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A Randomized Controlled Trial of the Efficacy of Blood Glucose and Diet and Physical Activity Monitoring

Not Applicable
Recruiting
Conditions
type 2 diabetes mellitus
C18.452.394.750.149, C19.246.300
Registration Number
JPRN-jRCTs032210502
Lead Sponsor
Hirohito Sone
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
60
Inclusion Criteria

1. type 2 diabetic patients
2. patients on insulin medication
3. patients who use smartphones on a daily basis and can use the smartphone application SyncHealth
4. patients whose daily food intake (excluding snacks) is three times a day
5. age between 20 and 80 years old at the time of consent.
6. patients with HbA1c between 7% and 10% at the time of consent.
7. patients who have given written consent to participate in the study after the study content has been explained using an explanatory document.

Exclusion Criteria

1. patients with a BMI of less than 15 kg/m2 or greater than 40 kg/m2
2. patients with carcinoma (malignant tumor (equivalent to C00-C97 in ICD-10 classification) less than 5 years after diagnosis of cure, or history of intraepithelial neoplasia (equivalent to D00-D09) less than 1 year after diagnosis of cure)
3. patients with hepatic impairment of Child-Pugh B or higher
4. patients on renal replacement therapy or with renal impairment with eGFR less than 30ml/min
5. patients with excessive alcohol intake (daily net alcohol intake of 40g or more for men and 20g or more for women)
6. patients with other implantable medical devices such as pacemakers
7. other patients who are deemed inappropriate by the physician

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Difference in change in HbA1c at Visit_15 weeks from Visit 0 weeks between the two groups
Secondary Outcome Measures
NameTimeMethod
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