Effect of Smartphone Based Telemedicine and Education in Patients With Type 1 Diabetes Mellitus

Study Overview
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Brief Summary
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Objective: evaluation of effect of smartphone based telemedicine and education in patients with type 1 diabetes mellitus Outline: Among the patients with type 1 diabetes, the group with telemedicine and education using smartphone set as a experimental group and the group without those set as a control group, respectively. Sample size: experimental group (n=50), control group (n=50) Inclusion criteria: patients with type 1 diabetes with A1c>8.0% Exclusion criteria: chronic disease, psychological disease, children aged under 12 with parents with psychological disease, athletics Method: We divide subjects as an experimental group and a control group by randomization, and they visit outpatient clinic every 12 weeks. We perform telemedicine and education with smartphone application to the experimental group every 2 weeks. We evaluate the effect of smartphone based telemedicine and education in patients with type 1 diabetes mellitus with checking A1c and checklist at baseline, 12 weeks and 24 weeks after starting of the research. Variables: A1c, satisfaction, knowledge, self-confidence, willing to continuing, quality of life, physical activity, drinking, smoking Primary endpoint: Improvement in HbA1c of experimental group Secondary endpoint: No improvement in HbA1c of control group

Official Title
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Effect of Smartphone Based Telemedicine and Education in Patients With Type 1 Diabetes Mellitus

Conditions
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Type 1 Diabetes Mellitus

Intervention / Treatment
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* Device: Experimental : Smartphone-based telemedicine with the app 'Songaree diabetes'


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: a. patients aged under 30 with type 1 diabetes b. patients who control glucose level with multiple daily injection of insulin pump c. Patients who agree the task to check glucose level during the experiment d. patients who has been diagnosed as type 1 diabetes more than 3 months e. patients whose A1c more than 8.0% within 6 months f. Patients who can use smartphone all day 2) exclusion criteria chronic disease (except thyroid disorders with euthyroidism), psychological disease Patients aged under 12 whose parents have psychological disease Patients who cannot use smartphone app properly athletics Patients who use continuous glucose monitoring Exclusion Criteria: -

Ages Eligible for Study
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Minimum Age: 0 Months
Maximum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Inclusion criteria: patients with type 1 diabetes with A1c>8.0% Exclusion criteria: chronic disease, psychological disease, children aged under 12 with parents with psychological disease, athletics Method: We divide subjects as an experimental group and a control group by randomization, and they visit outpatient clinic every 12 weeks. We perform telemedicine and education with smartphone application to the experimental group every 2 weeks. We evaluate the effect of smartphone based telemedicine and education in patients with type 1 diabetes mellitus with checking A1c and checklist at baseline, 12 weeks and 24 weeks after starting of the research.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Smartphone-based telemedicine<br> | Device: Experimental : Smartphone-based telemedicine with the app 'Songaree diabetes'<br>* Experimental group: outpatient clinic and offline education every 12 weeks plus telemedicine and education with smartphone app 'Songaree diabetes' every 2 weeks for 24 weeks<br>|
| No Intervention: Conventional management without telemedicine<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in HbA1c of experimental group |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| No change in HbA1c of control group |  | 6 months later | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes Mellitus, Telemedicine, Smartphone, Type 1, Child, Adolescent, Young Adult