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

NCT ID: NCT01600664

Last Updated: 2014-05-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2013-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Type 1 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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interactive computer game

Participants will be using the interactive computer game- "My Diabetic Friend", installed on Intel-powered convertible classmate PC.

Group Type EXPERIMENTAL

Interactive computer game

Intervention Type BEHAVIORAL

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

Convertible PC

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

Group Type ACTIVE_COMPARATOR

Convertible PC

Intervention Type BEHAVIORAL

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

Interventions

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Interactive computer game

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

Intervention Type BEHAVIORAL

Convertible PC

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

7 Years

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Intel Corporation

INDUSTRY

Sponsor Role collaborator

Rabin Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Moshe Phillip, Prof

Role: PRINCIPAL_INVESTIGATOR

Rabin Medical Center

Locations

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Schneider Medical Center

Petah Tikva, , Israel

Site Status

Countries

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Israel

Other Identifiers

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rmc006814ctil

Identifier Type: -

Identifier Source: org_study_id

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