Skip to main content
OpenTrials
Completed

NCT Number: NCT01600664

The Effect of the Use of Computer Game- "My Diabetic Friend" 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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

7 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Schneider Medical Center

Petah Tikva, Israel

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Interactive computer game

Behavioral

Participants will use the interactive computer game installed on a convertible PC

Convertible PC

Behavioral

Participants will be using the convertible PC without the interactive computer game

Primary outcomes

  1. Quality of life

    Time frame: After 12 weeks (end of study)

    Quality of life questionnaires will be completed

Secondary outcomes

  1. Metabolic control

    Time frame: After 12 weeks (end of study)

    HbA1c will be measured

  2. Diabetes knowledge

    Time frame: After 12 weeks

    Diabetes knowledge questionnaires will be completed

  3. Patient's gaming duration

    Time frame: After 12 weeks

    The frequency and the duration of use of the interactive computer game by each participant will be monitored by the study team

  4. Compliance to diabetes treatment

    Time frame: After 12 weeks

    Patient's parents will undergo clinical interview about patient's diabetes adherence

  5. Average glucose levels

    Time frame: After 12 weeks (end of study)

  6. Average number of blood glucose measurements

    Time frame: After 12 weeks (end of study)

  7. Measurements within normal range

    Time frame: After 12 weeks (end of study)

  8. Hypoglycemia events

    Time frame: After 12 weeks (end of study)

  9. Hyperglycemia events

    Time frame: After 12 weeks (end of study)

Sponsors and collaborators

Lead sponsor

Rabin Medical Center

Other

Collaborators

  • Intel Corporation

Registry information

Official study 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.

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
May 17, 2012
Registry last updated
May 6, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.