← Back to Search

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

Study 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.Check my eligibility

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.See study design

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

Select...

I am older than 18 years.

Select...

I am on a basal-bolus insulin regimen.

Select...

I have been diagnosed with diabetes due to cystic fibrosis.

Select...

I have cystic fibrosis and have had a lung transplant.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 weeks

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

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

Primary outcome measures

Time in Target

Secondary outcome measures

Hypoglycemia duration

Hypoglycemia number

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

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Jagdeesh UllalLead Sponsor

Wake Forest University Health SciencesOTHER

1,240 Previous Clinical Trials

1,004,187 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

Frequently Asked Questions

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

To whom is access to this trial open?

"This research requires 20 individuals with diabetes mellitus, aged 18-80. Additionally, the participants must have cystic fibrosis related diabetes and require basal bolus insulin therapy or have had a lung transplantation due to their condition."

Answered by AI

Are people of all ages, including those under 40 years old, able to participate in this research?

"This trial has set the age restriction of participants between 18 to 80 years old. There are 276 studies for underage patients, and 1294 have already been conducted for those over 65."

Answered by AI

Are there any potential risks associated with administering insulin?

"Insulin has been authorized for medical use, thus its safety rating is 3. This corresponds to Phase 4 of the clinical trial process."

Answered by AI

Has Insulin already been subject to any other medical trials?

"Currently, there are 72 active trials researching Insulin's efficacy with 13 of these in Phase 3. With 248 different locations across the world running these clinicals studies, a majority of them can be found in Sao Luis, MA."

Answered by AI

Are participants still being enrolled for this trial?

"This medical trial, initially publicized on March 17th 2021 is presently recruiting participants. The data was last edited and updated on September 7th 2022 as reported by clinicaltrials.gov."

Answered by AI

How many participants can take part in this experiment?

"Indeed, the information on clinicaltrials.gov affirms that this medical research is actively seeking participants. It was initially posted on March 17th 2021 and has been revised as recently as September 7th 2022. The trial seeks to recruit 20 patients from a singular site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Comparison of Meal-Time Dosing of Insulin in Cystic Fibrosis Related Diabetes

Jagdeesh Ullal 2021. "Comparison of Meal-Time Dosing of Insulin in Cystic Fibrosis Related Diabetes". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04533646.

All > Fibrosis > Cystic Fibrosis