PROMISE Study: An Evaluation of an Implantable Continuous Glucose Sensor up to 180 Days

NCT03808376 | Completed Results DMC FDA Device

• 1 other identifier: CTP-0036
• Study Type: interventional
• Target: 208
• Locations: 1 country
• Sites: 8

Brief Summary

The purpose of this clinical investigation is to evaluate the accuracy of the Eversense® continuous Glucose Monitoring System (Eversense® 180 CGM System) measurements when compared with reference standard measurements up to 180 days of sensor use. The investigation will also evaluate safety of the Eversense® 180 CGM System usage.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Effectiveness Measure - Mean Absolute Relative Difference (MARD) for Paired CGM and Reference Glucose Measurements

  The effectiveness endpoint is the mean absolute relative difference (MARD), calculated for paired CGM Sensor and reference glucose measurements through 180 days post-sensor insertion for reference glucose values from 40-400 mg/dL. MARD is defined as the average of absolute difference of paired Sensor and reference glucose readings divided by the reference glucose reading (reference) for reference glucose values from 40-400 mg/dL, that is: MARD = ((SUM \| (Glucose)sensor - (Glucose)reference \| / (Glucose)reference ) / n ) x 100%, where n is the total number of Sensor and reference glucose pairs after 180 days of sensor use (MARD is expressed as a percent). Lower MARDs indicate higher (better) accuracy.

  180 days

• Safety Endpoint - Incidence of Device-related or Sensor Insertion/Removal Procedure-related Serious Adverse Events

  Incidence of device-related or sensor insertion/removal procedure-related serious adverse events occurring up to 180 days after the insertion procedure.

  180 days

Study Arms (1)

Continuous Glucose Monitoring Device

EXPERIMENTAL

The Eversense® 180 CGM System

Device: Continuous Glucose Monitoring System

Interventions

Continuous Glucose Monitoring System DEVICE

The Eversense® 180 CGM System

Also known as: Eversense CGM system

Continuous Glucose Monitoring Device

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 unexplained 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
• Subjects with gastroparesis
• 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 \>60%
• History of hepatitis B, hepatitis C, or HIV
• Current treatment for a seizure disorder unless written clearance by neurologist to participate in study
• History of adrenal insufficiency
• 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 (as defined further in protocol)

Sponsors & Collaborators

• Senseonics, Inc.: lead

Study Sites (8)

John Muir Physician Network Clinical Research Center

Concord, California, 94520, United States

Location

AMCR Institute Inc.

Escondido, California, 92025, United States

Location

Diablo Clinical Research

Walnut Creek, California, 94598, United States

Location

Barbara Davis Center for Diabetes

Aurora, Colorado, 80045, United States

Location

Atlanta Diabetes Care

Atlanta, Georgia, 30318, United States

Location

Rocky mountain Diabetes Center C/O Research Department

Idaho Falls, Idaho, 83404, United States

Location

Clinical Trials of Texas

San Antonio, Texas, 78229, United States

Location

Rainier Clinical Research Center

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

301-515-7260

Study Officials

• Satish Garg, MD

  Barbara Davis Center

  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: January 15, 2019
• First Posted: January 17, 2019
• Study Start: December 27, 2018
• Primary Completion: May 8, 2020
• Study Completion: May 8, 2020
• Last Updated: August 20, 2024
• Results First Posted: August 20, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (8)