CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 13 enrolled
Drug / intervention
Insulin +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04533646
NCT04533646Phase 4Completed

Comparison of Meal-Time Dosing of Rapid Acting Insulin Using Carbohydrate Counting vs. Fixed Doses Utilizing Continuous Glucose Monitoring In Patients With Cystic Fibrosis Related Diabetes

Jagdeesh Ullal·interventional·Posted Aug 31, 2020·Updated Oct 15, 2025

In Brief

A Phase 4 clinical trial evaluating Insulin and Continuous glucose monitor (CGM) for Cystic Fibrosis-related Diabetes. Completed, enrolled 13 participants across 1 site.

Detailed Summary

The aim of this study is to assess the utility of CGMs to determine the optimal method to dose meal-time insulin. The investigators will examine glucose excursions in patients with CF who will dose meal-time rapid-acting insulin by carbohydrate counting versus fixed-dose rapid-acting insulin. The carbohydrate ratio and fixed doses will be determined by existing doses, total daily insulin doses, body weight, and insulin sensitivity along with predisposition to hypoglycemia. Bolus insulin dosing is an important part of CFRD management due to the high nutritional demands of these patients. If dosed incorrectly, this could lead to marked hyperglycemia and could worsen nutritional status due to urinary glucose losses. In this project, the investigators will perform a within-subjects' comparison of the 2 standard methods of meal-time rapid-acting insulin dosing.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 4CompletedFinished
202120222023202420252026
First PostedAug 31, 2020
Enrollment StartSep 15, 2020
Primary CompletionJul 31, 2023
Study CompletionSep 1, 2025
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 5.8 years ago

Interventions

Insulindrug

Participants will be asked to dose insulin during the first week using fixed doses. During the second week of the study, participants will dose insulin based on carbohydrate counting. Blood sugar control will be compared between the 2 weeks to determine the outcomes of the study.

Continuous glucose monitor (CGM)device

Participants will be required to wear a CGM to measure glucose trends