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Study on a program for prevention of aggravation of diabetes: effectiveness of behavior modification model using Internet of Things including interventions by multiple types of professionals

Study on a program for prevention of aggravation of diabetes: effectiveness of behavior modification model using Internet of Things including interventions by multiple types of professionals - Effectiveness of a program using IoT for prevention of aggravation of diabetes

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000035077
Enrollment
105
Registered
2018-12-03
Start date
2018-12-10
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/pre-diabetes

Interventions

Use of the smartwatch, use of the mobile application for self-monitoring health data, and advice by doctors (video call at 1 month and 3 months from start), pharmacists (weekly chatting for patients w

Sponsors

Nagoya Station Clinic
Lead Sponsor
Milliman Inc.
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. With HbA1c 7.0% or more and 8.0% or less 2. Aged 25 years or more and less than 75 (male and female) 3. Daily smartphone user 4. Wishing to participate to the program

Exclusion criteria

Exclusion criteria: 1. Having comorbidity of severe hepatic dysfunction (3 times or more of upper limit of reference value for AST or ALT), hemodialysis, or comorbidity of cancer 2. Receiving treatment with insulin 3. In pregnancy or planning to get pregnant 4. Being restricted exercise 5. Having cognitive dysfunction 6. Having serious cardiovascular diseases (myocardial infarct, angina, serious arrhythmia, hypertension with a systolic blood pressure 180 mmHg or more or with a diastolic blood pressure 110 mmHg or more) 7. Being deemed inappropriate to participate to this study by his/her primary physician

Design outcomes

Primary

MeasureTime frame
Change in hemoglobin (Hb) A1c at 12 and 24 weeks from baseline

Secondary

MeasureTime frame
1. Change in body weight (body mass index) at 12 and 24 weeks from baseline 2. Change in abdominal girth at 12 and 24 weeks from baseline 3. Change in blood pressure at 12 and 24 weeks from baseline 4. Change in blood test values (fasting blood glucose, total cholesterol, triglycerides, HDL cholesterol, LDL cholesterol) at 12 and 24 weeks from baseline 5. Change in lifestyle behavior and depression status based on questionnaires at 24 weeks from baseline 6. Monthly change in exercise behavior based on recorded number of steps

Countries

Japan

Contacts

Public ContactKohei Sasaki

Sugi Pharmacy Co., Ltd. Corporate Planning division

ko-sasaki@drug-sugi.co.jp0562-45-2700

Outcome results

None listed

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