Cystic Fibrosis-related Diabetes
Conditions
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: 1. 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 2. Participants who utilize carbohydrate counting will have fewer hypoglycemia events compared to participants who use fixed-dose meal-time insulin Specific Aims: 1. 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. 2. 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. 3. To test the use of 'rule of 500' for carb counting estimation in patients with CFRD 4. To compare the effect of two methods of rapid-acting insulin delivery on fasting glycemia
Interventions
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
Sponsors
Study design
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.
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time in Target | 2 weeks | Measurement of percentage of time in target of glucose level |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hypoglycemia | 2 weeks | To determine the time spent in hypoglycemia as defined as blood sugar under 70 mg/dl |
Countries
United States
Participant flow
Recruitment details
Study subjects were recruited from the Cystic Fibrosis Diabetes Clinic. The study was started on 9-15-2020 and concluded on 07-31-2023.
Pre-assignment details
Study subjects served as their own controls. There was no wash out or run-in period.
Participants by arm
| Arm | Count |
|---|---|
| Fixed Dosing, Followed by Carbohydrate Counting Dosing of premeal insulin with fixed doses
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.
Continuous glucose monitor (CGM): Participants will be required to wear a CGM to measure glucose trends | 13 |
| Total | 13 |
Baseline characteristics
| Characteristic | Fixed Dosing, Followed by Carbohydrate Counting |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 12 Participants |
| Baseline weight | 152 pounds STANDARD_DEVIATION 9 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 12 Participants |
| Region of Enrollment United States | 13 Participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 13 | 0 / 8 |
| other Total, other adverse events | 0 / 13 | 0 / 8 |
| serious Total, serious adverse events | 0 / 13 | 0 / 8 |
Outcome results
Time in Target
Measurement of percentage of time in target of glucose level
Time frame: 2 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fixed Dosing, Followed by Carbohydrate Counting | Time in Target | Fixed Dose | 67 percentage of time in range | Standard Deviation 5.9 |
| Fixed Dosing, Followed by Carbohydrate Counting | Time in Target | Carb Counting | 68 percentage of time in range | Standard Deviation 0.4 |
Hypoglycemia
To determine the time spent in hypoglycemia as defined as blood sugar under 70 mg/dl
Time frame: 2 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fixed Dosing, Followed by Carbohydrate Counting | Hypoglycemia | Fixed dose | 134 minutes | Standard Deviation 54 |
| Fixed Dosing, Followed by Carbohydrate Counting | Hypoglycemia | Carb Counting | 112 minutes | Standard Deviation 57 |