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

NCT ID: NCT03154060

Last Updated: 2017-08-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-19
• Study Completion Date: 2017-08-04

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.

Conditions

Diabetes Mellitus, Type 1

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Intervention

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

Group Type: EXPERIMENTAL

Abbott FreeStyle Libre Flash Glucose Monitoring sensors

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Onze Lieve Vrouwziekenhuis Aalst

OTHER

Sponsor Role: collaborator

Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role: lead

Responsible Party

prof dr Pieter Gillard

Professor Doctor Pieter Gillard

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Onze-Lieve-Vrouwziekenhuis Aalst

Aalst, , Belgium

UZ Leuven

Leuven, , Belgium

Countries

Belgium

Other Identifiers

OOS-60146

Identifier Type: -

Identifier Source: org_study_id