PRECISION Study: Multi-center Study of Performance of a Novel Implanted CGM System Using a Next Generation Transmitter and Algorithm

NCT ID: NCT03251079

Last Updated: 2024-02-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-25
• Study Completion Date: 2018-02-01

Brief Summary

The purpose of this multi-center, prospective clinical study is to evaluate the performance of a novel, implanted Senseonics continuous glucose monitoring system (Senseonics CGM System) compared to Yellow Springs Instrument (YSI) glucose analyzer reference standard measurements using a next generation transmitter and algorithm. Other measures evaluated will be the effects of compression on performance and the safety of the Senseonics CGM system.

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Continuous Glucose Monitoring Device

Senseonics continuous glucose monitoring system

Group Type: EXPERIMENTAL

Continuous glucose monitoring system

Intervention Type: DEVICE

Implanted continuous glucose monitoring system

Interventions

Continuous glucose monitoring system

Implanted continuous glucose monitoring system

Intervention Type: DEVICE

Other Intervention Names

Senseonics continuous glucose monitoring 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 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. 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.

4. A condition preventing or complicating the placement, operation, or removal of the Sensor or wearing of transmitter, including upper extremity deformities or skin condition.

5. 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 Premature Atrial Contractions (PACs) and Premature Ventricular Contractions (PVCs) allowed).

Subjects with asymptomatic coronary artery disease (e,g, coronary artery bypass graft (CABG), stent placement or angioplasty) may participate if negative stress test within 1 year prior to screening and written clearance from Cardiologist documented.

6. Hematocrit <30% or >55%

7. History of hepatitis B, hepatitis C, or HIV

8. Current treatment for a seizure disorder unless written clearance by neurologist to participate in study

9. History of adrenal insufficiency

10. 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)

11. A condition requiring or likely to require magnetic resonance imaging (MRI)

12. Known topical or local anesthetic allergy

13. Known allergy to glucocorticoids

14. 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

15. Participation in another clinical investigation (drug or device) within 2 weeks prior to screening or intent to participate during the study period

16. The presence of any other active implanted device (as defined further in protocol)

17. The presence of any other CGM sensor or transmitter located in upper arm (other location is acceptable)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Senseonics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mark Christiansen, MD

Role: PRINCIPAL_INVESTIGATOR

Diablo Clinical Research

Locations

AMCR Institute Inc.

Escondido, California, United States

Diablo Clinical Research

Walnut Creek, California, United States

Rainier Clinical Research Center

Renton, Washington, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

CTP-0031

Identifier Type: -

Identifier Source: org_study_id