Clinical Trials Logo
  1. Home
  2. Hypoglycemia
  3. NCT02380339
  4. Details
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
See also
  Status Clinical Trial Phase
Completed NCT03482154 - Malglycemia in the Pediatric Hematopoietic Stem Cell Transplant Population
Completed NCT03667053 - Trial to Confirm the Efficacy and Safety of Dasiglucagon in the Treatment of Hypoglycemia in T1DM Children Phase 3
Active, not recruiting NCT03422471 - Hypoglycemia and Autonomic Nervous System Function- B2 N/A
Recruiting NCT05379686 - Low-Dose Glucagon and Advanced Hybrid Closed-Loop System for Prevention of Exercise-Induced Hypoglycaemia in People With Type 1 Diabetes N/A
Completed NCT05597605 - The SHINE Study: Safety of Implant and Preliminary Performance of the SHINE SYSTEM in Diabetic Subjects N/A
Not yet recruiting NCT05990933 - Role of Adrenaline in in the Inflammatory Response in Diabetes N/A
Withdrawn NCT03736083 - Introducing CGM at Type 1 Diabetes Diagnosis N/A
Completed NCT02966275 - Post Bariatric Closed Loop Glucagon Trial N/A
Not yet recruiting NCT02909881 - Dose Response Oxidation of a Sweet-corn Derived Sugar (PhytoSpherix) During Exercise in Endurance Trained Athletes N/A
Withdrawn NCT02518022 - How to be Safe With Alcoholic Drinks in Diabetes N/A
Completed NCT02213003 - Allogeneic Islet Cells Transplanted Onto the Omentum Phase 1/Phase 2
Completed NCT01176656 - Hypoglycemia: Physician and Patient Perspectives N/A
Completed NCT01147276 - Vildagliptin and the Glucagon Response to Hypoglycemia in Type 1 Diabetes Phase 4
Completed NCT00998374 - Comparison Between Pyloric Preserving and Non-Pyloric Preserving Bariatric Surgery With Glucose Challenge N/A
Terminated NCT01225159 - Tight Glycaemic Control During Cardiac Surgery N/A
Completed NCT00373854 - Study of How Low Blood Sugar Affects the Way Blood Vessels Work N/A
Completed NCT00285233 - Delayed Mycophenolate Mofetil in Single-Donor Islet Allotransplantation in Type 1 Diabetes Phase 1/Phase 2
Recruiting NCT05916131 - Pilot Feasibility Study for HypoPals, a Mobile Health Program for Improving Hypoglycemia Management. N/A
Terminated NCT04026750 - Insulin Tolerance Test Study in Patients With Type 1 Diabetes Phase 1
Completed NCT05133765 - The SMART B Exercise Study :''The SMART Study'' N/A