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

Study Overview
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Brief Summary
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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
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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

Official Title
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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

Conditions
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Diabetes Mellitus, Type 1

Intervention / Treatment
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* Device: Dexcom G5-Eversense
* Device: Eversense-Dexcom G5


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dexcom G5 - Eversense<br>Patients will wear first Dexcom G5 (Dexcom San Diego, CA, USA) transcutaneous sensor for 3 months, then Eversnese(Senseonics Inc, MD, USA) implantable sensor for 3 months Accuracy and efficacy will be evaluated | Device: Dexcom G5-Eversense<br>* 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<br>|
| Experimental: Eversense- Dexcom G5<br>Patients will wear first Eversense (Senseonics Inc, MD, USA) implantable sensor for 3 months, then Dexcom G5 (Dexcom San Diego, CA, USA) transcutaneous sensor for 3 months accuracy and efficacy will be evaluated | Device: Eversense-Dexcom G5<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| device accuracy | sensors' accuracy expressed in terms of MARD (mean absolute relative difference) versus capillary blood glucose in different glycaemic ranges | after 3 months, at the end of the study for each arm of the study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time spent in target | % Time spent in target (70-180 mg/dl) using each sensor to evaluate sensor efficacy | after 3 months, at the end of the study for each arm of the study | 
| HbA1c | HbA1c changes using different sensors, to evaluate sensor efficacy | after 3 months, at the end of the study for each arm of the study | 
| failure | % Sensors' failure rate to evaluate sensor duration | after 3 months, at the end of the study for each arm of the study | 
| Adverse events | Adverse events (skin reactions, haematomas) | after 3 months, at the end of the study for each arm of the study | 
| changes in quality of life | DTSQ questionnaire | after 3 months, at the end of the study for each arm of the study | 
| changes in fear of hypoglycaemia | HFSII questionnaire | after 3 months, at the end of the study for each arm of the study |