NCT03945747: MERMAID-T1D

MEtabolic and Renal Effects of AutoMAted Insulin Delivery Systems in Youth With Type 1 Diabetes Mellitus

Active, enrolled Last updated 30 March 2025

What this trial tests

trial testing Blood draw in Type1 Diabetes Mellitus in 50 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

14 August 2019

Primary endpoint
1 August 2026

1 August 2026

Quick facts

Lead sponsor	University of Colorado, Denver
Status	Active, enrolled
Study type	OBSERVATIONAL
Enrollment	50
Start date	14 August 2019
Primary completion	1 August 2026
Estimated completion	1 August 2026
Sites	1 location across United States

Drugs / interventions tested

• Blood draw — full drug profile →
• Urine sample collection — full drug profile →
• DXA scan

Conditions studied

• Type1 Diabetes Mellitus — all drugs for Type1 Diabetes Mellitus →
• Diabetes Mellitus, Type 1 — all drugs for Diabetes Mellitus, Type 1 →
• Autoimmune Diabetes — all drugs for Autoimmune Diabetes →
• Juvenile Diabetes — all drugs for Juvenile Diabetes →

Sponsor

University of Colorado, Denver

Who can join

Adults 7 to 18, any sex, with Type1 Diabetes Mellitus or Diabetes Mellitus, Type 1. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

In type 1 diabetes (T1DM), automated insulin delivery (AID) systems such as the hybrid closed loop artificial pancreas (HCL AP) combine the use of an insulin pump, continuous blood sugar monitor, and control algorithm to adjust background insulin delivery to improve time in target blood sugar range. Systems such as the predictive low glucose suspend system (PLGS) pause insulin delivery to try and reduce low blood sugars. We aim to complete a pilot study involving recruitment of youth ages 7 to 18 years from the following groups with type 1 diabetes: control participants consisting of youth on either multiple daily insulin injections or conventional insulin pump therapy that plan to continue with their current treatment modality, youth being transitioned to the HCL AP system, and youth being transitioned to the PLGS system. Individuals will be recruited into each of the aforementioned study groups based on their own expressed desire to either continue on MDI/standard insulin pump therapy or transition to either the HCL AP or PLGS systems. The decision to either continue with current therapy or transition therapy will remain entirely up to the participant and their family and will be based on personal preference and insurance coverage for that individual. We will not be randomizing the participants to any given treatment group during this study but rather will be recruiting based on the participant's decision. We would like to complete a physical exam with pubertal staging, collect blood and urine samples to evaluate cardiometabolic and renal markers, and complete a DXA scan to evaluate total lean and fat mass. After 3-6 months of either continuation of current treatment with either multiple daily insulin injections or conventional insulin pump therapy or transitioning to the HCL AP or PLGS systems, we would like to repeat the previously described blood, urine, and imaging tests for comparison. We are interested in examining the impact of the HCL AP and PLGS systems on maintaining blood sugars in target range, insulin sensitivity, and markers of cardiometabolic and renal function. We hypothesize that pauses in insulin delivery, as seen in the setting of automated insulin delivery systems, will result in improvements in insulin sensitivity, cardiometabolic markers, and renal function markers.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.