
* Estimated glomerular filtration rate \< 60 mL/min/1.73 m2 or serum creatinine \> 1.2 mg/dL or history of urinary albumin to creatinine ratio ≥ 300mg/g or history of acute kidney injury
* Use of anti-diabetic agents except insulin, angiotensin converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARB's), diuretics, daily non-steroidal anti-inflammatory drugs (NSAIDs) or aspirin, sulfonamides, procaine, thiazosulfone or probenecid
* Seafood or iodine allergy
* Pregnancy or breast feeding for females

Where it's running

• Seattle Children's Hospital
  Seattle, Washington, United States Recruiting
• Children's Hospital Colorado/University of Colorado Anschutz Medical Campus
  Aurora, Colorado, United States Active not recruiting

Study contacts

• Study coordinator: Kalie Tommerdahl, MD
• Email: ktomme@uw.edu
• Phone: (206) 616-9015

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.