Type 1 Diabetes Mellitus
Conditions
Keywords
Diabetes Mellitus, Telemedicine, Smartphone, Type 1, Child, Adolescent, Young Adult
Brief summary
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
Interventions
DEVICEExperimental : Smartphone-based telemedicine with the app 'Songaree diabetes'
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
Sponsors
Yonsei University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Masking description
Open label
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
0 Months to 30 Years
Healthy volunteers
No
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
1. chronic disease (except thyroid disorders with euthyroidism), psychological disease 2. Patients aged under 12 whose parents have psychological disease 3. Patients who cannot use smartphone app properly 4. athletics 5. Patients who use continuous glucose monitoring
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| change in HbA1c of experimental group | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| No change in HbA1c of control group | 6 months later |
Countries
South Korea
Contacts
Primary ContactHo-Seong Kim
Outcome results
None listed