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

Study Overview
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Brief Summary
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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; 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. 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.

Official Title
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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.

Conditions
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Type 1 Diabetes

Intervention / Treatment
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* Behavioral: Interactive computer game
* Behavioral: Convertible PC


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Type 1 diabetes diagnosed at least one year prior to study entry. Age:7-11 years old. Treatment either with CSII or MDI. HbA1c>8.0% Signing an informed consent form. Exclusion Criteria: 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. Inability to understand/ complete the questionnaires.

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 11 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 1 diabetes, My Diabetic friend, interactive computer game