Trial Outcomes & Findings for A Cognitive Behavioral Intervention to Reduce Fear of Hypoglycemia in Young Adults With Type 1 Diabetes (NCT NCT03165786)
NCT ID: NCT03165786
Last Updated: 2025-02-03
Results Overview
A reliable and valid psychological scale. It is a 5-point Likert scale \[0-4\], that is summed for a single total continuous scale score. Scores may range from 0-72. Higher numbers indicate greater fear of hypoglycemia.
COMPLETED
NA
10 participants
12 weeks
2025-02-03
Participant Flow
Subjects will be recruited through Chicago metropolitan area university medical centers, local diabetes websites, and organizations using flyers, e-announcements, and recruitment letters.
Participant milestones
| Measure |
FREE Group
Cognitive behavioral therapy intervention with real-time continuous glucose monitoring.
FREE: Cognitive behavioral therapy with real-time continuous glucose monitoring.
|
Control Group
Real-time continuous glucose monitoring
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
5
|
|
Overall Study
COMPLETED
|
5
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Cognitive Behavioral Intervention to Reduce Fear of Hypoglycemia in Young Adults With Type 1 Diabetes
Baseline characteristics by cohort
| Measure |
FREE Group
n=5 Participants
Cognitive behavioral therapy intervention with real-time continuous glucose monitoring.
FREE: Cognitive behavioral therapy with real-time continuous glucose monitoring.
|
Control Group
n=5 Participants
Real-time continuous glucose monitoring
|
Total
n=10 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=5 Participants
|
5 participants
n=7 Participants
|
10 participants
n=5 Participants
|
|
Hypoglycemia Fear Survey II - Worry subscale
|
36.6 units on a scale
STANDARD_DEVIATION 18.4 • n=5 Participants
|
38.8 units on a scale
STANDARD_DEVIATION 6.0 • n=7 Participants
|
37.7 units on a scale
STANDARD_DEVIATION 12.9 • n=5 Participants
|
|
Diabetes Self-management Questionnaire
|
56.2 units on a scale
STANDARD_DEVIATION 13.2 • n=5 Participants
|
52.2 units on a scale
STANDARD_DEVIATION 11.5 • n=7 Participants
|
54.2 units on a scale
STANDARD_DEVIATION 11.9 • n=5 Participants
|
|
A1C
|
7.2 percentage
STANDARD_DEVIATION 1.29 • n=5 Participants
|
7.96 percentage
STANDARD_DEVIATION 1.3 • n=7 Participants
|
7.58 percentage
STANDARD_DEVIATION 1.28 • n=5 Participants
|
|
Glycemic variability
|
66.04 mg/dL
STANDARD_DEVIATION 16.7 • n=5 Participants
|
79.3 mg/dL
STANDARD_DEVIATION 12.9 • n=7 Participants
|
71.03 mg/dL
STANDARD_DEVIATION 15.9 • n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeksA reliable and valid psychological scale. It is a 5-point Likert scale \[0-4\], that is summed for a single total continuous scale score. Scores may range from 0-72. Higher numbers indicate greater fear of hypoglycemia.
Outcome measures
| Measure |
FREE Group
n=5 Participants
Cognitive behavioral therapy intervention with real-time continuous glucose monitoring.
FREE: Cognitive behavioral therapy with real-time continuous glucose monitoring.
|
Control Group
n=5 Participants
Real-time continuous glucose monitoring
|
|---|---|---|
|
Hypoglycemia Fear Scale Score (HFS_2)
|
21.4 units on a scale
Standard Deviation 10.9
|
38.6 units on a scale
Standard Deviation 8.2
|
SECONDARY outcome
Timeframe: 12 weeksA reliable and valid behavioral scale, provides total continuous scale score, ranging from 0-81, higher numbers indicate better self-management.
Outcome measures
| Measure |
FREE Group
n=5 Participants
Cognitive behavioral therapy intervention with real-time continuous glucose monitoring.
FREE: Cognitive behavioral therapy with real-time continuous glucose monitoring.
|
Control Group
n=5 Participants
Real-time continuous glucose monitoring
|
|---|---|---|
|
Diabetes Self-Management Questionnaire Scale Score (DSMQ)
|
58.7 units on a scale
Standard Deviation 12.6
|
50.6 units on a scale
Standard Deviation 12.1
|
SECONDARY outcome
Timeframe: 12 weeksHemoglobin A1c represents the average blood glucose over a 2-3 month period and is an index of glycemic control. The American Diabetes Association recommends a hemoglobin A1C below 7% for most people with diabetes. Higher percentages indicate higher average blood glucose levels.
Outcome measures
| Measure |
FREE Group
n=5 Participants
Cognitive behavioral therapy intervention with real-time continuous glucose monitoring.
FREE: Cognitive behavioral therapy with real-time continuous glucose monitoring.
|
Control Group
n=5 Participants
Real-time continuous glucose monitoring
|
|---|---|---|
|
Glycemic Control, the Average Blood Glucose Over a 2-3 Month Period of Time.
|
6.94 percentage
Standard Deviation 1.29
|
7.66 percentage
Standard Deviation 1.02
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: Same as above
Twenty-four hour fluctuations in glucose measured by a continuous glucose monitor that provides interstitial glucose readings every 5 minutes. This is a continuous measure. A higher standard deviation reflects greater glycemic variability.
Outcome measures
| Measure |
FREE Group
n=5 Participants
Cognitive behavioral therapy intervention with real-time continuous glucose monitoring.
FREE: Cognitive behavioral therapy with real-time continuous glucose monitoring.
|
Control Group
n=5 Participants
Real-time continuous glucose monitoring
|
|---|---|---|
|
Glycemic Variability
|
73.0 mg/dL
Standard Deviation 13.8
|
73.3 mg/dL
Standard Deviation 11.8
|
Adverse Events
FREE Group
Control Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Pamela Martyn-Nemeth, Professor
University of Illinois Chicago
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place