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

Yonsei University

Status: Unknown

Conditions: Type 1 Diabetes Mellitus

Treatments: Device: Experimental : Smartphone-based telemedicine with the app 'Songaree diabetes'

Study type: Interventional

Funder types: Other

Identifiers

NCT04721509

4-2020-0880

Details and patient eligibility

About

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

Enrollment: 100 estimated patients

Sex: All

Ages: Under 30 years old

Volunteers: No Healthy Volunteers

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

Exclusion criteria

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Smartphone-based telemedicine

Experimental group

Treatment:

Device: Experimental : Smartphone-based telemedicine with the app 'Songaree diabetes'

Conventional management without telemedicine

No Intervention group