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| Name | Class |
|---|---|
| Intel Corporation | INDUSTRY |
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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;
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| interactive computer game | Experimental | Participants will be using the interactive computer game- "My Diabetic Friend", installed on Intel-powered convertible classmate PC. |
|
| Convertible PC | Active Comparator | Participants will be using the convertible classmate PC without the interactive computer game |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Interactive computer game | Behavioral | Participants will use the interactive computer game installed on a convertible PC |
|
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life | Quality of life questionnaires will be completed | After 12 weeks (end of study) |
| Measure | Description | Time Frame |
|---|---|---|
| Metabolic control | HbA1c will be measured | After 12 weeks (end of study) |
| Diabetes knowledge | Diabetes knowledge questionnaires will be completed |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Moshe Phillip, Prof | Rabin Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Schneider Medical Center | Petah Tikva | Israel |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Convertible PC | Behavioral | Participants will be using the convertible PC without the interactive computer game |
|
| 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) |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |