The main objective is to determine the accuracy of the Guardian Sensor 3 in combination with the transmitter developed by Inreda Diabetic BV. Secondary objectives are to assess differences in sensor performance parameters between the Guardian Sensor…
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main parameter to express glucose accuracy is the MARD value (mean absolute
relative difference between self-monitoring of blood glucose (SMBG)
measurements and Guardian Sensor 3 measurements).
Secondary outcome
Secondary accuracy parameters are:
* Overall percentage of measured glucose values that fall within ± 0.83 mmol/l
of a SMBG measurement at a glucose level of < 5.55 mmol/l.
* Overall percentage of measured glucose values that fall within 15% of a SMBG
measurement at a glucose level of >5.55 mmol/l.
* Overall percentage of measured glucose values that fall in zone A and B of
the Clarke Error Grid.
* PARD value of the Guardian Sensor 3 in combination with the Enlite Sensor.
AP-related outcome parameters are:
* Life-time of the sensors;
* Percentage of time that the sensors are available as input for the algorithm.
Other study parameters are demographic characteristics, weight, length, HbA1c
and amount of administered insulin during usual diabetes treatment.
Background summary
Inreda Diabetic BV. (Goor, The Netherlands) developed a bi-hormonal reactive
close loop system to automate control glucose regulation in patients with
diabetes mellitus type 1. This artificial pancreas (AP) consists of two
subcutaneous glycose enzyme sensors with transmitters to measure continuously
the blood glucose values and consists of a algorithm to determine the amount of
insulin or glucagon to be administered. In the current CE-marked AP, glucose
values are measured by Enlite Sensor (Medtronic) in combination with Inreda
Diabetic transmitters. In the future, Medtronic will replace the Enlite Sensor
by the Guardian Sensor 3 (Medtronic).
Study objective
The main objective is to determine the accuracy of the Guardian Sensor 3 in
combination with the transmitter developed by Inreda Diabetic BV. Secondary
objectives are to assess differences in sensor performance parameters between
the Guardian Sensor 3 and Enlite Sensor both in combination with Inreda
transmitter; to explore AP-related outcomes for both the Guardian Sensor 3 and
Enlite Sensor.
Study design
This study is a single center, prospective, observational, sensor validation
trial.
Intervention
not applicable
Study burden and risks
There are no major risks associated with this study since the patients will use
their usual diabetes therapy during the study. The most prominent risk is that
patients may devevlop irritation and redness caused by the plaster to attach
the sensors and possibly hematoma or pain from the SMBGs/sensors. The burden of
the study is also relatively low. Patients have to visit the CRC only twice and
are only asked to perform and register 7 SMBG measurements per day. There are
no individual benefits for participating this study.
Klavermaten 65-5
Goor 7472 DD
NL
Klavermaten 65-5
Goor 7472 DD
NL
Listed location countries
Age
Inclusion criteria
* Diagnosed with diabetes mellitus type 1;
* Age between 18 and 75 years;
* Willing and able to sign informed consent.
Exclusion criteria
* BMI > 35 kg/m2;
* Skin condition prohibiting needle insertion;
* Known or suspected problem related to enzyme based glucose sensor usage;
* Use of acetaminophen during the study period;
* Patients who go swimming or visit a sauna during the study period.
Design
Recruitment
Medical products/devices used
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In other registers
| Register | ID |
|---|---|
| CCMO | NL74582.091.20 |