Eversense and Dexcom G5 Comparison in Real Life: a Randomized Crossover Trial in Type 1 Diabetic Patients to Evaluate Differences in Accuracy, Efficacy and Quality of Life
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- device accuracy
研究概览
简要总结
Continuous Glucose Monitoring (CGM) systems improve glycaemic control in type 1 diabetic patients but they have different characteristics that could influence patients' quality of life and glycaemic control.
In this randomized cross over study investigators will compare 2 different CGM systems: Eversense implantable sensor (Senseonics, Germantown, MD, USA) and the standard transcutaneous sensor Dexcom G5 (Dexcom, San Diego, CA, USA). Investigators will evaluate sensors' accuracy, impact on quality of life and efficacy in optimizing glycaemic control.
The investigator's study's results might help clinicians choose the sensor and evaluate how sensor differences could impact glycaemic control.
详细描述
Good glycaemic control in type 1 diabetic patients prevents the onset and progression of chronic complications. Continuous Glucose Monitoring (CGM) systems help patients improve glycaemic control by providing real-time glucose levels, glycaemic tendency, glycaemic swing rate and by alerting the patient when the glucose value read by the sensor reaches a predefined threshold of hyper or hypoglycaemia.
Several CGM systems are available and they have different characteristics that could influence patients' quality of life and glycaemic control.
In this randomized cross over study investigators will compare 2 different CGM systems: Eversense implantable sensor (Senseonics, Germantown, MD, USA) and the standard transcutaneous sensor Dexcom G5 (Dexcom, San Diego, CA, USA). Investigators will evaluate sensors' accuracy, impact on quality of life and efficacy in optimizing glycaemic control.
Patients will use Dexcom G5 or Eversense for three months, respectively, in a randomized order. Accuracy will be evaluated comparing sensors values with capillary blood glucose at home.
Quality of life will be assessed at the beginning and at the end of each three-month period through validated questionnaires to underline differences in different sensors use.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female participants of at least 18 years of age
- •Diagnosis of type 1 diabetes mellitus (diagnosed according to World Health Organization criteria) for at least 1 year
- •Body Mass Index (BMI) <35 kg / m²
- •Availability to wear study equipment and to comply with the study protocol for its entire duration
- •HbA1c <10%
- •Signature of informed consent before any procedure related to the study.
排除标准
- •Pregnancy, breastfeeding, intention to undergo pregnancy or refusal to use contraceptive methods during the study period (for female subjects).
- •Known allergies to skin patches or disinfectants used during the study.
- •Skin lesions, irritation, redness, edema in sites where sensors can be applied, as this might interfere with sensor's placement or with the accuracy of the glycaemic value detection.
- •Use of drugs that may interfere with glucose metabolism (such as steroids) unless they are chronic therapies whose dosage has remained stable over the past 3 months and is expected to remain stable during the study period.
- •Use of acetaminophen or other drugs that could influence sensor accuracy
- •Severe medical or psychological conditions, which, in the opinion of the medical team, may compromise patients' safety while participating in the study.
- •Patients enrolled in other clinical trials.
- •Known disorders of adrenal glands, pancreatic tumors or insulinoma
- •Patient's inability to comply with the procedures of the study
结局指标
主要结局
device accuracy
时间窗: after 3 months, at the end of the study for each arm of the study
sensors' accuracy expressed in terms of MARD (mean absolute relative difference) versus capillary blood glucose in different glycaemic ranges
次要结局
- changes in fear of hypoglycaemia(after 3 months, at the end of the study for each arm of the study)
- Time spent in target(after 3 months, at the end of the study for each arm of the study)
- HbA1c(after 3 months, at the end of the study for each arm of the study)
- failure(after 3 months, at the end of the study for each arm of the study)
- Adverse events(after 3 months, at the end of the study for each arm of the study)
- changes in quality of life(after 3 months, at the end of the study for each arm of the study)
研究者
Daniela Bruttomesso
principal investigator, MD, PhD, Metabolic Unit, University of Padua
University of Padova