NCT07336329

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Kangbuk Samsung Hospital · Academic / Other
• Sex: All
• Age: 19 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetes Mellitus, Type 2

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-01-02
• Primary completion: 2026-12-31
• Completion: 2027-06-30
• First posted: 2026-01-13
• Last updated: 2026-01-13

Locations

1 site across 1 country: South Korea

Regulatory

• FDA-regulated device study