Performance Evaluation of Blood Glucose Monitoring Systems

Phase 4

Completed

• Conditions: Diabetes Mellitus
• Interventions: Other: Sugar infusion; Drug: insulin infusion

• Registration Number: NCT01504620
• Lead Sponsor: IKFE Institute for Clinical Research and Development

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).

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 Timeline

• Study Start: 2011-01
• Primary Completion: 2011-04
• Study Completion: 2011-06
• Status Verified: 2011-12
• Study First Submitted: 2011-12-27
• Study First Submitted QC: 2012-01-03
• Last Update Submitted: 2012-01-03
• Study First Posted: 2012-01-05
• Last Update Posted: 2012-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 106

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Sugar infusion	Sugar infusion	Diagnostic assessment of blood glucose by means of different devices
insulin infusion	insulin infusion	infusion of insulin to achieve low glucose levels

Primary Outcome Measures

Name	Time	Method
Accuracy of the blood glucose meter in comparison to a standard reference	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

Name	Time	Method
Intra-Assay precision	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.
Hematocrit Interference (Helios)	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.

Trial Locations

Locations (1)

IKFE - Institute for Clinical Research and Development; 🇩🇪 Mainz, Germany