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

Официальное название

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

Обзор

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.

Вмешательства

• Устройство 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

Первичные конечные точки

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

Вторичные конечные точки (12)

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

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

South Korea · 1 центр

• Kangbuk Samsung Hospital — Seoul

Идентификаторы

NCT: NCT07336329 · KBSMC 2025-07-031

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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