The study of the effect of isCGM on lifestyle changes in patients with non-insulin treated type 2 diabetes

JRCT ID: jRCT1042220139

Registered date:09/02/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Diabetes
• Date of first enrollment: 09/02/2023
• Target sample size: 30
• Study type: Interventional
• Intervention(s): We will conduct a 4-week intervention with Free Style Libre. Free Style libre is divided into sensor and reader and we will wear the sensor on the wrist of the patient. The patient will check the blood suger and he try to improve his lifestyle based on the blood suger transition. The sensor is replaced once every two weeks, and two sensors are used.

Outcome(s)

• Primary Outcome: SDSCA(The Summary of Diabetes Self-Care Activities Measure)

Secondary Outcome

BDHQ(brief-type self-administered diet history questionnaire)
IPAQ(International Physical Activity Questionnaire)
NEAT(Non-Exercise-Activity Thermogenesis)score
PSQI(Pittsburgh Sleep Quality Index)
DTSQ(Diabetes Treatment Satisfaction Questionnaire)
Transtheoretical model of health behavior change
Life record table
Glucose data obtained by FreeStyle Libre
Qualitative Data from Semi-Structured Interviews After Libre Wearing
Changes in HbA1c levels and antidiabetic drugs after 4 weeks, 12 weeks, and 24 weeks of intervention compared to the start of intervention

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

Patients with type 2 diabetes
Patients who can understand diabetes education
Patients who understand the content of the research and give consent
Patients with HbA1c more than 7% and less than 9%

Exclude criteria

Patient performing self measurement of blood glucose
Patients using insulin or GLP1-RA
Patients with stage 4 or higher diabetic nephropathy
Patients with diabetic retinopathy more than preproliferative retinopathy
Patients with severe complications and inadequate exercise therapy
Patients unable to operate the device properly
Patients with dementia
Patients with implanted medical devices such as pacemakers
Patients judged inappropriate for participation in this study by the physician

Related Information

• Primary Sponsor: Arima Hiroshi