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

Last updated: September 10, 2019
Sponsor: Hadassah Medical Organization
Overall Status: Active - Recruiting

Phase

N/A

Condition

Hormone Deficiencies

Diabetes (Pediatric)

Treatment

N/A

Clinical Study ID

NCT02380339
0098-14-HMO-CTIL
  • Ages 18-65
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 orgreater than 3 on at least one of the item on the HFS-W ).

Exclusion

Exclusion Criteria: Patient with severe hypoglycemia event in the last 6 months will be excluded. Patient withmental illness will be excluded

Study Design

Total Participants: 20
Study Start date:
March 01, 2018
Estimated Completion Date:
December 31, 2019

Connect with a study center

  • Hadassah Medical Organization, Jerusalem, Israel

    Jerusalem,
    Israel

    Active - Recruiting

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