Diabetes Mellitus, Type 1 Clinical Trial
Official title:
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
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.
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.
Time spent in target (70-180 mg/dl), in hypoglycamiea and hyperglycemia will be evaluated
with both sensors to assess differences in glycaemic control induced by different alarm
system and by the presence of predictive alarms
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