In this article, William Willis from Inside Biometrics Ltd reviews the current guidance on ketone testing from the National Institute for Health and Care Excellence (NICE).
NICE is widely recognised for providing the NHS and patients with advice on effective and good value healthcare. In 2015 they published five updates of diabetes clinical guidelines, emphasising the importance of the treatment of diabetes and its complications to patients and the NHS. Three of these updates gave new recommendations on blood glucose monitoring and the need to measure ketones as part of diabetes management. These specific guidance are detailed in the following documents: NICE guidelines for adults with type 1 diabetes (NG17), pregnant women (NG3) and children and young people (NG18).
1. NG17 recommends (§1.11.1) that ketone monitoring in blood or urine should be considered as part of 'sick-day rules' for adults with T1D, to facilitate self-management of an episode of hyperglycaemia. Educating people with type 1 diabetes about sick day rules is clearly important so that they can take appropriate precautions when they are most at risk of developing diabetic ketoacidosis (DKA).
2. NICE’s recent clinical guideline NG3 'Diabetes in pregnancy: management from preconception to the postnatal period' 2015 recommends that women with Type 1 diabetes who want to be or who are pregnant should be offered a blood ketone meter and advised to test for ketonaemia if they become hyperglycaemic or feel unwell and to seek urgent medical advice if they become hyperglycaemic. https://www.nice.org.uk/guidance/ng3/chapter/1-Recommendations. The occurrence of diabetic ketoacidosis in pregnancy is known to compromise both the foetus and the mother. It can be problematic as it has been reported as occurring at lower blood glucose levels and more rapidly than in non-pregnant patients often causing delay in the diagnosis. NG3 also recommends pregnant women with diabetes should test their blood glucose frequently.
3. The final NICE guideline NG18 (Diabetes (type 1 and type 2) in children and young people: diagnosis and management, 2015) advised that:
• Children and young people or their carers should check their blood glucose at least 5 times a day
• All children and young people with Type 1 diabetes should be offered a blood ketone meter and they or their carers should test for ketonaemia if they become ill or hyperglycaemic.
NICE guideline NG18 also advises that children and young people with Type 1 diabetes can develop DKA even when their blood glucose is at normal levels (euglycaemic DKA).
Here is the challenge for existing testing practice as without a high glucose result, a subsequent ketone test would not usually be prompted. The KEYA® test strip’s 2-in-1 measurement overcomes this challenge as ketones are measured during every blood test, regardless of glucose concentration, providing a simple solution to at risk patients.
KEYA® Smart is an award winning blood sugar meter that discretely checks for elevated ketones during routine blood sugar testing. Until now it has been difficult to maintain awareness of ketone levels which if elevated can lead to a diabetic emergency called diabetic ketoacidosis (DKA). Rising ketones can be self-treated if the warning signs are picked up early enough and a ketone test performed. However, this requires patients to have a ketone test at-hand which means carrying extra supplies. KEYA® removes this burden as it automatically checks for ketones every time a blood glucose test is performed. This means patients can feel confident that ketone levels are normal regardless of how they feel during everyday blood glucose management.
KEYA® Smart is the only test of its kind available today for people with diabetes and KEYA® Smart test strips have now been approved by the UK NHS for prescription throughout England, Scotland, Wales and Northern Ireland.
The 2-in-1 KEYA® test only requires 5 seconds, one tiny drop of blood, has a colour touchscreen and a 1200 results memory plus Bluetooth® capability.
Ask your healthcare professional about switching to KEYA® Smart and providing you with the test strips on NHS prescription.
The KEYA® Smart test strips can be prescribed using the PIP code 403-7859.
Alternatively, KEYA® Smart test strips can be purchased at most high street pharmacy chains or at www.keyasmart.com/purchase.
For further information on the KEYA® Smart product, please visit www.keyasmart.com.
Leading self-tracking medical devices Company, Inside Biometrics Limited (IBL), is very proud to announce that they are the winner of the Innovation Category at the 2017 Scottish Life Science Awards for the KEYA® Smart diabetes product.
The awards, which were held on 2 February 2017 in Edinburgh, recognise the success and achievements of Scotland’s internationally renowned life sciences sector in areas including innovation, export and international trade, investment, community engagement and collaboration.
IBL is an industry leader in the design, development and manufacture of innovative medical devices and produces the new KEYA® Smart blood glucose system under CE mark to the European market.
KEYA® Smart allows people with diabetes to monitor their blood glucose levels as part of regular testing for diabetes self-management. The KEYA® innovation however, is the first meter that also monitors blood ketones as part of every glucose test and provides warnings if levels exceed clinically relevant limits.
Charlotte Wright, Interim Chief Executive at Highlands & Islands Enterprise (HIE), said: “We are absolutely delighted for the winning companies from our region, both of which we have supported to develop and grow. The profile of the Highlands and Islands at the awards reflects the growth and success in the life sciences and technology sector in our region.”
Dr Selly Saini, CEO at Inside Biometrics added, “We are delighted to have won the Innovation Award which recognises our company’s cutting edge biometric technology in providing new benefits to patients while improving accessibility for healthcare providers.”
Photograph (Left to Right): Fred MacAulay (Host), Andy Savage (Director, IBL), Dr Selly Saini (Founder CEO, IBL), Paul Wheelhouse (Minister for Business, Innovation and Energy).
Further information on the KEYA® Smart product, visit www.keyasmart.com.
We are pleased to announce that KEYA® Smart has been shortlisted for the Scottish Enterprise Life Science Awards 2017 in the Innovation Award category. The awards, which will be held on 2 February 2017 in Edinburgh, recognise the success and achievements of Scotland’s internationally renowned life sciences sector in areas including innovation, export and international trade, investment, community engagement and collaboration.
Inside Biometrics, the Company behind KEYA® Smart held a special workshop and practical demonstrations at the Diabetes Professional Care Conference held at Olympia on 16-17 November 2016. The aim was to obtain detailed expert opinion of the clinical benefits and value of the KEYA® Smart meter for patients under the care of the National Health Service.
The Diabetes Professional Care Conference held a four-stream program covering all aspects of diabetes including technologies, complications and comorbidities, diagnostics, prevention of diabetes, paediatrics, primary and secondary care and commissioning better services. Attending the conference were diabetes experts from a wide range of backgrounds, CCG commissioners, consultant endocrinologists, GPs with special interests in diabetes, and diabetes Nurse Specialists caring for both paediatric and adult patients with diabetes. Further details are available at: https://www.diabetesprofessionalcare.com/commissioning-workshops-at-dpc2016
Inside Biometrics met with 25 leading healthcare professionals with extensive experience of diabetes care in NHS funded organisations and presented information about KEYA® Smart meter and provided hands-on practical demonstrations for simultaneous glucose and ketone testing followed by Q&A. At the end of each session, participants were asked to provide a summary statement on their experience of the KEYA® Smart meter as clinicians in diabetes care, the clinical benefits that KEYA® Smart would provide to patients and the types of patients they believe would gain the greatest benefit by using the meter.
The diabetes experts found KEYA® Smart easy to use and the unique simultaneous testing of glucose and ketone in a single strip, using a single small blood sample, was seen as offering a clinical benefit for patients. They thought that early detection of ketones could lead to reduction in DKA and hospital admissions. The experts concluded that patient groups that would most benefit included those at high risk of DKA, children and young people, pregnant women and patients using insulin pumps.
We are pleased to announce the following paper has been accepted for publication in Diabetes Stoffwechsel und Herz, 2016; 25: 343 – 347.
“Clinical and Laboratory Evaluation of a new Blood Glucose Meter for Patient Self-Testing with Integrated Background-Surveillance of the Ketone Bodies”
Authors: S. MacRury1, D. Sachsennnheimer2, L. Mills3, S. Deakin3, K. Moore3, S. Saini3, A. Pfützner2