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
University of California, San Francisco
30 participants
Jul 15, 2022
INTERVENTIONAL
Conditions
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
Inclusion Criteria11
- 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 Criteria12
- 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
Interventions
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.
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)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05454891