GUIDELINES FOR CHOICE OF BLOOD GLUCOSE TESTING STRIPS, LANCETS AND METERS These Guidelines are intended to assist healthcare professionals in the selection of appropriate blood glucose meters and testing strips for patients to self-monitor their blood glucose levels. These Guidelines should be used in conjunction with Mid Essex Self Blood Glucose Monitoring (SBGM) Guidelines. The recommendations on choice of meter in this guideline reflect a multi-disciplinary review of several requirements including: Compliance with the new ISO standards (01.05.2016) for glucose testing meters Cost and expiry of test strips Clinical features of meters for example connectivity, suitability for particular patient groups, support for patient self-management, any known interference with prescribed medicines Compatibility with DVLA requirements The need for a meter for newly diagnosed diabetics will be assessed by a healthcare professional and if required a suitable meter will be supplied to the patient. These meters will be provided free of charge from GP surgeries or diabetic clinics. There should be no need for a patient to purchase a meter and patients should be dissuaded from doing so without consulting their specialist first. Prescribing of strips and lancets for patients who purchase a meter is not supported by the CCG. This guideline has divided meters into 2 broad categories. 1. The majority of patients with diabetes (including those using insulin) should be offered a meter from category 1, these are cost-effective and the table of key features (pg3) enables informed decision making between clinician and patient. Practices should routinely stock these meters (available free of charge from the manufacturer) and offer them to patients who meet the criteria for self-management of blood glucose While the CCG would not challenge the prescribing of alternative test strips, priced at less than £10 / 50 strips; healthcare professionals who recommend or prescribe these to patients are accepting responsibility for ensuring compliance of these meters with ISO and DVLA requirements GlucoseTestingStrips&MetersGUI201602V2.0FINAL Page 1 of 8 Who should be testing? All patients with Type 1 diabetes All pregnant women with pre-existing or gestational diabetes All patients with Type 2 diabetes using insulin Non-insulin managed patients with T2DM who: o Are prescribed sulfonylureas or glinides o and who also drive (see right) o Have been newly initiated or dose titrated with GLP analogue (e.g. exenatide) for short term only (<3 months) Who Should Not Need to Test? Those with Type 2 DM controlled by diet and exercise alone Patients with Type 2 diabetes controlled by metformin alone or in combination with pioglitazone or a gliptin 2. Category 2 meters are reserved for specific groups of patients with T1DM, they are usually initiated in secondary care or tier 2 diabetes services and strips continued in primary care. It is not anticipated that category 2 test strips would account for more than 20% of primary care test strip prescribing. Category 2 meters do not need to be routinely stocked in primary care but may be ordered ad hoc from manufacturers if patient meets criteria for use. Criteria for category 2 meters: Carbohydrate counting insulin users who have undergone BERTIE course or similar or T1DM with brittle control (frequent DKA) Those using a sub-cutaneous insulin pump Patients prescribed these products who meet this criteria should not be changed by healthcare professionals in primary care, as they have been specifically selected for complex patients Patients, who purchase a meter where an off-formulary strip is used, should expect to purchase the strips as well. Community pharmacists should not sell blood glucose meters to patients with diabetes without prior discussion and approval from the patient’s diabetes healthcare professional. Practices should dispose of, or not accept, free samples of non-formulary meters from drug companies. All of the meters included in this guideline are available at no cost to the patient. Glucose testing for drivers?1 Treated with Insulin Group 2 Drivers (lorries/buses): o Should monitor blood glucose at least twice daily and at times relevant to driving (no more than 2 hours before the start of the first journey and every 2 hours while driving). o Must use a meter with a memory function with no delete facility which records blood glucose levels, as they will be required to have three months of blood glucose readings available for inspection at an annual examination by a consultant diabetologist. Group 1 Drivers (cars/motorcycles): o Should monitor blood glucose at least twice daily and at times relevant to driving (no more than 2 hours before the start of the first journey and every 2 hours while driving). Treated with tablets which carry a risk of hypoglycaemia (Sulfonylureas and Glinides) Group 2 Drivers (lorries/buses): o Should monitor blood glucose at least twice daily and at times relevant to driving Group 1 Drivers (cars/motorcycles): o The frequency of testing depends upon the clinical context, it may be appropriate to monitor blood glucose regularly and at times relevant to driving to enable the detection of hypoglycaemia. o The greatest risk of hypoglycaemia with sulphonylureas is in the first three months of treatment therefore people who are just starting treatment, experiencing hypoglycaemia, or have reduced awareness are likely to need to test more frequently. GlucoseTestingStrips&MetersGUI201602V2.0FINAL Page 2 of 8 Category 1: Meters suitable for majority of people with T2DM (including those using insulin), and some people with T1DM Glucomen Areo Contour TS Supercheck 2 One Touch Select Plus Product photo Memory Smart phone upload Compatible test strips 50 strips (£) Expiry after opening Lancets Preferred meter () , alternative choice () or not suitable () Contra-indications 250 tests Yes Glucomen Areo No Contour TS 500 tests No Supercheck 2 £9.99 £9.95 £9.50 £8.49 Note: no interference with medication/drugs in normal ranges Note: no interference with medication/drugs in normal ranges Interference with results accuracy in patients taking levodopa Note: no interference with medication/drugs in normal ranges DM in pregnancy Partially sighted (unless Group 2 driver) (unless Group 2 driver) (unless Group 2 driver) Contact to order FREE meters Patient helpline details 730 tests 18 months 6 months 24 months 6 months Use the most cost effective lancets (<£3/100), these are not necessarily the ones supplied with the meter. Refer to Cost effective lancet table on page 7 T2DM (noninsulin treated) T2DM using insulin T1DM Additional considerations on choice of meter 500 tests No One Touch Good for tracking patterns, averages Colour range indicator for low, high or in range Target ranges can be individualised Patients wishing to use with Smart phone Drivers, (especially Group 2) using insulin who require large test memory for DVLA Type 2 diabetes who require occasional / infrequent testing Simple to use, especially for manual dexterity issues (when smaller, modern meters may pose handing problems) Speaking results function RNIB approved Simple to use meter Not compatible with Gp2 DVLA requirements (can erase results) Sam Frazer: 07976138629 Jitesh: 07885 555676 [email protected] Helen: [email protected] Tel: 01636 831201 Mon – Fri 8.30am – 6pm and Saturday 9am – 1pm: 0800 121 200 Mon to Fri 8:30am - 5:30pm 0800 243 667 / 0118 9444128 Bayer/ Ascensia Diabetes Support 0845 600 6030 Tel: 01636 831201 [email protected] GlucoseTestingStrips&MetersGUI201602V2.0FINAL Page 3 of 8 Category 2: Meters suitable for people with T1DM who have undertaken BERTIE course and other specific groups of patients (for example: carbohydrate counting, insulin pump users, paeds or brittle glycaemic control) Name of Meter Accu-Chek Aviva Expert Contour Next Accu-Chek Performa Nano Accu-Chek Mobile 1000 tests Accu-Chek Aviva 800 tests Contour NEXT strips 500 tests Accu-Chek Performa 500 tests Accu-Chek Mobile test cassette Product photo Memory Compatible test strips 50 strips (£) Expiry after opening Lancets Contra-indications Preferred meter for Additional considerations on choice of meter Contact to order FREE meters Patient helpline details £15.72 £15.04 £9.95 £16.09 18 months 24 months 18 months 3 months Use the most cost effective lancets (<£3/100), these are not necessarily the ones supplied with the meter. Refer to Cost effective lancet table on page 7 Test results affected by drugs that contain or metabolise to maltose: peritoneal dialysis fluids, immunoglobulins, abatacept Note: no known interference with medication/drugs in normal ranges Carb counting T1DM Calculates the units of insulin required based on test result, expected carb intake and previous insulin doses Brittle glycaemic control or Low haematocrit levels Fastclix Lancet drums (£9.75/204) reserved for T1DM patients with needle phobia, mobility problems or visual impairment. Otherwise refer to cost effective lancet table on page 7 Test results affected by drugs that Note: no known interference with contain or metabolise to maltose: medication/drugs in normal ranges peritoneal dialysis fluids, immunoglobulins, abatacept Paediatric patients with T1DM Restricted – see below Can accurately test even when haematocrit levels are low Helpful for those with brittle control Reserved for T1DM patients with mobility problems or who are visually impaired Prescribing of cassettes to patients in primary care who do not meet criteria is not supported Sajad Rahman : 07912 163529 Helen: [email protected] Sajad Rahman : 07912 163529 Sajad Rahman : 07912 163529 Mon to Fri 8am - 6pm (excluding bank holidays): 0800 701 000 Bayer Diabetes Support 0845 600 6030 Mon to Fri 8am - 6pm (excluding bank holidays): 0800 701 000 Mon to Fri 8am - 6pm (excluding bank holidays): 0800 701 000 Some patients self-fund the Free Style Libre meter which comes with a sensor the patients insert into their arm for 14 days and can scan for blood glucose. These are not currently considered cost effective and in the absence of a positive decision from the National Institute of Health and Clinical Excellence, MECCG do NOT support prescribing of the sensors. However patients require compatible blood glucose test strips for the meter if hypo or for DVLA. This is appropriate in Type 1 patients who are self-funding the sensor device since the price of the additional strips would not be expected to exceed monitoring costs for other people with type 1 diabetes. Compatible strips are Freestyle Optium Neo (£15.64 / 50 strips). GlucoseTestingStrips&MetersGUI201602V2.0FINAL Page 4 of 8 Prescribing of Blood Ketone Testing Strips in patients with Type 1 diabetes Ketone testing is occasionally required for some patients (e.g. those using insulin subcutaneous pumps, pregnant T1DM, those who are carbohydrate counting or brittle glycaemic control). Patients required to self-test for ketones will be identified by the diabetes specialist service and provided with the initial supply by the specialist service. It may be necessary for primary care to repeat prescribe such strips. The use must be carefully monitored and it is not expected that this will exceed more than one pack per year, with the exception of insulin pump patients. The local diabetes team do not support the use of combined meters for both glucose and ketone testing (where patients may measure both on the same device by using different strips) due to safety concerns of inadvertent mix up of the strips or results. These meters should only be used for ketone testing, an alternative glucose meter should be selected from the appropriate category above. Meter Company Ketone test strip Price Freestyle Optium Abbott Optium β Ketone £20.63 x 10 Expiry once open 18 months (individually foil wrapped) Glucomen LX plus Menarini Glucomen LX Ketone £20.75 x 10 9 months Recommended? Yes – on specialist recommendation only No (due to expiry) Quality Standards There are no reliable national or international datasets comparing the quality and accuracy of different BG machines. The field of Health Technology Assessment (HTA) is several years behind the quality standards achieved in medicines licensing. The new range of BG machines have device components frequently developed and /or utilised in the Far East, and then repacked and authorised for European Union markets. It is important that healthcare professionals should be aware that variability of device accuracy and durability can occur with any of the above medical devices, and that if a patient reports problems it is perfectly appropriate to re-issue a new or replacement device from the same class. Educational Support The cornerstone of good glycaemic care is the quality of the support and educational relationship between the healthcare professional and the patient, and not the BG machine per se. A patient who doesn’t understand why and when BG testing should be done, will either inappropriately over-test or fail to test when needed. We would strongly encourage a patient-centred approach to explaining to all patients the rationale for BG checks for different situations, at the point when BG machines are first issued and when BG results are periodically inspected. GlucoseTestingStrips&MetersGUI201602V2.0FINAL Page 5 of 8 Switching blood glucose meters: The meters and strips recommended in this guideline have been reviewed as meeting all the minimum standards for safety, quality control, memory and costeffectiveness. Mid Essex CCG currently spend more than £1m per year on blood glucose testing strips. 61% blood glucose test strips prescribed in MECCG cost over £15/50 strips despite their being many available and suitable meters on the market with strips costing less than £10 for the same quantity. The category 1 meters in this guideline are examples of some of these that meet the ISO required accuracy standards and many have new features and usability, enabling a wider patient choice in this price bracket. It is recommended that all patients with Type 2 diabetes currently prescribed strips costing more than £10 per 50 test strips are reviewed and that the category 1 table is used, in consultation with the patient, to select a suitable alternative. Remember that if a meter is to be switched for the purpose of cost saving, any existing supply of strips the patient has for the old meter should be used up first. It is not expected that patients already on a meter with strips costing less than £10 / 50 strips would be changed, provided the meter is complaint with ISO requirements (to be met by May 2016). Meters that do not meet these requirements have largely been removed from the market and are only likely to present as an issue in patient who test infrequently. Should a patient present with a discontinued meter / test strips, review the need for glucose testing and if required, use the category 1 table above to select a suitable alternative. While the CCG would not challenge the prescribing of alternative test strips, priced at less than £10 / 50 strips; healthcare professionals who recommend or prescribe these to patients are accepting responsibility for ensuring compliance of these meters with ISO and DVLA requirements 1 ‘At a glance guide to the current medical standards of fitness to drive’: May 2014. Available at: http://www.dft.gov.uk/dvla/medical/ataglance.aspx [Accessed 28.8.14] GlucoseTestingStrips&MetersGUI201602V2.0FINAL Page 6 of 8 Lancets: o Use cost-effective lancets (which may not be the ones provided with the meter). There are a range of different sized lancets available on prescription at a cost of ≤£3 / 100 and these are listed in the table below. o The higher the gauge (G) of a lancet; the smaller the diameter of the needle. A low gauge needle (28G) may be quite uncomfortable for the patient while a higher gauge (33G) may not provide sufficient blood for testing. Generally 30G lancets are suitable for most patients o Lancets are designed to fit into proprietary finger-pricking devices but from local experience most appear to be a universal fit for all. Finger pricking devices are not prescribable but are supplied with the blood glucose monitoring meter. o Lancets are for single use only, ensure patients are educated about safe disposal via sharps bin o Multi-device lancets (Multiclix Roche or Fastclix drum), which contain a preloaded lancet drum, should be restricted to those with clinical need e.g. those with dexterity problems, needle phoebia or visual impairment Medium gauge 30G lancets - suitable for most patients (0.28 – 0.38 mm) with low acquisition cost (≤£3.00/100) Lancet Diameter / Gauge Packsize Cost / pack Carasens 0.31mm/30g 100 £2.95 Safety lancets – Do NOT prescribe on FP10 GlucoRX 0.31mm/30g 200 £5.50 o Unistik 3 are safety lancets, the needle retracts after use. ICare Advanced 0.38mm/30g 100 £2.85 o ICare Advanced 0.38mm/30g 200 £4.45 IME-DC 0.3mm/30g 100 £3.00 Microdot 0.31mm/30g 100 £3.00 Microdot 0.31mm/30g 200 £6.00 Mylife (multicoloured ) 0.3mm/30g 200 £5.50 Mylife (standard) 0.3mm/30g 200 £5.50 These are primarily for the benefit of healthcare workers to avoid needle stick injury, not for the benefit of the patient They should not be prescribed by GPs on FP10s. They may be ordered as a stock item by healthcare providers who require them to ensure the safety of their staff Omnicon Lance Soft 0.3mm/30g 200 £5.45 TRUEplus 0.32mm/30g 100 £2.90 GlucoseTestingStrips&MetersGUI201602V2.0FINAL o o Page 7 of 8 Title Document reference Author Approved by Date approved Review date Glucose Testing Strips and Meters GlucoseTestingStrips&MetersGUI201602V2.0FINAL Catherine Hamilton, Deputy Chief Pharmacist, MECCG Mid Essex Medicines Management Committee February 2016 February 2018 Previous version Guidelines for choice of blood glucose testing strips and meters - August 2014 Cost effective lancets for patient use - June 2014 Key changes Combined glucose testing strips, meters and lancets into one guidance GlucoseTestingStrips&MetersGUI201602V2.0FINAL Page 8 of 8
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