Performance Evaluation of Blood Glucose Monitoring Systems (Polaris)

IKFE Institute for Clinical Research and Development

Status and phase: Completed; Phase 4

Conditions: Diabetes Mellitus

Treatments: Other: Sugar infusion; Drug: insulin infusion

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01504620

BGSTA_C_05445

SAN-BGM-002 Precision (Other Identifier)

SAN-HCT-002 Helios (Other Identifier)

Details and patient eligibility

About

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).

Full 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%.

Enrollment: 106 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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106 participants in 2 patient groups

Sugar infusion

Other group

Description:

Diagnostic assessment of blood glucose by means of different devices

Treatment:

Other: Sugar infusion

insulin infusion

Experimental group

Description:

infusion of insulin to achieve low glucose levels

Treatment:

Drug: insulin infusion