RecruitingPhase 4NCT05454891

Extended Bolus for Meals in a Closed-loop System

Postprandial Glucose Control Using an Extended Bolus for High-fat High Protein Meals in a Closed-loop System in Patients With Type 1 Diabetes

Sponsor

University of California, San Francisco

Enrollment

30 participants

Start Date

Jul 15, 2022

Study Type

INTERVENTIONAL

Conditions

Type 1 Diabetes

Summary

This study aims to evaluate whether the use of an extended bolus will improve glucose control with high-fat high protein meals using a closed-loop system. The new knowledge gained from this study may provide a method to allow for the proper administration of insulin over an extended period to mitigate the risk of prolonged hyperglycemia or early hypoglycemia.

Eligibility

Min Age: 13 YearsMax Age: 19 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether using an extended insulin bolus — delivering mealtime insulin more slowly over time rather than all at once — can improve blood sugar control after eating in teenagers with type 1 diabetes who use the Control IQ closed-loop insulin pump system (an "artificial pancreas"). **You may be eligible if...** - You are between 13 and 19 years old with type 1 diabetes - You have been using the Control IQ closed-loop insulin pump for at least some time - Your HbA1c (average blood sugar) is between 6% and 10% - You have been diagnosed with type 1 diabetes for at least 1 year - You live in the United States **You may NOT be eligible if...** - Your HbA1c is above 10% (indicating very poor blood sugar control) - You have had a severe low blood sugar episode or diabetic ketoacidosis (DKA) requiring ER care in the past 3 months - You have gastroparesis (delayed stomach emptying), seizure disorder, or serious kidney/liver disease - You are on non-insulin diabetes medications (other than metformin) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGExtended bolus of insulin then standard bolus of insulin

For a standardized HFHP breakfast, participants will receive an extended meal bolus of insulin on the first morning and a standard meal bolus of insulin on the second morning of the study.

DRUGStandard bolus of insulin then extended bolus of insulin

For a standardized HFHP breakfast, participants will receive a standard bolus of insulin on the first morning and an extended bolus of insulin on the second morning of the study.