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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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04533646
Enrollment
13
Registered
2020-08-31
Start date
2020-09-15
Completion date
2025-09-01
Last updated
2025-10-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cystic Fibrosis-related Diabetes

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

DRUGInsulin

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.

DEVICEContinuous glucose monitor (CGM)

Participants will be required to wear a CGM to measure glucose trends

Sponsors

Wake Forest University Health Sciences
CollaboratorOTHER
Jagdeesh Ullal
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

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

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

MeasureTime frameDescription
Time in Target2 weeksMeasurement of percentage of time in target of glucose level

Secondary

MeasureTime frameDescription
Hypoglycemia2 weeksTo 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

ArmCount
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
Total13

Baseline characteristics

CharacteristicFixed 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 weight152 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 typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 130 / 8
other
Total, other adverse events
0 / 130 / 8
serious
Total, serious adverse events
0 / 130 / 8

Outcome results

Primary

Time in Target

Measurement of percentage of time in target of glucose level

Time frame: 2 weeks

ArmMeasureGroupValue (MEAN)Dispersion
Fixed Dosing, Followed by Carbohydrate CountingTime in TargetFixed Dose67 percentage of time in rangeStandard Deviation 5.9
Fixed Dosing, Followed by Carbohydrate CountingTime in TargetCarb Counting68 percentage of time in rangeStandard Deviation 0.4
p-value: <0.01Means testing
Secondary

Hypoglycemia

To determine the time spent in hypoglycemia as defined as blood sugar under 70 mg/dl

Time frame: 2 weeks

ArmMeasureGroupValue (MEAN)Dispersion
Fixed Dosing, Followed by Carbohydrate CountingHypoglycemiaFixed dose134 minutesStandard Deviation 54
Fixed Dosing, Followed by Carbohydrate CountingHypoglycemiaCarb Counting112 minutesStandard Deviation 57

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026