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

Ohnishi Yukiko0 sites200 target enrollmentMay 17, 2020

Overview

No summary available.

Registry

who.int

Start Date

May 17, 2020

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

Ohnishi Yukiko

•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.

•1\) Women who wish to become pregnant, are pregnant, or are breastfeeding.
•2\) Premenopausal women with a positive pregnancy test (urine)
•3\) Patients who have been diagnosed with type 1 diabetes
•4\) Patients who have been diagnosed with secondary diabetes mellitus
•5\) Patients who received insulin within 12 weeks (84 days) retroactive to Visit 1
•6\) Patients with a history of requiring third party intervention for the treatment of hypoglycemia
•7\) Patients with or undergoing treatment for diabetic proliferative retinopathy
•8\) Patients who developed cardiovascular disease within 12 weeks (84 days) retroactive to Visit 1
•9\) Patients with noncompensated heart failure
•10\) Patients with serious hepatic impairment (ALT value (central bulk measurement at Visit 1\) greater than 3 times the upper limit of the reference value)

Not specified