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

This study has been completed.
Sponsor:
Collaborator:
Intel Corporation
Information provided by (Responsible Party):
Rabin Medical Center
ClinicalTrials.gov Identifier:
NCT01600664
First received: May 16, 2012
Last updated: May 4, 2014
Last verified: May 2014
  Purpose

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.

Condition Intervention
Type 1 Diabetes
Behavioral: Interactive computer game
Behavioral: Convertible PC

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
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.

Resource links provided by NLM:


Further study details as provided by Rabin Medical Center:

Primary Outcome Measures:
  • Quality of life [ Time Frame: After 12 weeks (end of study) ] [ Designated as safety issue: No ]
    Quality of life questionnaires will be completed


Secondary Outcome Measures:
  • Metabolic control [ Time Frame: After 12 weeks (end of study) ] [ Designated as safety issue: No ]
    HbA1c will be measured

  • Diabetes knowledge [ Time Frame: After 12 weeks ] [ Designated as safety issue: No ]
    Diabetes knowledge questionnaires will be completed

  • Patient's gaming duration [ Time Frame: After 12 weeks ] [ Designated as safety issue: No ]
    The frequency and the duration of use of the interactive computer game by each participant will be monitored by the study team

  • Compliance to diabetes treatment [ Time Frame: After 12 weeks ] [ Designated as safety issue: No ]
    Patient's parents will undergo clinical interview about patient's diabetes adherence

  • Average glucose levels [ Time Frame: After 12 weeks (end of study) ] [ Designated as safety issue: No ]
  • Average number of blood glucose measurements [ Time Frame: After 12 weeks (end of study) ] [ Designated as safety issue: No ]
  • Measurements within normal range [ Time Frame: After 12 weeks (end of study) ] [ Designated as safety issue: No ]
  • Hypoglycemia events [ Time Frame: After 12 weeks (end of study) ] [ Designated as safety issue: No ]
  • Hyperglycemia events [ Time Frame: After 12 weeks (end of study) ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: June 2012
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: interactive computer game
Participants will be using the interactive computer game- "My Diabetic Friend", installed on Intel-powered convertible classmate PC.
Behavioral: Interactive computer game
Participants will use the interactive computer game installed on a convertible PC
Active Comparator: Convertible PC
Participants will be using the convertible classmate PC without the interactive computer game
Behavioral: Convertible PC
Participants will be using the convertible PC without the interactive computer game

  Eligibility

Ages Eligible for Study:   7 Years to 11 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01600664

Locations
Israel
Schneider Medical Center
Petach- Tikva, Israel
Sponsors and Collaborators
Rabin Medical Center
Intel Corporation
Investigators
Principal Investigator: Moshe Phillip, Prof Rabin Medical Center
  More Information

No publications provided

Responsible Party: Rabin Medical Center
ClinicalTrials.gov Identifier: NCT01600664     History of Changes
Other Study ID Numbers: rmc006814ctil
Study First Received: May 16, 2012
Last Updated: May 4, 2014
Health Authority: Israel: Ministry of Health

Keywords provided by Rabin Medical Center:
Type 1 diabetes
"My Diabetic friend"
interactive computer game

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on September 18, 2014