None listed
Conditions
Interventions
Others : Evaluate the enrolled subjects for 26 weeks with a random 1:1:1 assignment to the Usual care group (control group), Mobile diabetes management group (iCareD Observation group), and the Mobile
Sponsors
The Catholic University of Korea, St. Vincent's Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: To participate in this clinical trial, all of the following criteria must be met: 1) Type 2 diabetes patients who need to measure their own blood sugar and are trained in diabetes self-management 2) Men and women aged 19 years or older and under 75 years of age 3) HbA1c 7.5% or more at baseline 4) BMI 18.5 kg/m2 or higher 5) Those who can use a smartphone 6) Those who agree to participate in this clinical trial and who agree in writing to the consent
Exclusion criteria
Exclusion criteria: Any of the following subjects should be excluded from this clinical trial: 1) Patients on treatment with insulin pump 2) Patients with severe renal diseases: eGFR <30ml/min 3) Patients with heart failure corresponds to New Your Heart Association III-IV 4) Persons who have been diagnosed with malignant tumors within the last five years and have not been treated 5) Recipients of organ transplants or persons requiring long-term immunosuppression 6) Pregnant or breastfeeding 7) Those who plan to conceive during a clinical trial or who do not agree to appropriate contraception 8) Persons who participated in other clinical trials within 90 days of screening (excluding observational studies) 9) Persons are considered unfit to participate in a this clinical trial when judging by the investigators
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in HbA1c over 26 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in HbA1c over 52 weeks;Change from baseline in fasting plasma glucose over 26, 52 weeks;Change from baseline in lifestyle (activity, eating records);Change from baseline in cardiovascular disease risk factors (body weight, blood pressure, lipid profile);Change from baseline in quality of life;Program satisfaction and compliance;An acummulated unexpected utilization rate by medical institutions due to the development of hypoglycemia or hyperglycemia;An effect on development of hypoglycemia and hyperglycemia;Change from baseline in Homeostasis Model Assessment (HOMA)-insulin resistance,Homeostasis Model Assessment -beta over 26, 52 weeks | — |
Countries
Korea, Republic of
Contacts
Public ContactSeon-Ah Cha
The Catholic University of Korea, St. Vincent's Hospital
Outcome results
None listed