Evaluation of the Accuracy and Precision of Flash Glucose Monitoring Sensors in Different Sites (OUT OF SIGHT)

Universitaire Ziekenhuizen KU Leuven

Status

Completed

Conditions

Diabetes Mellitus, Type 1

Treatments

Device: Abbott FreeStyle Libre Flash Glucose Monitoring sensors

Study type

Interventional

Funder types

Other

Identifiers

NCT03154060

OOS-60146

Details and patient eligibility

About

On the first of July 2016, reimbursement for the Freestyle Libre Flash Glucose Monitoring (FGM) was introduced by the Belgian healthcare authority by means of a new diabetes convention. Making this the only way to receive the device in Belgium. Since then, many type 1 diabetes (T1D) patients switched to FGM. But some patients found the sensor on the upper arm too visible. Abbott does not recommend to place the sensor on a different place of the body than the back of the upper arm, because no tests were done yet (besides on the upper arm) to make an accuracy claim. With this study, we want to evaluate the accuracy and the precision of the Freestyle Libre FGM by using three FGM sensors simultaneously on different places of the body and perform regular self-monitoring of blood glucose (SMBG) tests.

Enrollment

23 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients with a diagnosis of T1D for more than 6 months
Adult patients ≥ 18 years
Signed informed consent form

Exclusion criteria

Pregnancy
Patients with severe cognitive dysfunction or other disease which makes FGM use difficult.
History of allergic reaction to any of the FGMs materials or adhesives when in contact with the skin.
History of allergic reaction to chlorhexidine or alcohol anti-septic solution.
Abnormal skin at the anticipated glucose sensor insertion sites (excessive hair, burn, inflammation, infection, rash, and/or tattoo).
Presence of concomitant pathology that might cause edema at the insertion sites (such as heart failure, liver failure, kidney failure defined as eGFR < 45 ml/min).