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Single arm intervention study of the efficacy of the App for improving the lifestyle behavior in patients with Type 2 DM

Single arm intervention study of the efficacy of the App for improving the lifestyle behavior in patients with Type 2 DM - Single arm intervention study of the efficacy of the App for improving the lifestyle behavior in patients with Type 2 DM

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000043815
Enrollment
100
Registered
2021-04-05
Start date
2021-03-29
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes

Interventions

Lifestyle behavior improvement support by feedback from the App based on input data.

Sponsors

Mitsubishi Tanabe Pharma Corporation
Lead Sponsor
Habitus Care Inc.
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Patients aged over 20 years or older at the time of informed consent (both genders) 2) Patients with documented consent to participate in the study 3) Patients diagnosed with type 2 diabetes mellitus 4) Patients taking hypoglycemic drugs 5) Patients with HbA1c >= 6.5 6) Patients with a smartphone

Exclusion criteria

Exclusion criteria: 1) A female subject who wishes to become pregnant, is pregnant, or is breastfeeding 2) Patients diagnosed with type 1 diabetes mellitus 3) Patients with a diagnosis of secondary diabetes mellitus 4) Patients with physician-determined advanced complications 5) Patients scheduled for hospitalization or surgery during this study 6) Patients with diseases other than diabetes mellitus who are instructed to restrict exercise 7) Patients who have participated in a clinical study or a post-marketing clinical study of another prescription drug or a medical device within 3 months, who are now participating in such a study, or who plan to participate in such a study during this study 8) Patients who have used a mobile application running on a smartphone terminal for the purpose of managing or assisting diabetes mellitus within the past 3 months 9) Medical institution staff or close relatives involved in this study 10) Other patients judged by the investigator to be inappropriate for inclusion in this study

Design outcomes

Primary

MeasureTime frame
weight, HbA1c, completion rate, utilization of App, improvement of blood test value

Countries

Japan

Contacts

Public ContactKoji Tokutomi

Mitsubishi Tanabe Pharma Corporation Digital Transformation Department

tokutomi.koji@mr.mt-pharma.co.jp03-6748-7637

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026