The Effect of the Use of Computer Game- "My Diabetic Friend" in Children With Type 1 Diabetes

Clalit Health Services

Status: Completed

Conditions: Type 1 Diabetes

Treatments: Behavioral: Convertible PC; Behavioral: Interactive computer game

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01600664

rmc006814ctil

Details and patient eligibility

About

A randomized controlled study to evaluate the effect of 3 months use with interactive computer game- "My Diabetic Friend"- comparing to conventional diabetes education on metabolic control, quality of life and diabetes knowledge.Patients will be randomized into two groups- one group will be supplied with interactive computer game, "My Diabetic friend", installed on a computer designed for children's educational needs for a period of three months and the other group will be supplied with the same computer without the interactive computer game for three months. Metabolic control, quality of life and diabetes knowledge will be evaluated before and after the use of the computer.

The trial is consisting of two main periods: 3 months of the main study period and an optional extension period consisting of the following 3 months :

The study will include two main periods;

1. Period 1 which will last 3 months, in a randomized controlled manner, this period will serve as the main study period to assess the primary and secondary endpoints of the study.
2. Period 2: this extension period will not be an integral part of the study, and only patients who are willing will take part at this period, will continue to participate at the optional extension period. During the extension period, patients in the intervention group will be offered to continue the use of the Computer game -"My diabetic friend) for the following 3 months, and patients who participated at the control group during period 1, will be offered to start to use the Computer Game - "My Diabetic Friend" for the following 3 months.

Enrollment: 30 patients

Sex: All

Ages: 7 to 11 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Type 1 diabetes diagnosed at least one year prior to study entry.
2. Age:7-11 years old.
3. Treatment either with CSII or MDI.
4. HbA1c>8.0%
5. Signing an informed consent form.

Exclusion criteria

1. Any significant disease or conditions, including psychiatric disorders that in the opinion of the investigator are likely to affect subject compliance or subject's ability to complete the study.
2. Inability to understand/ complete the questionnaires.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

interactive computer game

Experimental group

Description:

Participants will be using the interactive computer game- "My Diabetic Friend", installed on Intel-powered convertible classmate PC.

Treatment:

Behavioral: Interactive computer game

Convertible PC

Active Comparator group

Description:

Participants will be using the convertible classmate PC without the interactive computer game

Treatment:

Behavioral: Convertible PC