Evaluation of the Accuracy and Precision of Flash Glucose Monitoring Sensors in Different Sites

Evaluation of the Accuracy and Precision of Flash Glucose Monitoring Sensors in Different Sites: the Abdomen and Upper Thigh Compared to the Upper Arm

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03154060

Acronym

OUT OF SIGHT

Enrollment

Registered

2017-05-15

Start date

2017-05-19

Completion date

2017-08-04

Last updated

2017-08-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 1

Keywords

Flash glucose monitoring, Accuracy, Precision

Brief summary

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.

Interventions

DEVICEAbbott FreeStyle Libre Flash Glucose Monitoring sensors

Three FGM sensors will be inserted simultaneously (one on the back of the upper arm, abdomen and thigh) and will be worn for a consecutive 14 days. Throughout the study, patients should measure capillary blood glucose (BG) with the built-in BG meter of the Freestyle Libre at least 7 times per day (before and 1-2 hours after every meal and before bedtime). Additionally, patients should scan each sensor at least every 8 hours to obtain every measured interstitial glucose value. At the end visit (after 14 days), patients will come back to the hospital to download FGM and SMBG data.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Masking

NONE

Intervention model description

open-label, prospective, single-arm study

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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).

Design outcomes

Primary

Measure	Time frame	Description
Mean Absolute Relative Difference	14 days	Mean Absolute Relative Difference (MARD) between FGM measurements for the three insertion sites and paired SMBG measurements.

Secondary

Measure	Time frame	Description
Precision Absolute Relative Deviation	14 days	Precision Absolute Relative Deviation (PARD) between FGM measurements of the sensor on the back of the upper arm and paired FGM measurements of sensors on the abdomen and upper thigh.

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026