Trial Outcomes & Findings for Comparison of Meal-Time Dosing of Insulin in Cystic Fibrosis Related Diabetes (NCT NCT04533646)

NCT ID: NCT04533646

Last Updated: 2025-10-15

Results Overview

Measurement of percentage of time in target of glucose level

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 13 participants
• Primary outcome timeframe: 2 weeks
• Results posted on: 2025-10-15

Participant Flow

Study subjects were recruited from the Cystic Fibrosis Diabetes Clinic. The study was started on 9-15-2020 and concluded on 07-31-2023.

Study subjects served as their own controls. There was no wash out or run-in period.

Participant milestones

Measure	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
Fixed Insulin Dosing (7 Days) STARTED	13
Fixed Insulin Dosing (7 Days) COMPLETED	8
Fixed Insulin Dosing (7 Days) NOT COMPLETED	5
Carbohydrate Counting ( 7 Days) STARTED	8
Carbohydrate Counting ( 7 Days) COMPLETED	8
Carbohydrate Counting ( 7 Days) NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Comparison of Meal-Time Dosing of Insulin in Cystic Fibrosis Related Diabetes

Baseline characteristics by cohort

Measure	Fixed Dosing, Followed by Carbohydrate Counting n=13 Participants 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
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	12 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	13 Participants n=5 Participants
Baseline weight	152 pounds STANDARD_DEVIATION 9 • n=5 Participants

PRIMARY outcome

Timeframe: 2 weeks

Measurement of percentage of time in target of glucose level

Outcome measures

Measure	Fixed Dosing, Followed by Carbohydrate Counting n=8 Participants 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
Time in Target Fixed Dose	67 percentage of time in range Standard Deviation 5.9
Time in Target Carb Counting	68 percentage of time in range Standard Deviation 0.4

SECONDARY outcome

Timeframe: 2 weeks

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

Outcome measures

Measure	Fixed Dosing, Followed by Carbohydrate Counting n=8 Participants 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
Hypoglycemia Fixed dose	134 minutes Standard Deviation 54
Hypoglycemia Carb Counting	112 minutes Standard Deviation 57

Adverse Events

Carb Counting

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Fixed Dosing

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Associate Professor of Medicine

University of Pittsburgh Medical Center

Phone: 4125869700

Email: ullalj@upmc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place