Posted by on Mar 5, 2016 in Diabetes mellitus | 0 comments

In a nutshell

This trial recruiting in Israel aims to evaluate the effectiveness of biofeedback, virtual reality, and education in helping patients cope with the fear of hypoglycemia (very low blood sugar levels). The main outcome being investigated is a decrease in the fear of hypoglycemia. 

The details

In diabetes blood sugar levels that are too high or too low can be damaging to the body. Hypoglycemia (very low blood sugar levels) is one of the major barriers of good blood sugar control. It is associated with a range of unpleasant symptoms including hunger, sweating, and confusion, as well as difficulties in thinking. Fear of hypoglycemia may cause a patient to decrease their insulin intake or increase the amount of carbohydrate they eat. This behavior could lead to poor blood sugar control.

New psychological treatment methods could be useful in treating fear of hypoglycemia. Biofeedback is a method of controlling automatic body processes (such as heart rate) using electrical sensors that provide information (feedback) on what the body is doing. Virtual reality is an artificial environment that is created with special software and presented to the user in such a way that the user is able to recognize their self and operate in that environment. This trial will investigate whether education combined with biofeedback or virtual reality can help patients cope with their fear of hypoglycemia. The main outcome of this study will be measured through questionnaires focusing on fear of hypoglycemcia.

Who are they looking for?

This trial will recruit 20 participants with type 1 diabetes who have a significant fear of hypoglycemia. They are seeking both men and women aged 18 to 65 years old.

Those who have had a severe hypoglycemic event (dangerously low levels of glucose) within 6 months of entering the study are not eligible to participate in the study. Participants must not have any type of mental illness.

How will it work

Participants will be divided into two groups. Both groups will take part in educational sessions on fear of hypoglycemia, how this fear might affect behavior, and the consequences of those behaviors. One group will learn biofeedback techniques. The other group will learn combined biofeedback and virtual reality techniques.

Participants will complete questionnaires focusing on fear of hypoglycemia at the start of the study and after 2 months.

Clinical trial locations

Locations near 20147, United States (Change):
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Study ID:NCT02380339
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