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

Diabetes Mellitus, Type 1 Clinical Trial

— OUT OF SIGHT  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03154060
• Other study ID #: OOS-60146
• Status: Completed
• Phase: N/A
• First received: May 12, 2017
• Last updated: August 4, 2017
• Start date: May 19, 2017
• Est. completion date: August 4, 2017

Study information

• Verified date: August 2017
• Source: Universitaire Ziekenhuizen Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: August 4, 2017
• Est. primary completion date: August 4, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

Device:
• Abbott 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.

Locations

Country	Name	City	State
Belgium	Onze-Lieve-Vrouwziekenhuis Aalst	Aalst
Belgium	UZ Leuven	Leuven

Sponsors (2)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven	Onze Lieve Vrouwziekenhuis Aalst

Country where clinical trial is conducted

Belgium, 

Outcome

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