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NCT04533646CompletedPhase 4

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

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

Source: ClinicalTrials.gov · Last updated 15 Oct 2025

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
13 (actual)
First submitted
23 Aug 2020
Start date
15 Sept 2020
Primary completion date
31 Jul 2023
Lead sponsor
Jagdeesh Ullal
NCT number
NCT04533646

What you commit to

  • Study type: Interventional · Phase 4
  • Participants enrolled: 13
  • From 15 Sept 2020 to the primary completion date, 31 Jul 2023
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Lab values

  • Use of continuous glucose monitors

Other

  • Patient unable to check fingerstick blood sugars

Who the study is looking for

  • Age \>18 age of years
  • Diagnosis of cystic fibrosis related diabetes
  • Using basal bolus insulin
  • Cystic Fibrosis with Lung Transplantation

Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University of Pittsburgh Medical Center, Center for Diabetes and Endocrinology
Coordinator of this site? Confirm its status
PittsburghUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.