Extended bolus of insulin then standard bolus of insulin for Type 1 Diabetes Mellitus
Phase-Based Progress Estimates
Effectiveness
Safety
University of California San Francisco, San Francisco, CA
Type 1 Diabetes Mellitus+1 More
Extended bolus of insulin then standard bolus of insulin - DrugEligibility
< 65
All Sexes
What conditions do you have?
Select
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
This is further along than 93% of similar trials
Other trials for Type 1 Diabetes Mellitus
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
This is further along than 85% of similar trials
Other trials for Type 1 Diabetes Mellitus
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: DrugHigh 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: DrugTrial 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
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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 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.
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