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A Clinical Trial to Validate the Efficacy of Monitoring Blood Glucose, Diet, and Physical Activity in Patients with Prediabetes

A Clinical Trial to Validate the Efficacy of Monitoring Blood Glucose, Diet, and Physical Activity in Patients with Prediabetes - A Clinical Trial to Validate the Efficacy of Monitoring Blood Glucose, Diet, and Physical Activity in Patients with Prediabetes

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000046400
Enrollment
200
Registered
2022-09-30
Start date
2021-12-17
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

Prediabetes

Interventions

Monitoring of diet and physical activity and recording of FGM data using a smartphone application. Patients can check the relationship between blood glucose, physical activity, and diet data as needed

Sponsors

Niigata University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. pre-diabetic patients (those with a recent HbA1c of 5.6-6.4% or fasting blood glucose of 110-125 mg/dl at a medical checkup conducted after April 2020) 2. Those who can use the smartphone application "Synk Health" (H2 Inc.) 3. Those who already have a physical activity meter (including smartphone application) that is linked to the "Think Health" smartphone application. 4. age between 20 and 80 years old at the time of consent 5. Those who have a BMI of at least 23 kg/m2 or less than 40 kg/m2. 6. Those who have given written consent to participate in the study after the study content has been explained using an explanatory document.

Exclusion criteria

Exclusion criteria: 1. those under treatment for diabetes mellitus 2. those undergoing cancer treatment 3. those taking adrenal corticosteroids 4. other persons deemed inappropriate by the physician

Design outcomes

Primary

MeasureTime frame
Changes in blood glucose levels above 70 and below 140 in time before and after the intervention

Countries

Japan

Contacts

Public ContactMasaru KITAZAWA

Niigata University Graduate School of Medical and Dental Sciences Department of Hematology, Endocrinology and Metabolis

m-kitazawa@med.niigata-u.ac.jp025-368-9026

Outcome results

None listed

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