STEP-DM

JRCT ID: jRCT1070220007

Registered date:27/04/2022

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Diabetes Mellitus, Type 2
• Date of first enrollment: 27/04/2022
• Target sample size: 60
• Study type: Interventional
• Intervention(s): Patients use a wearable device (Fitbit) and a lifestyle modification support app (TOMOCO) for 12 weeks.

Outcome(s)

• Primary Outcome: Change in HbA1c levels from baseline at 12 weeks

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 75age old
• Gender: Both

Include criteria

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.

Exclude criteria

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

Related Information

• Primary Sponsor: Kunisaki Makoto
• Secondary Sponsor: Mitsubishi Tanabe Pharma Corporation