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| ID | Type | Description | Link |
|---|---|---|---|
| SAN-HCT-002 Helios | Other Identifier | IKFE | |
| SAN-BGM-002 Precision | Other Identifier | IKFE |
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| Name | Class |
|---|---|
| Sanofi-Synthelabo | INDUSTRY |
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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).
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%.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sugar infusion | Other | Diagnostic assessment of blood glucose by means of different devices |
|
| insulin infusion | Experimental | infusion of insulin to achieve low glucose levels |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sugar infusion | Other | Infusion of glucose to achieve high blood glucose levels |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Hematocrit Interference (Helios) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andreas Pfützner, MD, PhD | IKFE Institute for Clinical Research and Development | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IKFE - Institute for Clinical Research and Development | Mainz | 55116 | Germany |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D007332 | Insulin Infusion Systems |
| ID | Term |
|---|---|
| D016503 | Drug Delivery Systems |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D007260 | Infusion Pumps |
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| insulin infusion | Drug | i.v. infusion of insulin |
|
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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 |
| D004864 |
| Equipment and Supplies |
| D001187 | Artificial Organs |
| D013523 | Surgical Equipment |