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



Status:Recruiting
Conditions:Diabetes, Diabetes, Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - Any
Updated:3/27/2019
Start Date:December 27, 2018
End Date:December 2019
Contact:Dawn White
Email:Dawn.white@ucdenver.edu
Phone:303-724-6770

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

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.


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)
We found this trial at
8
sites
Concord, California 94520
Principal Investigator: Anna R Chang, MD
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Concord, CA
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7940 Floyd Curl Dr.
San Antonio, Texas 78229
210-949-0122
Principal Investigator: Douglas Denham, MD
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from
San Antonio, TX
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Atlanta, Georgia 30318
Principal Investigator: Bruce Bode, MD
Phone: 404-355-4393
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from
Atlanta, GA
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Aurora, Colorado 80045
Principal Investigator: Halis Kaan Akturk, MD
Phone: 303-724-6761
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from
Aurora, CO
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Escondido, California 92026
Principal Investigator: Timothy Bailey, MD
Phone: 760-466-1523
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from
Escondido, CA
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Idaho Falls, Idaho 83404
Principal Investigator: David Liljenquist, MD
Phone: 208-528-9642
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from
Idaho Falls, ID
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Renton, Washington 98057
Principal Investigator: Ronald Brazg, MD
Phone: 425-251-1720
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from
Renton, WA
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Walnut creek, California 94598
Principal Investigator: Mark Christiansen, MD
Phone: 925-930-7267
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from
Walnut creek, CA
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