Taking it Home

Did you know that half of all adults living with diabetes today are undiagnosed (1)? And with the incidence of diabetes increasing all across the globe, the International Diabetes Federation describes the situation as “spiraling out of control” (2).

What’s more, approximately 1 in 5 UK pregnancies are impacted by gestational diabetes mellitus (GDM) (3). Undiagnosed or untreated, GDM can lead to perinatal complications such as fetal macrosomia (larger than average babies) that warrant unscheduled or even emergency changes to the birth plan to protect both mother and baby. In addition, 50 percent of women experiencing GDM can go on to develop type 2 diabetes (T2D) within 5 to 7 years (4). The condition also increases the risk for the child of developing T2D in adulthood (4). Prompt identification is key to mitigating its harm at an individual and population health level.

Hoping to catch more at-risk patients during pregnancy, Medway NHS Foundation Trust, UK, is pioneering a new home diabetes test. The remote oral glucose tolerance test (OGTT) kit, known as GTT@home, is offered to those identified by their midwife as being at higher risk of developing the disease. 

James Jackson, inventor of GTT@home and Chief Executive and founder of Digostics, explained the new test and its potential benefits for patients and the health service.

What is GTT@home?
 

The GTT@home managed service is based on a simple-to-use home test kit used by the patient and an online platform through which tests are booked and test data is analyzed by healthcare professionals.

The test kit contains everything required to complete an OGTT remotely. Mailed at the time the recipient’s test is due, the kit features the test device, a preformulated glucose drink, finger prickers, easy-to-follow English and non-English language instructions, and a prepaid envelope. The kit is also complemented by online guidance and telephone support.

Once the test is completed, the user can immediately send their test data to their care team by scanning a snap-off fob attached to the test device with a dedicated smartphone app. This is enabled by the near field communication (NFC) functionality within the device, with the process akin to making a contactless mobile payment in a store. Alternatively, the patient can post the fob in the supplied prepaid envelope for processing.

Our system uses capillary-based testing, which is less invasive than OGTT and of greater convenience as a blood collection method. However, the results reviewed by the healthcare professional are venous blood equivalent. The calibration between the two collection methods happens in real-time at the point of processing.

What inspired its development?
 

The OGTT is the gold standard in diabetes testing. There is no test which comes close to its efficacy and, in several settings, including pregnancy, OGTT is the only recommended diabetes test. However, the complexities and problems inherent in traditional clinic-based OGTT provision are universally understood.

Traditional testing requires the expectant mother to travel to a scheduled hospital appointment and have two separate blood tests two hours apart. Appointments may be missed due to lack of transportation, the time required to complete the test, or unforeseen circumstances.

The development of the home test kit stems from our drive to enable healthcare providers to identify everyone with diabetes, and those at risk of developing the condition, by eliminating the common barriers that inhibit accurate and timely testing using the OGTT.

This new test has retained everything that makes the OGTT an effective detection method while removing the aspects that presently limit its widespread application. 

Why have you specifically targeted GDM?
 

We are collaborating with global healthcare research partners to improve the screening of glucose intolerance for several conditions, notably T1D, prediabetes and T2D, and cystic fibrosis. However, it is in GDM that adoption of OGTT home testing promises to have the most significant near- and medium-term impact.

Additionally, we find that even within comparatively wealthy countries, such as the United Kingdom, the patient groups most at risk of developing GDM are disproportionately represented in those tested late or missed by clinic-based screening programmes. To that end, there is also a significant health equity dynamic that necessitates a step change in how we screen. In the National Health Service (NHS), this is driving significant effort to reduce health inequalities.

By taking testing directly to the expectant mother, we are not only making the OGTT more accessible and facilitating earlier intervention, but we are enabling healthcare providers to reach those key, often underserved groups that can be frequently missed.

What are the benefits for patients?
 

The kit allows pregnant patients to carry out the test at home, at a time that is convenient to them, meaning the test can be carried out without delay. With early detection of GDM, treatment can be started sooner to help keep both mum and baby safe.

The kit’s first real-world implementation at University Hospital Southampton (UHS) saw 100 percent of women recommending home testing over traditional clinic-based testing. This preference was particularly pronounced in those who had been screened by the traditional method in an earlier pregnancy.

The UHS study also saw 97 percent describe the ability to choose which day they tested as advantageous. The same percentage also valued the ability to save associated travel expenses. We also noticed that users favored testing early in the day and on weekends, making it easier for busy patients to juggle both professional and childcare commitments with their own health care.

What are the benefits for the NHS?
 

At UHS, 100 percent of women were tested in their scheduled test window. More timely testing leads to better patient management of gestational diabetes, if detected, resulting in healthier patients and less burden on resources for the NHS.

When evaluating the total cost of ownership of delivering the traditional OGTT, the home testing managed service consistently comes in for prospective customers at between a third or half the cost. The true cost of the OGTT is not just the consumables and laboratory processing of samples, but also the numerous direct and indirect facilities, along with clerical, midwifery, and phlebotomy staffing costs of delivering the traditional OGTT.

Another emerging advantage, albeit not one necessarily envisaged in the development of the home test kit, is the additional reliability of home test results over those derived from the clinic-based OGTT workflow. The elapsed time between taking a blood sample and the laboratory analysis can affect the result of the OGTT, whereas the home test kit analyzes all samples immediately.

Do most patients use the test correctly, in your experience?
 

All studies to date have shown no user difficulties in using the test kit, as well as universal preference over an in-clinic OGTT.

One study included a comparison of untrained subjects OGTT home testing versus trained nurses testing the same subjects in-clinic. It revealed no differences in use, the data collected, or glycemic status of the subjects observed between the sites and also with untrained and trained subjects.

Another study of 10- to 16-year-old cystic fibrosis patients saw all (either parents/carers or the children) use the test kit successfully. Furthermore, all who had experienced both the home test and the in-clinic test, said they preferred the home test.

To what extent have pathology services been involved in the validation of the test?
 

The test was developed in collaboration with the Oxford University Diabetes Trials Unit and with the diabetes department at Swansea University. All testing and validation has been conducted externally from Digostics, with data and results shared throughout development with leading diabetes experts – including those who set OGTT diagnostic policies. Validation testing, and ongoing quality control testing, was conducted in laboratories at Swansea University on the Singleton Hospital site.

Will the new test save the NHS money? Would it be affordable in low- and -middle income countries?
 

In a direct fully costed comparison, health economists connected to Imperial College have costed the product at approximately 50 percent of the cost of in-clinic OGTT. As this new product scales, manufacturing costs will reduce and future versions of the product can be designed for very low-cost manufacture. We have already had discussions with the Gates Foundation about how low-cost offerings could be developed for low- and middle-income countries.

Our aim is to make the test kit as accessible as possible, and we are already opening operations in the Middle East and Asia Pacific to meet the significant demand for GDM testing within these geographies. As we achieve scale, we are also committed to working with charitable partners on a model that will enable us to extend the product, or a version of it that is reflective of actualities on the ground, to lower income regions.

However, home testing brings wider cost savings than just cost per test. Testing more at-risk women accurately and on time will undoubtedly save the NHS money, as our economic analyses show. There are predictable cost savings from being able to intervene earlier in the pregnancy when there is a greater scope for effective treatment and from being able to ensure there is a postnatal care plan in place for those with GDM to mitigate their risk of developing T2D.

If successful, is the test likely to be rolled out across other NHS Trusts? Have any expressed an interest?
 

We are experiencing a lot of domestic demand for the home test kit. Other NHS hospitals have contracted with Digostics and are currently implementing GTT@home. Another much larger group of hospitals are formulating their own individual business cases for doing the same.

The issues with the OGTT in its traditional clinic-based guise, together with the clinical case for improvement, are universally understood. We are confident that innovators such as the team at Medway Maritime Hospital, and those that are set to follow shortly afterwards, will only make the transition to home OGTT easier and more compelling for all healthcare providers.

What are other potential areas for at-home testing?
 

For pregnancy, we are looking at screening for preeclampsia, postpartum hyperglycaemia (for mothers affected by GDM during pregnancy), and postnatal depression. For T1D, we recently prototyped a smartphone-linked c-peptide test (funded by an Innovate UK grant) – adding c-peptide to our T1D offering would add power to our ability to monitor the development of T1D. 

We are also looking at the provision of GDM management apps and glucose meters for GDM monitoring. It should be noted that the test kit being used in pregnancy provides the same OGTT that is required in other aspects of women’s health, and in T1D, prediabetes, T2D, cystic fibrosis, organ transplantation, sleep apnea, and other conditions where glucose intolerance and diabetes are important complicators.