Type 1 DiabetesNCT01600664
The Effect of the Use of Computer Game- "My Diabetic Friend" in Children With Type 1 Diabetes
A study testing Interactive computer game and Convertible PC in people with Type 1 Diabetes, run by Rabin Medical Center at 1 site in Israel.
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… Read more about this study
- Who is it for?
- Ages 7 to 11 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Interactive computer game and Convertible PC
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIsrael
- Study dates
- Jun 2012to Aug 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
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 :
Read more
The study will include two main periods;
- 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.
- 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.
- Conditions
- Type 1 Diabetes
- Being tested
- Interactive computer game, Convertible PC
- Keywords
- Type 1 diabetes, "My Diabetic friend", interactive computer game
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interactive computer gameBehavioural
Participants will use the interactive computer game installed on a convertible PC
Convertible PCBehavioural
Participants will be using the convertible PC without the interactive computer game
| Study group | Role | What they receive |
|---|---|---|
| interactive computer game | Experimental | Participants will be using the interactive computer game- "My Diabetic Friend", installed on Intel-powered convertible classmate PC. Receives: Behavioral: Interactive computer game |
| Convertible PC | Active comparator | Participants will be using the convertible classmate PC without the interactive computer game Receives: Behavioral: Convertible PC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life
Quality of life questionnaires will be completed
Measured: After 12 weeks (end of study)
Secondary outcomes (9)
Metabolic control
HbA1c will be measured
Measured: After 12 weeks (end of study)
Diabetes knowledge
Diabetes knowledge questionnaires will be completed
Measured: After 12 weeks
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
Measured: After 12 weeks
Compliance to diabetes treatment
Patient's parents will undergo clinical interview about patient's diabetes adherence
Measured: After 12 weeks
Average glucose levels
Measured: After 12 weeks (end of study)
Average number of blood glucose measurements
Measured: After 12 weeks (end of study)
Measurements within normal range
Measured: After 12 weeks (end of study)
Hypoglycemia events
Measured: After 12 weeks (end of study)
Hyperglycemia events
Measured: After 12 weeks (end of study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2012 (estimated)
- Study startJun 2012
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Intel Corporation
- Responsible party
- Sponsor
- Investigators
- Moshe Phillip, Prof, Principal investigator, Rabin Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01600664
- Sponsor's protocol ID
- rmc006814ctil
- Status last verified
- May 2014
- First submitted
- 16 May 2012
- Last updated
- 6 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01600664
- Acronym / sponsor ID
- rmc006814ctil
- Conditions
- Type 1 Diabetes
- Keywords
- Type 1 diabetes, "My Diabetic friend", interactive computer game
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Collaborators
- Intel Corporation
- Study start
- Jun 2012
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 17 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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;
- 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.
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| interactive computer game | Experimental | Behavioral: Interactive computer gameParticipants will be using the interactive computer game- "My Diabetic Friend", installed on Intel-powered convertible classmate PC. |
| Convertible PC | Active comparator | Behavioral: Convertible PCParticipants will be using the convertible classmate PC without the interactive computer game |
Who may qualify
- Ages
- 7 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interactive computer gameParticipants will use the interactive computer game installed on a convertible PC | Behavioural | interactive computer game |
| Convertible PCParticipants will be using the convertible PC without the interactive computer game | Behavioural | Convertible PC |
Primary outcome
Quality of life
Time frame: After 12 weeks (end of study)
Quality of life questionnaires will be completed
9 secondary outcomes
Metabolic control
Time frame: After 12 weeks (end of study)
Diabetes knowledge
Time frame: After 12 weeks
Patient's gaming duration
Time frame: After 12 weeks
Compliance to diabetes treatment
Time frame: After 12 weeks
Average glucose levels
Time frame: After 12 weeks (end of study)
Average number of blood glucose measurements
Time frame: After 12 weeks (end of study)
Measurements within normal range
Time frame: After 12 weeks (end of study)
Hypoglycemia events
Time frame: After 12 weeks (end of study)
Hyperglycemia events
Time frame: After 12 weeks (end of study)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Moshe Phillip, Prof principal investigator
Rabin Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interactive computer game and Convertible PC in people with Type 1 Diabetes, run by Rabin Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life (time frame: After 12 weeks (end of study)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2014.