臨床研究等提出・公開システム

Effect of Lifestyle Management with a Wearable Device (Fitbit) and a Mobile App (TOMOCO) on Glycemic Control in Medicated Patients with Insufficiently Controlled Type 2 Diabetes Mellitus
(STEP-DM)

STEP-DM (STEP-DM)

61

Of 59 patients adopted as full analysis set (FAS), 42 patients (71.2%) were male, and 17 patients (28.8%) were female. The mean +- SD of age and HbA1c were 60.1+-8.7 years and 7.48+-0.37%, respectively. The mean+-SD of body weight and BMI were 68.69+-13.26 kg and 25.16+-3.72 kg/m2, respectively.

Written informed consent was obtained from 72 patients. 11 of these patients discontinued the study during the pre-observation period (4 patients violated the inclusion/exclusion criteria and 7 patients withdrew consent) and 61 patients were enrolled in the study. 59 of them completed the observation period.

6 cases of adverse events, eczema, related to the study were reported in 5 patients in this study, but all of them were judged to be able to continue this study. There were no adverse events leading to discontinuation of study participation.

The mean+-SD of the change from baseline in HbA1c in Week 12 was -0.41+-0.41%, with a significant reduction (p<0.001). The mean+-SD change from baseline in body weight at Week 12 was -0.88+-1.58 kg (p<0.001). In the questionnaire survey conducted at Week 12, the majority of participants answered that their motivation to engage in diet/exercise therapy was "increased" or "slightly increased" after using each of TOMOCO and Fitbit.

The combination use of TOMOCO and Fitbit may promote behavioral changes in people with type 2 diabetes mellitus and could be one of the effective tools as an adjunct to diabetes treatment.

Sept. 30, 2023

No

https://jrct.mhlw.go.jp/latest-detail/jRCT1070220007

Kunisaki Makoto

KUNISAKI MAKOTO CLINIC

1-7-6 Imajuku Ekimae, Nishi-ku, Fukuoka City, Fukuoka Prefecture

makoto1@kunisaki-cc.jp

Awano Hideto

EPS Corporation

1-7 Toyotsu-cho, Suita-shi, Osaka King Osaka Building 7th floor

+81-6-7176-5731

prj-dm_device@eps.co.jp

Complete

April. 25, 2022

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

1. Patients with type 2 diabetes mellitus who are visiting the research site as outpatients at the time of screening (SCR).
2. patients >=20 and <75 years old at SCR
3. Patients with type 2 diabetes mellitus receiving at least one and at the most four antidiabetic drugs in addition to diet and exercise therapy at SCR
4. Patients who have not changed in the dosing regimen of antidiabetic drugs for at least 12 weeks prior to SCR
5. Patients whose HbA1c at SCR increased or decreased <= 0.2% compared to 12 weeks before SCR
6. Patients with HbA1c >=7.0% and <8.5% at SCR. Only if the patient is >=65 years old and receiving drugs potentially associated with severe hypoglycemia (e.g. Insulins, sulfonylureas, glinides), HbA1c range of >=7.5% and <8.5% is applied.
7. Patients who have a smart phone device on which apps can be installed, do not plan to change the device during the research period, and agree to the terms and conditions related to the wearable device and the app to be used in this research
8. Patients who have not used a wearable device or lifestyle modification support app for diabetes management or its support within the last 12 weeks prior to SCR.
9. Patients who have given written consent to participate in this research and to provide subject information prior to the research participation.

1. Female patients who are pregnant, or who wish to become pregnant during the research period
2. Patients diagnosed with or suspected to have type 1 diabetes mellitus, diabetes mellitus due to some other specific mechanism or disease, and gestational diabetes mellitus
3. Patients who have difficulty in controlling blood glucose due to perioperative period or infectious diseases
4. Patients whose diet / exercise therapy is restricted due to comorbidities such as cardio-vascular disease and renal disease
5. Patients who have experienced the need for assistance due to hypoglycemia and are judged by the principal investigator to be difficult to participate in this research
6. Patients with significant changes in blood glucose control during the last 6 months prior to SCR as judged by the investigator
7. Patients who have difficulty with using wearable devices and lifestyle modification support app as judged by the investigator
8. Patients who are likely to require changes in diet/exercise therapy and drug therapy during the research period as judged by the investigator
9. Patients who are participating in other clinical trials, clinical studies, lifestyle-related improvement programs, etc. (excluding observational studies without intervention)
10. Patients who are inappropriate for participation in this research for any other reason such as physical, mental, or social reasons as judged by the investigator

Both

Diabetes Mellitus, Type 2

Patients use a wearable device (Fitbit) and a lifestyle modification support app (TOMOCO) for 12 weeks.

Diabetes Mellitus, Type 2

D003924

Change in HbA1c levels from baseline at 12 weeks

Following variables at 12 weeks
1. Patient questionnaire responses
2. Change in body weight

+81-952-31-7771

April. 13, 2022

none