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Performance Evaluation of Blood Glucose Monitoring Systems (Polaris)

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ClinicalTrials.gov Identifier: NCT01504620
Recruitment Status : Completed
First Posted : January 5, 2012
Last Update Posted : January 5, 2012
Information provided by (Responsible Party):

Study Description
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).

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Other: Sugar infusion Drug: insulin infusion Phase 4

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 106 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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 Start Date : January 2011
Primary Completion Date : April 2011
Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Sugar
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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 Name: 5 % glucose solution
Experimental: insulin infusion
infusion of insulin to achieve low glucose levels
Drug: insulin infusion
i.v. infusion of insulin
Other Name: insuman rapid

Outcome Measures

Primary Outcome Measures :
  1. Accuracy of the blood glucose meter in comparison to a standard reference [ Time Frame: within 10 min up to 300 min after start of experiment ]
    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

Secondary Outcome Measures :
  1. Intra-Assay precision [ Time Frame: within 10 min up to 300 min after start of experiment ]
    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.

  2. Hematocrit Interference (Helios) [ Time Frame: within 10 min up to 300 min after start of the experiment ]
    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.

Eligibility Criteria

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01504620

IKFE - Institute for Clinical Research and Development
Mainz, Germany, 55116
Sponsors and Collaborators
IKFE Institute for Clinical Research and Development
Principal Investigator: Andreas Pfützner, MD, PhD IKFE Institute for Clinical Research and Development
More Information

Responsible Party: IKFE Institute for Clinical Research and Development
ClinicalTrials.gov Identifier: NCT01504620     History of Changes
Other Study ID Numbers: BGSTA_C_05445
SAN-HCT-002 Helios ( Other Identifier: IKFE )
SAN-BGM-002 Precision ( Other Identifier: IKFE )
First Posted: January 5, 2012    Key Record Dates
Last Update Posted: January 5, 2012
Last Verified: December 2011

Keywords provided by IKFE Institute for Clinical Research and Development:
diabetes mellitus
blood glucose self-assessment
Intra-Assay precision
Hematocrit interference

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Hypoglycemic Agents
Physiological Effects of Drugs