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

Primary Purpose

Diabetes Mellitus, Type 1

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Dexcom G5-Eversense
Eversense-Dexcom G5
Sponsored by
University of Padova
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Diabetes Mellitus, Type 1

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Padova

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Dexcom G5 - Eversense

Eversense- Dexcom G5

Arm Description

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

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

Outcomes

Primary Outcome Measures

device accuracy
sensors' accuracy expressed in terms of MARD (mean absolute relative difference) versus capillary blood glucose in different glycaemic ranges

Secondary Outcome Measures

Time spent in target
% Time spent in target (70-180 mg/dl) using each sensor to evaluate sensor efficacy
HbA1c
HbA1c changes using different sensors, to evaluate sensor efficacy
failure
% Sensors' failure rate to evaluate sensor duration
Adverse events
Adverse events (skin reactions, haematomas)
changes in quality of life
DTSQ questionnaire
changes in fear of hypoglycaemia
HFSII questionnaire

Full Information

First Posted
April 26, 2018
Last Updated
March 26, 2020
Sponsor
University of Padova
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1. Study Identification

Unique Protocol Identification Number
NCT03613805
Brief Title
Eversense and Dexcom G5: Efficacy and Accuracy in Type 1 Diabetic Patients
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
March 14, 2018 (Actual)
Primary Completion Date
December 31, 2018 (Actual)
Study Completion Date
September 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Padova

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 1

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dexcom G5 - Eversense
Arm Type
Active Comparator
Arm Description
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
Arm Title
Eversense- Dexcom G5
Arm Type
Experimental
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Dexcom G5-Eversense
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
Eversense-Dexcom G5
Intervention Description
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
Primary Outcome Measure Information:
Title
device accuracy
Description
sensors' accuracy expressed in terms of MARD (mean absolute relative difference) versus capillary blood glucose in different glycaemic ranges
Time Frame
after 3 months, at the end of the study for each arm of the study
Secondary Outcome Measure Information:
Title
Time spent in target
Description
% Time spent in target (70-180 mg/dl) using each sensor to evaluate sensor efficacy
Time Frame
after 3 months, at the end of the study for each arm of the study
Title
HbA1c
Description
HbA1c changes using different sensors, to evaluate sensor efficacy
Time Frame
after 3 months, at the end of the study for each arm of the study
Title
failure
Description
% Sensors' failure rate to evaluate sensor duration
Time Frame
after 3 months, at the end of the study for each arm of the study
Title
Adverse events
Description
Adverse events (skin reactions, haematomas)
Time Frame
after 3 months, at the end of the study for each arm of the study
Title
changes in quality of life
Description
DTSQ questionnaire
Time Frame
after 3 months, at the end of the study for each arm of the study
Title
changes in fear of hypoglycaemia
Description
HFSII questionnaire
Time Frame
after 3 months, at the end of the study for each arm of the study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
University of Padova
City
Padova
Country
Italy

12. IPD Sharing Statement

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

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