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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dexcom G5 - Eversense | Active Comparator | 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 |
|
| Eversense- Dexcom G5 | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexcom G5-Eversense | Device | 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 |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Padova | Padova | Italy |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Eversense-Dexcom G5 | Device | 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 |
|
| 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 |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |