Metformin + Automated Insulin Delivery for Type 1 Diabetes
(MANATEE-T1D Trial)
Trial Summary
Will I have to stop taking my current medications?
The trial requires that participants do not use anti-diabetic agents other than insulin, ACE inhibitors, ARBs, diuretics, daily NSAIDs or aspirin, sulfonamides, procaine, thiazosulfone, or probenecid. If you are taking other anti-diabetic medications, you may need to stop them.
Is Metformin safe for use in humans?
Metformin, also known by names like Glucophage and Fortamet, is generally considered safe for humans when used as prescribed. It is commonly used to manage type 2 diabetes and is often combined with other medications to improve blood sugar control. The most common side effects are mild and include gastrointestinal issues like nausea and diarrhea.12345
How does the drug Metformin + Automated Insulin Delivery differ from other treatments for Type 1 Diabetes?
This treatment is unique because it combines Metformin, a drug that improves insulin action, with an automated insulin delivery system, which uses a smartphone-based controller to manage insulin levels. This combination aims to improve blood sugar control in patients with Type 1 Diabetes who struggle with traditional insulin therapy alone.678910
What is the purpose of this trial?
This trial tests a device that automatically adjusts insulin levels and a medication called metformin in young people with type 1 diabetes. The goal is to see if this combination can better manage blood sugar and improve heart and kidney health. The use of metformin along with insulin therapy has been suggested as a means of improving diabetes control and alleviating weight gain in type 1 diabetes.
Eligibility Criteria
This trial is for young people aged 12-21 with type 1 diabetes who use an automated insulin delivery system or injections plus a glucose monitor. They should weigh over 54 kg, have a BMI above the 5th percentile, and not have had recent severe diabetic complications. Participants must not be pregnant, taking certain medications (like ACE inhibitors), or have high blood pressure, kidney issues, or seafood/iodine allergies.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive metformin or placebo for 4 months while using automated insulin delivery systems or multiple daily injections with continuous glucose monitoring
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Metformin Hcl
Metformin Hcl is already approved in European Union, United States, Canada for the following indications:
- Type 2 diabetes mellitus
- Polycystic ovary syndrome
- Type 2 diabetes mellitus
- Type 2 diabetes mellitus
Find a Clinic Near You
Who Is Running the Clinical Trial?
Kalie Tommerdahl
Lead Sponsor
University of Colorado, Denver
Collaborator
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator