Cystic Fibrosis-related Diabetes Clinical Trial
Official title:
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
Verified date | October 2023 |
Source | University of Pittsburgh |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 | Active, not recruiting |
Enrollment | 20 |
Est. completion date | December 1, 2024 |
Est. primary completion date | September 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Pittsburgh Medical Center, Center for Diabetes and Endocrinology | Pittsburgh | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Jagdeesh Ullal | Wake Forest University Health Sciences |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Time in Target | Measurement of percentage of time in target of glucose level | 2 weeks | |
Secondary | Hypoglycemia number | To determine the number of hypoglycemic events under 70 mg/dl | 2 weeks | |
Secondary | Hypoglycemia duration | To determine the duration of hypoglycemic events in minutes | 2 weeks |
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