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

NCT04533646 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2025-10-15

Study results available
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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.

Conditions

  • Cystic Fibrosis-related Diabetes

Interventions

DRUG

Insulin

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.

DEVICE

Continuous glucose monitor (CGM)

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

Sponsors & Collaborators

  • Wake Forest University Health Sciences

    collaborator OTHER

  • Jagdeesh Ullal

    lead OTHER

Principal Investigators

  • Jagdeesh Ullal, MD · University of Pittsburgh Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-15
Primary Completion
2023-07-31
Completion
2025-09-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04533646 on ClinicalTrials.gov