RecruitingNot ApplicableNCT07336329

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

Sponsor

Kangbuk Samsung Hospital

Enrollment

150 participants

Start Date

Jan 2, 2026

Study Type

INTERVENTIONAL

Conditions

Diabetes Mellitus, Type 2

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.

Eligibility

Min Age: 19 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing continuous use vs. intermittent (periodic) use of continuous glucose monitoring (CGM) — a wearable device that tracks blood sugar in real time — in adults with type 2 diabetes who are not using insulin. The goal is to find the most effective and convenient way to use CGM in this group. **You may be eligible if...** - You are between 19 and 80 years old - You have type 2 diabetes and are not using insulin - You are being treated with GLP-1 agonists, oral diabetes medications, and/or lifestyle changes only - Your HbA1c (average blood sugar over 3 months) is between 7.5% and 10.0% - Your diabetes treatment has been stable for at least 3 months - You are willing to wear a CGM device and use a linked smartphone app **You may NOT be eligible if...** - You have type 1 diabetes or gestational diabetes - You have had your pancreas removed - You have used insulin continuously for 7 or more days in the past 3 months - You have had recent surgery, serious infection, or severe illness in the past 3 months - You do not read Korean (this study is conducted in Korea) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEFreeStyle 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.