type 2 diabetes mellitus type 2 diabetes mellitus
Conditions
Interventions
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.
Continuous blood glucose monitoring, Lifestyle monitoring
Sponsors
Hirohito Sone
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Difference in change in HbA1c at Visit_15 weeks from Visit 0 weeks between the two groups | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Contacts
Public ContactKitazawa Masaru
Niigata University Medical and Dental Hospital
Outcome results
None listed