Actively Recruiting
Continuous Glucose Monitoring in Non-Insulin Treated Type 2 Diabetes: Continuous vs. Periodic Use
Led by Kangbuk Samsung Hospital · Updated on 2026-01-13
150
Participants Needed
1
Research Sites
77 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Continuous Glucose Monitoring in Non-Insulin Treated Type 2 Diabetes: Continuous vs. Periodic Use
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- 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 certain medications, devices, or treatments during the study such as other CGM devices, X-ray/MRI/CT scans, radiofrequency therapy, pacemakers, immunosuppressants, steroids, IV vitamin preparations, cancer treatments, dialysis, or insulin therapy
- Uncontrolled thyroid disease or severe endocrine disorders
- Severe allergic reaction to skin adhesives
- Recent whole blood donation, apheresis, or blood transfusion within specified timeframes before device use
- Judged unable to handle the continuous glucose monitoring device by investigator
- Pregnant or lactating women
- Planning pregnancy within 1 year
- Otherwise judged inappropriate for participation by investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
Kangbuk Samsung Hospital
Seoul, South Korea, South Korea, 03181
Actively Recruiting
Research Team
S
Sun-Joon Moon, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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