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NCT02380339 Clinical Trial

A Combined Biofeedback-virtual Reality System for Reduction of Fear of Hypoglycemia

Hypoglycemia Clinical Trial

Official title:
A Combined Biofeedback-virtual Reality System for Reduction of Fear of Hypoglycemia

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02380339
Other study ID # 0098-14-HMO-CTIL
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 1, 2018
Est. completion date December 2019

Study information
Verified date August 2019
Source Hadassah Medical Organization
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 20
Est. completion date December 2019
Est. primary completion date December 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- 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 ).

Exclusion Criteria:

Patient with severe hypoglycemia event in the last 6 months will be excluded. Patient with mental illness will be excluded

Study Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• Psych-Educational session and virtual reality
Psych-Educational session and virtual reality
• Psych-Educational and BF sessions
Psych-Educational and BF sessions

Locations
Country Name City State
Israel Hadassah Medical Organization, Jerusalem, Israel Jerusalem

Sponsors (1)
Lead Sponsor Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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