Phase 4
N=13
Comparison of Meal-Time Dosing of Insulin in Cystic Fibrosis Related Diabetes
Cystic Fibrosis-related Diabetes
Bottom Line
View on ClinicalTrials.gov: NCT04533646 ↗Enrolled (actual)
13
Serious AEs
0.0%
Results posted
Mar 2025
Primary outcome: Primary: Time in Target — 67; 68 percentage of time in range — p=<0.01
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Insulin (Drug); Continuous glucose monitor (CGM) (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Jagdeesh Ullal
- Primary completion
- Jul 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time in Target |
67; 68 | <0.01 sig |
| SECONDARY Hypoglycemia |
134; 112 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Age >18 age of years
- Diagnosis of cystic fibrosis related diabetes
- Using basal bolus insulin
- Cystic Fibrosis with Lung Transplantation
Exclusion Criteria
- Use of continuous glucose monitors
- Patient unable to check fingerstick blood sugars
Data sourced from ClinicalTrials.gov (NCT04533646). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.