MANATEE-T1D: Metformin ANd AutomaTEd Insulin Delivery System Effects on Renal Vascular Resistance, Insulin Sensitivity, and Cardiometabolic Function in Youth With Type 1 Diabetes

Launched by KALIE TOMMERDAHL · Sep 22, 2021

Keywords

ClinConnect Summary

The MANATEE-T1D trial is studying how a medication called metformin, when used with an automated insulin delivery system, affects kidney health and insulin use in young people with type 1 diabetes. The goal is to see if combining these treatments can improve how the body uses insulin and help protect the kidneys, which are often at risk in people with diabetes. This research is important because diabetes can lead to serious conditions like kidney disease and heart problems, especially if blood sugar levels are not well controlled.

To participate, young people aged 12 to 25 who have type 1 diabetes and have been using an automated insulin delivery system or multiple daily insulin injections for at least six months may be eligible. Participants will receive either metformin or a placebo (a treatment with no active medication) for four months. Throughout the study, researchers will measure changes in kidney function and how well the body responds to insulin. It's a chance to contribute to important research that could help improve care for young people with diabetes.

Gender

ALL

Eligibility criteria

• 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