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

NCT03154060 | Completed

• 1 other identifier: OOS-60146
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 2

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

Keywords

Flash glucose monitoring; Accuracy; Precision

Outcome Measures

Primary Outcomes (1)

• Mean Absolute Relative Difference

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

  14 days

Secondary Outcomes (1)

• Precision Absolute Relative Deviation

  14 days

Study Arms (1)

Intervention

EXPERIMENTAL

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

Interventions

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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with a diagnosis of T1D for more than 6 months
• Adult patients ≥ 18 years
• Signed informed consent form

You may not qualify if:

• 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).

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead
• Onze Lieve Vrouwziekenhuis Aalst: collaborator

Study Sites (2)

Onze-Lieve-Vrouwziekenhuis Aalst

Aalst, 9300, Belgium

Location

UZ Leuven

Leuven, 3000, Belgium

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Doctor Pieter Gillard

Model Details: open-label, prospective, single-arm study

Study Record Dates

• First Submitted: May 12, 2017
• First Posted: May 15, 2017
• Study Start: May 19, 2017
• Primary Completion: August 4, 2017
• Study Completion: August 4, 2017
• Last Updated: August 7, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

BE (2)