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Behavioural Intervention

InsuLearn for Type 1 Diabetes (InsuLearn Trial)

N/A
Waitlist Available
Led By Anas Fathi, PhD
Research Sponsored by University of Virginia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Currently using insulin under multiple daily injections (MDI) therapy for at least six months
Clinical diagnosis of type 1 diabetes for at least one year
Must not have
Presence of a known adrenal disorder
NPH (neutral protamine hagedorn) insulin
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Summary

This trial is testing a new way to optimize insulin doses for diabetes patients. Participants will either start with the new intervention or the usual care. The new intervention involves collecting data at home for 4 weeks

Who is the study for?
This trial is for adults over 18 with Type 1 Diabetes who have been on multiple daily insulin injections for at least six months, have a Hemoglobin A1c between 7.0% - 10.0%, and struggle with carbohydrate counting. They must be able to use the internet, wear a continuous glucose monitor, and if female and sexually active, agree to use contraception.
What is being tested?
The InsuLearn intervention is being tested against usual care in people with Type 1 Diabetes. It involves optimizing insulin doses based on data from a home monitoring period of four weeks. Participants are randomly assigned to start with either InsuLearn or their regular treatment.
What are the potential side effects?
Since this trial focuses on an educational tool (InsuLearn) rather than medication, direct side effects are not anticipated as it's related to learning how to manage insulin dosing better.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been using insulin injections multiple times a day for at least 6 months.
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I have been diagnosed with type 1 diabetes for over a year.
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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a diagnosed adrenal gland disorder.
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I use NPH insulin for my diabetes.
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I am currently receiving treatment for seizures.
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I am currently taking medication to lower my blood sugar that is not insulin.
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I have an ongoing infection that won't clear before the study starts.
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My blood pressure is not higher than 100/180 mmHg.
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I have not been hospitalized for psychiatric reasons in the last 6 months.
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My kidney function is reduced.
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I am currently being treated for gastroparesis.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

2Treatment groups
Active Control
Group I: InsuLearn→Usual CareActive Control1 Intervention
During the first 24 hours of the hotel admission (visit 6), participants' insulin dose will be calculated by the InsuLearn, MD approved, report. The second 24 hours of the hotel admission (visit 7), participants will use their usual care method to calculate their insulin dose.
Group II: Usual Care→InsuLearnActive Control1 Intervention
During the first 24 hours of the hotel admission (visit 6), participants' insulin dose will be calculated by their usual care method. The second 24 hours of the hotel admission (visit 7), participants will use the InsuLearn, MD approved, report to calculate their insulin dose.

Find a Location

Who is running the clinical trial?

University of VirginiaLead Sponsor
771 Previous Clinical Trials
1,284,287 Total Patients Enrolled
MedtronicIndustry Sponsor
613 Previous Clinical Trials
759,723 Total Patients Enrolled
DexCom, Inc.Industry Sponsor
142 Previous Clinical Trials
35,323 Total Patients Enrolled
~5 spots leftby Dec 2024
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