Comparison of Meal-Time Dosing of Insulin in Cystic Fibrosis Related Diabetes
Primary Purpose
Cystic Fibrosis-related Diabetes
Status
Active
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Insulin
Continuous glucose monitor (CGM)
Sponsored by
About this trial
This is an interventional treatment trial for Cystic Fibrosis-related Diabetes
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
Sites / Locations
- University of Pittsburgh Medical Center, Center for Diabetes and Endocrinology
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Fixed Dosing, Followed by Carbohydrate Counting
Arm Description
Dosing of premeal insulin with fixed doses
Outcomes
Primary Outcome Measures
Time in Target
Measurement of percentage of time in target of glucose level
Secondary Outcome Measures
Hypoglycemia number
To determine the number of hypoglycemic events under 70 mg/dl
Hypoglycemia duration
To determine the duration of hypoglycemic events in minutes
Full Information
NCT ID
NCT04533646
First Posted
August 23, 2020
Last Updated
October 17, 2023
Sponsor
Jagdeesh Ullal
Collaborators
Wake Forest University Health Sciences
1. Study Identification
Unique Protocol Identification Number
NCT04533646
Brief Title
Comparison of Meal-Time Dosing of Insulin in Cystic Fibrosis Related Diabetes
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 17, 2021 (Actual)
Primary Completion Date
September 1, 2024 (Anticipated)
Study Completion Date
December 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jagdeesh Ullal
Collaborators
Wake Forest University Health Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed Description
Background and Introduction Cystic fibrosis-related diabetes (CFRD) is the most common extra-pulmonary comorbidity in patients with cystic fibrosis (CF). CFRD is also associated with an accelerated decline in pulmonary function, increased pulmonary exacerbations, and increased mortality. Continuous glucose monitoring (CGM) involves the use of a small disposable sensor sited in the subcutaneous interstitial fluid that makes frequent glucose measurements. There is data suggesting that the Medtronic iPro continuous glucose monitors (CGM) can predict hemoglobin a1c levels in patients with CFRD.
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.
Hypothesis:
Postprandial interstitial fluid glucose levels in participants who utilize carbohydrate counting to dose mealtime rapid-acting insulin will have improved control as defined as the area under the curve and time in target compared to participants who used fixed-dose mealtime insulin
Participants who utilize carbohydrate counting will have fewer hypoglycemia events compared to participants who use fixed-dose meal-time insulin
Specific Aims:
To compare within-subject glucose excursions defined as the percentage of time in target glucose level, percentage of glucose in target, and peak postprandial glucose with fixed insulin dosing versus carbohydrate count based insulin dosing.
To compare the frequency and duration of hypoglycemia (defined as the daily, weekly, and average duration of the event) between insulin delivery methods described above.
To test the use of 'rule of 500' for carb counting estimation in patients with CFRD
To compare the effect of two methods of rapid-acting insulin delivery on fasting glycemia
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis-related Diabetes
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Model Description
This study design involves a within-subjects comparison using a sequential cross over that occurs over a 2-week time frame. During the first seven days of wear, the participants will be asked to dose their mealtime rapid-acting insulin by fixed-dose, and the next seven days, participants will be asked to dose their mealtime rapid-acting insulin by carbohydrate counting. After the 14 days, participants will return their continuous glucose monitor (CGM) devices for analysis and interpretation.
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Fixed Dosing, Followed by Carbohydrate Counting
Arm Type
Experimental
Arm Description
Dosing of premeal insulin with fixed doses
Intervention Type
Drug
Intervention Name(s)
Insulin
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Continuous glucose monitor (CGM)
Intervention Description
Participants will be required to wear a CGM to measure glucose trends
Primary Outcome Measure Information:
Title
Time in Target
Description
Measurement of percentage of time in target of glucose level
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Hypoglycemia number
Description
To determine the number of hypoglycemic events under 70 mg/dl
Time Frame
2 weeks
Title
Hypoglycemia duration
Description
To determine the duration of hypoglycemic events in minutes
Time Frame
2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jagdeesh Ullal, MD
Organizational Affiliation
University of Pittsburgh Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pittsburgh Medical Center, Center for Diabetes and Endocrinology
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Comparison of Meal-Time Dosing of Insulin in Cystic Fibrosis Related Diabetes
We'll reach out to this number within 24 hrs