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

Not Applicable

Completed

• Conditions: Diabetes Mellitus, Type 1
• Interventions: Device: Abbott FreeStyle Libre Flash Glucose Monitoring sensors

• Registration Number: NCT03154060
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-05-12
• Study First Submitted QC: 2017-05-12
• Study First Posted: 2017-05-15
• Study Start: 2017-05-19
• Status Verified: 2017-08
• Primary Completion: 2017-08-04
• Study Completion: 2017-08-04
• Last Update Submitted: 2017-08-04
• Last Update Posted: 2017-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention	Abbott FreeStyle Libre Flash Glucose Monitoring sensors	Using 3 Abbott FreeStyle Libre Flash Glucose Monitoring sensors in parallel and measure 7 times a day BG by capillary finger stick testing.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (2)

UZ Leuven; 🇧🇪 Leuven, Belgium

Onze-Lieve-Vrouwziekenhuis Aalst; 🇧🇪 Aalst, Belgium