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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 13
Maximum Age: 19
Healthy Volunteers: f
View:

• 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

Locations
United States
California
University of California San Francisco
RECRUITING
San Francisco
Contact Information
Primary
Laya Ekhlaspour, MD
laya.ekhlaspour@ucsf.edu
415-514-8531
Backup
Rebecca Wesch
Rebecca.wesch@ucsf.edu
(415) 476-5984
Time Frame
Start Date: 2022-07-15
Estimated Completion Date: 2025-09-30
Participants
Target number of participants: 30
Treatments
Experimental: High Fat High Protein (HFHP) Meal- extended then standard insulin bolus arm
Subjects will receive extended meal bolus for breakfast on the first day and standard meal bolus on the second day of the study.
Experimental: High Fat High Protein (HFHP) Meal- standard then extended insulin bolus arm
Subjects will receive standard meal bolus for breakfast on the first day and extended meal bolus on the second day.
Related Therapeutic Areas
Sponsors
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Leads: University of California, San Francisco

This content was sourced from clinicaltrials.gov