Type 1 Diabetes
Conditions
Keywords
Type 1 diabetes, My Diabetic friend, interactive computer game
Brief 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.
Interventions
BEHAVIORALInteractive computer game
Participants will use the interactive computer game installed on a convertible PC
BEHAVIORALConvertible PC
Participants will be using the convertible PC without the interactive computer game
Sponsors
Intel Corporation
Rabin Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
7 Years to 11 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life | After 12 weeks (end of study) | Quality of life questionnaires will be completed |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Diabetes knowledge | After 12 weeks | Diabetes knowledge questionnaires will be completed |
| Patient's gaming duration | 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 |
| Compliance to diabetes treatment | After 12 weeks | Patient's parents will undergo clinical interview about patient's diabetes adherence |
| Average glucose levels | After 12 weeks (end of study) | — |
| Metabolic control | After 12 weeks (end of study) | HbA1c will be measured |
| Measurements within normal range | After 12 weeks (end of study) | — |
| Hypoglycemia events | After 12 weeks (end of study) | — |
| Hyperglycemia events | After 12 weeks (end of study) | — |
| Average number of blood glucose measurements | After 12 weeks (end of study) | — |
Countries
Israel
Outcome results
None listed