Skip to content

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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02380339
Enrollment
20
Registered
2015-03-05
Start date
2018-03-01
Completion date
2019-12-31
Last updated
2019-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypoglycemia, Type One Diabetes

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.

Interventions

BEHAVIORALPsych-Educational session and virtual reality

Psych-Educational session and virtual reality

BEHAVIORALPsych-Educational and BF sessions

Psych-Educational and BF sessions

Sponsors

Hadassah Medical Organization
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime 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

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026