Performance Evaluation of Blood Glucose Monitoring Systems

Diabetes Mellitus Clinical Trial

— Polaris  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01504620
• Other study ID #: BGSTA_C_05445
• Secondary ID: SAN-HCT-002 Heli
• Status: Completed
• Phase: Phase 4
• First received: December 27, 2011
• Last updated: January 3, 2012
• Start date: January 2011
• Est. completion date: June 2011

Study information

• Verified date: December 2011
• Source: IKFE Institute for Clinical Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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).

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%.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: June 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Other:
• Sugar infusion
Infusion of glucose to achieve high blood glucose levels

Drug:
• insulin infusion
i.v. infusion of insulin

Locations

Country	Name	City	State
Germany	IKFE - Institute for Clinical Research and Development	Mainz

Sponsors (2)

Lead Sponsor	Collaborator
IKFE Institute for Clinical Research and Development	Sanofi-Synthelabo

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No