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

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01600664
• Other study ID #: rmc006814ctil
• Status: Completed
• Phase: N/A
• First received: May 16, 2012
• Last updated: May 4, 2014
• Start date: June 2012
• Est. completion date: August 2013

Study information

• Verified date: May 2014
• Source: Rabin Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 7 Years to 11 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

Behavioral:
• Interactive computer game
Participants will use the interactive computer game installed on a convertible PC
• Convertible PC
Participants will be using the convertible PC without the interactive computer game

Locations

Country	Name	City	State
Israel	Schneider Medical Center	Petach- Tikva

Sponsors (2)

Lead Sponsor	Collaborator
Rabin Medical Center	Intel Corporation

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of life	Quality of life questionnaires will be completed	After 12 weeks (end of study)	No
Secondary	Metabolic control	HbA1c will be measured	After 12 weeks (end of study)	No
Secondary	Diabetes knowledge	Diabetes knowledge questionnaires will be completed	After 12 weeks	No
Secondary	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	No
Secondary	Compliance to diabetes treatment	Patient's parents will undergo clinical interview about patient's diabetes adherence	After 12 weeks	No
Secondary	Average glucose levels		After 12 weeks (end of study)	No
Secondary	Average number of blood glucose measurements		After 12 weeks (end of study)	No
Secondary	Measurements within normal range		After 12 weeks (end of study)	No
Secondary	Hypoglycemia events		After 12 weeks (end of study)	No
Secondary	Hyperglycemia events		After 12 weeks (end of study)	No