Extended bolus of insulin then standard bolus of insulin for Type 1 Diabetes Mellitus

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
University of California San Francisco, San Francisco, CA
Type 1 Diabetes Mellitus+1 More
Extended bolus of insulin then standard bolus of insulin - Drug
Eligibility
< 65
All Sexes
What conditions do you have?
Select

Study 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.

Eligible Conditions

  • Type 1 Diabetes Mellitus

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

Study Objectives

1 Primary · 11 Secondary · Reporting Duration: Baseline and 5 hours post-bolus

Hour 5
Average glucose
Change in glucose
Glucose Area Under Curve [AUC]
Insulin dosage
Peak glucose concentration
Percentage of time between 70-140 mg/dL
Percentage of time between 70-180 mg/dL
Percentage of time in hyperglycemic range (defined as ≥180 mg/dL);
Percentage of time in hypoglycemic range (defined as < 70 mg/dL)
Time to baseline
Time to peak glucose
Time to target

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

2 Treatment Groups

High Fat High Protein (HFHP) Meal- extended then standard insulin bolus arm
1 of 2
High Fat High Protein (HFHP) Meal- standard then extended insulin bolus arm
1 of 2
Experimental Treatment

30 Total Participants · 2 Treatment Groups

Primary Treatment: Extended bolus of insulin then standard bolus of insulin · No Placebo Group · Phase 4

High Fat High Protein (HFHP) Meal- extended then standard insulin bolus arm
Drug
Experimental Group · 1 Intervention: Extended bolus of insulin then standard bolus of insulin · Intervention Types: Drug
High Fat High Protein (HFHP) Meal- standard then extended insulin bolus arm
Drug
Experimental Group · 1 Intervention: Standard bolus of insulin then extended bolus of insulin · Intervention Types: Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline and 5 hours post-bolus
Closest Location: University of California San Francisco · San Francisco, CA
Photo of University of California San Francisco 1Photo of university of california san francisco 2Photo of University of California San Francisco 3
2001First Recorded Clinical Trial
2 TrialsResearching Type 1 Diabetes Mellitus
345 CompletedClinical Trials

Who is running the clinical trial?

University of California, San FranciscoLead Sponsor
2,246 Previous Clinical Trials
11,473,644 Total Patients Enrolled
6 Trials studying Type 1 Diabetes Mellitus
863 Patients Enrolled for Type 1 Diabetes Mellitus
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,094 Previous Clinical Trials
5,051,463 Total Patients Enrolled
148 Trials studying Type 1 Diabetes Mellitus
50,275 Patients Enrolled for Type 1 Diabetes Mellitus
Laya Ekhlaspour, MDPrincipal InvestigatorUniversity of California, San Francisco

Eligibility Criteria

Age < 65 · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have been diagnosed with type 1 diabetes for at least one year.
The total daily dose of insulin must be at least 0.3 units/kg/day.
You have an Android or Apple smartphone.
You are willing to participate in all training sessions as directed by study staff.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.