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RECRUITING

NCT07336329

Continuous Glucose Monitoring in Non-Insulin Treated Type 2 Diabetes: Continuous vs. Periodic Use

Sponsor: Kangbuk Samsung Hospital

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to test whether wearing a continuous glucose monitor (CGM) part-time works as well as wearing it full-time in adults with type 2 diabetes who do not use insulin. The main questions it aims to answer are: * Does wearing CGM part-time (2 weeks per month) control blood sugar as well as wearing it continuously? * How do the two wearing patterns compare for blood sugar levels throughout the day, weight, blood pressure, and patient satisfaction? Researchers will compare part-time CGM use to continuous CGM use to see if part-time use is just as effective for blood sugar control. All participants will: * Wear a CGM device continuously for 3 months to learn how their blood sugar responds to different foods and activities * Then be randomly assigned to wear CGM either part-time (2 weeks each month) or continuously for another 3 months * Replace the CGM sensor on their arm every 2 weeks * Use a smartphone app to track their blood sugar readings * Visit the clinic 3 times for blood tests and check-ups * Receive education on adjusting diet based on their CGM readings * Keep their current diabetes medications unchanged during the study The study will last about 6 months total. Participants will use the FreeStyle Libre 2 CGM device, which is already approved for use in people with diabetes.

Official title: Effectiveness of Periodic Use of Continuous Glucose Monitoring After Three Months of Continuous Use in Patients With Non-Insulin-Treated Type 2 Diabetes Patients: A Multicenter, Randomized, Parallel-Group, Open-Label, Non-Inferiority, Investigator-Initiated Trial

Key Details

Gender

All

Age Range

19 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

150

Start Date

2026-01-02

Completion Date

2027-06-30

Last Updated

2026-01-13

Healthy Volunteers

Conditions

Diabetes Mellitus, Type 2

Interventions

DEVICE

FreeStyle Libre 2 Continuous Glucose Monitoring

FreeStyle Libre 2 continuous glucose monitoring system consisting of a sensor worn on the upper arm that measures interstitial glucose levels continuously for up to 14 days. Data is transmitted to a smartphone app (FreeStyle LibreLink). The sensor is a Class 3 medical device approved by MFDS (Korea). Participants receive education on adjusting diet based on postprandial glucose patterns observed through CGM. Existing diabetes medications (oral agents and/or GLP-1 agonists) are maintained without changes throughout the intervention period.

Inclusion Criteria: * Adults aged 19 to 80 years at the time of informed consent * Adults with type 2 diabetes not using insulin * Patients treated with GLP-1 agonist, oral hypoglycemic agents, and/or lifestyle modifications * Patients who have maintained stable diabetes treatment for at least 3 months without changes * HbA1c between 7.5% and 10.0% * Willing to wear personal continuous glucose monitoring device (CGM) * Willing to install and use CGM-linked app on personal smartphone with continuous access to WIFI or cellular data * Able to read and write Korean as judged by investigator * Willing to use medically acceptable contraception until end of study (sterile status, intrauterine device, or concurrent use of male/female barrier method with spermicide) * Fully informed about the clinical trial and voluntarily consenting to participate Exclusion Criteria: * Type 1 diabetes mellitus * Gestational diabetes mellitus * History of pancreatectomy * Continuous or intermittent insulin therapy for 7 days or more within 3 months * Oral or IV steroid treatment within 1 month prior to informed consent * Serious infection, surgery (scheduled or history), or severe trauma within 3 months prior to informed consent * History of malignancy within 1 year prior to informed consent (except thyroid cancer) * On hemodialysis or peritoneal dialysis or eGFR \< 30 mL/min/1.73m2 * 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 * Uncontrolled thyroid disease or clinically significant severe endocrine disorders (Cushing's syndrome, pheochromocytoma, etc.) * Severe allergic reaction to skin adhesives (e.g., dyspnea, severe rash, edema) * Whole blood donation within 60 days, apheresis within 30 days, or blood transfusion within 90 days prior to device application * Judged by investigator as unable to handle continuous glucose monitoring device * Pregnant or lactating women * Planning pregnancy within 1 year * Otherwise judged by investigator as inappropriate for participation in this clinical trial

Locations (1)

Kangbuk Samsung Hospital

Seoul, South Korea, South Korea