None listed
Conditions
Interventions
Medical Device : [Medical Device Used]
-Device name: FreeStyle Libre 2 (FSL2)
-Manufacturer: Abbott Ltd.
-Category: Personal continuous glucose monitoring system (Class 3, MFDS approved)
-Components:
Sponsors
Kangbuk Samsung Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adults aged 19 to 80 years at the time of informed consent 2. Adults with type 2 diabetes not using insulin 3. Patients treated with GLP-1 agonist, oral hypoglycemic agents, and/or lifestyle modifications 4. Patients who have maintained stable diabetes treatment for at least 3 months without changes 5. HbA1c between 7.5% and 10.0% 6. Willing to wear personal continuous glucose monitoring device (CGM) 7. Willing to install and use CGM-linked app on personal smartphone with continuous access to WIFI or cellular data 8. Able to read and write Korean as judged by investigator 9. Willing to use medically acceptable contraception until end of study (sterile status, intrauterine device, or concurrent use of male/female barrier method with spermicide) 10. Fully informed about the clinical trial and voluntarily consenting to participate
Exclusion criteria
Exclusion criteria: 1. Type 1 diabetes mellitus 2. Gestational diabetes mellitus 3. History of pancreatectomy 4. Continuous or intermittent insulin therapy for 7 days or more within 3 months 5. Oral or IV steroid treatment within 1 month prior to informed consent 6. Serious infection, surgery (scheduled or history), or severe trauma within 3 months prior to informed consent 7. History of malignancy within 1 year prior to informed consent (except thyroid cancer) 8. On hemodialysis or peritoneal dialysis or eGFR < 30 mL/min/1.73m2 9. Unable to avoid the following concomitant medications, devices, or treatments during the study: CGM other than study device, X-ray/MRI/CT scans, radiofrequency thermal therapy, implantable devices such as pacemakers, immunosuppressants, steroids, IV vitamin preparations, cancer treatment, hemodialysis/peritoneal dialysis, insulin therapy 10. Uncontrolled thyroid disease or clinically significant severe endocrine disorders (Cushing's syndrome, pheochromocytoma, etc.) 11. Severe allergic reaction to skin adhesives (e.g., dyspnea, severe rash, edema) 12. Whole blood donation within 60 days, apheresis within 30 days, or blood transfusion within 90 days prior to device application 13. Judged by investigator as unable to handle continuous glucose monitoring device 14. Pregnant or lactating women 15. Planning pregnancy within 1 year 16. Otherwise judged by investigator as inappropriate for participation in this clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Non-inferiority comparison of adjusted change in HbA1c from 3 months to 6 months (non-inferiority margin 0.3%) | — |
Secondary
| Measure | Time frame |
|---|---|
| Adjusted change in HbA1c from 3 months to 6 months;Adjusted change in blood pressure from 3 months to 6 months;Adjusted change in lipid parameters from 3 months to 6 months;Adjusted change in body weight from 3 months to 6 months;Adjusted change in HOMA-IR from 3 months to 6 months;Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ) from 3 months to 6 months;Change in Korean-Diabetes Management Self-Efficacy Scale (K-DMSES) from 3 months to 6 months;Change in Summary of Diabetes Self-Care Activities Questionnaire-Korean (SDSCA-K) from 3 months to 6 months;Non-inferiority comparison of time in range 70-180 mg/dL (non-inferiority margin 6%);Comparison of time in range 70-180 mg/dL;Comparison of time in tight range 70-140 mg/dL;Comparison of time above range 180 mg/dL; Comparison of time above range 250 mg/dL;Comparison of time below range 70 mg/dL;Comparison of time below range 54 mg/dL;Comparison of standard deviation (SD) of glucose;Comparison of coefficient of variation (CV) of glucose;Comparison of mean amplitude of glycemic excursions (MAGE);Comparison of glucose management indicator (GMI);Comparison of mean glucose | — |
Countries
Korea, Republic of
Contacts
Public ContactSun-Joon Moon
Kangbuk Samsung Medical Center
Outcome results
None listed