NCT04721509

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Yonsei University · Academic / Other
• Sex: All
• Age: 0 Months – 30 Years
• Healthy volunteers: Not accepted

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

Conditions

• Type 1 Diabetes Mellitus

Interventions

Type	Name	Description
DEVICE	Experimental : 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

Timeline

• Start date: 2021-02-01
• Primary completion: 2022-09-01
• Completion: 2022-09-01
• First posted: 2021-01-22
• Last updated: 2021-01-22

Locations

1 site across 1 country: South Korea