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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Insulin
Insulin, Globin Zinc
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 22, 2014