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

Last updated: January 10, 2026
Sponsor: Kangbuk Samsung Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Diabetes Mellitus, Type 2

Treatment

FreeStyle Libre 2 Continuous Glucose Monitoring

Clinical Study ID

NCT07336329
KBSMC 2025-07-031
  • Ages 19-80
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 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 lifestylemodifications

  • Patients who have maintained stable diabetes treatment for at least 3 months withoutchanges

  • 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 continuousaccess 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 (sterilestatus, intrauterine device, or concurrent use of male/female barrier method withspermicide)

  • Fully informed about the clinical trial and voluntarily consenting to participate

Exclusion

Exclusion Criteria:

  • 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 monthsprior to informed consent

  • History of malignancy within 1 year prior to informed consent (except thyroidcancer)

  • On hemodialysis or peritoneal dialysis or eGFR < 30 mL/min/1.73m2

  • Unable to avoid the following concomitant medications, devices, or treatments duringthe study: CGM other than study device, X-ray/MRI/CT scans, radiofrequency thermaltherapy, implantable devices such as pacemakers, immunosuppressants, steroids, IVvitamin preparations, cancer treatment, hemodialysis/peritoneal dialysis, insulintherapy

  • 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)

  • Whole blood donation within 60 days, apheresis within 30 days, or blood transfusionwithin 90 days prior to device application

  • Judged by investigator as unable to handle continuous glucose monitoring device

  • Pregnant or lactating women

  • Planning pregnancy within 1 year

  • Otherwise judged by investigator as inappropriate for participation in this clinicaltrial

Study Design

Total Participants: 150
Treatment Group(s): 1
Primary Treatment: FreeStyle Libre 2 Continuous Glucose Monitoring
Phase:
Study Start date:
January 02, 2026
Estimated Completion Date:
June 30, 2027

Connect with a study center

  • Kangbuk Samsung Hospital

    Seoul 1835848, South Korea 03181
    South Korea

    Active - Recruiting

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