A Combined Biofeedback-virtual Reality System for Reduction of Fear of Hypoglycemia
1 other identifier
interventional
20
1 country
1
Brief Summary
Uncontrolled diabetes is associated with increased risk for micro-vascular complication. Hypoglycemia is one of the major barriers in achieving good glucose control. Hypoglycemia is associated with a range of unpleasant symptoms including palpitations, tremor, hunger, sweating, confusion, difficulties in thinking as well as other idiosyncratic symptoms. Fear of hypoglycemia (FOH) refers to phobic avoidance reactions associated with hypoglycemia FOH may increase behavioral attempts to avoid hypoglycemia including decreased consumption of insulin and/or increased consumption of carbohydrates, resulting in poor glycemic control and an increased risk of diabetic complication. In this study, the investigators present a novel system, which simultaneously employs BioFeedback and Virtual Reality in order to cope with fear of hypoglycemia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 2, 2015
CompletedFirst Posted
Study publicly available on registry
March 5, 2015
CompletedStudy Start
First participant enrolled
March 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2019
CompletedSeptember 11, 2019
August 1, 2019
1.8 years
March 2, 2015
September 10, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Reduction of fear of hypoglycemia in type 1 diabetic patients as measured by reduction of 2 point on the HFS-W). pre-treatment and after two months post completion of treatment.
two months
Study Arms (2)
Psych-Educational and Bio Feedback (BF_
ACTIVE COMPARATORParticipants in the control group will undergo Psych-Educational and BF sessions in which they will receive information about FOH and about ways of coping with FOH and BF training. More specifically, they will learn about factors associated with FOH, behavioral manifestations of FOH, negative consequences of these behavioral manifestations and about ways of coping with FOH. They will be instructed to practice BF for 15 minutes, at home for 5 initial training sessions during a week. After which they will receive another session of BF training and will be instructed to practice it at home for 10 sessions course, (5 weekly sessions for 2 weeks). Each session will be for 15 minutes.
Psych-Educational session and virtual reality (VR)
EXPERIMENTALParticipants in the intervention group will receive Psych-Educational session as the control group and in addition they will participate in training for VR system and will be asked to use it at home for 5 initial training sessions during a week. During this week, they will practice reducing their GSR levels as indicated by the BF device. Following this they will receive a combined biofeedback-virtual reality system and use it at home for a 10 sessions course, (5 weekly sessions for 2 weeks). Each session will be for 15 minutes.
Interventions
Psych-Educational session and virtual reality
Psych-Educational and BF sessions
Eligibility Criteria
You may qualify if:
- Type 1 diabetic patient, male and females above the age of 18.
- Patients with significant fear of hypoglycemia as indicated in the HFS-W (equals or greater than 3 on at least one of the item on the HFS-W ).
You may not qualify if:
- Patient with severe hypoglycemia event in the last 6 months will be excluded. Patient with mental illness will be excluded
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hadassah Medical Organization, Jerusalem, Israel
Jerusalem, Israel
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 2, 2015
First Posted
March 5, 2015
Study Start
March 1, 2018
Primary Completion
December 1, 2019
Study Completion
December 1, 2019
Last Updated
September 11, 2019
Record last verified: 2019-08