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

Randomized Controlled Trial 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 in Children With Type 1 Diabetes.

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.

Study Overview

• Status: Completed
• Conditions: Type 1 Diabetes
• Intervention / Treatment: Behavioral: Interactive computer game; Behavioral: Convertible PC

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Petach- Tikva, Israel
    • Schneider Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 11 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: interactive computer game; Participants will be using the interactive computer game- "My Diabetic Friend", installed on Intel-powered convertible classmate PC.	Behavioral: Interactive computer game; Participants will use the interactive computer game installed on a convertible PC
Active Comparator: Convertible PC; Participants will be using the convertible classmate PC without the interactive computer game	Behavioral: Convertible PC; Participants will be using the convertible PC without the interactive computer game

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life	Quality of life questionnaires will be completed	After 12 weeks (end of study)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Metabolic control	HbA1c will be measured	After 12 weeks (end of study)
Diabetes knowledge	Diabetes knowledge questionnaires will be completed	After 12 weeks
Patient's gaming duration	The frequency and the duration of use of the interactive computer game by each participant will be monitored by the study team	After 12 weeks
Compliance to diabetes treatment	Patient's parents will undergo clinical interview about patient's diabetes adherence	After 12 weeks
Average glucose levels		After 12 weeks (end of study)
Average number of blood glucose measurements		After 12 weeks (end of study)
Measurements within normal range		After 12 weeks (end of study)
Hypoglycemia events		After 12 weeks (end of study)
Hyperglycemia events		After 12 weeks (end of study)

Collaborators and Investigators

• Sponsor: Rabin Medical Center
• Collaborators: Intel Corporation

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (Actual): August 1, 2013
• Study Completion (Actual): August 1, 2013

Study Registration Dates

• First Submitted: May 16, 2012
• First Submitted That Met QC Criteria: May 16, 2012
• First Posted (Estimate): May 17, 2012

Study Record Updates

• Last Update Posted (Estimate): May 6, 2014
• Last Update Submitted That Met QC Criteria: May 4, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Keywords: Type 1 diabetes; "My Diabetic friend"; interactive computer game
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: rmc006814ctil