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

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

Ohnishi Yukiko

The Institute for Adult Diseases, Asahi Life Foundation

2-2-6, Nihonbashi Bakurocho, Chuo-ku, Tokyo

y-ohnishi@asahi-life.or.jp

Nozoe Satoshi

Save Medical Corporation

1-9-10, Nihonbashi Horidomecho, Chuo-ku, Tokyo

+81-3-6661-2317

nozoe@savemedical.jp

Complete

May. 17, 2020

Interventional

randomized controlled trial

open(masking not used)

no treatment control/standard of care control

parallel assignment

treatment purpose

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)
11) Patients with renal impairment (eGFR less than 45 mL/min/1.73m2 or urinary micro albumin of 300 mg/gCre or more (both values from the central batch measurement at Visit 1).
12) Patients with chronic diseases requiring continuous use (internal, injection, inhalation) of corticosteroids, immunosuppressive agents, loop diuretics, etc.
13) Patients with a malignant tumor (recurrence-free period less than 5 years) or infection (sepsis)
14) Patients who are scheduled to be hospitalized or undergo surgical procedures during the study period
15) Patients with drug addiction, alcoholism, or unstable psychiatric illness
16) Patients with non-diabetic disease for whom exercise restriction is indicated
17) Patients whose HbA1c levels measured within 4-10 weeks prior to Visit 1 (in-hospital measurements) and the variability of HbA1c levels at Visit 1 (in-hospital measurements) is greater than +/-1.0%.
18) Patients who have participated, are currently participating, or will participate during the course of this study, in a clinical trial or post-marketing clinical trial for another prescription drug or medical device within 12 weeks (84 days) retroactive to Visit 1.
19) Patients who, within 12 weeks (84 days) prior to Visit 1, have used a mobile application running on a smartphone device for the purpose of managing or assisting in the management of diabetes or performing an autologous blood glucose measurement, and the investigator determines that the impact of such use on the evaluation of the efficacy of the study cannot be ruled out.
20) Patients planning to replace their smartphone device within 24 weeks of Visit 2
21) Medical institution staff or close relatives involved in the study
22) Employees of Save Medical, Inc. or employees of companies entrusted with work related to this clinical trial
23) Patients who are unable to comply with or do not agree to any of the rules for hospital visits and medication adherence specified in this study.
24) Other patients deemed by the investigator to be inappropriate for inclusion in the study.

Both

Type 2 Diabetes

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.

Type 2 Diabetes

D003924

Change in HbA1c from baseline at the end of the treatment period

HbA1c
Fasting Blood Glucose
Fasting Insulin
Fasting Intact Proinsulin to Insulin Ratio
Self Management Adherence Rate

April. 10, 2020

No

none