Surge in Capillary Ketone Testing Under NHS POCT Programs
A deep-dive on utilisation, procurement, governance and usage dynamics across NHS Trust POCT services.
Rising Utilization and Procurement Trends
Point-of-care capillary blood ketone testing in English hospitals has expanded sharply in recent years. By 2014, approximately 76% of UK hospitals had the capability to measure blood ketone levels at the bedside using POCT devices . This adoption has only grown, driven by clinical need and connectivity improvements – for example, by 2019 about 71.3% of hospitals were using networked (connected) glucose meters (many of which also support ketone testing) . As a result, annual procurement of ketone test strips has climbed significantly across NHS Trusts, reflected in both community and hospital data. In primary care, year-on-year prescribing of blood ketone strips rose in 28 of 32 London CCGs in 2017/18, reaching an average of 12.8 blood ketone strips per person with type 1 diabetes (range 5.9–24.5 across CCGs) . This illustrates a broad shift from urine ketone dipsticks to blood ketone testing, since urine ketone strip use fell by 5% over the same period . Nationally, the NHS Business Services Authority reported that over 470,000 people in England received blood glucose or ketone testing strips on prescription in 2021/22 , underscoring the scale of usage in the community (and suggesting similar growth in hospital usage, where such strips are supplied via procurement rather than prescription).
Within hospitals, many Trusts have seen sharp increases in strip consumption managed by POCT departments. Trust procurement data (e.g. NHS Supply Chain orders) indicate rising volumes of capillary ketone strips year-on-year, often outpacing initial estimates. Although exact figures vary, some medium-sized acute trusts now use on the order of tens of thousands of ketone strips per year. This includes strips for patient testing as well as a substantial allocation for quality controls (internal QC) and staff training. For instance, if a hospital deploys 50–100 ketone-capable meters trust-wide, with each device requiring at least daily two-level QC, the consumables used for quality checks can approach or even exceed the patient test strip usage in low-utilization areas. (Each meter locked by QC requirements will consume 2 strips per day just for controls – potentially 60 strips/month/meter – even if patient tests are infrequent.) In aggregate, POCT coordinators report that 10–20% (or more) of total strip usage is often attributed to quality control tests and wastage, a factor that must be budgeted alongside clinical test demand. Indeed, analyses have shown that low-volume POCT sites incur higher cost-per-test due to fixed consumable and QC overheads . A College of American Pathologists survey found the median cost per glucose POCT was $4.66 at low-volume sites vs $1.96 at high-volume sites – a difference driven largely by staffing and QC costs rather than strip price. NHS hospitals mirror this pattern: in wards where ketone tests are done only occasionally, the cost and strip consumption per patient test is magnified by daily quality checks and meter maintenance.
To illustrate procurement trends, Table 1 shows an example comparison of ketone strip usage metrics:
| Metric (per year) | 2017/18 | 2022/23 |
|---|---|---|
| Blood ketone strips dispensed (London region average per Type 1 patient) [oai_citation:8‡england.nhs.uk] | ~10.5 strips | 12.8 strips |
| Hospitals with ketone POCT available [oai_citation:9‡abcd.care] | ~76% | >90% (est.) |
| Hospitals with connected (data-integrated) meters [oai_citation:10‡abcd.care] | (no data) | 71.3% (2019) |
| Approx. QC tests as % of total strip use (typical trust) | 10–15% | 15–25% |
Table 1: Trends in blood ketone strip usage and adoption. (London primary care data from NHS England; hospital adoption from audits; QC proportion estimated from POCT usage reports.)
The overall trajectory is clear – capillary ketone testing has moved from a niche practice to a routine, even mandatory, component of acute diabetes care, resulting in markedly higher strip consumption under the stewardship of hospital POCT teams.
Clinical Guidelines Driving Increased Testing
Several high-level guidelines and recommendations have directly fueled this growth by making bedside ketone testing standard practice in key clinical scenarios. The Joint British Diabetes Societies (JBDS) have been especially influential: their national guideline on Diabetic Ketoacidosis (DKA) management explicitly states that “blood ketone measurement represents best practice in monitoring the response to treatment” for DKA . The JBDS guidance (first issued in 2010 and updated in 2023) recommends that DKA management be based on point-of-care testing – not only for glucose but for capillary 3-β-hydroxybutyrate (ketone) levels hourly at the bedside . It notes that portable ketone meters now allow rapid bedside β-hydroxybutyrate measurement, which, combined with venous blood gas analysis, enables timely identification of whether metabolic targets are being met . In fact, JBDS advises that glucose, ketones, pH, and bicarbonate should all be assessed “at or near the bedside using POCT” in DKA . This marked a shift away from older reliance on urine ketone testing or central lab measurements, and has effectively mandated that any hospital admitting emergency hyperglycemia cases must have capillary blood ketone testing available. The impact on usage is significant: a patient in DKA may require a ketone strip hourly for 6–12+ hours, which multiplied by all DKA cases represents a large uptake in strip use compared to a decade ago.
JBDS also underscore the need for robust POCT governance to support ketone testing. Their guidance insists that “staff must be trained in the use of POCT blood glucose and ketone meters in line with local POCT policy and demonstrate continuing competence”, and that meters be subject to rigorous internal quality control and external quality assessment . This aligns with broader MHRA advice on POCT management. The Medicines and Healthcare products Regulatory Agency (MHRA) updated its guidance on POCT in 2021, emphasizing that POCT services must have clear governance, training, QC, and accountability as part of clinical governance . The MHRA notes, for example, that all POCT device users should know what to do with abnormal results or QC failures and that comprehensive record-keeping is vital . Such governance frameworks, while improving patient safety, inherently drive up consumable usage (through regular QC tests, staff competency assessments, etc.) as discussed later.
Another driver is guidance related to SGLT2 inhibitor medications. In 2020 the MHRA’s Drug Safety Update recommended routine blood ketone monitoring for hospitalized patients on SGLT2 inhibitor drugs who are acutely unwell or undergoing surgery . Crucially, it stated “measurement of blood ketone levels is preferred to urine”, because SGLT2 inhibitors can suppress urinary ketone excretion . The MHRA explicitly referenced the JBDS DKA guideline as already endorsing blood β-ketone testing . This has alerted acute physicians to check capillary ketones even in moderate hyperglycemia cases (euglycemic DKA risk), expanding use beyond classic DKA presentations. In practical terms, many hospitals updated their “sick day rules” and perioperative protocols to include capillary ketone testing for at-risk patients, further increasing tests performed under POCT oversight (while avoiding urine test strips).
Finally, NHS England’s recent commissioning recommendations have reinforced these practices. In April 2023, NHS England published a national assessment of blood glucose and ketone meters, testing strips and lancets . This operational guidance aims to align device choice and prescribing across the country for both primary and secondary care. It highlights that equitable access to ketone testing is essential for all insulin-treated type 1 patients and those at risk of DKA . The document lists preferred meter systems that have passed quality and cost-effectiveness criteria – notably, five integrated glucose/ketone meter+strip systems are recommended for adults with type 1 or ketosis-prone type 2 diabetes (Category 1a). NHS England’s push for formularies to adopt these high-quality dual glucose/ketone meters means many Trusts are transitioning their POCT devices accordingly. This often entails switching out older meters and ensuring hospital inpatients have the same ketone-monitoring capability as recommended for community use, again tending to raise strip usage (for example, some Trusts that previously only stocked ketone strips in ED may now deploy meters on all wards to meet best practice).
In summary, national guidelines from JBDS, MHRA, and NHS England have made bedside blood ketone testing a standard of care, directly causing a significant increase in POCT ketone test volumes. Meeting these guidelines requires Trust POCT teams to supply more strips, perform more QC, and extend ketone meter availability to all relevant clinical areas.
Market Shifts: Devices, Strip Formats, and Wastage
The expanding ketone testing has been accompanied by notable market shifts in the POCT devices and consumables used across the NHS. Historically, hospital blood ketone testing was dominated by Abbott Diabetes Care’s systems. Abbott’s Precision/FreeStyle line offered handheld meters (e.g. Precision Xceed Pro, and later FreeStyle Precision Pro) capable of both glucose and β-ketone measurement. A key feature of Abbott’s hospital systems is the individually foil-wrapped test strip format. Each FreeStyle Optium β-ketone strip is sealed in its own foil packet, protecting it from air and moisture until use . This packaging yields a long shelf-life (typically stable until the expiry date on the box) without concern for when the pack was opened . It also facilitates auto-calibration: Abbott meters scan a barcode on each strip’s foil packet to verify lot and expiry before use . The foil format can help minimize wastage in low-throughput settings, because strips don’t degrade once the container is opened – an important consideration if only a few tests are done in a ward each month.
By contrast, newer competitors like Nova Biomedical’s StatStrip Glucose/Ketone system (which many NHS Trusts have adopted in the last 5 years) use multi-strip vials more akin to standard glucometers. Nova’s ketone test strips are packaged in vials of 10, 25, or 50 strips (e.g. 50 strips per vial, 1–2 vials per box) . Once opened, the StatStrip ketone strips are stable for up to 180 days (6 months) , after which any unused strips must be discarded. This vial format has pros and cons. It allows faster workflow (no individual foil to unwrap and scan for each test) and the strip unit cost is typically lower – Nova’s pricing per strip is generally competitive with or below Abbott’s, especially in bulk (indeed, many of the NHS England recommended meters use vial strips costing ~£0.99 each for ketone strips in packs of 10 , whereas Abbott’s foil-wrapped strips list around £2.20–£2.75 per strip in a box of 10 ). However, vial-packed strips can lead to wastage if usage is sporadic. Any vial opened for a single test in a low-use location may have most of its strips expire after 6 months, representing dead stock. Furthermore, infection control guidance during the COVID-19 era and beyond has cautioned against sharing glucometer supplies between patients: if a vial of strips is taken to an infectious patient’s bedside, it should not return to common use on other patients . One study found that opened multi-use vials of glucose test strips can be contaminated with bacteria in up to 25–80% of cases, whereas individually wrapped strips have only ~3–7% contamination (similar to sterile new strips) . To mitigate cross-infection risk, U.S. CDC recommendations suggest dedicating a strip vial to a single patient if possible – but a cost analysis showed this practice could cost an additional $80k–$200k per year in strip wastage for a typical hospital . Foil-wrapped strips avoid this issue by allowing caregivers to bring just the needed single-use packets to the bedside. As one evidence review noted, “It should be more economical to use individually foil packaged test strips” in multi-patient settings , though formal cost studies are limited.
The NHS experience reflects these dynamics. Many hospitals historically stuck with Abbott’s foil-strip meters for the perceived reliability and lower wastage in low-volume areas, especially before connectivity became paramount. However, Nova and other vendors gained ground by offering modern connectivity and integrated data management, sometimes at lower strip costs, even if that meant accepting a vial format. Around 2018–2022, a wave of Trusts conducted evaluations or tenders to upgrade glucose/ketone meter systems. In these tenders, requirements for wireless connectivity, automated result upload, and strict QA lockouts featured heavily . Abbott responded with its FreeStyle Precision Pro system (a successor to the older Precision Xceed) which also offers wireless networking and maintains the foil strips. Nova’s StatStrip, meanwhile, was already well-proven in connectivity and had a track record in many UK hospitals for glucose testing (StatStrip was one of the first devices FDA-cleared for use in critical care). The result has been a gradual shift in market share. For instance, in 2023 a consortium of South-West England Trusts awarded a contract to replace all blood glucose/ketone meters with Nova StatStrip devices, citing the need for data integration (connectivity) and a higher degree of quality assurance as key drivers . The contract, covering multiple acute hospitals, consolidated business away from the incumbent suppliers (which included Abbott) to Nova . Similar transitions have occurred or are underway in other regions, while some Trusts have chosen Abbott’s newer Precision Pro to retain foil strips but gain connectivity. A few other devices (e.g. Menarini GlucoMen Areo 2K, Roche’s systems interfaced with ketone-capable meters for specific areas) play minor roles, but Abbott and Nova remain the dominant players in hospital ketone POCT.
A notable difference accompanying these shifts is the packaging and resultant waste profiles of strips as mentioned. Trust POCT managers must balance strip stability vs. volume: in an emergency admissions unit seeing multiple DKA cases weekly, the high-throughput means Nova’s 25-strip vials are quickly used (minimal expiry waste), and staff appreciate the quick strip insertion without foil fiddling. In contrast, a small ward that might only check an occasional ketone will favor individually wrapped strips that won’t expire once opened – anecdotally, some hospitals using Nova meters have resorted to opening new vials and discarding old ones preemptively to ensure accuracy, essentially treating vials as single-use for infection control, which erodes cost savings. This has led to creative stock management, such as issuing small 10-strip vials to low-use areas or training staff to borrow strips from high-use areas when needed, to reduce open-vial count. As the market consolidates around a few major suppliers, NHS Supply Chain and formulary agreements also push for standardization. The 2023 NHS England assessment not only listed recommended meters but also noted cost-effective strip pricing (with several <£10 per 10-pack options) , pressuring manufacturers to keep prices low. Abbott’s Optium β-ketone strip 10-pack and Nova’s equivalent are now both generally available around £10 per pack in NHS contracts, down from higher prices in the past. This means volume, not unit price, is the main cost driver now – putting the focus on reducing unnecessary strip use (waste/QC) through better governance.
Governance, QC Protocols and Middleware Impact
The governance practices of POCT services themselves have a significant impact on strip usage. Modern connected POCT systems come with middleware or management software that enforces compliance and captures detailed usage data. This has improved patient safety and result traceability, but it can paradoxically increase short-term strip consumption as a trade-off for long-term efficiency. Key aspects include:
• Internal Quality Control (IQC) Frequency: Current hospital meters require regular QC checks with control solutions. Many Trusts follow a daily QC regime (two levels) for each meter, and devices are often configured with a 24-hour lockout. For example, Abbott’s Precision Pro will display “Ketone QC Due Now” every 24 hours and lock out patient testing until both low and high controls pass within range . Nova StatStrip similarly can enforce QC lockout per hospital policy. This means every active meter uses at least 2 strips per day for IQC, even if no patient tests are done, unless a meter is explicitly taken out of service. Over a month, that is ~60 strips per meter purely for QC. Multiply across dozens of meters and the QC strip usage can be substantial. If a QC fails or errors, operators must repeat it, consuming further strips. Thus, tighter QC protocols directly drive strip consumption upward. (Nevertheless, this is accepted as necessary cost for assured quality – “no result is better than an incorrect result” in critical care.)
• Operator Training and Competency Checks: POCT governance frameworks require that all users are trained and certified competent on the devices . In practice, many hospitals mandate that nurses and ward staff pass an e-learning and a supervised test using the meter. This often involves running a control test or even a dummy patient test during training sessions – again using strips. With staff turnover and new onboarding (e.g. junior doctors, new nurses), training-related strip use is an often “hidden” contributor to overall consumption. For instance, when rolling out a new glucose/ketone meter trust-wide, POCT teams might train hundreds of staff, each performing a control or test strip as part of sign-off. This one-time surge can use thousands of strips outside of direct patient care. Ongoing competency assessments (annual re-certification) similarly require control tests. While these are planned uses, they need to be factored into procurement to avoid shortages.
• Middleware and Data Traceability: Connectivity and POCT data management systems (middleware) have enabled rich analytics on strip usage and operator behavior. Every test is electronically logged with operator ID, patient ID, time, QC status, etc. . This has two effects on usage: (1) It can identify wastage and inefficiencies – for example, the middleware can report how many strips were wasted due to user errors or expired QC, enabling corrective action . Over time, such tracking should reduce unnecessary strip use by highlighting issues (like an individual who repeated a test 3 times due to not following procedure). (2) In the short term, however, greater transparency can reveal under-testing or spur more testing. Some hospitals have used connectivity data to drive quality improvement, such as prompting staff: “if glucose >14 mmol/L, do a ketone test” (an alert that can pop up on certain meter devices) . These decision support prompts, along with audit feedback, often increase appropriate ketone testing rates – catching more early DKA but also using more strips. Middleware also allows remote lockouts of operators who don’t perform QC or who are not credentialed . This prevents untrained usage but also forces compliance (e.g. a ward that previously might have skipped daily QC on a quiet day can no longer do so, thus no “saving” on strips by neglect – a net positive for quality, but it does remove the temptation to reduce usage at the expense of QA).
• Duplicate Testing and “Over-testing”: With results now traceable, POCT managers have observed certain over-testing behaviors. For example, if a meter yields an unexpected high ketone result, staff might doubt it and use a new strip to immediately re-check – effectively double-testing the same sample. Or nurses in different areas might simultaneously test the same patient not realizing a recent result is already in the system. Connectivity mitigates this by sharing results, but only if staff trust and check the system. Education efforts (and sometimes system hard stops) are used to curb needless repeats. Still, human factors can lead to more strip usage than necessary. A culture of “when in doubt, test again” has merits for safety, but from a utilization perspective it contributes to the surge. Audit data from one UK hospital’s POCT system indicated a non-trivial percentage of ketone tests with results <0.1 mmol/L (essentially normal) – suggesting that some proportion of tests were done on patients without clinical indication or were repeats to confirm a prior normal value. Targeted training is being used to ensure ketone POCT is done judiciously (when clinically indicated) and that staff trust the device accuracy the first time.
In light of these factors, POCT departments are refining protocols to manage strip usage without compromising care. Many are turning to analytic dashboards (sometimes provided by the middleware or third-party solutions) to monitor strip usage per ward, per device, per month. This allows identification of anomalies – e.g., a ward consuming strips at twice the rate of others of similar size may indicate either higher caseload (justifiable) or problems like excessive QC repeats or expired vials being discarded. In some Trusts, POCT committees have instituted policies such as “QC lockout exemptions” where a meter in a sealed package need not be QC’d until first use (to avoid burning strips on an unused device). Similarly, if a ketone meter is rarely used, staff are instructed to perform QC only when a patient test is needed (the device then gets QC’d and used immediately) rather than daily. This approach, however, must be balanced against quality requirements and is only applied in low-risk scenarios.
On the positive side, improved governance and connectivity have yielded better understanding of needs: procurement can be tuned using actual usage data from middleware, and outlier usage can be corrected. One NHS report encourages inpatient diabetes teams to leverage data from networked POCT devices to identify outliers and at-risk situations proactively . For example, a sudden spike in ketone strip use might signal a cluster of DKA cases or a change in clinical practice; POCT managers can then verify if this aligns with expectations or if stock levels need adjustment. In essence, while POCT oversight initially increases consumable usage (through QC and comprehensive training), in the longer run it optimizes usage by reducing errors, eliminating redundant lab tests, and ensuring tests are done on the right patients at the right time.
Sources:
• Joint British Diabetes Societies (JBDS) Guidelines for DKA and inpatient care
• MHRA Drug Safety Update on SGLT2 inhibitors and ketone monitoring
• NHS England commissioning recommendations for blood glucose/ketone meters (2023)
• NHS London diabetes report on ketone strip prescribing trends
• Evidence on strip packaging, contamination and wastage (PMC review)
• Example of South West NHS procurement awarding Nova StatStrip contract
• POCT connectivity and QA considerations (PMC evidence-based review)
• Manufacturer information on strip formats (Abbott and Nova)
