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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 1
• Intervention / Treatment: Device: Dexcom G5-Eversense; Device: Eversense-Dexcom G5

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

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Padova, Italy
    • University of Padova

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Dexcom G5 - Eversense; 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; 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
Experimental: Eversense- Dexcom G5; 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; 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Padova

Study record dates

Study Major Dates

• Study Start (Actual): March 14, 2018
• Primary Completion (Actual): December 31, 2018
• Study Completion (Actual): September 1, 2019

Study Registration Dates

• First Submitted: April 26, 2018
• First Submitted That Met QC Criteria: July 27, 2018
• First Posted (Actual): August 3, 2018

Study Record Updates

• Last Update Posted (Actual): March 27, 2020
• Last Update Submitted That Met QC Criteria: March 26, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: 4270/AO/17

Drug and device information, study documents

• 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