drugset / Trial / NCT04533646

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

NCT04533646

NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2020-09-15
Primary completion
2023-07-31
Completion
2025-09-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Insulin Protein / enzyme biologic