Performance Evaluation of Blood Glucose Monitoring Systems (Polaris)

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

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).

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus
• Intervention / Treatment: Other: Sugar infusion; Drug: insulin infusion

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%.

• Study Type: Interventional
• Enrollment (Actual): 106
• Phase: Phase 4

Contacts and Locations

Study Locations

• Germany
  • Mainz, Germany, 55116
    • IKFE - Institute for Clinical Research and Development

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: IKFE Institute for Clinical Research and Development
• Collaborators: Sanofi-Synthelabo
• Investigators: Principal Investigator: Andreas Pfützner, MD, PhD, IKFE Institute for Clinical Research and Development

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): April 1, 2011
• Study Completion (Actual): June 1, 2011

Study Registration Dates

• First Submitted: December 27, 2011
• First Submitted That Met QC Criteria: January 3, 2012
• First Posted (Estimate): January 5, 2012

Study Record Updates

• Last Update Posted (Estimate): January 5, 2012
• Last Update Submitted That Met QC Criteria: January 3, 2012
• Last Verified: December 1, 2011

More Information

Terms related to this study

• Keywords: Accuracy; diabetes mellitus; blood glucose self-assessment; Intra-Assay precision; Hematocrit interference
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin
• Other Study ID Numbers: BGSTA_C_05445; SAN-HCT-002 Helios (Other Identifier: IKFE); SAN-BGM-002 Precision (Other Identifier: IKFE)