Effectiveness of Using Real-time Continuous Glucose Monitoring Compared With Intermittent Continuous Glucose Monitoring in People With Type 2 Diabetes Treated With Insulin.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Time in Range
研究概览
简要总结
The objective is to compare the efficacy of TR-CGM versus isCGM in patients diagnosed with T2D who are treated with insulin and use CGM, as defined by time in range between 70 and 180 mg/dL.
An open-label clinical trial will be conducted. Patients with T2D who use intermittent glucose monitoring and insulin with poor metabolic control will be included. They will be randomized to continue with isCGM or RT-CGM.
The primary outcome: %TIR 70-180 mg/dL.
详细描述
All patients diagnosed with type 2 diabetes (T2D) who meet the inclusion criteria will be identified (see inclusion and exclusion criteria). They will then be invited to participate in the study and asked to sign an informed consent form. Demographic data, baseline clinical characteristics, and clinical tests related to metabolic control will be collected.
Visit 0 (V0): Informed consent signature and basal CGM system installation will be verified.
Visit 1 (V1): CGM data will be downloaded. All enrolled patients will receive the same instructions for device use and management of high and low glucose levels, according to standard clinical procedures. Then, randomization will be performed by someone who is blinded to the clinical characteristics of each patient and is not part of the research group. The allocation given by this mechanism cannot be changed by the treating physicians.
- Usual care + TR-CGM group: Patients in this group will receive a continuous interstitial glucose monitoring (CIGM) sensor via the FreeStyle Libre 2 Plus device and LibreLink app® (Abbott Diabetes Care, Inc., Alameda, CA). High alarms greater than 250 mg/dL and low glucose alerts less than 70 mg/dL will be programmed. All participants will be instructed to change their sensor according to the manufacturer's recommendations: every 15 days for the TR-CGM group.
- Usual care + CIGM group: Patients in this group will receive a CIGM sensor using the FreeStyle Libre 2 device (Abbott Diabetes Care Inc., Alameda, CA, USA). High alarms >250 mg/dL and low glucose alerts <70 mg/dL will be programmed. Additionally, they will be instructed to perform at least eight scans daily to avoid data loss. All participants were instructed to change their sensors according to the manufacturer's recommendations: every 15 days for isCGM.
Standard Care (Applies to Both Groups):
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
- 35 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Minimum age of 35 years.
- •HbA1c >7.0%
- •Treatment with one or more insulin injections.
- •Stable medication regimen for the 3 months prior to study entry.
- •Insulin treatment for ≥3 months with a stable dose prior to entry, with fasting blood glucose between 70 and 130 mg/dL.
- •Availability of an NFC-enabled smartphone.
排除标准
- •Pregnancy or planning to become pregnant during the study period.
- •History of bariatric surgery within the year prior to study entry or plans to undergo bariatric surgery during the study.
- •Having a condition that would likely require an MRI during the study period.
- •Use of medications containing high doses of ascorbic acid (>2000 mg/day), as it may falsely increase sensor readings.
- •Concomitant illness or condition that may compromise patient safety, including, but not limited to, serious mental illness, a diagnosed or suspected eating disorder, or any long-term medical/unmanageable disorder.
- •GFR less than 30 ml/min.
- •Psychiatric condition that interferes with study-related tasks.
- •Known (or suspected) significant allergy to medical-grade adhesives.
结局指标
主要结局
Time in Range
时间窗: 12 weeks
To compare the efficacy defined as time in range between 70 - 180 mg/dl of the TR-CGM compared to isCGM in patients diagnosed with T2DM treated with insulin who use CGM as part of usual clinical practice in follow-up at the endocrinology unit of the San Ignacio University Hospital.
次要结局
- Proportion of patients with a ≥5% increase in TIR(12 weeks)
- TAR(12 weeks)
- TBR <70 mg/dl(12 weeks)
- TBR <54 mg/dl(12 weeks)
- Severe hypoglycemia(12 weeks)
- Satisfaction with the device(12 weeks)