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NCT Number: NCT03154060

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

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.

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Key information

Conditions

Diabetes Mellitus, Type 1 Autoimmune Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Onze-Lieve-Vrouwziekenhuis Aalst, Aalst, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Abbott FreeStyle Libre Flash Glucose Monitoring sensors

Device

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.

Primary outcomes

  1. Mean Absolute Relative Difference

    Time frame: 14 days

    Mean Absolute Relative Difference (MARD) between FGM measurements for the three insertion sites and paired SMBG measurements.

Secondary outcomes

  1. Precision Absolute Relative Deviation

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Collaborators

  • Onze Lieve Vrouwziekenhuis Aalst

Registry information

Official study title

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

Acronym: OUT OF SIGHT

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
May 15, 2017
Registry last updated
Aug 7, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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