Trial Outcomes & Findings for A Cognitive Behavioral Therapy (CBT) Intervention to Reduce Fear of Hypoglycemia in Type 1 Diabetes (NCT NCT03549104)
NCT ID: NCT03549104
Last Updated: 2024-06-06
Results Overview
Change in Worry Subscale score. Fear of hypoglycemia is measured with the Worry Subscale of the Hypoglycemia Fear Survey II (HFS-II) which is an 18-item, 5-point Likert-style scale with a possible score range from 0-72. A higher score indicates greater fear of hypoglycemia.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
51 participants
Primary outcome timeframe
Assessing change between two time points: from baseline to week 8 of intervention.
Results posted on
2024-06-06
Participant Flow
One participant was administratively removed immediately following consent and randomization. Specifically, 4 hours later, we were contacted by the participant because they had developed a situation (unrelated to the study) that rendered them ineligible to participate.
Participant milestones
| Measure |
Fear Reduction Efficacy Evaluation (FREE)
The FREE intervention group will participate in eight weekly individual one-hour sessions using CBT and exposure treatment for specific fears.
Fear Reduction Intervention: FREE
|
Attention Control
The attention control group will participate in eight weekly individual one-hour Diabetes Self-Management Education (DSME) sessions.
Attention Control: DSMES
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
25
|
|
Overall Study
COMPLETED
|
19
|
21
|
|
Overall Study
NOT COMPLETED
|
6
|
4
|
Reasons for withdrawal
| Measure |
Fear Reduction Efficacy Evaluation (FREE)
The FREE intervention group will participate in eight weekly individual one-hour sessions using CBT and exposure treatment for specific fears.
Fear Reduction Intervention: FREE
|
Attention Control
The attention control group will participate in eight weekly individual one-hour Diabetes Self-Management Education (DSME) sessions.
Attention Control: DSMES
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
5
|
2
|
|
Overall Study
Covid shelter in place
|
1
|
2
|
Baseline Characteristics
A Cognitive Behavioral Therapy (CBT) Intervention to Reduce Fear of Hypoglycemia in Type 1 Diabetes
Baseline characteristics by cohort
| Measure |
Fear Reduction Efficacy Evaluation (FREE)
n=25 Participants
The FREE intervention group will participate in eight weekly individual one-hour sessions using CBT and exposure treatment for specific fears.
Fear Reduction Intervention: FREE
|
Attention Control
n=25 Participants
The attention control group will participate in eight weekly individual one-hour Diabetes Self-Management Education (DSME) sessions.
Attention Control: DSMES
|
Total
n=50 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
|
25 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
26.1 years
STANDARD_DEVIATION 5.5 • n=5 Participants
|
26.1 years
STANDARD_DEVIATION 4.8 • n=7 Participants
|
26.1 years
STANDARD_DEVIATION 5.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
22 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
40 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
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 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
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
21 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 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
|
25 participants
n=5 Participants
|
25 participants
n=7 Participants
|
50 participants
n=5 Participants
|
|
Fear of hypoglycemia
|
36.3 units on a scale
STANDARD_DEVIATION 11.8 • n=5 Participants
|
40.7 units on a scale
STANDARD_DEVIATION 11.4 • n=7 Participants
|
38.6 units on a scale
STANDARD_DEVIATION 11.7 • n=5 Participants
|
PRIMARY outcome
Timeframe: Assessing change between two time points: from baseline to week 8 of intervention.Change in Worry Subscale score. Fear of hypoglycemia is measured with the Worry Subscale of the Hypoglycemia Fear Survey II (HFS-II) which is an 18-item, 5-point Likert-style scale with a possible score range from 0-72. A higher score indicates greater fear of hypoglycemia.
Outcome measures
| Measure |
Fear Reduction Efficacy Evaluation (FREE)
n=19 Participants
The FREE intervention group will participate in eight weekly individual one-hour sessions using CBT and exposure treatment for specific fears.
Fear Reduction Intervention: FREE
|
Attention Control
n=21 Participants
The attention control group will participate in eight weekly individual one-hour Diabetes Self-Management Education (DSME) sessions.
Attention Control: DSMES
|
|---|---|---|
|
Fear of Hypoglycemia
Week 0
|
54.3 units on a scale
Standard Error 2.4
|
58.7 units on a scale
Standard Error 2.3
|
|
Fear of Hypoglycemia
Week 8
|
35.29 units on a scale
Standard Error 1.7
|
49.0 units on a scale
Standard Error 2.7
|
SECONDARY outcome
Timeframe: Assessing change between two time points: from baseline to week 8 of intervention.Change in HemoglobinA1c (A1C)
Outcome measures
| Measure |
Fear Reduction Efficacy Evaluation (FREE)
n=18 Participants
The FREE intervention group will participate in eight weekly individual one-hour sessions using CBT and exposure treatment for specific fears.
Fear Reduction Intervention: FREE
|
Attention Control
n=21 Participants
The attention control group will participate in eight weekly individual one-hour Diabetes Self-Management Education (DSME) sessions.
Attention Control: DSMES
|
|---|---|---|
|
Glycemic Control
Week 0
|
7.25 percentage of HbA1C
Standard Error 0.29
|
7.07 percentage of HbA1C
Standard Error 0.19
|
|
Glycemic Control
Week 8
|
6.68 percentage of HbA1C
Standard Error .26
|
6.69 percentage of HbA1C
Standard Error .20
|
SECONDARY outcome
Timeframe: Assessing change between two time points: from baseline to week 8 of interventionChange in glucose variability (continuous glucose monitor-derived, glucose (mg/dl) standard deviation. Higher numbers indicate worse glycemic variability.
Outcome measures
| Measure |
Fear Reduction Efficacy Evaluation (FREE)
n=18 Participants
The FREE intervention group will participate in eight weekly individual one-hour sessions using CBT and exposure treatment for specific fears.
Fear Reduction Intervention: FREE
|
Attention Control
n=21 Participants
The attention control group will participate in eight weekly individual one-hour Diabetes Self-Management Education (DSME) sessions.
Attention Control: DSMES
|
|---|---|---|
|
Glycemic Variability
Week 0
|
57.8 mg/dL
Standard Error 3.54
|
56.2 mg/dL
Standard Error 2.7
|
|
Glycemic Variability
Week 8
|
54.9 mg/dL
Standard Error 3.4
|
55.5 mg/dL
Standard Error 3.8
|
Adverse Events
Fear Reduction Efficacy Evaluation (FREE)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Attention Control
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place