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RECRUITINGPhase 4INTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Inclusion Criteria - Age between 13 and 19 years old, A1C \> 6% at screening - Diagnosed with type 1 diabetes for at least one year - Total daily dose (TDD) of insulin ≥ 0.3 units/kg/day - Currently using the Control IQ closed-loop system - Willing to abide by meal recommendations and study procedures - Willing and able to sign the willing to sign a consent form Form (ICF) and/or has a parent or guardian willing and able to sign the ICF - Use an Android or Apple smartphone - Willingness not to start any new non-insulin glucose-lowering agent during the course of the trial - Participant and parent(s)/guardian(s) willingness to participate in all training sessions as directed by study staff - Parent/guardian proficient in reading and writing English - Live in the United States, with no plans to move outside the United States during the study period Exclusion Criteria - A1C \>10% - One or more episodes of severe hypoglycemia or DKA requiring ER visit or hospitalization within the past three months - Used non-insulin anti-diabetic medication within the last 30 days other than metformin - Known history of gastroparesis, seizure disorder, adrenal insufficiency, or ongoing renal or hepatic disease - Pregnancy or lactation - Untreated or unstable hypothyroidism - Currently undergoing cancer treatment or systemic treatment with steroids - Untreated or inadequately treated mental illness - Current alcohol abuse - Current illness that would interfere with participation in the study - Delayed gastric emptying or any concurrent conditions that can be associated with delayed gastric emptying or altered digestion; and the use of any medication that affects gastric emptying - Celiac Disease Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria * Age between 13 and 19 years old, A1C \> 6% at screening * Diagnosed with type 1 diabetes for at least one year * Total daily dose (TDD) of insulin ≥ 0.3 units/kg/day * Currently using the Control IQ closed-loop system * Willing to abide by meal recommendations and study procedures * Willing and able to sign the Informed Consent Form (ICF) and/or has a parent or guardian willing and able to sign the ICF * Use an Android or Apple smartphone * Willingness not to start any new non-insulin glucose-lowering agent during the course of the trial * Participant and parent(s)/guardian(s) willingness to participate in all training sessions as directed by study staff * Parent/guardian proficient in reading and writing English * Live in the United States, with no plans to move outside the United States during the study period Exclusion Criteria * A1C \>10% * One or more episodes of severe hypoglycemia or DKA requiring ER visit or hospitalization within the past three months * Used non-insulin anti-diabetic medication within the last 30 days other than metformin * Known history of gastroparesis, seizure disorder, adrenal insufficiency, or ongoing renal or hepatic disease * Pregnancy or lactation * Untreated or unstable hypothyroidism * Currently undergoing cancer treatment or systemic treatment with steroids * Untreated or inadequately treated mental illness * Current alcohol abuse * Current illness that would interfere with participation in the study * Delayed gastric emptying or any concurrent conditions that can be associated with delayed gastric emptying or altered digestion; and the use of any medication that affects gastric emptying * Celiac Disease

Treatments Being Tested

DRUG

Extended 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.

DRUG

Standard 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.

Locations (1)

University of California San Francisco
San Francisco, California, United States