- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04533646
Comparison of Meal-Time Dosing of Insulin in Cystic Fibrosis Related Diabetes
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 Overview
Status
Conditions
Intervention / Treatment
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
Study Type
Enrollment (Estimated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Jagdeesh Ullal, MD
- Phone Number: 412-864-2780
- Email: ullalj@upmc.edu
Study Contact Backup
- Name: Shari Reynolds
- Phone Number: 412-383-0570
- Email: reynoldssl2@upmc.edu
Study Locations
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15213
- University of Pittsburgh Medical Center, Center for Diabetes and Endocrinology
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Fixed Dosing, Followed by Carbohydrate Counting
Dosing of premeal insulin with fixed doses
|
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.
Participants will be required to wear a CGM to measure glucose trends
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time in Target
Time Frame: 2 weeks
|
Measurement of percentage of time in target of glucose level
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2 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hypoglycemia number
Time Frame: 2 weeks
|
To determine the number of hypoglycemic events under 70 mg/dl
|
2 weeks
|
Hypoglycemia duration
Time Frame: 2 weeks
|
To determine the duration of hypoglycemic events in minutes
|
2 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Jagdeesh Ullal, MD, University of Pittsburgh Medical Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- Glucose Metabolism Disorders
- Metabolic Diseases
- Respiratory Tract Diseases
- Lung Diseases
- Endocrine System Diseases
- Infant, Newborn, Diseases
- Genetic Diseases, Inborn
- Pancreatic Diseases
- Fibrosis
- Diabetes Mellitus
- Cystic Fibrosis
- Hypoglycemic Agents
- Physiological Effects of Drugs
- Insulin
Other Study ID Numbers
- STUDY20060197
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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