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A Pragmatic Study Modifying Behaviors by Nutritionists to Diabetes Patients through IoT-based Self Monitoring System

A Pragmatic Study Modifying Behaviors by Nutritionists to Diabetes Patients through IoT-based Self Monitoring System - AMEND-IT

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000031446
Enrollment
150
Registered
2018-02-24
Start date
2018-02-01
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 Mellitus

Interventions

Providing diabetes self-management support once a week by dieticians over continuous 52 weeks. Providing diabetes self-management support 3 times a week for 9 weeks by dieticians intermittently, fro

Sponsors

National Center for Global Health and Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. HbA1c equals to or greater than 6.0% and eqauls to or less than 8.0% 2. No change in medications for diabetes during 8 weeks prior to the randomization. 3. Those able to sign a written consent form.

Exclusion criteria

Exclusion criteria: 1. Those with serious liver, renal, malignant neoplasms or infections. 2. Those treated with 3 or more oral antihyperglycemic agents. 3. Those treated with insulin or GLP-1 receptor agonists. 4. Those with active proliferative diabetic retinopathy. 5. Those with recent cardiovascular events for the past 6 months. 6. Those with decompensated congestive heart failure. 7. Pregnancy. 8. Those with history of hypoglycemia requiring assistance from others. 9. Those judged to be disqualified for the study by investigators.

Design outcomes

Primary

MeasureTime frame
Changes in HbA1c after 52-week self-management support.

Countries

Japan

Contacts

Public ContactMitsuru Ohsugi, MD

National Center for Global Health and Medicine Diabetes and Metabolism Information Center

moosugi@hosp.ncgm.go.jp03-3202-7181

Outcome results

None listed

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