Clinical trial NCT01504620: Performance Evaluation of Blood Glucose Monitoring Systems
Official title: Performance Evaluation of BGStar and iBGStar in Terms of Accuracy (Polaris), Intra-assay Precision, and Hematocrit Interference (Helios Substudy) Following ISO15197 and TNO Guidelines
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes Mellitus
Keywords: diabetes mellitus
blood glucose self-assessment
Accuracy
Intra-Assay precision
Hematocrit interference
Lead sponsor: IKFE Institute for Clinical Research and Development
Sponsor class: OTHER
Collaborators: name: Sanofi-Synthelabo
First posted: 2012-01-05
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The goal of this single-center, comparative, open label, in-vitro diagnostic device performance evaluation was to investigate the performance of two sanofi-aventis BGMSs (BGStar® and iBGStar®) with regard to system accuracy (Polaris), precision and Hct influence (Helios).

Detailed description: The main study (Polaris) investigated blood glucose measuring accuracy and intra-assay precision while the substudy (Helios) investigated potential haematocrit interference of sanofi-aventis BGMSs BGStar® and iBGStar® and partly of competitor BGMSs according to ISO 15197 \[1\] and TNO 2001 Quality Guideline \[2\], respectively.

The primary objective of the system accuracy evaluation is to identify the number of blood glucose readings of both sanofi-aventis devices within the ISO 15197 area of acceptable accuracy of ± 20% \[DEV%\] for blood samples with glucose concentration \> 75 mg/dL (4.2 mmol/L) and within the ISO 15197 area of acceptable accuracy of ± 15 mg/dL (± 0.83 mmol/L) for blood samples with glucose concentration \< 75 mg/dL (4.2 mmol/L) as compared to the StatStrip® Connectivity reference method. The primary objective of the haematocrit interference evaluation is to demonstrate that the BGStar® and iBGStar® devices meet the Hct interference requirements according to TNO 2001 Quality Guideline when used to measure BG of venous whole blood as compared to a venous plasma reference method (YSI 2300 STAT Plus™) at Hct levels between 35 - 55% in terms of:(1) a mean deviation not exceeding ± 10% \[DEV%\] for hyperglycaemic glucose concentrations (150 - 180, 250 - 280, 320 - 350 mg/dL) and (2)a mean deviation not exceeding ± 18 mg/dL (1.0 mmol/L) \[DEVtotal\] for hypo- and normoglycaemic glucose values (50 - 60, 100 - 120 mg/dL) compared to the reference method at Hct levels between 35 - 55%.

Eligibility criteria: Inclusion Criteria:

* healthy subjects or patients with type 1 or type 2 diabetes
* screening glucose levels fall into required glucose ranges
* screening hematocrit values between 36 % to 55 %

Exclusion Criteria:

* history of hypotension during blood draws
* intake of drugs known to interfere with blood glucose readings
* biochemical safety parameters outside of reference ranges
* Hb \< 11 g/dL
* lack of compliance
* history of frequent hypoglycemia

Primary outcomes:
measure: Accuracy of the blood glucose meter in comparison to a standard reference
timeFrame: within 10 min up to 300 min after start of experiment
Secondary outcomes:
measure: Intra-Assay precision
timeFrame: within 10 min up to 300 min after start of experiment
measure: Hematocrit Interference (Helios)
timeFrame: within 10 min up to 300 min after start of the experiment
Other outcomes:
Locations:
city: Mainz
country: Germany
facility: IKFE - Institute for Clinical Research and Development
Study officials:
affiliation: IKFE Institute for Clinical Research and Development
name: Andreas Pfützner, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: