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

Official title

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

Overview

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.

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

Primary outcome measures

• Change in HbA1c from 3 to 6 months [Time frame: At 6 months (V3)]

Secondary outcome measures (12)

• Change in HbA1c [Time frame: At 6 months (V3)]
• Change in Blood Pressure [Time frame: At 6 months (V3)]
• At 6 months (V3) [Time frame: At 6 months (V3)]
• Change in Body Weight [Time frame: At 6 months (V3)]
• Change in HOMA-IR [Time frame: At 6 months (V3)]
• Change in Diabetes Treatment Satisfaction (DTSQ) [Time frame: At 6 months (V3)]
• Change in Diabetes Self-Efficacy (K-DMSES) [Time frame: At 6 months (V3)]
• Change in Diabetes Self-Care Activities (SDSCA-K) [Time frame: At 6 months (V3)]
• Time in Range 70-180 mg/dL (Non-inferiority) [Time frame: Combined period of 3.5-4 months, 4.5-5 months, and 5.5-6 months]
• Time in Range 70-180 mg/dL [Time frame: Combined period of 3.5-4 months, 4.5-5 months, and 5.5-6 months]
• Time in Tight Range 70-140 mg/dL [Time frame: Combined period of 3.5-4 months, 4.5-5 months, and 5.5-6 months]
• Time Above Range 180 mg/dL [Time frame: Combined period of 3.5-4 months, 4.5-5 months, and 5.5-6 months]

Eligibility criteria

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 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

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 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 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
• 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 transfusion within 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 clinical trial

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

South Korea · 1 center

• Kangbuk Samsung Hospital — Seoul

Identifiers

NCT: NCT07336329 · KBSMC 2025-07-031

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗