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Extended Bolus for Meals in a Closed-loop System

RECRUITINGPhase 4Sponsored by University of California, San Francisco
Actively Recruiting
PhasePhase 4
SponsorUniversity of California, San Francisco
Started2022-07-15
Est. completion2025-07-30
Eligibility
Age13 Years – 19 Years
Healthy vol.Accepted
Locations1 site
View on ClinicalTrials.gov →

NCT05454891

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

Age: 13 Years – 19 YearsHealthy volunteers accepted
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

Conditions2

DiabetesType 1 Diabetes

Locations1 site

University of California San Francisco
San Francisco, California, 94158
Rebecca Wesch

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