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

Diabetes Mellitus, Type 2 Clinical Trial

— PROMISE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03808376
• Other study ID #: CTP-0036
• Status: Completed
• Phase: N/A
• Start date: December 27, 2018
• Est. completion date: May 8, 2020

Study information

• Verified date: July 2020
• Source: Senseonics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 181
• Est. completion date: May 8, 2020
• Est. primary completion date: May 8, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Diabetes Mellitus, Type 2

Intervention

Device:
• Continuous Glucose Monitoring System
The Eversense® 180 CGM System

Locations

Country	Name	City	State
United States	Atlanta Diabetes Care	Atlanta	Georgia
United States	Barbara Davis Center for Diabetes	Aurora	Colorado
United States	John Muir Physician Network Clinical Research Center	Concord	California
United States	AMCR Institute Inc.	Escondido	California
United States	Rocky mountain Diabetes Center C/O Research Department	Idaho Falls	Idaho
United States	Rainier Clinical Research Center	Renton	Washington
United States	Clinical Trials of Texas	San Antonio	Texas
United States	Diablo Clinical Research	Walnut Creek	California

Sponsors (1)

Lead Sponsor	Collaborator
Senseonics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effectiveness Measure - mean absolute relative difference (MARD)	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.	180 days
Primary	Safety Endpoint - Incidence of device-related or sensor insertion/removal procedure-related serious adverse	Incidence of device-related or sensor insertion/removal procedure-related serious adverse events through 180 days post-Sensor insertion or removal and follow-up.	180 days