Performance Evaluation of Blood Glucose Monitoring Systems

Study Overview
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Brief Summary
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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
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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%.

Official Title
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Performance Evaluation of BGStar and iBGStar in Terms of Accuracy (Polaris), Intra-assay Precision, and Hematocrit Interference (Helios Substudy) Following ISO15197 and TNO Guidelines

Conditions
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Diabetes Mellitus

Intervention / Treatment
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* Other: Sugar infusion
* Drug: insulin infusion


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Sugar infusion<br>Diagnostic assessment of blood glucose by means of different devices | Other: Sugar infusion<br>* Infusion of glucose to achieve high blood glucose levels<br>* Other names: 5 % glucose solution;|
| Experimental: insulin infusion<br>infusion of insulin to achieve low glucose levels | Drug: insulin infusion<br>* i.v. infusion of insulin<br>* Other names: insuman rapid;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of the blood glucose meter in comparison to a standard reference | After start of the experiment, blood glucose will be measured by means of the test devices and blood will be drawn for assessment of venous blood glucose concentration with a standard laboratory reference method | within 10 min up to 300 min after start of experiment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intra-Assay precision | Blood samples from 5 individuals with different levels of blood glucose were each measured with 10 meters of both investigational devices, the BGStar® and iBGStar®, ten times resulting in a total number of 500 measurements. | within 10 min up to 300 min after start of experiment | 
| Hematocrit Interference (Helios) | One patient provided blood and artificial samples are generated from venous heparinized blood. These blood samples were adjusted to five different BG levels (2.8 mmol/L, 5.6 mmol/L, 8.3 mmol/L, 13.9 mmol/L, 19.4 mmol/L) at five different Hct levels (35%, 40%, 45%, 50%, 55%) to fulfill the range required by the TNO 2001 and tested by all devices. | within 10 min up to 300 min after start of the experiment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetes mellitus, blood glucose self-assessment, Accuracy, Intra-Assay precision, Hematocrit interference