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 (YSI glucose analyzer). The…
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Mean absolute relative difference (MARD) of Sensor readings compared with the
reference measurements (YSI) at successive 30-days intervals through 180 days
post-insertion.
Secondary outcome
1. Additional accuracy measures during the period of Sensor use * mean absolute
difference; median absolute relative difference; agreement as expressed by
readings within 20%, 30% and 40% of reference values; trend accuracy measured
over time at different glucose rates of change and starting ranges.
2. Clarke Error Grid, Consensus Error Grid and Continuous Glucose Error Grid.
3. Deming regression analysis
4. Bland Altman analysis
5. Low/High glucose alert/alarm performance * accuracy of detection of hypo-
and hyperglycemic states; sensitivity and specificity.
(The glucose alert and alarm performance of the Senseonics CGM System will be
evaluated through post-processing of data collected)
Background summary
The Senseonics Continuous Glucose Monitoring System is a glucose monitoring
device indicated for continually measuring interstitial fluid glucose levels in
adults with diabetes for the operating life of the sensor. The Senseonics
Continuous Glucose Monitoring System is intended to be used:
* To aid in the management of diabetes.
* To provide real-time glucose readings directly to the user.
* To provide glucose trend information.
* To provide alarms for the detection and prediction of episodes of low
blood glucose (hypoglycemia) and high blood glucose (hyperglycemia).
Continuous glucose monitoring has proven to be an adequate and effective method
to improve diabetes treatment in patients with type 1 diabetes.
Safety, accuracy and reliability are essential components of a good functioning
sensor system and should therefore be assessed in clinical trials.
Study objective
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 (YSI glucose
analyzer). The investigation will also evaluate safety of the Senseonics CGM
System usage, while in the clinic and during home use.
Study design
This is a prospective, single-arm multi-center investigation enrolling
approximately 15 (a total of 82 in Europe) adult subjects with diabetes
mellitus. Subjects will be screened for inclusion and exclusion criteria and
informed consent obtained. Each subject will have two Sensors inserted on Visit
2 (Day 0), one Sensor in each upper arm. One of the Sensors in each subject
will be designated as the *primary Sensor.* A subset of subjects will have the
Sensor in their selfreported dominant arm designated as the primary Sensor and
a subset of subjects will have the Sensor in their self-reported non-dominant
arm designated as the primary Sensor. The investigation will include 11
in-clinic visits: a screening visit to determine subject eligibility, one
3-hour visit (on Visit 2, Day 0) to insert the Sensors, three 8-hour daytime
visits (on Visits 5, 7, and 9; Days 30, 90, and 150) and five 24-hour overnight
visits (on Visits 3, 4, 6, 8, and 10; Days 1, 14, 60, 120, and 180), to
evaluate Sensor performance, removal of the Sensors at the completion of Visit
10 (on Day 180) and a final visit (Visit 11, Day 190) to evaluate healing of
Sensor insertion/removal sites. Between in-clinic visits, subjects will wear an
external Transmitter over the primary designated Sensor for data collection in
the home except during charging, bathing or any other water activity. Subjects
will not wear an external Transmitter over the secondary designated Sensor in
the home.
Subjects will be given access to the glucose data collected on the primary
designated sensor Transmitter (*primary Transmitter*), including glucose
alerts/alarms, during home use only. Data collected on the secondary designated
sensor Transmitter (*secondary Transmitter*) during the in-clinic visits will
be used to evaluate the precision of the Senseonics CGM System.
Intervention
Each subject will have two Sensors inserted on Visit 2 (Day 0), one Sensor in
each upper arm. One of the Sensors in each subject will be designated as the
*primary Sensor.* A subset of subjects will have the Sensor in their
selfreported dominant arm designated as the primary Sensor and a subset of
subjects will have the Sensor in their self-reported non-dominant arm
designated as the primary Sensor. Sensor performance will be assessed by
comparing sensor measurements to reference methods for measuring bloodglucose.
Study burden and risks
The duration of the of the study for each patient will be between 190 and 220
days (including 11 hospital visits, 149 hours). Risk to the patient includes
haematoma or infection around the blood collection catheter sites or the sensor
insertion/ removal site. The risk of hypo- and hyperglycaemia is present in
every patient with Type 1 diabetes. There is a risk of anemia due to frequent
blood sampling with an estimated maximum blood loss due to blood withdrawal of
275.5 mL in a period of 8 weeks.
Seneca Meadows Parkway 20451
Germantown MD 20876
US
Seneca Meadows Parkway 20451
Germantown MD 20876
US
Listed location countries
Age
Inclusion criteria
1. Males and Females Aged *18 years of age.
2. Clinically confirmed diagnosis of diabetes mellitus for a duration of 1
year and uses insulin therapy for their diabetes management
(including subjects on insulin pump therapy).
3. Subject understands study procedures and risks, is willing to comply with protocol requirements, and has signed an informed consent document.
Exclusion criteria
1. History of severe hypoglycemia in the last 6 months prior to study start.
2. Severe diabetic ketoacidosis in the past 6 months.
3. Any condition preventing or complicating the placement, operation or removal of the Sensor including upper extremity deformities or skin condition.
4. Any medical condition or illness that in the judgment of the investigator might interfere with the procedures, results or compliance during the course of this investigation, or increase the risk of induced hypoglycemia or repeated blood testing including significantly impaired hepatic function and renal failure.
5. Known microvascular (diabetic) complications, including active proliferative diabetic retinopathy or macular edema, active nonproliferative retinopathy, diabetic nephropathy including active retinopathy, or neuropathy.
6. Hematocrit >50% or <30%
7. Females pregnant or intending to become pregnant during the course of the investigation.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| Other | 16693 |
| CCMO | NL48503.018.14 |