Blood glucose monitoring system
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 and 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 system measures blood glucose levels between 4.7% and 14.3% glycated haemoglobin (HbA1c), which is the measure of blood glucose attached to haemoglobin.
The system consists of the OneDraw blood collection device and the 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.
It also includes other accessories such as alcohol prep pad, bandage, gauge pad and instructions for sample collection in a certified manner.
The device draws capillary blood by utilising a combination of capillary action and vacuum extraction mechanisms.
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 into 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.
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 principle and 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.
A total of 263 patients enrolled at three locations for a clinical study on the system. The study compared 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.
The OneDraw system enables healthcare professionals to draw the 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 capillary with minimal pain. The blood is stabilised immediately, which eliminates the need for cold chain transportation and enables shipping of the samples via regular mail.
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.
LP1250 is a wireless remote monitoring system developed by LifeSignals Group to allow healthcare professionals to continuously collect electrocardiography (ECG)…
Vercise™ Gevia™ deep brain stimulation (DBS) system is a directional neurostimulation device developed by Boston Scientific for the symptomatic treatment…
Radiance 330® proton therapy system is a proton beam delivery device developed by ProTom International that is used to produce…