CompletedNCT02647905PRECISEIIUpdated Jun 6, 2018Results posted

Evaluation of the Accuracy of an Implanted Glucose Sensor

An interventional study of Continuous Glucose Monitoring System in Diabetes Mellitus, sponsored by Senseonics, Inc.. Completed at 9 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-06-06.

Sponsored by Senseonics, Inc. · Not applicable, Interventional, and Diagnostic

Phase: Not applicable
Study type: Interventional
Enrollment: 90
Allocation: Not applicable
Ages: 18 Years and older
Sex: All

Study summary

The purpose of this clinical investigation is to evaluate the accuracy of the Senseonics Continuous Glucose Monitoring System (Senseonics CGM System) measurements when compared with reference standard measurements The investigation will also evaluate safety of the Senseonics CGM System usage.

Conditions studied

Diabetes Mellitus

Keywords

type 1 diabetes
type 2 diabetes
CGM
implantable
accuracy
longevity

In context

Lead sponsor

Senseonics, Inc. is the lead sponsor of 11 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Adult subjects, age ≥18 years
Clinically confirmed diagnosis of diabetes mellitus for ≥1 year
Subject has signed an informed consent form and is willing to comply with protocol requirements

Exclusion criteria

Exclusion Criteria:

History of severe hypoglycemia in the previous 6 months. Severe hypoglycemia is defined as hypoglycemia resulting in loss of consciousness or seizure
History of diabetic ketoacidosis requiring emergency room visit or hospitalization in the previous 6 months
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.
A condition preventing or complicating the placement, operation, or removal of the Sensor or wearing of transmitter, including upper extremity deformities or skin condition.
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.
Hematocrit \<30% or >55%
History of hepatitis B, hepatitis C, or HIV
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.

Study design

Phase: Not applicable
Primary purpose: Diagnostic
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 90 participants (actual)

Study arms

Experimental
Accuracy assessment, CGMS
To determine accuracy of the Senseonics Continuous Glucose Monitoring System measurements through approximately 90 days post-insertion. Manipulation of glucose levels during multiple clinic days
Device: Continuous Glucose Monitoring System

Interventions

DeviceContinuous Glucose Monitoring System
Accuracy and safety assessment of a continuous glucose monitoring device

What researchers measure

Primary outcomes

CGM Relative Difference to Laboratory Reference Reported as MARD
Mean absolute relative difference (MARD) for paired Sensor and reference measurements through 90 days post-insertion for reference glucose values from 40-400 mg/dL will be calculated for comparison.
Time frame: 90 days

Other outcomes

CGM System Agreement With Reference Control
The percentage of system readings within ±15 mg/dL or 15% of YSI reference values (15/15%)
Time frame: 90 days

Results

Posted Jun 6, 2018

Participant flow

Participant flow — Overall Study
Milestone	Accuracy Assessment, CGMS
Started	90
Completed	87
Not completed	3
Withdrew: Lost to follow-up	1
Withdrew: Withdrawal by subject	2

Outcome measures

PrimaryCGM Relative Difference to Laboratory Reference Reported as MARD

Mean absolute relative difference (MARD) for paired Sensor and reference measurements through 90 days post-insertion for reference glucose values from 40-400 mg/dL will be calculated for comparison.

Time frame:: 90 days
Reported as:: Mean · percent

CGM Relative Difference to Laboratory Reference Reported as MARD
percent	Accuracy Assessment, CGMS
CGM Relative Difference to Laboratory Reference Reported as MARD	8.5 (8.0 to 9.1)

Other pre-specifiedCGM System Agreement With Reference Control

The percentage of system readings within ±15 mg/dL or 15% of YSI reference values (15/15%)

Time frame:: 90 days
Reported as:: Number · percent of readings within 15/15%

CGM System Agreement With Reference Control
percent of readings within 15/15%	Accuracy Assessment, CGMS
CGM System Agreement With Reference Control	86.8

Adverse events

Collected over 90 days post insertion or sensor removal and follow-up. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Accuracy Assessment, CGMS	0/90 (0%)	1/90 (1.1%)	43/90 (47.8%)

Most frequent serious events

Most frequent serious events
Event	Accuracy Assessment, CGMS
Surgical procedure to remove sensorSurgical and medical procedures	1/90

Most frequent other events

Showing 10 of 48

Most frequent other events
Event	Accuracy Assessment, CGMS
HeadacheNervous system disorders	4/90
Common coldRespiratory, thoracic and mediastinal disorders	4/90
GastroenteritisGastrointestinal disorders	4/90
Sensor location site- Pain/discomfortGeneral disorders	3/90
SyncopeVascular disorders	2/90
Shoulder painMusculoskeletal and connective tissue disorders	2/90
Sore throatGastrointestinal disorders	2/90
Device Fragement not recoveredSurgical and medical procedures	2/90
DiarrheaGastrointestinal disorders	2/90
NauseaGastrointestinal disorders	2/90

Baseline characteristics

Age, Continuous
Age, Continuous(years)	Accuracy Assessment, CGMS
Mean	45.1 ± 16.2

Sex: Female, Male
Sex: Female, Male(Participants)	Accuracy Assessment, CGMS
Female	36
Male	54

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Accuracy Assessment, CGMS
American Indian or Alaska Native	2
Asian	3
Native Hawaiian or Other Pacific Islander	1
Black or African American	7
White	77
More than one race	0
Unknown or Not Reported	0

Region of Enrollment
Region of Enrollment(Participants)	Accuracy Assessment, CGMS
United States	90

Dominant Hand
Dominant Hand(Participants)	Accuracy Assessment, CGMS
Right	78
Left	12

Body mass Index
Body mass Index(Participants)	Accuracy Assessment, CGMS
Normal (<25 kg/m2)	22
Overweight (≥25 and <30)	27
Obese (≥ 30)	41

Years since diabetes diagnosis
Years since diabetes diagnosis(years)	Accuracy Assessment, CGMS
Mean	20.1 ± 13.7

Diabetes Type
Diabetes Type(Participants)	Accuracy Assessment, CGMS
Type I	61
Type II	29

2 further baseline measures are reported on the registry.

Study locations

9 sites

John Muir Physician Network Clinical Research Center
Concord, California 94520, United States
AMCR Institute
Escondido, California 92025, United States
Diablo Clinical Research
Walnut Creek, California 94598, United States
Atlanta Diabetes Care
Atlanta, Georgia 30318, United States
Mount Sinai Diabetes Center
New York, New York 10029, United States
Worldwide Clinical Trials
San Antonio, Texas 78217, United States
Clinical Trials of Texas
San Antonio, Texas 78229, United States
UVA Diabetes and Endocrine Clinic
Charlottesville, Virginia 22903, United States
Rainier Clinical Research
Renton, Washington 98057, United States

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jun 6, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02647905
Lead sponsor: Senseonics, Inc.
Responsible party: Sponsor
First posted: Jan 6, 2016
Start date: Jan 2016
Primary completion: Jul 2016
Completion: Jul 2016
Results posted: Jun 6, 2018
Last update: Jun 6, 2018

Study contacts

Mark Christiansen, MD

principal investigator · Diablo Clinical Research

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2018. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

Senseonics, Inc.

Start the discussion