The objectives of this study are (a) to train healthcare workers to use of the Medtronic Sentrino® system, and (b) to obtain feedback from healthcare workers on its usability.
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is the accuracy of subcutaneous CGM glucose
measurements.
Secondary outcome
The secondary endpoint of this study is to train healthcare workers to use of
the Medtronic Sentrino® system, and to obtain feedback from the users on the
usability of the Medtronic Sentrino® system.
Background summary
Hyperglycemia, hypoglycemia, and glycemic variability are all independently
associated with morbidity and mortality of critically ill patients. Blood
glucose control with insulin prevents hyperglycemia but is associated with an
increased incidence of hypoglycemia and may not affect blood glucose
variability. Implementation strategies of blood glucose control with insulin in
critically ill patients have mainly used manually operated whole blood portable
glucose meters. These meters are impracticable, possibly unsafe, and time* and
blood*consuming. Utilization of subcutaneous continuous glucose monitoring has
the potential to improve the safety (i.e., prevention of hypoglycemia) and
effectiveness (i.e., obtain a higher percent of values in the therapeutic range
and less blood glucose variability) of insulin titration in critically ill
patients. In addition, utilization of subcutaneous continuous glucose
monitoring devices is less time* and blood*consuming than the use of manually
operated whole blood portable glucose meters. Medtronic has developed a
subcutaneous continuous glucose monitoring especially for critically ill
patients, called the Sentrino®.
Study objective
The objectives of this study are (a) to train healthcare workers to use of the
Medtronic Sentrino® system, and (b) to obtain feedback from healthcare workers
on its usability.
Study design
This study concerns an investigator*initiated observational implementation
study in critically ill patients subjected to blood glucose control with
insulin, aiming at a blood glucose level of 90 - 150 mg/dL.
Study burden and risks
The Sentrino® has been tested and validated in a number of pre*clinical and
clinical studies in patients outside the intensive care unit (ICU), and has
been found to be safe and accurate for trend. Potential benefits include
reduced risk of hypoglycemia, and decreased glycemic variability. Burden and
risks include local irritations, bleeding and infection at the site of the
sensor.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
- Patient is at least 18 years old
- Patient is admitted to the ICU of the Academic Medical Center, The Netherlands.
- Patient has anticipated life expectancy greater than 96 hours
- Patient has recent platelet count greater than 30,000 per micro-liter
Exclusion criteria
- Patient currently has a suspected or diagnosed medical condition that, in the opinion of the Investigator, warrants exclusion from the study or prevents the patient from completing the study
- Patient is currently participating in another investigational drug or device study
- Patient is pregnant, as determined by hospital admission
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
In other registers
| Register | ID |
|---|---|
| CCMO | NL41498.018.12 |
| Other | volgt |
| OMON | NL-OMON29113 |