Diabetes Mellitus
Conditions
Keywords
diabetes mellitus, blood glucose self-assessment, Accuracy, Intra-Assay precision, Hematocrit interference
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%.
Interventions
OTHERSugar infusion
Infusion of glucose to achieve high blood glucose levels
DRUGinsulin infusion
i.v. infusion of insulin
Sponsors
Sanofi-Synthelabo
IKFE Institute for Clinical Research and Development
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Germany
Outcome results
None listed