Diabetes is now a worldwide epidemic. In 1985, an estimated 30 million people across the globe, a figure which had leapt to 285 million by 2009, of which 90-95 per cent is Type 2.
Type 1 diabetes is an auto-immune disease and requires insulin to regulate glucose levels. Type 2 is related to diet, lifestyle and obesity. It often lies undiagnosed and in Britain alone, there are eight million pre-diabetics, where the ailment is at such an early stage, sugar levels are not high enough to trigger alarm.
SmartSensor telemed, based at Milton Park, is developing a simple test kit for use at home. Analysis of the results will show up both pre-diabetes and other forms of diabetes, allowing changes to diet and lifestyle, plus treatments, to tackle problems early.
The company was established in 2000, initially designing a small tri-fold home kit that allowed a patient to take a sample of blood first thing in the morning.
The left-hand sheet contained electronics and a battery while the middle had small buttons that allowed the patient to choose risk factors and the right-hand portion analysed a drop of blood.
The risk factors and blood results were recorded by the electronics, the left-hand portion was torn off and sent to the GP. The GP scanned the small package and the data was entered, then actioned.
But in the mid-2000s, disposable wireless technology was in its infancy. Most wireless was based on Bluetooth and expensive. In addition, electronic patient records were the exception rather than the norm.
Venture capitalists were sceptical of the company’s ideas and funding proved difficult.
Chief executive James Jackson said: “We went in search of corporate funding, where our technology would provide a benefit to a company’s business.”
After false starts with two healthcare insurers and a consumer healthcare company, SmartSensor entered into an arrangement with pharma major Novartis.
The gold standard in detecting Type 2 diabetes and gestational diabetes in pregnant women is the Glucose Tolerance Test or GTT.
This involves a visit to a clinic early in the day, where two samples are taken. The first is a fasting sample. The patient is then given glucose, usually some kind of sweet drink and a further sample taken two hours later.
Intolerance to glucose gives an accurate measure of diabetic problems. Because it is a mornings–only test, only small patient numbers can be seen.
To screen greater numbers of undiagnosed diabetics, the test used in recent years has been the HbA1c. This is a standard check-up test for diagnosed Type 1 and 2 diabetics, where a blood sample taken at any time of the day is analysed to reveal the average blood sugar levels over the preceding three to six months.
The test is effective in detecting 75 per cent of cases. But HbA1c will not pinpoint the pre-diabetics because sugar levels are not high enough to flag up problems.
Such cases may then not be picked up until much later, when blood sugar levels have hit danger point.
Novartis researches and markets non-insulin based drugs to treat Type-2 diabetes, so has a direct interest in earlier detection.
The company agreed to fund the development of a GTT kit for home use. For a pharma giant, the actual investment is small, but the public health benefit enormous.
Novartis has made it clear that while there is significant commercial interest in the test, it is also happy to fund it as a benefit to world health.
The carefully researched and developed kit contains a beautifully designed two-stage test — fasting and after glucose — complete with step-by-step instructions on both icons and script attached to the device, and also a well-illustrated booklet.
Removing the cover from the first test switches on the device. Using one of the provided lancets, the patient pricks their finger and places it next to a wick, which absorbs the blood for analysis.
A timer sends a reminder about the second test two hours later, after the patient has drunk the sweet drink provided.
The second test is identical to the first. Once tests are complete, a tear-off portion at the base is placed in an envelope and sent to the relevant clinic, where it is wirelessly scanned.
The kit is registered to the patient before despatch, ensuring accuracy of data collection and transfer to records.
The whole kit has been meticulously designed and user-tested so it is foolproof and can be operated from the attached instructions even without recourse to the booklet.
Prototypes are continually being refined and product is due on the market in 2013.
Price is still to be determined, but is aimed at well below the current £60-85 cost of one GTT test.
“Glucose intolerance has far wider implications than just diabetes,” explained Mr Jackson. “It is a significant factor in cystic fibrosis, transplants, in-vitro fertilisation and HIV. We see a huge market and demand for our products.”
Contact: 01235 838530
Web: www.smartsensortelemed.com
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