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

NCT03945747 | Active Not Recruiting

• 3 other identifiers: 18-1558UL1TR0025355T32DK063687-15
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Automated insulin delivery systems; Insulin sensitivity; Cardiometabolic function; Renal function

Outcome Measures

Primary Outcomes (1)

• Change in estimated insulin sensitivity

  Estimated by calculating the eIS, Pittsburgh eGDR, and SEARCH IS equations

  3-6 months

Secondary Outcomes (5)

• Change in estimated glomerular filtration rate (GFR)

  3-6 months

• Change in body mass index (BMI)

  3-6 months

• Change in lipid profile

  3-6 months

• Change in c-peptide

  3-6 months

• Change in DXA scan

  3-6 months

Study Arms (3)

Control group

Individuals continue current treatment regimen with either standard insulin pump therapy or multiple daily insulin injections for the duration of the study.

Diagnostic Test: Blood draw; Diagnostic Test: Urine sample collection; Diagnostic Test: DXA scan

Hybrid closed-loop artificial pancreas system group

Individuals transition from either standard insulin pump therapy or multiple daily injections to a hybrid closed-loop system at the beginning of the study after initial labs and imaging studies are completed.

Diagnostic Test: Blood draw; Diagnostic Test: Urine sample collection; Diagnostic Test: DXA scan

Predictive low glucose suspend system group

Individuals transition from either standard insulin pump therapy or multiple daily injections to a predictive low glucose suspend system at the beginning of the study after initial labs and imaging studies are completed.

Diagnostic Test: Blood draw; Diagnostic Test: Urine sample collection; Diagnostic Test: DXA scan

Interventions

Blood draw DIAGNOSTIC_TEST

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.

Control group; Hybrid closed-loop artificial pancreas system group; Predictive low glucose suspend system group

Urine sample collection DIAGNOSTIC_TEST

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

Control group; Hybrid closed-loop artificial pancreas system group; Predictive low glucose suspend system group

DXA scan DIAGNOSTIC_TEST

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

Control group; Hybrid closed-loop artificial pancreas system group; Predictive low glucose suspend system group

Eligibility Criteria

• Age: 7 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Individuals aged 7-18 years with known type 1 diabetes mellitus who are either planning to continue with standard insulin pump or multiple daily insulin injection therapy OR planning to transition to an automated insulin delivery system such as the hybrid closed-loop artificial pancreas system or the predictive low glucose suspend system.

You may qualify if:

• Age 7-18 years
• Type 1 diabetes with at least two of the following criteria: diabetes-associated antibody-positivity, rapid conversion to insulin requirement after diagnosis, absent c-peptide, or DKA at diagnosis
• Currently receiving insulin therapy by multiple daily injections or standard insulin pump therapy

You may not qualify if:

• Non-type 1 diabetes mellitus
• Pregnant or breastfeeding
• Receiving treatment with non-insulin glucose-altering medications including oral anti-hyperglycemic medications, steroids, or antipsychotics
• Following a ketogenic diet

Sponsors & Collaborators

• University of Colorado, Denver: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• Colorado Clinical & Translational Sciences Institute: collaborator
• National Center for Advancing Translational Sciences (NCATS): collaborator

Study Sites (1)

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Urine and blood samples

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Diabetes Complications; Diabetic Nephropathies; Metabolic Diseases; Insulin Resistance

Interventions

Blood Specimen Collection; Absorptiometry, Photon

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Hyperinsulinism

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Radiography; Diagnostic Imaging; Densitometry; Photometry; Chemistry Techniques, Analytical

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2019
• First Posted: May 10, 2019
• Study Start: August 14, 2019
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: March 30, 2025

Record last verified: 2025-03

Locations

US (1)