Type 1 Diabetes Clinical Trial
Official title:
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.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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