type 2 diabetes type 2 diabetes
Conditions
Interventions
Type 2 diabetes patients not on insulin therapy will be randomly assigned at a 1:1 ratio to an intervention group (device use group) and a control group (device non-use group)
Continuous glucose monitoring
Sponsors
Miyoshi Kengo
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Patients diagnosed with type 2 diabetes who have a history of pharmacotherapy using oral hypoglycemic agents for 1 year or more at the time of obtaining consent (2) Patients who are not performing self-monitoring of blood glucose associated with self-injection therapy using insulin, GLP-1 receptor agonists, or GIP/GLP-1 receptor agonists (3) Patients whose most recent HbA1c level measured between 4 weeks prior to consent and the date of consent is >= 7.0% and = 22 kg/m2 (5) Patients who use a smartphone on a daily basis and can install the application dedicated to the study device on their own smartphone (6) Age: Patients aged >= 18 years and < 75 years at the time of obtaining consent (7) Gender: Any (8) Patients who have provided written informed consent of their own free will after receiving a full explanation regarding participation in this study and fully understanding it (9) Patients capable of outpatient visits according to the study schedule
Exclusion criteria
Exclusion criteria: (1) Patients with hyperglycemic emergencies (diabetic ketoacidosis, hyperosmolar hyperglycemic state) (2) Patients who, within the three years preceding the date of consent acquisition, have a history of receiving prescriptions for insulin or GLP-1 receptor agonists and using home self-monitoring of blood glucose or continuous glucose monitoring, or who have a history of habitually using SMBG or CGM regardless of the method of acquisition (3) Patients with cerebrovascular disease, heart disease, kidney disease, skeletal muscle disease, mental disease, or other diseases deemed inappropriate by the attending physician for implementation of diet and exercise therapy (4) Patients scheduled to undergo insulin therapy between the time of obtaining consent and the end of the study period (5) Patients using implantable medical devices such as pacemakers (6) Patients who are pregnant or possibly pregnant (7) Patients who are breastfeeding (8) Any other patients judged by the principal investigator or co-investigator to be inappropriate for participation in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HbA1c level at 12 weeks after the start of intervention | — |
Secondary
| Measure | Time frame |
|---|---|
| (1) HbA1c level at 12 weeks after the completion of intervention (2) Change in HbA1c from baseline to 12 weeks after the start of intervention (3) Change in HbA1c from baseline to 12 weeks after the completion of intervention (4) Changes in body weight and BMI from baseline to 12 weeks after the start of intervention (5) Changes in body weight and BMI from baseline to 12 weeks after the completion of intervention (6) Changes in continuous glucose monitoring metrics (TIR, TITR, TAR, TBR) measured for 14 days starting at 12 weeks after the start of intervention, from the continuous glucose monitoring metrics (TIR, TITR, TAR, TBR) measured for 14 days starting before the start of intervention (7) Changes in continuous glucose monitoring metrics (TIR, TITR, TAR, TBR) measured for 14 days starting at 12 weeks after the completion of intervention, from the continuous glucose monitoring metrics (TIR, TITR, TAR, TBR) measured for 14 days starting before the start of intervention (Visit 0) (8) Changes in dietary behavior questionnaire scores from baseline to 12 weeks after the start of intervention (9) Changes in dietary behavior questionnaire scores from baseline to 12 weeks after the completion of intervention (10) Changes in body fat mass, skeletal muscle mass, and body fat percentage from baseline to 12 weeks after the start of intervention (11) Changes in body fat mass, skeletal muscle mass, and body fat percentage from baseline to 12 weeks after the completion of intervention (12) Frequency of dose reduction, discontinuation, dose increase, and addition of diabetes medications from baseline to 12 weeks after the start of intervention (13) Frequency of dose reduction, discontinuation, dose increase, and addition of diabetes medications from baseline to 12 weeks after the completion of intervention (14) Frequency and proportion of hypoglycemia and severe hypoglycemia (15) Frequency and proportion of adverse events and malfunctions | — |
Contacts
Public ContactKengo Miyoshi
The University of Tokyo Hospital
Outcome results
None listed