OneDraw A1C Test System, US

The OneDraw™ A1C test system is a blood glucose monitoring system developed by Drawbridge Health for diabetes management in adult patients.

Drawbridge and Thorne Research have entered a strategic commercial partnership providing Thorne, as well as partner companies Wellness FX and Onegevity Health, access to the OneDraw™ device for health and wellness in the US market.

The company submitted a 510(k) application for the device to the US Food and Drug Administration (FDA) in November 2018. The device received FDA clearance in August 2019.

The OneDraw™ A1C test system also received the CE Mark in February 2020. It was awarded the prestigious Red Dot Award: Product Design 2020 in the Medical Devices category in June 2020.

The system measures blood glucose levels between 4.7% and 14.3% glycated haemoglobin (HbA1c), which is the measure of blood glucose attached to haemoglobin.

OneDraw™ A1C blood glucose monitoring system component details

The system consists of the OneDraw™ blood collection device and OneDraw™ A1C test.

The collection device is a sterile, single-use system used for blood sample collection, stabilisation and transportation. It includes a sample pouch, with desiccant for sample packaging, two assembled sterile, tiny stainless-steel lancets and a transport sleeve.

Other accessories included are an alcohol prep pad, bandage, gauge pad and instructions for sample collection in a certified manner.

The device draws capillary blood through a combination of capillary action and vacuum extraction mechanisms.

The functioning of OneDraw™ A1C test system

The OneDraw™ blood collection device attaches to the upper arm of the patient by a ring of hydrogen adhesives. The steel lancets on the device create two small incisions in the skin, gently vacuuming 150µL of blood through channels. A push-button controls lancet activation and vacuum action.

The blood accumulates in two removable collection and stabilisation matrix cartridges, which can be removed and inserted into the transport sleeve for shipping. Collection of the samples takes place through certified healthcare professionals.

Testing of blood samples by the glucose monitoring device

The blood sample is tested using the Beckman Coulter AU480 Chemistry Analyser and HbA1c reagents method.

The chemistry analyser is a fully automated chemistry system, which is based on spectrophotometry and potentiometry principles. It is used at low or mid-range hospitals and laboratories. The samples are eluted with Beckman HbA1c haemolytic reagent and analysed using FDA-cleared reagents on the chemistry analyser.

The system has a capacity of 80 samples with continuous loading. It functions with 13 different wavelengths, ranging between 340nm and 800nm, and has a throughput of 400 photometric tests an hour.

Quantitative measurement of HbA1c is performed using latex agglutination inhibition method.

OneDraw™ clinical studies

A total of 263 patients enrolled at three locations for a clinical study of the system. The study compared the OneDraw™ system with standard venipuncture or fingerstick methods.

OneDraw™ demonstrated significant similarities between the results of HbA1c measured, collected and analysed compared to venipuncture. The patients showed a preference for the OneDraw™ system as opposed to the other methods during the study.

Benefits of the blood glucose monitoring system

The OneDraw™ system enables healthcare professionals to draw blood quickly and comfortably. It optimises the process of blood sampling for both patients and professionals.

The conventional hypodermic needle pierces the vein of the patient, whereas the OneDraw™ system draws blood from capillaries with minimal pain.  The blood is stabilised immediately, which eliminates the need for cold chain transportation and enables shipping of samples by regular mail.

The OneDraw™ blood collection device allows remote collection of blood at any time and from any location in a simple and comfortable manner that improves patient care and compliance.

Marketing commentary on Drawbridge Health

Drawbridge Health is a medical device company based in the US. Founded in 2015, it is a spinout of GE Ventures and GE Healthcare.

The company focuses on the development of technologies to ease the blood drawing process and blood stabilisation.