NCT07336329Recruiting
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
Source: ClinicalTrials.gov · Last updated 13 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 150 (estimated)
- First submitted
- 10 Jan 2026
- Start date
- 2 Jan 2026
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Kangbuk Samsung Hospital
- Diseases
- Type 2 diabetes
- NCT number
- NCT07336329
What you commit to
- Study type: Interventional
- Planned participants: 150
- From 2 Jan 2026 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- 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
- Whole blood donation within 60 days, apheresis within 30 days, or blood transfusion within 90 days prior to device application
Other illness
- Type 1 diabetes mellitus
- Gestational diabetes mellitus
- History of pancreatectomy
- History of malignancy within 1 year prior to informed consent (except thyroid cancer)
- 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)
Lab values
- On hemodialysis or peritoneal dialysis or eGFR \< 30 mL/min/1.73m2
- Judged by investigator as unable to handle continuous glucose monitoring device
Other
- Pregnant or lactating women
- Planning pregnancy within 1 year
- Otherwise judged by investigator as inappropriate for participation in this clinical trial
Who the study is looking for
- 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
Age in the registry: 19 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Kangbuk Samsung Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.