NCT07336329招募中不适用
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
Kangbuk Samsung Hospital1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2026年1月2日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Change in HbA1c from 3 to 6 months
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Change in HbA1c from 3 to 6 months
时间窗: At 6 months (V3)
Non-inferiority comparison of the adjusted change in glycated hemoglobin A1c (HbA1c) from month 3 (V2, randomization visit) to month 6 (V3, end of study). The non-inferiority margin is set at 0.3%. The periodic use group will be considered non-inferior to the continuous use group if the lower bound of the 97.5% one-sided confidence interval for the difference in HbA1c change (periodic minus continuous) is greater than -0.3%.
次要结局
- Change in HbA1c(At 6 months (V3))
- Change in Blood Pressure(At 6 months (V3))
- At 6 months (V3)(At 6 months (V3))
- Change in Body Weight(At 6 months (V3))
- Change in HOMA-IR(At 6 months (V3))
- Change in Diabetes Treatment Satisfaction (DTSQ)(At 6 months (V3))
- Change in Diabetes Self-Efficacy (K-DMSES)(At 6 months (V3))
- Change in Diabetes Self-Care Activities (SDSCA-K)(At 6 months (V3))
- Time in Range 70-180 mg/dL (Non-inferiority)(Combined period of 3.5-4 months, 4.5-5 months, and 5.5-6 months)
- Time in Range 70-180 mg/dL(Combined period of 3.5-4 months, 4.5-5 months, and 5.5-6 months)
- Time in Tight Range 70-140 mg/dL(Combined period of 3.5-4 months, 4.5-5 months, and 5.5-6 months)
- Time Above Range 180 mg/dL(Combined period of 3.5-4 months, 4.5-5 months, and 5.5-6 months)
- Time Above Range 250 mg/dL(Combined period of 3.5-4 months, 4.5-5 months, and 5.5-6 months)
- Time Below Range 70 mg/dL(Combined period of 3.5-4 months, 4.5-5 months, and 5.5-6 months)
- Time Below Range 54 mg/dL(Combined period of 3.5-4 months, 4.5-5 months, and 5.5-6 months)
- Glucose Standard Deviation (SD)(Combined period of 3.5-4 months, 4.5-5 months, and 5.5-6 months)
- Glucose Coefficient of Variation (CV)(Combined period of 3.5-4 months, 4.5-5 months, and 5.5-6 months)
- Mean Amplitude of Glycemic Excursions (MAGE)(Combined period of 3.5-4 months, 4.5-5 months, and 5.5-6 months)
- Glucose Management Indicator (GMI)(Combined period of 3.5-4 months, 4.5-5 months, and 5.5-6 months)
- Mean Glucose(Combined period of 3.5-4 months, 4.5-5 months, and 5.5-6 months)
研究者
Sun Joon, Moon
Professor
Kangbuk Samsung Hospital
研究点 (1)
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