Evaluation of the Accuracy of an Implanted Glucose Sensor

NCT02647905 | Completed Results

• 1 other identifier: CTP-0023
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 9

Brief Summary

The purpose of this clinical investigation is to evaluate the accuracy of the Senseonics Continuous Glucose Monitoring System (Senseonics CGM System) measurements when compared with reference standard measurements The investigation will also evaluate safety of the Senseonics CGM System usage.

Conditions

Diabetes Mellitus

Keywords

type 1 diabetes; type 2 diabetes; CGM; implantable; accuracy; longevity

Outcome Measures

Primary Outcomes (1)

• CGM Relative Difference to Laboratory Reference Reported as MARD

  Mean absolute relative difference (MARD) for paired Sensor and reference measurements through 90 days post-insertion for reference glucose values from 40-400 mg/dL will be calculated for comparison.

  90 days

Other Outcomes (1)

• CGM System Agreement With Reference Control

  90 days

Study Arms (1)

Accuracy assessment, CGMS

EXPERIMENTAL

To determine accuracy of the Senseonics Continuous Glucose Monitoring System measurements through approximately 90 days post-insertion. Manipulation of glucose levels during multiple clinic days

Device: Continuous Glucose Monitoring System

Interventions

Continuous Glucose Monitoring System DEVICE

Accuracy and safety assessment of a continuous glucose monitoring device

Accuracy assessment, CGMS

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
• Subject has signed an informed consent form and is willing to comply with protocol requirements

You may not qualify if:

• History of severe hypoglycemia in the previous 6 months. Severe hypoglycemia is defined as hypoglycemia resulting in loss of consciousness or seizure
• History of diabetic ketoacidosis requiring emergency room visit or hospitalization in the previous 6 months
• 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 in the past 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.
• Hematocrit \<30% or \>55%
• History of hepatitis B, hepatitis C, or HIV
• Any condition that in the investigator's opinion would make the subject unable to complete the study or would make it not in the subject's best interest to participate in the study.

Sponsors & Collaborators

• Senseonics, Inc.: lead

Study Sites (9)

John Muir Physician Network Clinical Research Center

Concord, California, 94520, United States

Location

AMCR Institute

Escondido, California, 92025, United States

Location

Diablo Clinical Research

Walnut Creek, California, 94598, United States

Location

Atlanta Diabetes Care

Atlanta, Georgia, 30318, United States

Location

Mount Sinai Diabetes Center

New York, New York, 10029, United States

Location

Worldwide Clinical Trials

San Antonio, Texas, 78217, United States

Location

Clinical Trials of Texas

San Antonio, Texas, 78229, United States

Location

UVA Diabetes and Endocrine Clinic

Charlottesville, Virginia, 22903, United States

Location

Rainier Clinical Research

Renton, Washington, 98057, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Interventions

Continuous Glucose Monitoring

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Vice President, Clinical Sciences
• Organization: Senseonics

katherine.tweden@senseonics.com

3015157260

Study Officials

• Mark Christiansen, MD

  Diablo Clinical Research

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

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: December 31, 2015
• First Posted: January 6, 2016
• Study Start: January 1, 2016
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: June 6, 2018
• Results First Posted: June 6, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (9)