Type 1 Diabetes Mellitus
Conditions
Keywords
fear of hypoglycemia, glycemic control, glycemic variability, self-management behavior
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALFear Reduction Intervention
FREE
BEHAVIORALAttention Control
DSMES
Sponsors
Loyola University Chicago
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
University of Illinois at Chicago
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
Principal Investigator and outcome assessors masked.
Intervention model description
randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fear of Hypoglycemia | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Glycemic Control | Assessing change between two time points: from baseline to week 8 of intervention. | Change in HemoglobinA1c (A1C) |
| Glycemic Variability | Assessing change between two time points: from baseline to week 8 of intervention | Change in glucose variability (continuous glucose monitor-derived, glucose (mg/dl) standard deviation. Higher numbers indicate worse glycemic variability. |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 25 |
| Attention Control The attention control group will participate in eight weekly individual one-hour Diabetes Self-Management Education (DSME) sessions.
Attention Control: DSMES | 25 |
| Total | 50 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Covid shelter in place | 1 | 2 |
| Overall Study | Withdrawal by Subject | 5 | 2 |
Baseline characteristics
| Characteristic | Fear Reduction Efficacy Evaluation (FREE) | Total | Attention Control |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 25 Participants | 50 Participants | 25 Participants |
| Age, Continuous | 26.1 years STANDARD_DEVIATION 5.5 | 26.1 years STANDARD_DEVIATION 5.1 | 26.1 years STANDARD_DEVIATION 4.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 10 Participants | 7 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 22 Participants | 40 Participants | 18 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Fear of hypoglycemia | 36.3 units on a scale STANDARD_DEVIATION 11.8 | 38.6 units on a scale STANDARD_DEVIATION 11.7 | 40.7 units on a scale STANDARD_DEVIATION 11.4 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 6 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 21 Participants | 39 Participants | 18 Participants |
| Region of Enrollment United States | 25 participants | 50 participants | 25 participants |
| Sex: Female, Male Female | 15 Participants | 30 Participants | 15 Participants |
| Sex: Female, Male Male | 10 Participants | 20 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 25 |
| other Total, other adverse events | 0 / 25 | 0 / 25 |
| serious Total, serious adverse events | 0 / 25 | 0 / 25 |
Outcome results
Primary
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fear Reduction Efficacy Evaluation (FREE) | Fear of Hypoglycemia | Week 8 | 35.29 units on a scale | Standard Error 1.7 |
| Fear Reduction Efficacy Evaluation (FREE) | Fear of Hypoglycemia | Week 0 | 54.3 units on a scale | Standard Error 2.4 |
| Attention Control | Fear of Hypoglycemia | Week 8 | 49.0 units on a scale | Standard Error 2.7 |
| Attention Control | Fear of Hypoglycemia | Week 0 | 58.7 units on a scale | Standard Error 2.3 |
Secondary
Glycemic Control
Change in HemoglobinA1c (A1C)
Time frame: Assessing change between two time points: from baseline to week 8 of intervention.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fear Reduction Efficacy Evaluation (FREE) | Glycemic Control | Week 0 | 7.25 percentage of HbA1C | Standard Error 0.29 |
| Fear Reduction Efficacy Evaluation (FREE) | Glycemic Control | Week 8 | 6.68 percentage of HbA1C | Standard Error 0.26 |
| Attention Control | Glycemic Control | Week 0 | 7.07 percentage of HbA1C | Standard Error 0.19 |
| Attention Control | Glycemic Control | Week 8 | 6.69 percentage of HbA1C | Standard Error 0.2 |
Secondary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fear Reduction Efficacy Evaluation (FREE) | Glycemic Variability | Week 0 | 57.8 mg/dL | Standard Error 3.54 |
| Fear Reduction Efficacy Evaluation (FREE) | Glycemic Variability | Week 8 | 54.9 mg/dL | Standard Error 3.4 |
| Attention Control | Glycemic Variability | Week 0 | 56.2 mg/dL | Standard Error 2.7 |
| Attention Control | Glycemic Variability | Week 8 | 55.5 mg/dL | Standard Error 3.8 |