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

Summary

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.

Conditions

• Type1 Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Autoimmune Diabetes
• Juvenile Diabetes
• Diabetes Mellitus Complication
• Diabetic Nephropathies
• Metabolic Disease
• Diabetic Kidney Disease

Interventions

DIAGNOSTIC_TEST

Blood draw

Participants will undergo a blood collection for hemoglobin A1c, adiponectin, total cholesterol, LDL, HDL, triglycerides, and c-peptide at baseline and follow up in 3-6 months.

DIAGNOSTIC_TEST

Urine sample collection

Participants will undergo urine sample collection for urine microalbumin and urine creatinine at baseline and follow up in 3-6 months.

DIAGNOSTIC_TEST

DXA scan

Participants will undergo a DXA scan for lean and fat mass measurements at baseline and follow up in 3-6 months.

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

  collaborator NIH

• Colorado Clinical & Translational Sciences Institute

  collaborator OTHER

• National Center for Advancing Translational Sciences (NCATS)

  collaborator NIH

• University of Colorado, Denver

  lead OTHER

Eligibility

Min Age

7 Years

Max Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-08-14

Primary Completion

2026-08-01

Completion

2026-08-01

Countries

• United States

Study Locations