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

NCT ID: NCT03808376

Last Updated: 2024-08-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 208 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-27
• Study Completion Date: 2020-05-08

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Continuous Glucose Monitoring Device

The Eversense® 180 CGM System

Group Type: EXPERIMENTAL

Continuous Glucose Monitoring System

Intervention Type: DEVICE

The Eversense® 180 CGM System

Interventions

Continuous Glucose Monitoring System

The Eversense® 180 CGM System

Intervention Type: DEVICE

Other Intervention Names

Eversense CGM system

Eligibility Criteria

Inclusion Criteria

1. Adult subjects, age ≥18 years

2. Clinically confirmed diagnosis of diabetes mellitus for ≥1 year

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

Exclusion Criteria

1. History of unexplained severe hypoglycemia in the previous 6 months. Severe hypoglycemia is defined as hypoglycemia resulting in loss of consciousness or seizure

2. History of diabetic ketoacidosis requiring emergency room visit or hospitalization in the previous 6 months

3. Subjects with gastroparesis

4. 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.

5. A condition preventing or complicating the placement,operation, or removal of the Sensor or wearing of transmitter, including upper extremity deformities or skin condition.

6. 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.

7. Hematocrit <30% or >60%

8. History of hepatitis B, hepatitis C, or HIV

9. Current treatment for a seizure disorder unless written clearance by neurologist to participate in study

10. History of adrenal insufficiency

11. Currently receiving (or likely to need during the study period): immunosuppressant therapy; chemotherapy; anticoagulant/antithrombotic therapy (excluding aspirin); glucocorticoids (excluding ophthalmic or nasal). This exclusion does include the use of inhaled glucocorticoids and the use of topical glucocorticoids (over sensor site only); antibiotic for chronic infection (e.g. osteomyelitis, endocarditis)

12. A condition requiring or likely to require magnetic resonance imaging (MRI)

13. Known topical or local anesthetic allergy

14. Known allergy to glucocorticoids

15. 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. Conditions include but are not limited to psychiatric conditions, known current or recent alcohol abuse or drug abuse by subject history, a condition that may increase the risk of induced hypoglycemia or risk related to repeated blood testing. Investigator will supply rationale for exclusion

16. Participation in another clinical investigation (drug or device) within 2 weeks prior to screening or intent to participate during the study period

17. The presence of any other active implanted device (as defined further in protocol)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Senseonics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Satish Garg, MD

Role: PRINCIPAL_INVESTIGATOR

Barbara Davis Center

Locations

John Muir Physician Network Clinical Research Center

Concord, California, United States

AMCR Institute Inc.

Escondido, California, United States

Diablo Clinical Research

Walnut Creek, California, United States

Barbara Davis Center for Diabetes

Aurora, Colorado, United States

Atlanta Diabetes Care

Atlanta, Georgia, United States

Rocky mountain Diabetes Center C/O Research Department

Idaho Falls, Idaho, United States

Clinical Trials of Texas

San Antonio, Texas, United States

Rainier Clinical Research Center

Renton, Washington, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

CTP-0036

Identifier Type: -

Identifier Source: org_study_id