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

NCT07336329 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2026-01-13

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Kangbuk Samsung Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-02
Primary Completion
2026-12-31
Completion
2027-06-30
FDA Device
Yes

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07336329 on ClinicalTrials.gov