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.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Rabin Medical Center
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Quality of life
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 7 Years to 11 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Quality of life
Time Frame: After 12 weeks (end of study)
Quality of life questionnaires will be completed
Secondary Outcomes
- Metabolic control(After 12 weeks (end of study))
- 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))
- Diabetes knowledge(After 12 weeks)
- Patient's gaming duration(After 12 weeks)
- Compliance to diabetes treatment(After 12 weeks)