Comparison of Meal-Time Dosing of Insulin in Cystic Fibrosis Related Diabetes
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| ClinicalTrials.gov Identifier: NCT04533646 |
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Recruitment Status :
Recruiting
First Posted : August 31, 2020
Last Update Posted : April 5, 2021
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Cystic Fibrosis-related Diabetes | Drug: Insulin Device: Continuous glucose monitor (CGM) | Phase 4 |
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 : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 20 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Intervention 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) |
| Primary Purpose: | Treatment |
| 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 |
| Actual Study Start Date : | March 17, 2021 |
| Estimated Primary Completion Date : | September 1, 2022 |
| Estimated Study Completion Date : | February 1, 2023 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Fixed Dosing, Followed by Carbohydrate Counting
Dosing of premeal insulin with fixed doses
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Drug: Insulin
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. Device: Continuous glucose monitor (CGM) Participants will be required to wear a CGM to measure glucose trends |
- Time in Target [ Time Frame: 2 weeks ]Measurement of percentage of time in target of glucose level
- Hypoglycemia number [ Time Frame: 2 weeks ]To determine the number of hypoglycemic events under 70 mg/dl
- Hypoglycemia duration [ Time Frame: 2 weeks ]To determine the duration of hypoglycemic events in minutes
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| Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age >18 age of years
- Diagnosis of cystic fibrosis related diabetes
- Using basal bolus insulin
Exclusion Criteria:
- Transplant recipients
- Use of continuous glucose monitors
- Patient unable to check fingerstick blood sugars
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04533646
| Contact: Anju A Paul, MD | 4125869700 | paulaa@upmc.edu | |
| Contact: Shari Reynolds | 412-383-0570 | reynoldssl2@upmc.edu |
| United States, Pennsylvania | |
| University of Pittsburgh Medical Center, Center for Diabetes and Endocrinology | Recruiting |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| Contact: Jagdeesh Ullal, MD 412-586-9700 ullalj@upmc.edu | |
| Contact: Anju A Paul, MD paulaa@upmc.edu | |
| Principal Investigator: | Jagdeesh Ullal, MD | University of Pittsburgh Medical Center |
| Responsible Party: | Jagdeesh Ullal, Clinical Associate Professor, University of Pittsburgh |
| ClinicalTrials.gov Identifier: | NCT04533646 |
| Other Study ID Numbers: |
STUDY20060197 |
| First Posted: | August 31, 2020 Key Record Dates |
| Last Update Posted: | April 5, 2021 |
| Last Verified: | March 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| 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 |
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Cystic Fibrosis Diabetes Mellitus Fibrosis Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Pathologic Processes Pancreatic Diseases |
Digestive System Diseases Lung Diseases Respiratory Tract Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Insulin Hypoglycemic Agents Physiological Effects of Drugs |