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

• ClinicalTrials.gov Identifier: NCT03808376
• Recruitment Status: Completed
• First Posted: January 17, 2019
• Last Update Posted: April 1, 2021
• Sponsor: Senseonics, Inc.
• Information provided by (Responsible Party): Senseonics, Inc.

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Diabetes Mellitus; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2	Device: Continuous Glucose Monitoring System	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 181 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: PROMISE Study: A Prospective, Multicenter Evaluation of Accuracy and Safety of an Implantable Continuous Glucose Sensor Lasting up to 180 Days
• Actual Study Start Date: December 27, 2018
• Actual Primary Completion Date: May 8, 2020
• Actual Study Completion Date: May 8, 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: Continuous Glucose Monitoring Device; The Eversense® 180 CGM System	Device: Continuous Glucose Monitoring System; The Eversense® 180 CGM System; Other Name: Eversense CGM system

Outcome Measures

Primary Outcome Measures :

1. Effectiveness Measure - mean absolute relative difference (MARD) [ Time Frame: 180 days ]
   The effectiveness endpoint will be mean absolute relative difference (MARD) for paired Sensor and reference measurements through 180 days post-insertion for reference glucose values from 40-400 mg/dL.
2. Safety Endpoint - Incidence of device-related or sensor insertion/removal procedure-related serious adverse [ Time Frame: 180 days ]
   Incidence of device-related or sensor insertion/removal procedure-related serious adverse events through 180 days post-Sensor insertion or removal and follow-up.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

United States, California

John Muir Physician Network Clinical Research Center

Concord, California, United States, 94520

AMCR Institute Inc.

Escondido, California, United States, 92025

Diablo Clinical Research

Walnut Creek, California, United States, 94598

United States, Colorado

Barbara Davis Center for Diabetes

Aurora, Colorado, United States, 80045

United States, Georgia

Atlanta Diabetes Care

Atlanta, Georgia, United States, 30318

United States, Idaho

Rocky mountain Diabetes Center C/O Research Department

Idaho Falls, Idaho, United States, 83404

United States, Texas

Clinical Trials of Texas

San Antonio, Texas, United States, 78229

United States, Washington

Rainier Clinical Research Center

Renton, Washington, United States, 98057

Sponsors and Collaborators

Senseonics, Inc.

Investigators

• Principal Investigator: Satish Garg, MD; Barbara Davis Center

More Information

• Responsible Party: Senseonics, Inc.
• ClinicalTrials.gov Identifier: NCT03808376
• Other Study ID Numbers: CTP-0036
• First Posted: January 17, 2019
• Last Update Posted: April 1, 2021
• Last Verified: July 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Device Product Not Approved or Cleared by U.S. FDA: Yes

Additional relevant MeSH terms:

Diabetes Mellitus; Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases