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JAPANESE
国立保健医療科学院
JRCT ID: jRCTs032210502

Registered date:21/12/2021

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

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedtype 2 diabetes mellitus
Date of first enrollment21/12/2021
Target sample size60
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)In addition to the Flash Glucose monitoring treatment, patients monitor their own data through a smartphone app linked to their blood glucose fluctuations, physical activity, and diet records.

Outcome(s)

Primary OutcomeDifference in change in HbA1c at Visit_15 weeks from Visit 0 weeks between the two groups
Secondary OutcomeDifference between the two groups in the change from Visit 0 week in the following items at Visit_15 weeks Physical examination: blood pressure, BMI Diabetes medication survey: insulin dosage Blood and urine tests: HbA1c, AST, ALT, gamma-GTP, total cholesterol, HDL cholesterol, triglycerides, creatinine, uric acid, urinary protein, urinary glucose Monitoring adherence: frequency of blood glucose measurements Difference between the two groups in the amount of change from the values measured by Freestyle Libre Pro by Visit 0 weeks in the following items measured by FGM performed at Visit_10 to 15 weeks Blood glucose variability test: Mean blood glucose level, Blood glucose variability index: TIR, TAR (>180 mg/dl), TAR (>240 mg/dl), TAR (>300 mg/dl), TBR (<70 mg/dl), TBR (<55 mg/dl), TBR (<45 mg/dl), MAGE, SD, CV, LBGI, HBGI, BGRI, CONGA (2h) MODD Difference in change in freestyle libre wearing time from Visit 0 to 5 weeks between the two groups at Visit_10 to 15 weeks Difference between the two groups in the change from Visit 0-5 weeks in freestyle libre wearing time, physical activity monitor wearing time, energy expenditure (Kcal/day), number of steps (steps/day), and number of meals recorded during Visit_10 to 15 weeks in the intervention group Difference in the frequency of blood glucose monitoring at Visit_15 weeks compared to Visit_0 weeks in the intervention group

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximum<= 80age old
GenderBoth
Include criteria1. 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.
Exclude criteria1. 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

Related Information

Contact

Public contact
Name Kitazawa Masaru
Address 754 Asahimachi-dori Ichibancho, Chuo-ku, Niigata City, Niigata Prefecture Niigata Japan 950-8122
Telephone +81-25-368-9026
E-mail m-kitazawa@med.niigata-u.ac.jp
Affiliation Niigata University Medical and Dental Hospital
Scientific contact
Name Sone Hirohito
Address 754 Asahimachi-dori Ichibancho, Chuo-ku, Niigata City, Niigata Prefecture Niigata Japan 951-8520
Telephone +81-25-368-9026
E-mail sone@med.niigata-u.ac.jp
Affiliation Niigata University Medical and Dental Hospital