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| ID | Type | Description | Link |
|---|---|---|---|
| R21DK116146 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Loyola University Chicago | OTHER |
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fear Reduction Efficacy Evaluation (FREE) | Experimental | The FREE intervention group will participate in eight weekly individual one-hour sessions using CBT and exposure treatment for specific fears. |
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| Attention Control | Active Comparator | The attention control group will participate in eight weekly individual one-hour Diabetes Self-Management Education (DSME) sessions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fear Reduction Intervention | Behavioral | FREE |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Assessing change between two time points: from baseline to week 8 of intervention. |
| Measure | Description | Time Frame |
|---|---|---|
| Glycemic Control | Change in HemoglobinA1c (A1C) | 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. |
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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
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| Name | Affiliation | Role |
|---|---|---|
| Pamela Martyn-Nemeth, PhD | University of Illinois at Chic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Illinois at Chicago | Chicago | Illinois | 60612 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38677235 | Derived | Martyn-Nemeth P, Duffecy J, Quinn L, Park C, Reutrakul S, Mihailescu D, Park M, Penckofer S. FREE: A randomized controlled feasibility trial of a cognitive behavioral therapy and technology-assisted intervention to reduce fear of hypoglycemia in young adults with type 1 diabetes. J Psychosom Res. 2024 Jun;181:111679. doi: 10.1016/j.jpsychores.2024.111679. Epub 2024 Apr 20. | |
| 31888691 | Derived | Martyn-Nemeth P, Duffecy J, Quinn L, Park C, Mihailescu D, Penckofer S. A cognitive behavioral therapy intervention to reduce fear of hypoglycemia in young adults with type 1 diabetes (FREE): study protocol for a randomized controlled trial. Trials. 2019 Dec 30;20(1):796. doi: 10.1186/s13063-019-3876-4. |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | Attention Control | The attention control group will participate in eight weekly individual one-hour Diabetes Self-Management Education (DSME) sessions. Attention Control: DSMES |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Attention Control |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Error | units on a scale | Assessing change between two time points: from baseline to week 8 of intervention. |
|
13 weeks
Definitions do not differ
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pamela Martyn-Nemeth | University of Illinois at Chicago | 312-996-7903 | pmartyn@uic.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 12, 2021 | Feb 3, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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randomized controlled trial
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Principal Investigator and outcome assessors masked.
| Attention Control |
| Behavioral |
DSMES |
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| Assessing change between two time points: from baseline to week 8 of intervention |
The attention control group will participate in eight weekly individual one-hour Diabetes Self-Management Education (DSME) sessions. Attention Control: DSMES |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Fear of hypoglycemia | Hypoglycemia Fear Scale II - Worry Subscale | Mean | Standard Deviation | units on a scale |
|
The attention control group will participate in eight weekly individual one-hour Diabetes Self-Management Education (DSME) sessions.
Attention Control: DSMES
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| Secondary | Glycemic Control | Change in HemoglobinA1c (A1C) | Posted | Mean | Standard Error | percentage of HbA1C | Assessing change between two time points: from baseline to week 8 of intervention. |
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| Secondary | Glycemic Variability | Change in glucose variability (continuous glucose monitor-derived, glucose (mg/dl) standard deviation. Higher numbers indicate worse glycemic variability. | Posted | Mean | Standard Error | mg/dL | Assessing change between two time points: from baseline to week 8 of intervention |
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|
|
|
| 0 |
| 25 |
| 0 |
| 25 |
| 0 |
| 25 |
| EG001 | Attention Control | The attention control group will participate in eight weekly individual one-hour Diabetes Self-Management Education (DSME) sessions. Attention Control: DSMES | 0 | 25 | 0 | 25 | 0 | 25 |
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| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |