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A Clinical Interventional Study to Validate the Efficacy of Monitoring Blood Glucose, Diet, and Physical Activity in Diabetic Patients

A Clinical Interventional Study to Validate the Efficacy of Monitoring Blood Glucose, Diet, and Physical Activity in Diabetic Patients - A Study of the Efficacy of Combination Therapy for Monitoring Blood Glucose Levels and Lifestyle

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000043517
Enrollment
40
Registered
2022-09-30
Start date
2021-04-01
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

Glucose monitoring by FGM for 14 days will be performed every 5 weeks for a total of 3 times.During the post-monitoring visits, guidance will be given and medications will be changed as needed at the

Sponsors

Niigata University Faculty of Medicine Department of Internal Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Those with diabetes mellitus 2. Patients on insulin medication 3. Patients who can use the smartphone application "Think Health" (H2 Co., Ltd.) 4. Patients who are between 20 and 80 years old at the time of consent. 5. HbA1c 7.0% or higher, but less than 10.0%. 6.Patients with a BMI of more than 15 kg/m2 or less than 30 kg/m2. 7.Patients who have given written consent to participate in the study

Exclusion criteria

Exclusion criteria: 1. Patients with food intake (excluding snacks) other than three times a day 2. Patients with anorexia nervosa 3. Patients with alcohol overdose 4. Patients who are deemed inappropriate by the physician

Design outcomes

Primary

MeasureTime frame
After obtaining consent, 40 diabetic patients who require lifestyle improvement for blood glucose control will be assigned to 1) FGM alone (FGM alone group) or 2) FGM plus lifestyle monitoring (FGM plus lifestyle monitoring group). The degree of improvement in blood glucose control (Time In Range = percentage of target blood glucose of 70 mg/dl-180 mg/dl measured by FGM) after 3 months will be compared.

Countries

Japan

Contacts

Public ContactMasaru Kitazawa

Niigata University Faculty of Medicine Department of Internal Medicine Department of Community Medicine and Health

mkitazawa-nii@umin.ac.jp+81253689026

Outcome results

None listed

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