Patients with type 2 diabetes using smartphone on a daily basis (including a person who newly visits to a clinic/hospital)
Conditions
Interventions
Download "
Omron Connect"
and "
Shichifukujin"
applications to patients'
smartphone and input the information required to use "
applications. The study subjects measure the amount of activity, body weight, and blood pressure on a daily basis using lent measurement apparatuses, connects "
to the measurement apparatuses, and synchronizes them every day as much as possible. Investigators of the study and family doctors will plan the behavioral targets tailored to the subjects in the inte
application as appropriate feedbacks according to the implementation situation (IoT information). At visit at 12, 24, 36, and 52 weeks or during health guidance, share the measurement data of "
and the comment of "
applications with the investigators of the study and the family doctors. In addition, investigators and family doctors can access the administrators section in the "
application webpage, check/confirm the summary of the measurement data, graphs and lifestyle habits, and use them appropriately as the assistance data/documents for medical treatment and guidance base
Sponsors
National Center for Global Health and Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. A patient whose HbA1c value is 6.0% or higher but 8.9% or lower. 2. A patient whose age is 20 years or older but younger than 75 years old. 3. A patient whose dosage and dose regimen of medications regarding diabetes have not been changed for 8 weeks or longer before the allocation. 4. A patient from whom informed consent of the participation in the study is obtained in written form.
Exclusion criteria
Exclusion criteria: 1. A patient with serious hepatic impairment (his/her ALT exceeds 3-fold of the upper limit of the standard value), kidney diseases (his/her eGFR is less than 30 mL/min/1.73 m2), malignancies (patient whose time to recurrence is less than 5 years), or active infectious diseases (including sepsis). 2. A patient receiving 4 or more oral therapeutic agents for diabetes. 3. A patient receiving any insulin or GLP1 receptor agonist. 4. A patient with active proliferative diabetic retinopathy. 5. A patient who had developed cardiovascular disease within 6 months. 6. A patient with an uncompensated cardiac insufficiency. 7. A patient who is pregnant or is planning to become pregnant within 2 years. 8. A patient who requires assistance from another person to treat hypoglycemia. 9. A patient who is instructed to follow the exercise restrictions due to diseases other than diabetes mellitus. 10. A patient for whom the person in charge of the study judges that his/her participation in this study is inappropriate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in HbA1c at week 52 after the start of the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Inter-group comparison will be done for the following items at weeks 12, 24, 36, and 52 after the initiation of the study. 1. Glucose metabolism (blood glucose) 2. Lipid metabolism (total cholesterol, HDL cholesterol) 3. Liver function (ALT), renal function (creatinine) 4. Brief-type self-administered Diet History Questionnaire (BDHQ) (baseline and at 52 weeks) 5. Diabetes Therapy-Related-QOL (DTR-QOL) 6. Lifestyle questionnaire 7. Weight, BMI, systolic and diastolic blood pressures | — |
Countries
Japan
Contacts
Public ContactRyotaro Bouchi
National Center for Global Health and Medicine Diabetes and Metabolism Information Center
Outcome results
None listed