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Insulin

Extended Insulin Bolus for Type 1 Diabetes

Phase 4
Recruiting
Led By Laya Ekhlaspour, MD
Research Sponsored by University of California, San Francisco
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosed with type 1 diabetes for at least one year
Age between 13 and 18 years old, A1C > 6% at screening
Must not have
Known history of gastroparesis, seizure disorder, adrenal insufficiency, or ongoing renal or hepatic disease
Currently undergoing cancer treatment or systemic treatment with steroids
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 5 hours post-bolus
Awards & highlights
No Placebo-Only Group
All Individual Drugs Already Approved
Drug Has Already Been Approved
Pivotal Trial

Summary

This trial will test whether using an extended bolus of insulin will improve glucose control during high-fat, high-protein meals, using a closed-loop system.

Who is the study for?
This trial is for teens (13-18) with Type 1 Diabetes who use a smartphone and the Control IQ closed-loop system. They must have an A1C over 6%, not be on new diabetes meds other than insulin, and agree to follow meal/study guidelines. It's not for those with severe diabetes complications, untreated thyroid issues, or certain chronic conditions.
What is being tested?
The study tests if extending the time insulin is delivered after eating high-fat/protein meals can better control blood sugar in Type 1 Diabetics using a closed-loop system. Participants will try both standard and extended boluses of insulin to see which manages glucose levels more effectively.
What are the potential side effects?
While specific side effects are not listed, typical risks may include low blood sugar (hypoglycemia) from too much insulin or high blood sugar (hyperglycemia) if the dose isn't enough. There could also be discomfort at injection sites.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with type 1 diabetes for over a year.
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I am between 13 and 18 years old with an A1C level over 6%.
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I take 0.3 units or more of insulin per kilogram of my body weight daily.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a history of gastroparesis, seizures, adrenal issues, or kidney/liver disease.
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I am currently receiving cancer treatment or taking steroids.
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My thyroid condition is not being treated or is unstable.
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I've been to the ER or hospitalized for severe low blood sugar or diabetic ketoacidosis recently.
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I have been diagnosed with Celiac Disease.
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I have taken diabetes medication other than insulin or metformin in the last 30 days.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and 5 hours post-bolus
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 5 hours post-bolus for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Glucose Area Under Curve [AUC]
Secondary study objectives
Average glucose
Change in glucose
Insulin dosage
+8 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Group I: High Fat High Protein (HFHP) Meal- standard then extended insulin bolus armExperimental Treatment1 Intervention
Subjects will receive standard meal bolus for breakfast on the first day and extended meal bolus on the second day.
Group II: High Fat High Protein (HFHP) Meal- extended then standard insulin bolus armExperimental Treatment1 Intervention
Subjects will receive extended meal bolus for breakfast on the first day and standard meal bolus on the second day of the study.

Find a Location

Who is running the clinical trial?

University of California, San FranciscoLead Sponsor
2,586 Previous Clinical Trials
15,084,225 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,444 Previous Clinical Trials
4,331,186 Total Patients Enrolled
Laya Ekhlaspour, MDPrincipal InvestigatorUniversity of California, San Francisco
~1 spots leftby Dec 2024
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