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Biguanide

Metformin + Automated Insulin Delivery for Type 1 Diabetes (MANATEE-T1D Trial)

Phase 1
Recruiting
Research Sponsored by University of Colorado, Denver
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 12-21 years
No recent episodes of diabetic ketoacidosis (DKA) or hyperglycemic hyperosmolar syndrome (HHS)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 months
Awards & highlights

MANATEE-T1D Trial Summary

This trial is testing whether metformin and automated insulin delivery systems, combined or separately, can improve renal vascular resistance and insulin sensitivity in youth with type 1 diabetes, compared to youth with type 1 diabetes who only use a continuous glucose monitor.

Who is the study for?
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.Check my eligibility
What is being tested?
The MANATEE-T1D study tests if metformin can improve kidney function and insulin sensitivity in youth with type 1 diabetes using automated insulin systems versus those on standard injections. It's a randomized trial where some get metformin and others get a placebo for four months to see effects on renal resistance and cardiometabolic health.See study design
What are the potential side effects?
Metformin may cause digestive upset like nausea or diarrhea, vitamin B12 deficiency with long-term use, and rarely lactic acidosis—a serious condition requiring immediate medical attention. The contrast agents used could cause allergic reactions or affect thyroid function.

MANATEE-T1D Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 12 and 21 years old.
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I haven't had recent severe diabetic complications.
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I weigh more than 54 kg and my BMI is above the 5th percentile for my age and sex.
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I am a young person with type 1 diabetes confirmed by pancreatic antibody.

MANATEE-T1D Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Glomerular filtration rate
Renal vascular resistance
Secondary outcome measures
Arterial stiffness
Endothelial function
Insulin sensitivity

MANATEE-T1D Trial Design

3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Multiple daily insulin injections plus continuous glucose monitorExperimental Treatment2 Interventions
Participants with type 1 diabetes using multiple daily injections plus a continuous glucose monitor will not be randomized to receive medication treatment but will undergo RPF (Aminohippurate Sodium Injections 20%), GFR (Iohexol Inj 300 MG/ML), and insulin sensitivity (hyperinsulinemic-euglycemic clamp) assessments, in additional to assessments of cardiovascular and endothelial function.
Group II: Metformin plus automated insulin delivery systemActive Control3 Interventions
Some participants with type 1 diabetes using an automated insulin delivery system will be randomized to receive treatment with metformin and will undergo RPF (Aminohippurate Sodium Injections 20%), GFR (Iohexol Inj 300 MG/ML), and insulin sensitivity (hyperinsulinemic-euglycemic clamp) assessments, in additional to assessments of cardiovascular and endothelial function.
Group III: Placebo plus automated insulin delivery systemPlacebo Group3 Interventions
Some participants with type 1 diabetes using an automated insulin delivery system will be randomized to receive treatment with a placebo pill which is identical in appearance to the metformin pill and will undergo RPF (Aminohippurate Sodium Injections 20%), GFR (Iohexol Inj 300 MG/ML), and insulin sensitivity (hyperinsulinemic-euglycemic clamp) assessments, in additional to assessments of cardiovascular and endothelial function.

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

University of Colorado, DenverLead Sponsor
1,738 Previous Clinical Trials
2,149,466 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,838 Previous Clinical Trials
47,851,594 Total Patients Enrolled

Media Library

Metformin Hcl (Biguanide) Clinical Trial Eligibility Overview. Trial Name: NCT05065372 — Phase 1
Type 1 Diabetes Research Study Groups: Placebo plus automated insulin delivery system, Metformin plus automated insulin delivery system, Multiple daily insulin injections plus continuous glucose monitor
Type 1 Diabetes Clinical Trial 2023: Metformin Hcl Highlights & Side Effects. Trial Name: NCT05065372 — Phase 1
Metformin Hcl (Biguanide) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05065372 — Phase 1
Type 1 Diabetes Patient Testimony for trial: Trial Name: NCT05065372 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What have previous research endeavors uncovered regarding the efficacy of combining Metformin and automated insulin delivery systems?

"Currently, 43 Metformin plus automated insulin delivery system-focused trials are in Phase 3 and 179 experiments remain active. Although the majority of these investigations take place in Montréal, Quebec, there is a total of 2075 research sites operating related studies."

Answered by AI

What is the standard application of a Metformin plus automated insulin delivery system?

"Metformin coupled with an automated insulin delivery system is typically used to treat exercise related ailments. It can also offer relief from abdominal CT and contrast enhancement, as well as type 1 diabetes mellitus."

Answered by AI

What criteria must one fulfill in order to be eligible for this medical research effort?

"To be eligible for this experiment, subjects must possess cardiovascular conditions and range in age from 12 to 21. The research team is currently recruiting up to 60 volunteers."

Answered by AI

Is this medical trial accommodating participants younger than 50 years old?

"The age requirements for this study are between 12 and 21 years old. There is an abundance of 406 clinical trials designed to accommodate minors and 2046 studies intended for the elderly population above 65."

Answered by AI

What adverse effects could be experienced by patients taking Metformin and an automated insulin delivery system?

"As this is a Phase 1 trial, the combined safety of Metformin and an automated insulin delivery system was rated at a score of 1 due to limited data supporting its efficacy."

Answered by AI

What is the current enrollment size for this clinical trial?

"Affirmative. Clinicaltrials.gov reveals that this trial is still accepting applicants, having first been posted on July 1st of 2022 and recently updated near the end of the same month. 60 test subjects are needed from a single medical facility."

Answered by AI

Does this trial have vacancies for participants?

"Yes, according to the clinicaltrials.gov website, this study is presently searching for participants. It was first listed on July 1st 2022 and revised two weeks later on July 28th 2022; they are looking to recruit 60 people at a single site."

Answered by AI

Who else is applying?

What state do they live in?
New Mexico
What site did they apply to?
University of Colorado Anschutz Medical Campus
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I am interested on the effects of metformin on type 1 diabetics.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
MANATEE-T1D: Metformin ANd AutomaTEd Insulin Delivery System Effects on Renal Vascular Resistance, Insulin Sensitivity, and Cardiometabolic Function in Youth With Type 1 Diabetes
2022. "MANATEE-T1D: Metformin ANd AutomaTEd Insulin Delivery System Effects on Renal Vascular Resistance, Insulin Sensitivity, and Cardiometabolic Function in Youth With Type 1 Diabetes". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05065372.
All > Diabetic Kidney Disease > Allergy
~29 spots leftby Jan 2026
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