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

JRCT ID: jRCTs032210502

Registered date:21/12/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: type 2 diabetes mellitus
• Date of first enrollment: 21/12/2021
• Target sample size: 60
• Study type: Interventional
• 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 Outcome: Difference in change in HbA1c at Visit_15 weeks from Visit 0 weeks between the two groups

Secondary Outcome

Difference between the two groups in the change from Visit_0 week for the following items at Visit_15 weeks
Physical survey: blood pressure, BMI, and
Diabetes medication study: insulin dosage
Blood and urine tests: HbA1c, AST, ALT, GGT, total cholesterol, HDL cholesterol, triglycerides, creatinine, uric acid, urinary protein, urinary sugar

Difference between the two groups in the change in the following items measured by FGM performed between Visit_10 and 15 weeks from the values measured by Freestyle Libre Pro performed by Visit_0 weeks
Blood glucose variability tests: mean blood glucose, blood glucose variability indices: TIR, TAR (>180 mg/dl), and
TAR (>240 mg/dl), TAR (>300 mg/dl), TBR (<70 mg/dl), and
TBR (<54 mg/dl), MAGE, SD, CV, CONGA (2h)

Difference between the 2 groups in the amount of change in freestyle libre wearing time from Visit_10 to 15 weeks from Visit_0 to 5 weeks

Difference in time wearing freestyle libre, time wearing physical activity meter, energy expenditure (Kcal/day), number of steps (steps/day), and number of meals recorded from Visit_0 to 5 weeks in the intervention group from Visit_10 to 15 weeks

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 80age old
• Gender: Both

Include 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.

Exclude 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

Related Information

• Primary Sponsor: Hirohito Sone
• Source(s) of Monetary Support: Sompo Himawari Life Insurance Inc.