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
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus||Other: Sugar infusion Drug: insulin infusion||Phase 4|
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  and TNO 2001 Quality Guideline , 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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||106 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Primary Completion Date :||April 2011|
|Actual Study Completion Date :||June 2011|
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
- 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
- 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.
- 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.
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|
|Principal Investigator:||Andreas Pfützner, MD, PhD||IKFE Institute for Clinical Research and Development|