Extended Bolus for Meals in a Closed-loop System

Part of paid clinical trials in San Francisco, California.

Sponsor
University of California, San Francisco
Study ID
NCT05454891
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
13 Years - 19 Years
Healthy Volunteers
Not accepted

Interventions

  • Tandem t:slim X2 insulin pump: Extended bolus of insulin then standard bolus of insulin — DEVICE
    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.
  • Tandem t:slim X2 insulin pump: Standard bolus of insulin then extended bolus of insulin — DEVICE
    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.

Study Details

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.

Key Dates

Start date
Jul 15, 2022
Status verified
Apr 2026
Primary completion
Dec 19, 2024
Completion
Dec 19, 2024

Study Design

Enrollment
30 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Glucose Area Under Curve [AUC] [ Time Frame: 0 to 5 hours post-meal onset ]

Locations (1)

FacilityCityStateZIP
University of California San FranciscoSan FranciscoCalifornia94158

Find similar trials in San Francisco, CA

By condition
Type 1 diabetes
By specialty
Endocrinology
By research site
University of California San Francisco· San Francisco, CA

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