NCT03613805

Eversense and Dexcom G5: Efficacy and Accuracy in Type 1 Diabetic Patients

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: University of Padova · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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

Conditions

• Diabetes Mellitus, Type 1

Interventions

Type	Name	Description
DEVICE	Dexcom G5-Eversense	Patients will wear sensor for 3 months, monitor blood capillary values 4 times/day. At the beginning and at the end of the period HbA1c will be measured and questionnaires will be administered
DEVICE	Eversense-Dexcom G5	Patients will wear sensor for 3 months, monitor blood capillary values 4 times/day. At the beginning and at the end of the period HbA1c will be measured and questionnaires will be administered. After 30-50 days of sensor implantation patients will wear also Dexcom G5 for a week to compare accuracy simultaneously

Timeline

• Start date: 2018-03-14
• Primary completion: 2018-12-31
• Completion: 2019-09-01
• First posted: 2018-08-03
• Last updated: 2020-03-27

Locations

1 site across 1 country: Italy