Diabetes is a condition where a person's blood glucose levels are too high. It can occur when not enough insulin is produced or the insulin that is produced is not utilised effectively (ie type 2 diabetes) or when the body cannot produce any insulin at all (ie type 1 diabetes) (Diabetes UK, 2021a). There are currently 4.7 million people in the UK who have been diagnosed with diabetes and this figure is predicted to rise to 5.5 million by 2030 (Diabetes UK, 2021b). Approximately 90% of these individuals have type 2 diabetes, 8% have type 1 diabetes and 2% have rarer types of diabetes (such as monogenic diabetes) (Diabetes UK, 2021b). Type 1 diabetes is the most common form of diabetes found in children. More recent research, however, has shown that 42% of new diagnosis of type 1 diabetes occurs after age 30 years (Thomas et al, 2018).
Type 2 diabetes usually appears in middle-aged or older individuals, although more frequently it is being diagnosed in younger individuals who are overweight. With the increase in incidence in type 2 diabetes, along with an ageing population, this is set to have a major impact on the NHS going forward.
According to the British Geriatrics society (2018), around half of all individuals with diabetes in the UK are over the age of 65, with a quarter of these being over 75 years of age.
The spend on diabetes as a whole within the NHS is immense, with around 10% of the NHS budget being allocated to the condition. This equates to approximately £10 billion a year, or approximately £1 million an hour and is predicted to double within the next 15 years (Baxter et al, 2016).
The vast majority of this (around 80%) is spent on managing the complications caused by diabetes, such as retinopathy, foot problems, cardiovascular disease (CVD), nephropathy and neuropathy etc (Diabetes UK, 2021b). CVD, such as myocardial infarction and stroke is the main complication seen in people with diabetes. Individuals with diabetes have about twice the risk of developing a range of CVD, compared with those without diabetes (Diabetes UK, 2015).
Approximately 40% of people with type 1 and type 2 diabetes will develop chronic kidney disease during their lifetime; however, newer agents such as SGLT-2 inhibitors and GLP-1 analogues have demonstrated improvement in clinical outcomes independent of glucose lowering and, in the future, may be used primarily in the prevention and treatment of diabetic kidney disease (Association of British Clinical Diabetologists and The Renal Association, 2021).
Type 2 diabetes is largely preventable. Research shows that individuals can reduce their chances of developing type 2 diabetes by making some simple lifestyle changes. These include losing weight, being more physically active (at least 30 minutes of physical activity 5 days a week) and making healthy meal choices. These modifications reduce a person's risk of developing type 2 diabetes as a healthy diet and keeping active help manage blood glucose levels (NHS, 2020). NHS England (2020) claim that around two million of the UK population are at risk of developing type 2 diabetes.
The National Institute for Health and Care Excellence (NICE) (2017) have produced a guideline for the prevention of type 2 diabetes, including those at high risk. The NHS diabetes prevention programme was launched in 2016 to help identify those at high risk of diabetes. It identifies those at high risk of developing type 2 diabetes and refers them onto a behaviour change programme (NHS, 2021). Within the first 12 months, the programme had reached 75% of the population of England (NICE, 2018).
Diabetes best practice is an area that NICE have been providing guidance on for a number of years. Their latest guidance for the management of adults for type 2 diabetes was updated in 2020 (NG28) and for type 1 diabetes, which was updated in 2021 (NG17). Within both guidelines, there is a strong focus on providing individualised care. Structured education is suggested at the time of diagnosis for individuals with type 2 diabetes, and a 6-12 month post-diagnosis for individuals who have been diagnosed with type 1 diabetes.
Both sets of guidance suggest monitoring HbA1c levels of individuals for 3-6 months, initially. This can be reduced to 6 monthly for people with type 2 diabetes once their HbA1c and glucose lowering therapies are stable. With type 1 diabetes however, it is suggested that the frequency of monitoring can be increased if the results are rapidly changing.
NICE (2020) recommend an HbA1c target for individuals with type 2 diabetes of 48mmol/mol. If individuals have prescribed medications that are associated with hypoglycaemia however, this target is relaxed to 53mmol/mol. For people with type 1 diabetes, NICE (2021) recommend an HbA1c target of 48mmol/mol or lower in order to reduce the risk of longer-term complications. The guidance does mention however, that an individualised target should be agreed considering the individual's occupation, comorbidities and frequency of hypoglycaemia.
The American Diabetes Association (ADA) (2019) has succinctly shown the approach to determine the appropriate HbA1c target for an individual (Figure 1).
The self-monitoring of blood glucose is advised for all individuals with type 1 diabetes. NICE (2021) suggest that this should occur between 4 and 10 times daily. Those with type 2 diabetes, however, are only required to monitor their blood glucose levels for a number of specific reasons (NICE, 2020):
- Being on insulin
- Evidence of hypoglycaemia
- Taking oral therapy, which increases their risk of hypoglycaemia while driving or operating machinery
- Pregnancy or planning pregnancy.
For people with type 2 diabetes, there are no specific blood glucose targets set within the NICE (2020) guidelines. For individuals with type 1 diabetes however, the guidance suggests; a fasting blood glucose of 5-7mmol/l and a pre-meal blood glucose of 4-7mmol/l. A post-meal target of 5-9mol/l is also suggested (NICE, 2021).
When choosing blood glucose meters for individuals with type 1 diabetes, NICE (2021) suggest that the needs of the adult needs to be considered as well as ensuring the meter meets the current International Organization for Standardization (ISO) standards.
The requirements for meter systems are set by the ISO and ensure that they are of a suitable standard. The first ISO standard for meter systems was published in 2003 and the latest standards which were amended in 2013, reflect recent advances in technology.
The revised ISO 15197: 2013 standard will mean that health care professionals should only be recommending blood glucose meters that meet the updated standards. Among the changes to the Standard include the four revised criteria (British In Vitro Diagnostics Association, 2016):
- Higher stringency for minimum accuracy criteria; three different lots of strips must now be evaluated and reported individually and combined; 99% of results must fall within zones A+B of the Consensus Error Grid (CEG) for type 1; 95% of results >5.5mmol/L must fall within 15% of the reference method
- User performance evaluation: a full performance study with lay persons must be conducted and reported
- Haematocrit study: the effect of HCT/PCV must be determined and inserted in the pack insert if falling outside the criteria
- Chemical interference: updated chemicals and values must be analysed and reported.
The European standards (EN ISO 15197:2015) have also been updated and suggest:
- Revised performance criteria
- New considerations concerning the basis for the minimum analytical performance of blood glucose devices intended for self-monitoring
- Amendments to safety and reliability testing criteria and user performance evaluation.
4SURE monitors
The 4SURE blood glucose meter (4SURE Smart, NIPRO (Figure 2)) and the combined blood glucose and blood ketone meter (4SURE Smart Duo (Figure 3)) both exceed the updated ISO standards and are simple to use. They meet the standards for the Driver and Vehicle Licensing Agency (DVLA) guidance (Gov.UK, 2021) as well as the NICE guidance for diabetes in pregnancy (2020). 4SURE Smart Duo has the added benefit of being able to monitor blood glucose and blood ketones in one meter, which is extremely beneficial for individuals with type 1 diabetes as it provides individuals with the reassurance and reliability of being able to monitor either using one simple device.
The added functionality of using the Diabetes:M app (Figure 4) alongside the 4SURE products means that individuals are able to use the bolus advisor functionality as well as having access to the extensive food database. The use of the bolus advisor functionality is particularly beneficial for individuals who count carbohydrates as it assists them in accurately calculating the correct insulin dose for the meal they are eating. It is easy to install and provides a step-by-step set up so individuals can get the most out of the functions available. Users can also create reports in graphical or table format which can easily be sent in as a PDF to health professionals.
Health professionals are also able to log into Diabetes:M clinican view to monitor their patients' readings in real time without the need for patients to see their clinicians face-to-face or to upload their data to a computer. It allows the health professional to track therapy adherence, find recurring problems or generate detailed or summarised reports. Problems such as insulin spikes, due to patient's eating habits or injection sites can then be analysed and addressed appropriately. For patients and prescribers who are not using NIPRO 4SURE products, there is a health professional charge to access the Diabetes:M clinician view facility of €29 per month per ten patients. Although please note that as a trial period, the first 5 patients that each health professional uses the system with are free of charge.
Access to the self-monitoring blood glucose (SMBG) is a hugely important aspect, which aids self-management for individuals. The benefits of SMBG have been shown in a number of studies in both individuals with type 1 and type 2 diabetes, in particular, who are treated with insulin (Miller et al, 2013). The data from SMBG has been shown to improve glycaemic control and reduce hypoglycaemic episodes.
Evidence also shows that achieving good glycaemic control helps to prevent the various complications associated with diabetes (Telo et al, 2016). Despite this however, many individuals do not achieve such control, mostly because treatment adherence is suboptimal.
There are a number of reasons for lack of engagement with SMBG, such as emotional barriers, complex regimens, and financial burdens (Davies et al, 2013). It is important that these are addressed, and individuals are supported.
Research from the National Centre for Drug Adherence Testing (2019) at Leicester Hospital found that up to a third of individuals with type 2 diabetes were not taking their prescriptions correctly. Again, further education may be required for these individuals to ensure they are knowledgeable about the prescription medications they are taking and to offer follow-up support if there are concerns.
There is, however, a significant cost implication for the NHS with regards to SMBG as blood-glucose meters and test strips account for at least two-thirds of the diabetes technology market (Yi et al, 2019). The average spend for each individual with diabetes is said to be approximately £327.78 a year for diabetes medication, including insulin and blood glucose/ketone testing strips (Diabetes Research and Wellness Foundation, 2019). All blood glucose strips, and blood ketone strips are available to NHS patients free of charge when they complete the exemption form with their GP surgery. This enables the blood glucose and blood ketone testing strips to be added to the individual's prescription.
Having a blood glucose meter such as the 4SURE Smart that is simple to use with low-cost strips that exceed the ISO standards means individuals with diabetes are provided with the reassurance that they are receiving accurate results that they can base treatment modifications on (such as insulin dose adjustments). Having the option to also monitor blood ketones on the same meter with the 4SURE Smart Duo adds to this simplicity. This may aid adherence to monitoring for individuals as it is convenient to carry only one meter with both strips.
Based on the fact that 4.7 million individuals have diabetes in the UK, this means that approximately 376 000 (8%) have type 1 diabetes and need access to a blood glucose meter. Furthermore, there is a large percentage of individuals with type 2 diabetes who need access to SMBG due to being on insulin or at risk of hypoglycaemia. Individuals with type 1 diabetes also requiring access to ketone monitoring. NICE (2015) state that access to ketone monitoring (blood or urine) should be part of ‘sick-day rules’ for adults with type 1 diabetes, to help with self-management of hyperglycaemia and help reduce the risk of diabetic ketoacidosis (DKA). The 4SURE Smart Duo is ideally placed to offer both in one convenient device.
The Diabetes: M app with its built-in bolus advisor is one of a few apps that offer this essential function. This, coupled with the food data base allows the individuals to calculate insulin doses based on the carbohydrate, fat and protein content of the food. Additional features of the bolus advise include:
- Active insulin (IOB) calculation
- Extended bolus calculation
- Physical activity correction
- Sickness correction.
With blood glucose meters containing a bolus advise calculator becoming less common, the Diabetes: M app is ideally placed to offer this information for individuals who are calculating their mealtime insulin doses. The app is free to access when used with the 4SURE NIPRO products. Used without these products, a subscription service cost of £4.99 per month is required.
Case studies
Catherine
The author recently gave the 4SURE Smart Duo to a woman in her early 30s (Catherine*) who had recently been diagnosed with type 1 diabetes. Catherine quickly realised how different foods affected her blood glucose levels and wanted to know how to vary her insulin dose to what she was eating. As it was some weeks before she would attend formal structured education, the author suggested the Diabetes: M app to use in conjunction with her meter. Catherine found the food database extremely helpful, especially when she was out as it gave her an idea of the nutritional components of the meals she was eating. Catherine also liked the fact that she could add the meals that she had cooked at home to this list, to save time in the future when she was preparing the same meal.
Aisha
A 22-year old woman (Aisha*) was diagnosed with type 1 diabetes and given the 4Sure Smart Duo to use as a basic glucose and ketone meter at diagnosis. She found it very user-friendly, and from the perspective of a diabetes specialist nurse, it is an easy meter to teach due to the simplicity of its use.
Within a few days of using the meter, Aisha had downloaded the Diabetes:M app and started to use some of the functions such as setting a reminder for when to monitor. She also found it useful to look at some of the graphs to get an idea of where they needed to adjust their insulin doses. Aisha commented on how easy to use the meter was, especially at diagnosis when she had a lot of information to take on board.
Geoff
Geoff* is a male patient in his late 60s who has undergone a total pancreatectomy for cancer of the pancreas. Post-operatively, he was started on a basal bolus regimen and taught how to administer this. As part of his education, sick day rules and the importance of both glucose and ketone monitoring were discussed.
Geoff was given the 4SURE Smart Duo meter and was shown how to use it. He really liked the large screen with the ability to see his results clearly. He was impressed how compact the meter was even though it had the functionality of checking both glucose and ketones.
Geoff also liked the log book because he could document his readings to look for patterns while he was getting used to his new insulin regimen. The diabetes specialist nurse discussed the Diabetes:M app with him, which he was interested in as he liked the idea that there was an app that could help him calculate correct doses of insulin.
Conclusion
With the number of individuals being diagnosed with diabetes on the increase, accurate technology to support individuals that is simple to use is important in order to help engage individuals. The use of app-based technology is an area of diabetes that is constantly evolving and should be available free of charge to individuals in order to enhance their own self-management. It is important to offer individuals access to technology that meets the current ISO standards as well as being cost effective in terms of the NHS spend. The 4SURE Smart meters meet these criteria, with low-cost strips which do not compromise in their quality or accuracy. The meters and Diabetes:M app are user-friendly and provide guidance for individuals in the management of their condition.
KEY POINTS
- The incidence of type 2 diabetes is increasing
- Individuals with type 1 diabetes should have access to ketone monitoring
- ISO standards help provide accurate reliable results for individuals using blood glucose monitoring
- Self-monitoring of diabetes is crucial in order to manage the condition and is endorsed within the NICE guidance
CPD reflective questions
- Am I familiar with the functionality of the 4SURE meters, including the Diabetes:M app?
- Do I have conversations with the individuals with type 1 diabetes that I review regarding sick day rules and the continued need to have access to ketone monitoring?
- Am I familiar of the updated ISO standards and what these mean for me as a health care professional as well as for my patients?
- Do I discuss individualised HbA1c targets with the individuals with diabetes that I review?