A Cognitive Behavioral Therapy (CBT) Intervention to Reduce Fear of Hypoglycemia in Type 1 Diabetes
Status: | Recruiting |
---|---|
Conditions: | Endocrine, Diabetes, Diabetes |
Therapuetic Areas: | Endocrinology |
Healthy: | No |
Age Range: | 18 - 30 |
Updated: | 3/28/2019 |
Start Date: | November 20, 2018 |
End Date: | June 2020 |
Contact: | Pamela Martyn-Nemeth, PhD |
Email: | pmartyn@uic.edu |
Phone: | 312-996-7903 |
A Cognitive Behavioral Intervention to Reduce Fear of Hypoglycemia in Young Adults With T1DM
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.
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 30 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.
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 30 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.
Inclusion Criteria:
Diagnosis of T1DM ≥ 1 year, receive medical care from an endocrinologist, use insulin pump
therapy, have fear of hypoglycemia (screening questionnaire), and attended a basic diabetes
educational program
Exclusion Criteria:
Pregnant or breastfeeding, receiving psychotherapy for depression or anxiety disorders or
have received therapy specifically for fear of hypoglycemia, have a co-existing chronic
illness
We found this trial at
1
site
2035 W Taylor St
Chicago, Illinois
Chicago, Illinois
(312) 996-4350
Phone: 312-996-7903
University of Illinois at Chicago A major research university in the heart of one of...
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