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

PROMISE Study: A Prospective, Multicenter Evaluation of Accuracy and Safety of an Implantable Continuous Glucose Sensor Lasting up to 180 Days

Sponsors

Lead Sponsor: Senseonics, Inc.

Source Senseonics, Inc.
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.

Overall Status Active, not recruiting
Start Date December 27, 2018
Completion Date March 2020
Primary Completion Date March 2020
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Effectiveness Measure - mean absolute relative difference (MARD) 180 days
Safety Endpoint - Incidence of device-related or sensor insertion/removal procedure-related serious adverse 180 days
Enrollment 181
Condition
Intervention

Intervention Type: Device

Intervention Name: Continuous Glucose Monitoring System

Description: The Eversense® 180 CGM System

Arm Group Label: Continuous Glucose Monitoring Device

Other Name: 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)

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Satish Garg, MD Principal Investigator Barbara Davis Center
Location
Facility:
John Muir Physician Network Clinical Research Center | Concord, California, 94520, United States
AMCR Institute Inc. | Escondido, California, 92025, United States
Diablo Clinical Research | Walnut Creek, California, 94598, United States
Barbara Davis Center for Diabetes | Aurora, Colorado, 80045, United States
Atlanta Diabetes Care | Atlanta, Georgia, 30318, United States
Rocky mountain Diabetes Center C/O Research Department | Idaho Falls, Idaho, 83404, United States
Clinical Trials of Texas | San Antonio, Texas, 78229, United States
Rainier Clinical Research Center | Renton, Washington, 98057, United States
Location Countries

United States

Verification Date

April 2019

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: Continuous Glucose Monitoring Device

Type: Experimental

Description: The Eversense® 180 CGM System

Acronym PROMISE
Patient Data No
Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Primary Purpose: Diagnostic

Masking: None (Open Label)

Source: ClinicalTrials.gov