STEP-DM

Not Applicable

• Conditions: Diabetes Mellitus, Type 2; D003924

• Registration Number: JPRN-jRCT1070220007
• Lead Sponsor: Kunisaki Makoto

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-04-27
• Study Completion: 2022-12-03
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 61

Inclusion 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.

Exclusion 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified