Clinical trial NCT01600664: The Effect of the Use of Computer Game- "My Diabetic Friend" in Children With Type 1 Diabetes
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes
Keywords: Type 1 diabetes
"My Diabetic friend"
interactive computer game
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
Collaborators: name: Intel Corporation
First posted: 2012-05-17
Enrollment: 30
Sex: ALL
Minimum age (years): 7
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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;

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Quality of life
timeFrame: After 12 weeks (end of study)
Secondary outcomes:
measure: Metabolic control
timeFrame: After 12 weeks (end of study)
measure: Diabetes knowledge
timeFrame: After 12 weeks
measure: Patient's gaming duration
timeFrame: After 12 weeks
measure: Compliance to diabetes treatment
timeFrame: After 12 weeks
measure: Average glucose levels
timeFrame: After 12 weeks (end of study)
measure: Average number of blood glucose measurements
timeFrame: After 12 weeks (end of study)
measure: Measurements within normal range
timeFrame: After 12 weeks (end of study)
measure: Hypoglycemia events
timeFrame: After 12 weeks (end of study)
measure: Hyperglycemia events
timeFrame: After 12 weeks (end of study)
Other outcomes:
Locations:
city: Petach- Tikva
country: Israel
facility: Schneider Medical Center
Study officials:
affiliation: Rabin Medical Center
name: Moshe Phillip, Prof
role: PRINCIPAL_INVESTIGATOR
References: