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Insulin

CGM-Assisted Insulin Dosing for Cystic Fibrosis-Related Diabetes

Phase 4
Waitlist Available
Led By Jagdeesh Ullal, MD
Research Sponsored by Jagdeesh Ullal
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age >18 years
Using basal bolus insulin
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 weeks
Awards & highlights
Pivotal Trial
Drug Has Already Been Approved
No Placebo-Only Group

Summary

This trial is testing whether using a CGM to help calculate meal-time insulin doses leads to better blood sugar management for people with CF than the current standard method.

Who is the study for?
This trial is for adults over 18 with cystic fibrosis-related diabetes, including those who've had a lung transplant and are on basal bolus insulin therapy. It's not open to current CGM users or those unable to perform fingerstick blood sugar tests.
What is being tested?
The study compares two ways of dosing meal-time rapid-acting insulin in cystic fibrosis patients: calculating doses based on carbohydrate intake versus using fixed doses. The effectiveness will be measured using continuous glucose monitors.
What are the potential side effects?
Potential side effects may include low blood sugar (hypoglycemia) from incorrect insulin dosing, which can cause shakiness, sweating, confusion, and in severe cases, loss of consciousness.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am older than 18 years.
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I am on a basal-bolus insulin regimen.
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I have been diagnosed with diabetes due to cystic fibrosis.
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I have cystic fibrosis and have had a lung transplant.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Time in Target
Secondary study objectives
Hypoglycemia duration
Hypoglycemia number

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Fixed Dosing, Followed by Carbohydrate CountingExperimental Treatment2 Interventions
Dosing of premeal insulin with fixed doses
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Insulin
2000
Completed Phase 4
~4280

Find a Location

Who is running the clinical trial?

Jagdeesh UllalLead Sponsor
Wake Forest University Health SciencesOTHER
1,390 Previous Clinical Trials
2,546,615 Total Patients Enrolled
1 Trials studying Cystic Fibrosis
100 Patients Enrolled for Cystic Fibrosis
Jagdeesh Ullal, MD3.86 ReviewsPrincipal Investigator - University of Pittsburgh Medical Center
University of Pittsburgh
5Patient Review
He was phenomenal. Not only did he listen to my issues, but he provided additional resources and called me back to review my lab results.

Media Library

Insulin (Insulin) Clinical Trial Eligibility Overview. Trial Name: NCT04533646 — Phase 4
Insulin (Insulin) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04533646 — Phase 4
~4 spots leftby Nov 2025
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