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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03808376
Recruitment Status : Active, not recruiting
First Posted : January 17, 2019
Last Update Posted : December 18, 2019
Sponsor:
Information provided by (Responsible Party):
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.


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

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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
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Dextrose

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




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.



Information from the National Library of Medicine

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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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03808376


Locations
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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
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Principal Investigator: Satish Garg, MD Barbara Davis Center
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Responsible Party: Senseonics, Inc.
ClinicalTrials.gov Identifier: NCT03808376    
Other Study ID Numbers: CTP-0036
First Posted: January 17, 2019    Key Record Dates
Last Update Posted: December 18, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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