Performance Evaluation of Blood Glucose Monitoring Systems

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

106 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2011-06-30

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).

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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%.

Conditions

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Diabetes Mellitus

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Sugar infusion

Diagnostic assessment of blood glucose by means of different devices

Group Type OTHER

Sugar infusion

Intervention Type OTHER

Infusion of glucose to achieve high blood glucose levels

insulin infusion

infusion of insulin to achieve low glucose levels

Group Type EXPERIMENTAL

insulin infusion

Intervention Type DRUG

i.v. infusion of insulin

Interventions

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Sugar infusion

Infusion of glucose to achieve high blood glucose levels

Intervention Type OTHER

insulin infusion

i.v. infusion of insulin

Intervention Type DRUG

Other Intervention Names

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5 % glucose solution insuman rapid

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes