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Evaluation of the Accuracy and Precision of Flash Glucose Monitoring Sensors in Different Sites (OUT OF SIGHT)

Primary Purpose

Diabetes Mellitus, Type 1

Status

Completed

Phase

Not Applicable

Locations

Belgium

Study Type

Interventional

Intervention

Abbott FreeStyle Libre Flash Glucose Monitoring sensors

About this trial

This is an interventional other trial for Diabetes Mellitus, Type 1 focused on measuring Flash glucose monitoring, Accuracy, Precision

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

Onze-Lieve-Vrouwziekenhuis Aalst
UZ Leuven

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention

Arm Description

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

Outcomes

Primary Outcome Measures

Mean Absolute Relative Difference

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

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT03154060

First Posted

May 12, 2017

Last Updated

August 4, 2017

Sponsor

Universitaire Ziekenhuizen KU Leuven

Collaborators

Onze Lieve Vrouwziekenhuis Aalst

1. Study Identification

Unique Protocol Identification Number

NCT03154060

Brief Title

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

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2017

Overall Recruitment Status

Completed

Study Start Date

May 19, 2017 (Actual)

Primary Completion Date

August 4, 2017 (Actual)

Study Completion Date

August 4, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Universitaire Ziekenhuizen KU Leuven

Collaborators

Onze Lieve Vrouwziekenhuis Aalst

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes Mellitus, Type 1

Keywords

Flash glucose monitoring, Accuracy, Precision

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

open-label, prospective, single-arm study

Masking

None (Open Label)

Allocation

N/A

Enrollment

23 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Intervention

Arm Type

Experimental

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Abbott FreeStyle Libre Flash Glucose Monitoring sensors

Intervention Description

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 Outcome Measure Information:

Title

Mean Absolute Relative Difference

Description

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

Time Frame

14 days

Secondary Outcome Measure Information:

Title

Precision Absolute Relative Deviation

Description

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.

Time Frame

14 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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).

Facility Information:

Facility Name

Onze-Lieve-Vrouwziekenhuis Aalst

City

Aalst

ZIP/Postal Code

9300

Country

Belgium

Facility Name

UZ Leuven

City

Leuven

ZIP/Postal Code

3000

Country

Belgium

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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