Performance Evaluation of Blood Glucose Monitoring Systems (Polaris)

This study has been completed.
Sponsor:
Collaborator:
Sanofi-Synthelabo
Information provided by (Responsible Party):
IKFE Institute for Clinical Research and Development
ClinicalTrials.gov Identifier:
NCT01504620
First received: December 27, 2011
Last updated: January 3, 2012
Last verified: December 2011
  Purpose

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 Intervention Phase
Diabetes Mellitus
Other: Sugar infusion
Drug: insulin infusion
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by IKFE Institute for Clinical Research and Development:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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:
  • Intra-Assay precision [ Time Frame: within 10 min up to 300 min after start of experiment ] [ Designated as safety issue: No ]
    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.

  • Hematocrit Interference (Helios) [ Time Frame: within 10 min up to 300 min after start of the experiment ] [ Designated as safety issue: No ]
    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.


Enrollment: 106
Study Start Date: January 2011
Study Completion Date: June 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01504620

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

No publications provided

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, SAN-BGM-002 Precision
Study First Received: December 27, 2011
Last Updated: January 3, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

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

ClinicalTrials.gov processed this record on April 22, 2014