An interventional study of Fear Reduction Intervention and Attention Control in Type 1 Diabetes Mellitus, sponsored by University of Illinois at Chicago. Completed at 1 site in United States. Open to participants aged 18 Years to 35 Years. Per ClinicalTrials.gov, last updated 2024-06-06.
Sponsored by University of Illinois at Chicago · Not applicable, Interventional, and Treatment
All persons with type 1 diabetes are at risk for developing hypoglycemia (low blood sugar). This is a life-threatening condition that leads to profound fear of hypoglycemia and reduced quality of life. Fear of hypoglycemia results in glucose fluctuations (from high to low glucose levels). Young adults are particularly at risk because they report high levels of fear of hypoglycemia and poor glucose control. Currently, no diabetes self-management programs specifically address how to cope with fear of hypoglycemia. The investigators propose to pilot test a fear reduction intervention (Fear Reduction Efficacy Evaluation [FREE]) and its effects on fear of hypoglycemia, diabetes self-management, glucose control, and glucose variability.
In persons with type 1 diabetes (T1DM), hypoglycemia is the major limiting factor in achieving optimal blood glycemic control. All persons with T1DM are at risk for hypoglycemia (blood glucose level \< 70 mg/dl), which is life-threatening and accompanied by serious physical and psychological symptoms, resulting in a profound fear of hypoglycemia (FOH) and reduced quality of life. Young adults with T1DM are at greater risk for FOH and have worse glycemic control and self-management behavior than other age groups with T1DM. The investigator's preliminary research identified that 77% of young adults with T1DM reported FOH, and FOH resulted in increased glycemic variability. Glycemic variability (GV) is the minute-to-minute fluctuation in blood glucose that can be missed if looking only at A1C, a longer-term measure. Increased GV is dangerous because it is associated with cardiovascular events and diabetes complications. A major gap exists in how to manage FOH as a component of diabetes self-management. The Investigators specifically aim to: (1) determine the feasibility and acceptability of a fear reduction program in young adults with T1DM, who experience FOH; and (2) determine the impact of an 8-week cognitive behavioral therapy (CBT)-based intervention on the outcomes: FOH, self-management behavior, glycemic control, and GV. To achieve these aims, the investigators propose a randomized controlled trial in 50 young adults aged 18 to 35 years with T1DM. At completion, FOH will be measured and glycemic patterns will be analyzed to determine differences between the FREE and control groups. Findings from this proposed pilot study will serve as the foundation for a larger clinical trial to reduce FOH and improve self-management, glycemic control, and GV. This program of research promises to reduce the development of diabetes complications and improve quality of life for young adults with T1DM.
3,522 studies on the registry are indexed under Diabetes Mellitus, Type 1; 577 are open to participants now.
This study's enrollment of 51 is above the median of 40 across 2,649 interventional studies indexed under Diabetes Mellitus, Type 1.
Browse Diabetes Mellitus, Type 1 studies →University of Illinois at Chicago is the lead sponsor of 515 studies on the registry; 133 are open to participants now.
Of its 31 completed or terminated interventional studies of FDA-regulated products, 18 (58%) have results posted.
Counted across the registry records on this site, refreshed daily.
Diagnosis of T1DM ≥ 1 year, receive medical care from an endocrinologist, use insulin pump therapy or multiple daily injection (MDI), have fear of hypoglycemia (screening questionnaire), and attended a basic diabetes educational program
Exclusion Criteria:
Pregnant or breastfeeding, have received therapy specifically for fear of hypoglycemia, have a co-existing chronic illness
The FREE intervention group will participate in eight weekly individual one-hour sessions using CBT and exposure treatment for specific fears.
Behavioral: Fear Reduction Intervention
The attention control group will participate in eight weekly individual one-hour Diabetes Self-Management Education (DSME) sessions.
Behavioral: Attention Control
FREE
DSMES
Fear of Hypoglycemia
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.
Time frame: Assessing change between two time points: from baseline to week 8 of intervention.
Glycemic Control
Change in HemoglobinA1c (A1C)
Time frame: Assessing change between two time points: from baseline to week 8 of intervention.
Glycemic Variability
Change in glucose variability (continuous glucose monitor-derived, glucose (mg/dl) standard deviation. Higher numbers indicate worse glycemic variability.
Time frame: Assessing change between two time points: from baseline to week 8 of intervention
| Milestone | Fear Reduction Efficacy Evaluation (FREE) | Attention Control |
|---|---|---|
| Started | 25 | 25 |
| Completed | 19 | 21 |
| Not completed | 6 | 4 |
| Withdrew: Withdrawal by subject | 5 | 2 |
| Withdrew: Covid shelter in place | 1 | 2 |
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.
| units on a scale | Fear Reduction Efficacy Evaluation (FREE) | Attention Control |
|---|---|---|
| Week 0 | 54.3 ± 2.4 | 58.7 ± 2.3 |
| Week 8 | 35.29 ± 1.7 | 49.0 ± 2.7 |
Change in HemoglobinA1c (A1C)
| percentage of HbA1C | Fear Reduction Efficacy Evaluation (FREE) | Attention Control |
|---|---|---|
| Week 0 | 7.25 ± 0.29 | 7.07 ± 0.19 |
| Week 8 | 6.68 ± .26 | 6.69 ± .20 |
Change in glucose variability (continuous glucose monitor-derived, glucose (mg/dl) standard deviation. Higher numbers indicate worse glycemic variability.
| mg/dL | Fear Reduction Efficacy Evaluation (FREE) | Attention Control |
|---|---|---|
| Week 0 | 57.8 ± 3.54 | 56.2 ± 2.7 |
| Week 8 | 54.9 ± 3.4 | 55.5 ± 3.8 |
Collected over 13 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Fear Reduction Efficacy Evaluation (FREE) | 0/25 (0%) | 0/25 (0%) | 0/25 (0%) |
| Attention Control | 0/25 (0%) | 0/25 (0%) | 0/25 (0%) |
| Age, Categorical(Participants) | Fear Reduction Efficacy Evaluation (FREE) | Attention Control | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 25 | 25 | 50 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Fear Reduction Efficacy Evaluation (FREE) | Attention Control | Total |
|---|---|---|---|
| Mean | 26.1 ± 5.5 | 26.1 ± 4.8 | 26.1 ± 5.1 |
| Sex: Female, Male(Participants) | Fear Reduction Efficacy Evaluation (FREE) | Attention Control | Total |
|---|---|---|---|
| Female | 15 | 15 | 30 |
| Male | 10 | 10 | 20 |
| Ethnicity (NIH/OMB)(Participants) | Fear Reduction Efficacy Evaluation (FREE) | Attention Control | Total |
|---|---|---|---|
| Hispanic or Latino | 3 | 7 | 10 |
| Not Hispanic or Latino | 22 | 18 | 40 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Fear Reduction Efficacy Evaluation (FREE) | Attention Control | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 1 | 1 | 2 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 2 | 4 | 6 |
| White | 21 | 18 | 39 |
| More than one race | 1 | 2 | 3 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Fear Reduction Efficacy Evaluation (FREE) | Attention Control | Total |
|---|---|---|---|
| United States | 25 | 25 | 50 |
| Fear of hypoglycemia(units on a scale) | Fear Reduction Efficacy Evaluation (FREE) | Attention Control | Total |
|---|---|---|---|
| Mean | 36.3 ± 11.8 | 40.7 ± 11.4 | 38.6 ± 11.7 |
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University of Illinois at Chicago