Extended Bolus for Meals in a Closed-loop System

Phase 4

Recruiting

• Conditions: Type 1 Diabetes
• Interventions: Drug: Extended bolus of insulin then standard bolus of insulin; Drug: Standard bolus of insulin then extended bolus of insulin

• Registration Number: NCT05454891
• Lead Sponsor: University of California, San Francisco

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-06-24
• Study First Submitted QC: 2022-07-08
• Study First Posted: 2022-07-12
• Study Start: 2022-07-15
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-10
• Last Update Posted: 2024-10-11
• Primary Completion: 2024-12-30
• Study Completion: 2025-07-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
High Fat High Protein (HFHP) Meal- extended then standard insulin bolus arm	Extended bolus of insulin then standard bolus of insulin	Subjects will receive extended meal bolus for breakfast on the first day and standard meal bolus on the second day of the study.
High Fat High Protein (HFHP) Meal- standard then extended insulin bolus arm	Standard bolus of insulin then extended bolus of insulin	Subjects will receive standard meal bolus for breakfast on the first day and extended meal bolus on the second day.

Primary Outcome Measures

Name	Time	Method
Glucose Area Under Curve [AUC]	Baseline and 5 hours post-bolus	Area under the curve between glucose trace and starting glucose (mg/dL\* hour)

Secondary Outcome Measures

Name	Time	Method
Percentage of time in hypoglycemic range (defined as < 70 mg/dL)	Baseline and 5 hours post-bolus	Percentage of time spent with blood sugar less than 70 mg/dL based on Continuous Glucose Monitor (CGM) values
Percentage of time between 70-180 mg/dL	Baseline and 5 hours post-bolus	Percentage of time spent between 70-180 mg/dl based on Continuous Glucose Monitor (CGM) values
Insulin dosage	Baseline and 5 hours post-bolus	Total insulin received during 5 hrs ( manual bolus as well as automated)
Time to baseline	Baseline and 5 hours post-bolus	Time spent till blood glucose returns to baseline
Change in glucose	Baseline and 5 hours post-bolus	The difference between baseline to max glucose value
Peak glucose concentration	Baseline and 5 hours post-bolus	Max blood glucose
Percentage of time between 70-140 mg/dL	Baseline and 5 hours post-bolus	Percent of glucose readings from CGM system between 70-140 mg/dL per unit of time
Percentage of time in hyperglycemic range (defined as ≥180 mg/dL);	Baseline and 5 hours post-bolus	Percentage of time spent with blood sugar higher than 180 mg/dL based on Continuous Glucose Monitor (CGM) values
Time to target	Baseline and 5 hours post-bolus	Time spent till blood glucose returns to range
Average glucose	Baseline and 5 hours post-bolus	Average glucose value based on Continuous Glucose Monitor (CGM) values
Time to peak glucose	Baseline and 5 hours post-bolus	Time spent till blood glucose reaches the maximum value after meal

Trial Locations

Locations (1)

University of California San Francisco; 🇺🇸 San Francisco, California, United States