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

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.

Study Overview

• Status: Unknown
• Conditions: Hypoglycemia; Type One Diabetes
• Intervention / Treatment: Behavioral: Psych-Educational and BF sessions; Behavioral: Psych-Educational session and virtual reality

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Jerusalem, Israel
    • Recruiting
    • Hadassah Medical Organization, Jerusalem, Israel
    • Contact: Hadas Lemberg, PhD; Phone Number: 972-6777111; Email: Lhadas@HADASSAH.ORG.IL

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Psych-Educational and Bio Feedback (BF_; Participants 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.	Behavioral: Psych-Educational and BF sessions; Psych-Educational and BF sessions
Experimental: Psych-Educational session and virtual reality (VR); Participants 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.	Behavioral: Psych-Educational session and virtual reality; Psych-Educational session and virtual reality

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Hadassah Medical Organization

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2018
• Primary Completion (Anticipated): December 1, 2019
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: March 2, 2015
• First Submitted That Met QC Criteria: March 4, 2015
• First Posted (Estimate): March 5, 2015

Study Record Updates

• Last Update Posted (Actual): September 11, 2019
• Last Update Submitted That Met QC Criteria: September 10, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Hypoglycemia
• Other Study ID Numbers: 0098-14-HMO-CTIL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No