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

NCT03613805 | Completed

• 1 other identifier: 4270/AO/17
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Time spent in target

  after 3 months, at the end of the study for each arm of the study

• HbA1c

  after 3 months, at the end of the study for each arm of the study

• failure

  after 3 months, at the end of the study for each arm of the study

• Adverse events

  after 3 months, at the end of the study for each arm of the study

• changes in quality of life

  after 3 months, at the end of the study for each arm of the study

Study Arms (2)

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

Device: Dexcom G5-Eversense

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

Device: Eversense-Dexcom G5

Interventions

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

Dexcom G5 - Eversense

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

Eversense- Dexcom G5

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Padova: lead

Study Sites (1)

University of Padova

Padua, Italy

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator, MD, PhD, Metabolic Unit, University of Padua

Study Record Dates

• First Submitted: April 26, 2018
• First Posted: August 3, 2018
• Study Start: March 14, 2018
• Primary Completion: December 31, 2018
• Study Completion: September 1, 2019
• Last Updated: March 27, 2020

Record last verified: 2020-03

Locations

IT (1)