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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and 5 hours post-bolus

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and 5 hours post-bolus

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Glucose Area Under Curve [AUC]

Secondary outcome measures

Average glucose

Change in glucose

Insulin dosage

+8 more

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.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of California, San FranciscoLead Sponsor

2,507 Previous Clinical Trials

15,238,510 Total Patients Enrolled

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH

2,362 Previous Clinical Trials

4,315,014 Total Patients Enrolled

Laya Ekhlaspour, MDPrincipal InvestigatorUniversity of California, San Francisco

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the extended bolus of insulin regimen authorized by the FDA compared to standard bolus?

"Our team at Power evaluated the safety of Extended bolus of insulin then standard bolus in a Phase 4 trial and gave it an overall score of 3, considering that this treatment has already been approved."

Answered by AI

Do I meet the qualifications to participate in this medical study?

"This research project will include 30 minors between the ages of 13 and 18 suffering from type 1 diabetes. In order to participate, patients must meet several criteria: A1C > 6% at screening, having been diagnosed with T1DM for a minimum of one year, currently using the Control IQ closed-loop system, adhering to dietary recommendations and study procedures outlined by staff, TDD ≥ 0.3 units/kg/day; own an Android or Apple smartphone, sign (or have parent/guardian sign) ICF during informed consent process; abstain from taking any new glucose-lowering agent during trial period;"

Answered by AI

How many participants are enrolled in this experiment?

"Affirmative. Information hosted on clinicaltrials.gov confirms that this medical trial, first put up for recruitment on July 15th 2022 is currently recruiting patients. The goal is to enlist 30 individuals from a single site."

Answered by AI

Is this research endeavor seeking participants that are over four decades old?

"This research trial is seeking participants between the ages of 13 and 18."

Answered by AI

Are enrollees currently being accepted for this investigation?

"Affirmative. Clinicaltrials.gov reveals that this trial, which was first advertised on July 15th 2022, is actively searching for participants; the description was most recently updated on August 26th 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Extended Bolus for Meals in a Closed-loop System

2022. "Extended Bolus for Meals in a Closed-loop System". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05454891.