A Multicenter, Prospective, Randomized Controlled Trial: SMC-01: a Mobile Medical Application to Improve Self-Management of Patients with Type 2 Diabetes

Authors
Category Primary study
Registry of TrialsJapan Primary Registry Network
Year 2020
INTERVENTION: Subjects assigned to the SMC‐01 group will use the SMC‐01 in conjunction with self‐management between visits. In contrast, subjects assigned to the control group practice normal self‐management. In both the SMC‐01 and control groups, subjects will be provided with a blood pressure meter and a body weight meter, and they will use these instruments as necessary for self‐management between visits. CONDITION: D003924 Type 2 Diabetes ; Type 2 Diabetes PRIMARY OUTCOME: Change in HbA1c from baseline at the end of the treatment period SECONDARY OUTCOME: HbA1c; Fasting Blood Glucose; Fasting Insulin; Fasting Intact Proinsulin to Insulin Ratio; Self Management Adherence Rate INCLUSION CRITERIA: 1) Outpatients who are 20 years of age or older at the time of obtaining consent (regardless of gender) 2) Patients who have written consent at the time of Visit 1 3) Patients who, at Visit 1, have been diagnosed with type 2 diabetes for at least 12 weeks (84 days) 4) Patients being treated with diet and exercise therapy alone or taking hypoglycemic medications in addition to diet and exercise therapy, who have been on the same therapy for at least 12 weeks (84 days) at the time of Visit 1. 5) Patients with a Visit 1 HbA1c value of 7.0% to 9.0% or less 6) Patients who have a smartphone device and have been using it continuously for at least 12 weeks (84 days) at the time of Visit 1. 7) Patients who have been confirmed by the investigator as having no problems with the input eligibility of the test device.
Epistemonikos ID: 1541b7e711cbee237bb978359b77492351bd7176
First added on: Aug 24, 2024