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

Study Overview
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Brief Summary
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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.

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

Conditions
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Diabetes Mellitus, Type 1

Intervention / Treatment
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* Device: Abbott FreeStyle Libre Flash Glucose Monitoring sensors


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: open-label, prospective, single-arm study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Using 3 Abbott FreeStyle Libre Flash Glucose Monitoring sensors in parallel and measure 7 times a day BG by capillary finger stick testing. | Device: Abbott FreeStyle Libre Flash Glucose Monitoring sensors<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Precision Absolute Relative Deviation | 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. | 14 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Flash glucose monitoring, Accuracy, Precision