Home Use Sensor Study

NCT02932514 | Unknown

• 1 other identifier: CTP-0025
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this clinical investigation is to evaluate the accuracy of the Eversense Continuous Glucose Monitoring System (Eversense System) measurements when compared with a Self-monitoring blood glucose (SMBG) meter. The investigation will assess device performance in two insertion locations (abdomen and upper arm), evaluate safety of the Eversense System usage, and assess the usability of the Eversense system in the hands of user at home setting. Changes in HbA1c from baseline will also be evaluated.

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (2)

• Accuracy of Eversense CGM System for Arm and Abdomen Sensors compared to SMBG Meter as determined by Mean Absolute Relative Difference (MARD) calculations.

  180 Days

• Usability of the Eversense CGM System over 180 days will be evaluated through Study Questionnaires.

  180 days

Study Arms (1)

Eversense (Senseonics) CGM System

EXPERIMENTAL

Device: Eversense (Senseonics) Continuous Glucose Monitoring System

Interventions

Eversense (Senseonics) Continuous Glucose Monitoring System DEVICE

* Evaluate accuracy of Eversense CGM System to SMBG Meter. * Compare performance between abdomen and arm insertion sites. * Determine the usability of the Eversense System in a home-use setting for 180 days.

Eversense (Senseonics) CGM System

Eligibility Criteria

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

You may qualify if:

• Adult subjects, age ≥18 years
• Clinically confirmed diagnosis of diabetes mellitus for ≥1 year and using insulin by subcutaneous injection or insulin pump.
• Subject has signed an informed consent form and is willing to comply with protocol requirements

You may not qualify if:

• Female subjects of childbearing capacity (defined as not surgically sterile or not menopausal for ≥ 1 year) who are lactating or pregnant, intending to become pregnant, or not practicing birth control during the course of the study
• A condition preventing or complicating the placement, operation or removal of the sensor or wearing of transmitter, including upper extremity deformities or skin condition
• Symptomatic coronary artery disease; unstable angina; myocardial infarction, transient ischemic attack or stroke within 6 months; uncontrolled hypertension (systolic\>160 mm HG or diastolic \>100 mm Hg at time of screening); current congestive heart failure; history of cardiac arrhythmia (benign PACs and PVCs allowed). Subjects with asymptomatic coronary artery disease (e.g., CABG, stent placement or angioplasty) may participate if negative stress test within 1 year prior to screening and written clearance from cardiologist documented.
• History of hepatitis B, hepatitis C, or HIV
• A condition requiring or likely to require magnetic resonance imaging (MRI)
• Known topical or local anesthetic allergy
• Known allergy to glucocorticoids
• Participation in another clinical investigation (drug or device) within 2 weeks prior to screening or intent to participate during the study period
• The presence of any other active implanted device\*

Sponsors & Collaborators

• Senseonics, Inc.: lead

Study Sites (2)

Diabetic Center, Sahlgrenska University Hospital

Gothenburg, 41345, Sweden

Location

Skåne University Hospital

Lund, 22185, Sweden

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Continuous Glucose Monitoring

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Investigative Techniques

Study Officials

• Mona Landin-Olsson, M.D., Ph.D

  Skane University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2016
• First Posted: October 13, 2016
• Study Start: October 1, 2016
• Primary Completion: July 1, 2017
• Last Updated: May 22, 2017

Record last verified: 2017-05

Locations

SE (2)