DIABETES CARE IN THE UK FIT UK Forum for Injection Technique UK The UK Injection Technique Recommendations 3rd Edition Optimising Diabetes Care DR AF T THE INJECTION TECHNIQUE RECOMMENDATIONS Preface Forum for Injection Technique (FIT) UK provides evidencebased best practice recommendations for people with diabetes who are using injectable therapies and for clinicians who care for people with diabetes using injectable therapies. Through these recommendations, people with diabetes can achieve the best possible health outcomes by ensuring that the correct dose of medication is delivered to the correct injection site, using the correct technique. FIT UK understands that written guidelines alone will not change clinical practice unless appropriately implemented. FIT UK is committed to engaging in a range of initiatives including research, education and support for healthcare professionals, carers and people with diabetes. Our Objectives • To review the injection techniques currently being used by people with diabetes. • To identify, and to provide information on ‘Best Practice’ and eduction programmes used in the UK • To raise awareness of the impact that existing and emerging research regarding injection technique may have on health outcomes and wellbeing for those with diabetes that require subcutaneous injection therapy • To facilitate opportunities in which best practice can be discussed, developed, implemented and evaluated across the UK 3 THE INJECTION TECHNIQUE RECOMMENDATIONS Introduction Over 15 years ago a small pioneering group of medical and nursing staff gathered for the first time to explore the evidence for optimal injection technique. FIT UK was established following the 3rd International Injection Technique meeting in Athens 2009. Informed by the results of the International Injection Technique Survey(159) and contemporaneous injection technique evidence from around the world, the founders of FIT UK determined to share their findings and their passion for optimal injection technique not only in the UK but around the world. FIT UK has grown from a single entity based in the UK and is now represented in countries including: • • • • • • • Canada Dominican Republic India Ireland Philippines South Africa Switzerland Diabetes UK estimates that more than one in 16 people in the UK has diabetes (diagnosed or undiagnosed) and that there are 3.9 million people living with diabetes in the UK’. This is projected to rise to 5 million people by 2025. (192) Diabetes diagnosis rates are equivalent to: • more than 400 people every day • over 17 people every hour • around three people every ten minutes (192) 4 DATE PUBLISHED: September 2015 * data on file FIT UK Everyone with type 1 diabetes (T1DM) will need insulin from diagnosis. Currently there are are around 465,000 people over the age of 16 with T1DM using insulin. A Further 26,500 children and young people use insulin in the UK. It is estimated that 28.3% of all people with diabetes are prescribed insulin injections in the UK(160). Therefore more than 3.9 million people estimated to have diabetes, almost 1 million of these will need to inject insulin. (195) FIT UK’s overarching mission is: ‘To support people with diabetes using injectable therapies to achieve the best possible health outcomes that are influenced by correct injection technique’. To date FIT UK has delivered many education programmes and produced the First UK Injection Technique recommendations (2010) and Safety Recommendations (2012) which have been distributed and accessed online by many thousands of health care professionals. FIT UK has also produced a range of educational support materials and e-learning modules. FIT UK is committed to supporting the implementation of the recommendations and developing them further as new evidence emerges. We welcome any comments, suggestions and active participation in ensuring that the updated recommendations remain relevant and useful for now and in the future. web: www.fit4diabetes.com email: infouk@fit4diabetes.com Meet the team. Debbie Hicks Nurse Consultant – Diabetes (Chair) Barnet, Enfield & Haringey Mental Health Trust Dr Debra Adams Head of Infection Prevention and Control (Midlands and East). NHS Trust Development Authority Jane Diggle Specialist Practitioner, Practice Nurse. Church View HC South Kirkby, West Yorkshire Carole Gelder Childrens nurse specialist and lecturer, Leeds Childrens Hospital and University of York 5 THE INJECTION TECHNIQUE RECOMMENDATIONS New and emerging evidence shows that optimal injection technique is critical to improving health outcomes. A pioneering study by Blanco (189) demonstrated that almost two thirds of patients have lipohypertrophy due primarily to incorrect or no rotation of injection sites. Of the patients with lipohypertrophy 39.1% had unexplained hypoglycaemia and 49.1% had glycaemic variation. Patients with lipohypertrophy were found to be using much more insulin than those without, estimated to cost the Spanish Healthcare system €122million per year in excess insulin usage. A study by Grassi (190) demonstrated that a multimodal approach to injection technique education and support could reduce HbA1c by 6mmol/moL (0.58%) in patients treated with insulin. Interestingly this was achieved using less insulin and without any weight gain. The development of FIT UK and the subsequent UK recommendations for injection technique have been supported by BD Europe. They have also been endorsed by Diabetes UK along with the pharmaceutical companies whose therapies include subcutaneous injections of insulin and GLP-1 agonists. 6 DATE PUBLISHED: September 2015 * data on file DR AF T Contents Preface and Objectives Introduction FIT UK Endorsements 1.0 2.0 3.0 4.0 5.0 6.0 7.0 8.0 9.0 10.0 11.0 12.0 13.0 14.0 15.0 16.0 17.0 3 4 5 8 Psychological Challenges of Injections Therapeutic Education Injection Sites Injection Site Care Insulin Storage and Suspension Reduction of Injection Pain The Correct Use of Pen Devices The Correct Use of Syringes Absorption Rates Needle Length Lifted Skin Folds Rotation of Injecting Sites Lipohypertrophy Bleeding and Bruising Pregnancy Safety Issues Disposal of injecting material 11 12 13 14 15 15 16 17 18 21 23 24 24 25 26 27 31 References Contributors 32 39 7 THE INJECTION TECHNIQUE RECOMMENDATIONS Endorsements. “Diabetes UK both welcomes and supports the FIT initiative. Good injection technique leads to good blood glucose control which is vital in preventing the long term complications of diabetes. As so many people with diabetes are now being prescribed injectable medication, this is a timely and important enterprise which will bring great benefit to them. ” Simon O’Neill, Director of Health Intelligence. DIABETES UK “Advances in the treatment of diabetes have led to an increase in the number of injectable therapies available. Correct technique is of paramount importance in order to ensure the benefits of injectable therapies such as insulin and GLP1s. The Forum for Injectable Therapy (FIT) provides comprehensive evidenced basedguidelines to improve the process and education of self injection technique for people with diabetes. As a company committed to improving the care of patients with diabetes, Lilly UK welcomes the FIT initiative as an important step in supporting diabetes care in the United Kingdom. ” Ian Dane, Senior Director, Eli Lilly & Company “Novo Nordisk fully endorse the FIT initiative. The benefits of modern injectable medications for the treatment of diabetes can only be fully realised through the use of correct injection technique. Novo Nordisk believe it is imperative that Healthcare Professionals understand the importance of good injection technique and convey this to people with diabetes under their care. FIT is a superb initiative, from leading professionals in the diabetes care, which will make a big difference in this area. ” Kirsty Tait, Diabetes Marketing Director, Novo Nordisk Ltd. 8 DATE PUBLISHED: September 2015 * data on file BD Medical – Diabetes Care Sanofi are a company who strive to improve the care for people with diabetes who are using insulin and GLP-1 therapy by providing a range of injectables. We are proud to support the FIT (Forum for Injection Technique) initiative which is aiming to improve current practice through demonstration of best practice and the sharing of scientific evidence. We, too, appreciate the importance of good injection technique in ensuring people with diabetes who are using injectable therapy achieve the most benefit from their medication and wish FIT every success. We look forward to working with FIT in the future.” Nicky Barry, Divisional Director Diabetes, Sanofi “ AstraZeneca are pleased to support the FIT initiative. We are striving to provide medicines which can provide better outcomes for people with Type 2 Diabetes but this can only be achieved when they are used correctly. Adoption of the FIT guidelines in clinical practice will help ensure that the best outcome is obtained from all injectable medicines.” Jay Ark, Head of Injectable at Diabetes Marketing, AstraZeneca “Becton Dickinson are extremely proud of the heritage they share with the Forum for Injection Technique, and fully support the continued work of the FIT Board and FIT associates who continue to expand the boundaries of best practice within the fields of insulin injection and medication management. The first and second editions of the FIT recommendations have been shared with over 30,000 healthcare professionals, and the welcome third edition will surely continue to bring the many positive clinical benefits to patients and healthcare professionals alike. BD would like to personally congratulate the FIT board on this magnificent achievement, and look forward to supporting FIT for many years to come.” Loïc Herve, Business Unit Director Diabetes Care BD Supported by medical technology company Becton, Dickinson U.K. Limited. (www.bddiabetes.co.uk) BD and BD Logo are trademarks of Becton, Dickinson and Company. ©2015 BD 9 KEY A Scientific Advisory Board (SAB) (Athens 2009) led the review of available evidence and decided that for the strength of a recommendation the following scale would be used: A B C STRONGLY RECOMMENDED RECOMMENDED UNRESOLVED ISSUE For the scientific support the following scale was used. 1 2 3 At least one randomised controlled study At least one non-randomised (or non-controlled or epidemiologic) study Consensus expert opinion based on extensive patient experience. A number of significant studies have published evidence in the intervening years since 2009. Therefore FIT UK has conducted a further review of critical evidence and included this within the 3rd edition of the Injection Technique Recommendations. The new evidence has also been subjected to the rigour of the strength scale of recommendations as above. Thus each recommendation is followed by both a letter and number (i.e. A2). The letter indicates the weight a recommendation should have in daily practice and the number, its degree of support in the medical literature. The most relevant publications bearing on a recommendation are also cited. There are few randomised clinical trials in the field of injection technique (compared, for example, with blood pressure control) so judgements such as ‘strongly recommended’ versus ‘recommended’ are based on a combination of the weight of clinical evidence, the implications for patient therapy and the judgement of the group of experts. These recommendations apply to the majority of people with diabetes using injectable therapy, but there will inevitably be individual exceptions for which these recommendations must be adjusted. Acknowledgment The New Injection Recommendations for Patients with Diabetes: Diabetes & Metabolism 2010. Vol 36. informed these recommendations and we thank the editors of Diabetes & Metabolism for permission to use material from this article. 10 DATE PUBLISHED: September 2015 * data on file STRONGLY RECOMMENDED RECOMMENDED UNRESOLVED ISSUE At least one randomised controlled study At least one non-randomised (or non-controlled or epidemiologic) study Consensus expert opinion based on extensive patient experience. 1.0 Psychological Challenges of Injections 1.1 Children 1.2 Adults 1 Children have a lower threshold for pain than adults and sometimes find injecting uncomfortable. The healthcare professional (HCP) should ask about pain, since many young people with diabetes will not bring it up spontaneously. (18, 20) 1 The HCP should prepare all people with type 2 diabetes for likely future injectable therapy early in the disease pathway, by explaining the natural, progressive nature of the disease, stating that it includes injectable therapy and making clear that injectable therapy treatment is not a sign of patient failure. (30) 2 Younger children may be helped by distraction techniques (as long as they do not involve deception) or play therapy (e.g. practicing injections on a soft toy) while older children may respond better to Cognitive Behavioural Therapies (CBT) where available. (19) 3 CBT includes relaxation training, guided imagery, graded exposure, active behavioural rehearsal, modelling and reinforcement as well as incentive scheduling. (19) 4 HCPs should reflect on their own perceptions of injectable therapy and avoid using any terms which imply that such therapy is a sign of failure, a form of punishment or a threat. (33,34) 5 Pen devices may have psychological advantages over syringes and therefore maybe more acceptable. (31,35-37) 2 Both the short-term and long-term advantages of good glucose management should be emphasised. Finding the right combination of therapies including injectables leading to optimal glucose management should be the goal. (31,32) 3 Through culturally-appropriate pictures and stories, HCPs should show how injectable therapy could enhance both the duration and quality of life. (31) 11 THE INJECTION TECHNIQUE RECOMMENDATIONS 2.0 Therapeutic Education 1 The HCP should spend time exploring the individual’s anxieties about the injecting process and the injectable therapy itself. (33,40) 2 At the beginning of injection therapy (and at least every year thereafter) the HCP should discuss: • Injecting regimen • Choice and management of the devices used • Choice, care and self- examination of injection sites • Correct injection techniques (including site rotation, injection angle and possible use of skin folds) • Injection complications and how to avoid them • Optimal needle length • Safe disposal of used sharps (32-35, 38-41) 12 DATE PUBLISHED: September 2015 * data on file Ensure that each of these topics have been fully understood. (34) 3 Injection technique education should be put in place and regularly reviewed and recorded in the individuals care plan. 4 Current injection practice should be discussed and if possible observed. Injection sites should be examined and palpated, if possible at each visit but at least once a year. (38,40,41) STRONGLY RECOMMENDED RECOMMENDED UNRESOLVED ISSUE At least one randomised controlled study At least one non-randomised (or non-controlled or epidemiologic) study Consensus expert opinion based on extensive patient experience. 3.0 Injection Sites The diagram shows the current recommended injection sites for injectable therapy Figure 1: Recommended injection sites. 13 THE INJECTION TECHNIQUE RECOMMENDATIONS 4.0 Injection Site Care 1 The site should be inspected and palpated by the individual prior to injection. (5,6) 2 Avoid using a site showing signs of lipohypertrophy, inflammation, oedema or infection until the problem has been resolved. (15,49,50-55) 3 Injections should be given into a clean site using clean hands. (56) 4 The site should be cleansed with soap and water when found to be unclean. (56) 5 Disinfection of the site is usually not required; however, alcohol swabs may be used prior to injections given in the hospital or care home setting. (6, 57-60) 14 DATE PUBLISHED: September 2015 * data on file Keeping injection sites healthy: A simple six step programme that patients should be supported to follow for each injection 1. The site should always be inspected prior to the injection 2. Avoid injecting into sites with lipohypertrophy, oedema,inflammation or signs of infection 3. Inject only into a clean site with clean hands 4. Cleanse the site with domestic soap and water if required 5. Always rotate sites, try to spread the time between a single injection site as much as possible (Refer to section 13) 6. Never reuse needles STRONGLY RECOMMENDED RECOMMENDED UNRESOLVED ISSUE At least one randomised controlled study At least one non-randomised (or non-controlled or epidemiologic) study Consensus expert opinion based on extensive patient experience. 5.0 6.0 Insulin Storage and Suspension Reduction of Injection Pain 1 Store injectable medication in current use at room temperature (according to manufacturers instructions). Avoid direct sunlight and areas of temperature extremes. Store unopened injectable medication in an area of the refrigerator where freezing is unlikely to occur. (66,67) 2 Cloudy insulin (e.g. NPH and pre-mixed insulin) must be gently rolled ten times and inverted ten times (not shaken) until the crystals go back into suspension and the solution becomes milky white. (61-65) Tips for making injections less painful include: • Keeping injectable therapy in use, at room temperature. (66,67) • Using needles of shorter length and smaller diameter. (157) • Using a new needle at each injection. (5,6,17,36,68) • Insert the needle in a quick smooth movement through the skin. (69) • Inject slowly and ensure that the plunger (syringe) or thumb button (pen) has been fully depressed. (69) • Remove at same angle and keep hand steady. Suspension of NPH insulin before and after electronic tipping to 180° (one cycle) A: Before (after 24 sedimentation). B: After 7 cycles. C: After 20 cycles. 15 THE INJECTION TECHNIQUE RECOMMENDATIONS 7.0 The Correct Use of Insulin Pen Devices 1 Pen devices should be primed (observing at least a drop at the needle tip) according to the manufacturer’s instructions before each injection. Once flow is verified, the desired dose should be dialled and the injection administered. (36,68) 2 Pen devices and cartridges are for single person use only and should never be shared due to the risk of cross contamination. (37,57) 3 Pen needles should be used only once. (3,5,6,17,59,76,77) 4 Using a new needle each time may reduce the risk of needle breakage in the skin, ‘clogging’ of the needle, inaccurate dosing and indirect costs (e.g Abscess). (77) 5 First the needle is inserted into the skin. After pushing the dose button in completely, the individual should count slowly for 10 seconds before withdrawing the needle in order to deliver the full dose and prevent the leakage of medication. Counting past 10 seconds may be necessary for higher doses. (61,69,71,74,78,79) 6 Needles should be safely disposed of immediately after use and not left attached to the pen. This prevents the entry of air (or other contaminants) into the cartridge as well as the leakage of medication out of the cartridge, which can affect subsequent dose accuracy. (71-75) 1: Make sure you have a clean site and clean hands and check the injection site. 2: Place a new needle onto your pen device and screw firmly into place, but do not over tighten. 7 Injecting through clothing should be discouraged. As needle lengths are becoming shorter there is increased risk of intradermal injection. 3: Remove outer and inner cap. 16 DATE PUBLISHED: September 2015 * data on file STRONGLY RECOMMENDED RECOMMENDED UNRESOLVED ISSUE At least one randomised controlled study At least one non-randomised (or non-controlled or epidemiologic) study Consensus expert opinion based on extensive patient experience. 7.0 8.0 The Correct Use of Insulin Pen Devices The Correct Use of Syringes 1 A syringe should be used only once and disposed of safely. (3,5,6,17,59,76,77) 4: If the insulin is cloudy type, gently invert 10 times and roll between palms of hands 10 times to fully mix it. 7: Hold the pen in your fist; keep your thumb away from the dose button. With the pen at 90 degrees to the skin surface, gently push the needle through the skin into the injection site. 2 When drawing up insulin, the air equivalent to the dose should be drawn up first and injected into the vial to facilitate easier withdrawal. 3 If air bubbles are seen in the syringe, hold syringe with needle uppermost, tap the barrel to bring them to the top and then remove the bubbles by pushing the plunger to expel the air. 5: Test dose, set the dial to 2 units and with the needle tip pointing upwards and away from you bu still visable press the dose button. You should see a bead of insulin appear at the needle tip. repeat if no insulin appears. 8: Push down the dose button with your thumb. Hold the needle in the injection site for a full ten seconds after you have finished pushing the dose button. Then gently remove the needle from the skin. 6: Set your dose. 9: Remove the used pen needle and place in sharps box ready for safe disposal. 4 Never withdraw insulin from pen cartridges or prefilled pens with a syringe. 17 THE INJECTION TECHNIQUE RECOMMENDATIONS 9.0 Absorption Rates All insulin and GLP1 injections should be administered subcutaneously. 9.1 Human Insulin 1 Intramuscular (IM) injection of all human insulin should be avoided since rapid absorption and serious hypoglycaemia can result. ( 95,96) 2 The thigh and buttocks are the preferred injection sites when using NPH (intermediate acting) as the basal insulin, since absorption is slowest from these sites. (43,97) 3 The abdomen is the preferred site for soluble human insulin, since absorption is fastest there. (16,44,46,98-100) 4 The absorption of soluble (short acting) human insulin in the elderly can be slow and this insulin should not be used when a rapid effect is needed. (14,101) (Note: Insulin actions may overlap) 18 DATE PUBLISHED: September 2015 * data on file 5 For insulin in strengths other than 100units/ml (U100) please refer to manufacturers instructions for use. For those people who require very large doses of insulin U-500 insulin maybe an option instead of U-100. U-500 is only available as soluble insulin. However it has a pharmacokinetic profile more closely simulating NPH human intermediary insulin than soluble short acting human. U-100. (5,6,158) This can be short, intermediate or long acting and will absorb at different rates depending where on the body you inject. Bolus (fast acting) insulin. The abdomen is preferred for this soluble insulin since absorbtion is fastest here. It will deal quickly with a rise in blood glucose after eating 6 Massaging the site before or after injection may speed up absorption and is not generally recommended. (5,6,70) Basal (intermediate acting) insulin. The thigh and buttocks are the best sites for this insulin as absorbtion is slowest here. Will reduce the risk of hypo overnight. STRONGLY RECOMMENDED RECOMMENDED UNRESOLVED ISSUE At least one randomised controlled study At least one non-randomised (or non-controlled or epidemiologic) study Consensus expert opinion based on extensive patient experience. 9.0 Absorption Rates Continued 9.2 Premixed Insulin 1 Intramuscular (IM) injection of all human insulin should be avoided since rapid absorption and serious hypoglycaemia can result. (95,96) 2 Premixed insulin (human or analogue) should be given in the abdomen in the morning to increase the speed of absorption of the short-acting insulin in order to cover postbreakfast glycaemic excursions. (12) Pre-mixed human and pre-mixed analogue insulin will absorb at different rates depending where on the body you inject. Morning When injected in the morning or during the day this insulin will quickly reduce blood glucose levels after meals. Acts fastest when injected into the abdomen. 3 Premixed insulin should be given in the thigh or buttock before evening meal as this leads to slower absorption and decreases the risk of nocturnal hypoglycaemia. (93,97) 4 Massaging the site before or after injection may speed up absorption and is not generally recommended. (5,6,70) Evening Injecting into the thigh or buttocks in the evening or before bed will slow the insulin absorption and help reduce risk of hypo at night. 19 THE INJECTION TECHNIQUE RECOMMENDATIONS 9.0 Absorption Rates Continued 9.3 Insulin Analogues 1 Rapid-acting insulin analogues may be given at any of the injection sites, as absorption rates do not appear to be site-specific. (81-85) 2 Long-acting insulin analogues may be given at any of the injection sites, as absorption rates do not appear to be site-specific. (87,88) 3 IM injections of long-acting analogues must be avoided due to the risk of severe hypoglycaemia or erratic control. (89,90) 20 DATE PUBLISHED: September 2015 * data on file 9.4 GLP-1 Agonists 5 Do not inject a rapid and a long acting analogue insulin in the same site within a 24hr period. 6 Larger doses may cause a delay in the peak and increase the duration of action. (5,6) 7 Massaging the site before or after injection may speed up absorption and is not generally recommended. (5,6,70) 1 Pending further studies, people with diabetes who inject GLP1 agents should follow the manufacturers instructions. (72) STRONGLY RECOMMENDED RECOMMENDED UNRESOLVED ISSUE At least one randomised controlled study At least one non-randomised (or non-controlled or epidemiologic) study Consensus expert opinion based on extensive patient experience. 10.0 Needle Length 10.1 Children and Adolescents 1 Insulin must always be delivered into subcutaneous tissue to help ensure predictable absorption (163-167) 2 There is no clinical reason for recommending needles longer than 4mm for children and adolescents. (118,162) 3 Children and adolescents using a 5 or 6mm needles must lift a skin fold with each injection. (9,83,86,110,112-117,156,157,162) 4 In the majority of cases a 4mm needle may be inserted at 90 degrees without a lifted skin fold. However, considerable care must be taken to ensure there is sufficient combined subcutaneous fat and skin thickness to avoid intramuscular deposition (9,162) 10.2 Adults 5 If children have only an 8 mm needle available (as is currently the case with syringe users), it is essential to use a lifted skin fold and give injections into the buttocks to minimise the risk of intramuscular injection. (111,118,119,162) 6 Arms should only be used for injections if administered by a third party and using a lifted skin fold. 7 Avoid pushing the pen device in to the skin thus indenting the skin during the injection, as the needle may penetrate deeper than intended and enter the muscle. 1 Insulin must always be delivered into subcutaneous tissue to help ensure predictable absorption (163-167) 2 There is no clinical reason for recommending needles longer than 6mm for the administration of insulin. (105,119,132,161) 3 4, 5 and 6 mm needles are suitable for all people with diabetes regardless of BMI for insulin injections; they may not require a lifted skin fold; particularly if using 4 mm needles. (9,74,104,106 – 108,156,157,161) 4 injections of insulin with shorter needles (4, 5, 6 mm) should be given in adults at 90 degrees to the skin surface. (9,74,106 – 108,130,161) 21 THE INJECTION TECHNIQUE RECOMMENDATIONS 10.0 Needle Length Continued Adults Intramuscular injection (IM) 6 Individuals using ≥8mm needles should ensure they are using a lifted skin fold to avoid IM injections. (105,131,161) Skin layer - don't inject here Subcutaneous layer - inject here Muscle layer - dont inject here Intramuscular injection (IM) 22 DATE PUBLISHED: September 2015 * data on file 01 2 Any insulin injected into muscle will be absorbed too quickly into the bloodstream, which may result in high variability of blood glucose levels and increased risk of hypoglycaemia. To avoid injecting into the muscle layer it is important to use a short pen needle and if necessary use a lifted skin fold. 01 2 01 2 5 To prevent possible IM injections when injecting into slim limbs and abdomens, even short needles (4,5 and 6mm) may warrant use of a lifted skin fold. (9,105,106,131,161) Injecting into muscle is also known to be more painful and might cause bleeding and bruising. Longer pen needles increase the chance of injecting into the muscle, therefore it is crucial to perfect the technique for the needle you are using or switch to short pen needles. STRONGLY RECOMMENDED RECOMMENDED UNRESOLVED ISSUE At least one randomised controlled study At least one non-randomised (or non-controlled or epidemiologic) study Consensus expert opinion based on extensive patient experience. 11.0 Lifted Skin Folds The skin fold technique 1 All people with diabetes/carers should be taught the correct technique for lifting a skin fold from the onset of injectable therapy. (see Fig 2.) 2 The lifted skin fold should not be squeezed so tightly that it causes skin blanching or pain. 3 The optimal sequence should be: 1) Make a lifted skin fold 2) Insert needle into skin at 90˚ angle 3) Administer therapy 4) Leave the needle in the skin for at least 10 seconds after the thumb button plunger is fully depressed 5) Withdraw needle from the skin 6) Release lifted skin fold 7) Dispose of used needle safely (see section 17) This technique can reduce the risk of intramuscular injection BUT MUST be carried out properly as directed by your nurse or doctor. Only the thumb, index finger and middle finger should be used, and the skin fold should be held until after the pen needle is removed from the skin. BEWARE: this technique should take up skin and subcutaneous tissue only, leaving muscle behind. Figure 2: Correct (left) and incorrect (right) ways of performing the skin fold. 23 THE INJECTION TECHNIQUE RECOMMENDATIONS 12.0 13.0 Rotation of Injecting Sites Lipohypertrophy 1 Individuals should be taught an easy-to-follow rotation scheme from the onset of injection therapy. (146,147) 2 One scheme with proven effectiveness involves dividing the injection site into quadrants (or halves when using the thighs or buttocks); using one quadrant per week and moving always in the same direction, either clockwise or anti-clockwise (see Figures 3 and 4). (148) Figure 3: Injections within any quadrant should be spaced at least 1cm from each other 24 DATE PUBLISHED: September 2015 * data on file 3 Injections within any quadrant or half should be spaced at least 1cm from each other in order to avoid repeat tissue trauma. 4 HCP should verify that the rotation scheme is being followed at each visit and should provide advice where needed. 5 Use a variation of educational approaches and available tools to inform how to detect for lipohypertrophy. Figure 4: Sample structured rotation plan for abdomen and thighs. Divide the injection area into quadrants or zones. Use 1 zone per week and move clockwise4 1 Individuals should be taught to examine their own injection sites and how to detect lipohypertrophy. (41,138) 2 Sites should be inspected and any abnormalities documented by the HCP within the individual’s care plan. For more information please refer to the FIT SDP booklet. At a minimum, each site should be examined visually as well as a tactile inspection annually (preferably at each visit). It is recommended that the FIT UK Unexplained Hypoglycemia assessment tool is used. If lipohypertrophy is already present the sites should be monitored at every review. (41,138,189). 3 Using various available tools such as making two ink marks at opposite edges of the lipohypertrophy allows the lipo to be measured and its size recorded for long-term follow up. If visible the area of lipohypertrophy could also be photographed for the same purpose (189). STRONGLY RECOMMENDED RECOMMENDED UNRESOLVED ISSUE At least one randomised controlled study At least one non-randomised (or non-controlled or epidemiologic) study Consensus expert opinion based on extensive patient experience. 14.0 Bleeding and Bruising 4 Individuals should be advised (and rationale explained) not to inject into areas of lipohypertrophy until abnormal tissue returns to normal (which can take months to years). (139,140,189). 6 Caution is needed; too great a reduction in dose could lead to an increased risk of Diabetic Ketoacidosis in people with Type 1 Diabetes. However, too small a reduction could result in hypoglycaemia. 1 Individuals should be reassured that bleeding and bruising do not appear to have adverse clinical consequences for the absorption or action of injectable therapies. (149,150) 5 Switching injections from areas of lipohypertrophy to normal tissue often requires a decrease of the dose of insulin injected. The amount of change varies from one individual to another and should be guided by frequent blood glucose measurements. (50,140,189) 7 The best current preventative and therapeutic strategies for lipohypertrophy include rotation of injection sites with each injection, and non-reuse of needles. (136,137,139,141143,189) 2 If persistent bruising occurs review injection technique. Do not reuse. Figure 5: Examples of lipohypertrophy Lipoatrophy, although very rare, is a wasting of the subcutaneous tissue at injection sites. Injecting into these sites should be avoided. Figure 6: Cluster of injection punctures. 25 THE INJECTION TECHNIQUE RECOMMENDATIONS 15.0 Pregnancy 1 Due to the paucity of evidence regarding insulin injection technique during pregnancy, the following recommendations are based upon available research and clinical experience.(168,169) During pregnancy, questions often arise from women regarding why, where and how insulin is used. The initial concerns of the mother regarding the effect of insulin injections or infusion on the foetus must be explored, to facilitate medication adherence. Ease of use and safety issues (e.g. hypoglycaemia) should also be discussed.(170) 26 DATE PUBLISHED: September 2015 * data on file 15.1 Recommendations 1 Education regarding insulin use during pregnancy is essential for all pre-gestational women, and women with gestational diabetes who require insulin. This education should include discussion of the psychological adjustment to insulin use, changes to insulin requirements during pregnancy, appropriate injection sites and their rotation, and prevention of hypoglycaemia. 2 Shorter needles (4 mm or 5 mm) should be used to decrease the potential for intramuscular injection. (171-174) STRONGLY RECOMMENDED RECOMMENDED UNRESOLVED ISSUE At least one randomised controlled study At least one non-randomised (or non-controlled or epidemiologic) study Consensus expert opinion based on extensive patient experience. 16.0 Safety Issues 1 Sharp devices represent a risk for the transmission of bloodborne pathogens to the user in the event of a needle stick injury (NSI) or muco-cutaneous blood exposure.(175) 2 The priority for employers must be to secure the safest possible workplace. The Management of Health and Safety at Work Regulations 1999 make it a legal requirement for employers to carry out risk assessment of their activities. This should identify the measures they need to have in place to comply with their duties under health and safety. This should be achieved through a combination of awareness raising, information, risk assessment, preventing or controlling the risk, safe disposal of sharps and reporting incidents. See figures 1 & 2 page 29. (176) 3 In accordance with a new EU Directive and its transpositions into member-state legislation, use of sharps (Clause 3: definition 4) must be carried out using safety engineered devices where available. (177) This obligation covers all sharps used in diabetes management in the hospital and healthcare sector e.g. settings both private and public where healthcare takes place and might include; hospital, primary care, ambulances, care homes, schools, prisons, nurseries, caregivers in home settings, etc. (178-191) 4 The use of safety engineered devices where available should be considered for people with diabetes who self care, e.g. those known to be positive for HIV, HBV and HCV. Where there are vulnerable people within the household of someone with diabetes, safety engineered devices should be made available. This also includes those who have limited access to safe sharps disposal. 27 THE INJECTION TECHNIQUE RECOMMENDATIONS 16.0 Safety Issues Continued 5 When introduced into healthcare settings where a culture of safety has been fostered and appropriate training given, safetyengineered devices can significantly and sustainably decrease the incidence of NSI. (180-185) 6 Any health care setting which uses insulin pens must follow a strict one-patient/one-pen policy. (178,186) 7 When syringes are used, only safety-engineered ones must be accepted and the protective mechanism must be integral to the device.(187) Click here to read FIT4Safety 28 DATE PUBLISHED: September 2015 * data on file 8 All persons at risk must receive appropriate education and training on ways to minimize risk, including the importance of following optimal injection or lancing techniques, using available safety engineered devices and using Personal Protective Equipment (e.g. gloves).(188) 9 Healthcare providers must encourage reporting of NSI, near misses and incorrect technique within a ‘no blame’ culture. Central review of these reports must take place regularly to facilitate policy change and assess educational needs. 10 Procedures for what to do in the event of a NSI must be clearly communicated. Formal protocols with named clinical care contacts must be available in all areas where sharps are used. STRONGLY RECOMMENDED RECOMMENDED UNRESOLVED ISSUE At least one randomised controlled study At least one non-randomised (or non-controlled or epidemiologic) study Consensus expert opinion based on extensive patient experience. 16.0 Safety Issues FIGURE 1 Always Events and Safety Compliance Bundle This assessment tool is designed for all clinicians to use in their workplace. If you answer ‘No’ to any statement in the tool then there is a risk which needs to be addressed in your workplace ALWAYS EVENTS – THE PREVENTION OF SHARPS INJURIES Y/N. It is expected that; Y/N All healthcare providers in whatever setting will comply with the EU Council Directive 2010/32/EU by May 2013. All healthcare providers will risk assess the need for safety engineered devices (SED) when utilizing sharps in all scenarios. All users of sharps should be trained and instructed not to re-cap any sharps devices. All healthcare establishments will have in place sharps safety reporting through local governance systems (e.g. Infection Prevention and Control, Occupational Health and Safety, Risk Management et al) to monitor sharps injuries, evaluate potential trends associated with sharps injuries, audit practice, and co-ordinate the trialling and introduction of SED. Users of sharps will be involved in trialling and choosing the SED to be used. Users of SED will be trained how to optimally use and dispose of the device. All users of sharps/SED will be provided with appropriate sharps disposal containers for use at the point of care. All sharps will be disposed of in a safe and appropriate manner. All sharps disposal containers will be collected appropriately and disposed of according to National guidance. All sharps injuries will be reported appropriately through the local reporting system. Reproduced with kind permission of Dr. Debra Adams, January 2012. 29 THE INJECTION TECHNIQUE RECOMMENDATIONS 16.0 Safety Issues FIGURE 2 COMPLIANCE SAFETY STANDARD ALWAYS EVENTS The prevention of sharps injuries score. Alternatively Safety Bundle Approach might be as follows. Healthcare providers are aware of the deadline (May 2013) and the implications associated with EU2010/32. Healthcare providers have risk assessed the need for safety engineered devices (SED) when utilizing sharps in all scenarios e.g. diabetic syringes, vaccinations, needle/syringe, cannulas, suture, lancets, blades etc. Users of sharps are trained to, and do not re-cap any sharps device. SAFETY COMPLIANCE SCORE Scores <100% require an action plan to be developed and implemented. This assessment tool is designed for all clinicians to use in their workplace. If you answer ‘No’ to any statement in the tool then there is a risk which needs to be addressed in your workplace Healthcare providers have developed an Inoculation Injury Review Group (e.g. Infection Prevention and Control, Occupational Health and Safety, Risk Management et al) to monitor NSI, evaluate potential trends associated with NSI, audit practice, and co-ordinate the trialling and introduction of SED. Users of sharps are involvedin trialling and choosing the SED to be used (see Appendix 1 of WISE). Users of “sharps” have been trained in how to optimally operate/activate, and use the SED. Users of sharps/SED have been provided with appropriate sharps disposal containers for use at the point of care. Sharps are disposed of in a safe and appropriate manner. Management policies have been determined to ensure that sharps disposal containers are collected promptly and are disposed of according to National guidance. Home users are informed of how sharps disposal containers should be stored in the home and how disposal of the boxes may be actioned. All sharps injuries will be reported appropriately through the local reporting system. 30 DATE PUBLISHED: September 2015 * data on file Y/N STRONGLY RECOMMENDED RECOMMENDED UNRESOLVED ISSUE At least one randomised controlled study At least one non-randomised (or non-controlled or epidemiologic) study Consensus expert opinion based on extensive patient experience. 17.0 Disposal of injecting material 1 All HCPs and individuals/ carers should be aware of local regulations regarding sharps disposal. HCPs and individuals/ carers should be made aware of the consequences of inappropriate disposal of sharps (e.g. needle stick injuries to others such as refuse workers). (154) 5 Under no circumstance should sharps material be disposed of into the public rubbish or household refuse system. 6 Empty pen devices can be disposed of in the normal house hold refuse when the needle is removed. 2 Correct disposal should be taught to people with diabetes from the beginning of injection therapy and reinforced throughout. 3 Where available, a needle clipping device could be used. It can be carried in the injection kit. 4 Sharps guard (sharps box) is available on FP10. However, disposal is according to local policy. Figure 9. All needles should be disposed of in an approved sharps container after use 31 THE INJECTION TECHNIQUE RECOMMENDATIONS References 1 Partanen TM, Rissanen A. Injectable therapy injection practices, Pract Diabetes Int 2000;17:252-254. 2 Strauss K, De Gols H, Hannet I, Partanen TM, Frid A. A pan-European epidemiologic study of injectable therapy injection technique in people with diabetes with diabetes. 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Effects of the anatomical region used for injectable therapy injections on glycaemia in type 1 diabetes subjects. Diabetes Care 1993;16:1592-1597. 54 Overland J, Molyneaux L, Tewari S., et al. Lipohypertrophy: Does it matter in daily life? A study using a continuous glucose monitoring system. Diabetes, Obes Metab 2009;11:460-3. 32 Davidson M. No need for the needle (at first). Diabetes Care 2008;31:2070-2071. 44 55 33 Reach G. Patient non-adherence and healthcare-provider inertia are clinical myopia. Diabetes Metab 2008;34:382-385. Frid A, Lindén B. Intraregional differences in the absorption of unmodified injectable therapy from the abdominal wall. Diabetic Medicine 1992;9:236-239. 45 Koivisto VA, Felig P. Alterations in injectable therapy absorption and in blood glucose control associated with varying injectable therapy injection sites in diabetic people with diabetes. Annals of Internal Medicine 1980;92:59-61. Frid A, Linden B. Computed tomography of injection sites in people with diabetes with diabetes mellitus. In: Injection and Absorption of Injectable therapy. Thesis, Stockholm, 1992. 56 Gorman KC. Good hygiene versus alcohol swabs before injectable therapy injections (Letter). Diabetes Care 1993;16:960-961. 57 Le Floch JP, Herbreteau C, Lange F, Perlemuter L. Biologic material in needles and cartridges after injectable therapy injection with a pen in diabetic people with diabetes. Diabetes Care 1998;21:1502-1504. 58 McCarthy JA, Covarrubias B, Sink P. Is the traditional alcohol wipe necessary before an injectable therapy injection? Dogma disputed (Letter). Diabetes Care 1993;16:402. 59 Schuler G, Pelz K, Kerp L. Is the reuse of needles for injectable therapy injection systems associated with a higher risk of cutaneous complications? Diabetes Research and Clinical Practice 1992;16:209-212. 60 Swahn Å. 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Injectable therapy delivery using pen devices. Simple-touse tools may help young and old alike. Postgraduate Medicine 1999;106:57-58. 37 Bärtsch U, Comtesse C, Wetekam B. Injectable therapy Pen Devices for treatment of diabetes (article in German). Ther Umsch 2006;63:398-404. 38 Heinemann L, Hompesch M, Kapitza C, Harvey NG, Ginsberg BH, Pettis RJ. Intra-dermal injectable therapy lispro application with a new microneedle delivery system led to a substantially more rapid injectable therapy absorption than subcutaneous injection. Diabetologia 2006;49:755, abstract 1014. 39 DiMatteo RM, DiNicola DD. Achieving patient compliance. In The psychology of medical practitioner´s role. Pergamon Press Inc. Oxford 1982. 40 Joy SV. Clinical pearls and strategies to optimize patient outcomes. Diabetes Educ 2008;34:54S-59S. 41 Seyoum B, Abdulkadir J. Systematic inspection of injectable therapy injection sites for local complications related to incorrect injection technique. Trop Doct 1996;26:159-161. 42 Loveman E, Frampton G, Clegg A. The clinical effectiveness of diabetes education models for type 2 diabetes. Health Technology Assessment 2008;12:1-36. 46 Annersten M, Willman A. Performing subcutaneous injections: a literature review. Worldviews on Evidence-Based Nursing 2005; 2:122-130. 47 Vidal M, Colungo C, Jansà M. Actualización sobre técnicas y sistemas de administración de la injectable therapya (I). [Update on injectable therapy administration techniques and devices (I)]. Av Diabetol 2008;24:175-190. 48 Fleming D, Jacober SJ, Vanderberg M, Fitzgerald JT, Grunberger G. The safety of injecting injectable therapy through clothing. Diabetes Care 1997;20:244-247. 49 Ariza-Andraca CR, Altamirano-Bustamante E, Frati-Munari AC, Altamirano-Bustamante P, Graef-Sanchez A. Delayed injectable therapy absorption due to subcutaneous edema. Archivos de Investigación Medica 1991;22:229-233. 50 Saez-de Ibarra L, Gallego F. Factors related to lipohypertrophy in injectable therapytreated diabetic people with diabetes; role of educational intervention. Practical Diabetes International 1998;15:9-11. 51 Young RJ, Hannan WJ, Frier BM, Steel JM, et al. Diabetic lipohypertrophy delays injectable therapy absorption. Diabetes Care 1984;7:479-480. 52 Chowdhury TA, Escudier V. Poor glycaemic control caused by injectable therapy induced lipohypertrophy. BMJ 2003;327:383-384. 53 Johansson UB. Impaired absorption of injectable therapy aspart from lipohypertrophic injection sites. Diabetes Care 2005;28:2025-7. 33 THE INJECTION TECHNIQUE RECOMMENDATIONS 65 Springs MH. Shake, rattle, or roll?...”Challenging traditional injectable therapy injection practices” American Journal of Nursing 1999;99:14. 66 Ahern J, Mazur ML. Site rotation. Diabetes Forecast 2001;54:66-68. 67 68 69 Perriello G, Torlone E, Di Santo S. Fanelli C. De Feo P. Santusanio F. Brunetti P, Bolli GB. Effect of storage temperature on pharmacokinetics and pharmadynamics of injectable therapy mixtures injected subcutaneously in subjects with type 1 (injectable therapy-dependent) diabetes mellitus. Diabetologia 1988;31:811 -815. Ginsberg BH. Parkes JL, Sparacino C. The kinetics of injectable therapy administration by injectable therapy Pen Devices. Horm Metab Research 1994;26:584-587. Ezzo J. Donner T, Nickols D, Cox M. Is Massage Useful in the Management of Diabetes? A Systematic Review. Diabetes Spectrum 2001;14:218-224. 71 Annersten M, Frid A. Injectable therapy Pen Devices dribble from the tip of the needle after injection. Practical Diabetes International 2000;17:109-111. 73 74 Rissler J, Jørgensen C, Rye Hansen M, Hansen NA. Evaluation of the injection force dynamics of a modified prefilled injectable therapy pen. Expert Opin Pharmacother 2008;9:2217-22. 79 Broadway CA. 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Infusystems International 2006;5:17-19. Byetta Pen User Manual. Eli Lilly and Company, 2007. 84 Bärtsch U, Comtesse C, Wetekam B. Injectable therapy Pen Devices for treatment of diabetes (article in German). Ther Umsch 2006;63:398-404. Guerci B, Sauvanet JP. Subcutaneous injectable therapy: pharmacokinetic variability and glycemic variability. Diabetes Metab 2005;31:4S7-4S24. 85 Braakter EW, Woodworth JR, Bianchi R. Cermele B. Erkelens DW. Thijssen JH, Kurtz D. Injection site effects on the pharmacokinetics and glucodynamics of injectable therapy lispro and regular injectable therapy. Diabetes Care 1996;19:1437-1440. Jamal R, Ross SA, Parkes JL, Pardo S, Ginsberg BH. Role of injection technique in use of injectable therapy Pen Devices: prospective evaluation of a 31-gauge, 8mm injectable therapy pen needle. Endocr Pract 1999;5:245-50. 75 Chantelau E. Heinemann L, Ross D. Air Bubbles in injectable therapy Pen Devices. Lancet 1989;334:387-388. 76 Maljaars C. 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An angled insertion technique using 6mm needles markedly reduces the risk of IM injections in children and adolescents. Diabet Med 2007;24:1400-5. 115 Polak M, Beregszaszi M, Belarbi N, Benali K, Hassan M, Czernichow P, TubianaRufi N. Subcutaneous or intramuscular injections of injectable therapy in children. Are we injecting where we think we are? Diabetes Care 1996; 19:1434-1436. 116 Strauss K, Hannet I, McGonigle J, Parkes JL, Ginsberg B, Jamal R, Frid A. Ultrashort (5mm) injectable therapy needles: trial results and clinical recommendations. Practical Diabetes 1999;16:218-222. 117 Tubiana-Rufi N, Belarbi N, Du PasquierFediaevsky L, Polak M, Kakou B, Leridon L, Hassan M, Czernichow P. Short needles (8 mm) reduce the risk of intramuscular injections in children with type 1 diabetes. Diabetes Care 1999;22:1621-5. 118 Chiarelli F, Severi F, Damacco F, Vanelli M, Lytzen L, Coronel G. Injectable therapy leakage and pain perception in IDDM children and adolescents, where the injections are performed with NovoFine 6 mm needles and NovoFine 8 mm needles. Abstract presented at FEND, Jerusalem, Israel. 2000. 119 Ross SA, Jamal R, Leiter LA, Josse RG, Parkes JL, Qu S, Kerestan SP, Ginsberg BH. Evaluation of 8 mm injectable therapy pen needles in people with type 1 and type 2 diabetes. Practical Diabetes International 1999;16:145-148. 120 Strauss K. Injectable therapy injection techniques. Practical Diabetes International 1998;15:181-184. 121 Thow JC, Coulthard A, Home PD. Injectable therapy injection site tissue depths and localisation of a simulated injectable therapy bolus using a novel air contrast ultrasonographic technique in injectable therapy treated diabetic subjects. Diabetic Medicine 1992;9:915-920. 122 Thow JC, Home PD. Injectable therapy injection technique: depth of injection is important. BMJ 1990;301:3-4. 123 Hildebrandt P. Skinfold thickness, local subcutaneous blood flow and injectable therapy absorption in diabetic people with diabetes. Acta Physiol Scand 1991;603:41-45. 124 Vora JP, Peters JR, Burch A, Owens DR. Relationship between Absorption of Radiolabeled Soluble Injectable therapy Subcutaneous Blood Flow, and Anthropometry. Diabetes Care 1992;15:1484-1493. 125 Laurent A, Mistretta F, Bottigioli D, Dahel K, Goujon C, Nicolas JF, Hennino A, Laurent PE. Echographic measurement of skin thickness in adults by high frequency ultrasound to assess the appropriate microneedle length for intradermal delivery of vaccines. Vaccine 2007;25:6423-30. 126 Lasagni C, Seidenari S. Echographic assessment of age-dependent variations of skin thickness. Skin Research and Technology 1995;1:81-85. 35 THE INJECTION TECHNIQUE RECOMMENDATIONS 127 Swindle LD, Thomas SG, Freeman M, Delaney PM. View of Normal Human Skin In Vivo as Observed Using Fluorescent Fiber-Optic Confocal Microscopic Imaging. Journal of Investigative Dermatology 2003;121:706–712. 128 Huzaira M, Rius F, Rajadhyaksha M, Anderson RR, González S. Topographic Variations in Normal Skin, as Viewed by In Vivo Reflectance Confocal Microscopy. Journal of Investigative Dermatology 2001;116:846–852. 129 Tan CY, Statham B, Marks R, Payne PA. Skin thickness measured by pulsed ultrasound: its reproducibility, validation and variability. Br J Dermatol 1982;106:657-67. 130 Solvig J, Christiansen JS, Hansen B, Lytzen L. Localisation of potential injectable therapy deposition in normal weight and obese people with diabetes with diabetes using Novofine 6 mm and Novofine 12 mm needles. Abstract FEND, Jerusalem, Israel, 2000. 131 Frid A, Lindén B. Where do lean diabetics inject their injectable therapy? A study using computed tomography. BMJ 1986;292:1638. 132 Frid A, Lindén B. CT scanning of injections sites in 24 diabetic people with diabetes after injection of contrast medium using 8 mm needles (Abstract). Diabetes 1996;45:A444. 133 Thow JC, Johnson AB, Marsden S, Taylor R, Home PH. Morphology of palpably abnormal injection sites and effects on absorption of isophane (NPH) injectable therapy. Diabetic Medicine 1990;7: 795-799. 134 Richardson T, Kerr D. Skin-related complications of injectable therapy therapy: epidemiology and emerging management strategies. American J Clinical Dermatol 2003;4:661-667. 135 Photographs courtesy of Lourdes Saez-de Ibarra and Ruth Gaspar, Diabetes Nurses and Specialist Educators from La Paz Hospital, Madrid, Spain. 136 Nielsen BB, Musaeus L, Gæde P, Steno Diabetes Center, Copenhagen, Denmark. Attention to injection technique is associated with a lower frequency of lipohypertrophy in injectable therapy treated type 2 diabetic people with diabetes. Abstract EASD, Barcelona, Spain, 1998. 36 DATE PUBLISHED: September 2015 * data on file 137 Vardar B, Kizilci S. Incidence of lipohypertrophy in diabetic people with diabetes and a study of influencing factors. Diabetes Res Clin Pract 2007;77:231-6. 149 Kahara T Kawara S. Shimizu A, Hisada A, Noto Y, Kida H. Subcutaneous hematoma due to frequent injectable therapy injections in a single site. Intern Med 2004;43:148-149. 138 Teft G. Lipohypertrophy: patient awareness and implications for practice. Journal of Diabetes Nursing 2002;6:20-23. 150 Kreugel G, Beter HJM, Kerstens MN, Maaten ter JC, Sluiter WJ, Boot BS. Influence of needle size on metabolic control and patient acceptance. European Diabetes Nursing 2007;4:51-55. 139 Hambridge K. The management of lipohypertrophy in diabetes care. Br J Nurs 2007;16:520-524. 140 Jansà M, Colungo C, Vidal M. Actualisación sobre técnicas y sistemas de administración de la injectable therapya (II). [Update on injectable therapy administration techniques and devices (II)]. Av Diabetol 2008;24:255-269. 141 Ampudia-Blasco J, Girbes J, Carmena R. A case of lipoatrophy with injectable therapy glargine. Diabetes Care 2005;28: 2983. 142 De Villiers FP. Lipohypertrophy - a complication of injectable therapy injections. S Afr Med J 2005;95:858-9. 143 Hauner H, Stockamp B, Haastert B. Prevalence of lipohypertrophy in injectable therapy-treated diabetic people with diabetes and predisposing factors. Exp Clin Endocrinol Diabetes 1996; 104:106-10. 144 Bantle JP, Weber MS, Rao SM, Chattopadhyay MK, Robertson RP. Rotation of the anatomic regions used for injectable therapy injections day-to-day variability of plasma glucose in type 1 diabetic subjects. JAMA 1990;263: 1802-1806. 145 Davis ED, Chesnaky P. Site rotation... taking injectable therapy. Diabetes Forecast 1992;45:54-56. 146 Lumber T. Tips for site rotation. When it comes to injectable therapy. where you inject is just as important as how much and when. Diabetes Forecast 2004;57:68-70. 147 Thatcher G. Injectable therapy injections. The case against random rotation. American Journal of Nursing 1985;85:690-692. 148 Diagrams courtesy of Lourdes Saez-de Ibarra and Ruth Gaspar, Diabetes Nurses and Specialist Educators from La Paz Hospital, Madrid, Spain. 151 Engström L, Jinnerot H, Jonasson E. Thickness of Subcutaneous Fat Tissue Where Pregnant Diabetics Inject Their Injectable therapy - An Ultrasound Study. Poster at IDF 17th World Diabetes Congress, Mexico City, 2000. 152 Smith DR, Leggat PA. Needlestick and sharps injuries among nursing students. J Adv Nurs 2005;51:449-55. 153 Adams D, Elliott TS. Impact of safety needle devices on occupationally acquired needlestick injuries: a fouryear prospective study. J Hosp Infect 2006;64:50-5. 154 Workman RGN. Safe injection techniques. Primary Health Care 2000;10:43-50. 155 Bain A, Graham A. How do people with diabetes dispose of syringes? Practical Diabetes International 1998;15:19-21. 156 Gibney MA, Arce CH, Byron KJ, Hirsch LJ. Skin and subcutaneous adipose layer thickness in adults with diabetes at sites used for injectable therapy injections: Implications for needle length recommendations. In press. Curr Med Res Opin. 157 Hirsch L, Klaff L, Bailey T, Gibney M, Albanese J, Qu S, Kassler-Taub K. Glycemic control, safety and patient ratings for a new 4 mm x 32G pen needle versus 5 mm and 8 mm x 31G pen needles in adults with diabetes. In press. Curr Med Res Opin 158 Cochran E, Musso C & Gorden P. The use of U-500 in patients with extreme insulin resistance. Diabetes Care. May 2005 vol. 28 no. 5 1240-1244 159 De Coninck C., Frid A., Gaspar R., Hicks D., Hirsch L., Kreugel G., Liersch J., Letondeur C., Sauvanet J-P., Tubiana N., Strauss K. Results and analysis of the 2008-2009 Insulin Injection Technique Questionnaire survey. Journal of Diabetes 2 (2010) 168-179 160 Kostev Insulin Therapy in Type 2 Diabetes: A Reflection Upon the State of the Art Today, and the Potential Journeys yet to Come The American Journal of Medicine Volume 127, Issue 10, Supplement, October 2014, Pages S39– S48 161 Hirsch 2014., Laurence Hirsch, MD, Karen Byron, MS, and Michael Gibney, RN, MA. Intramuscular Risk at Insulin Injection Sites—Measurement of the Distance from Skin to Muscle and Rationale for Shorter-Length Needles for Subcutaneous Insulin Therapy. DIABETES TECHNOLOGY & THERAPEUTICS Volume 16, Number 12, 2014 162 Lo Presti D, Ingegnosi C, Strauss K. Skin and subcutaneous thickness at injecting sites in children with diabetes: ultrasound findings and injecting recommendations. Pediatric Diabetes, 2012. Volume 13, Issue 7, pages 525–533 163 Thow JC, Johnson AB, Fulcher G, et al.: Different absorption of isophane (NPH) insulin from subcutaneous and intramuscular sites suggests a need to reassess recommended insulin injection technique. Diabet Med 1990;7:600–602. 164 Karges B, Boehm BO, Karges W: Early hypoglycaemia after accidental intramuscular injection of insulin glargine. Diabet Med 2005;22:1444–1445. 165 Vaag A, Handberg A, Lauritzen M, et al.: Variation in absorption of NPH insulin due to intramuscular injection. Diabetes Care 1990;13:74–76. 166 Vaag A, Damgaard Pedersen K, Lauritzen M, et al.: Intramuscular versus subcutaneous injection of unmodified insulin; consequences for blood glucose control in patients with type 1 diabetes mellitus. Diabet Med 1990;7:335–342. 167 Frid A, Ostman J, Linde B: Hypoglycemia risk during exercise after intramuscular injection of insulin in thigh in IDDM. Diabetes Care 1990;13:473–477. 168 Kreugel G, Beijer HJM, Kerstein MN, et al. Influence of needle size for SC injectable therapy administration on metabolic control and patient acceptance. Eur Diabetes Nurs. 2007;4:1-5. 169 Kahara T, Kawara S, Shimizu A, et al. Subcutaneous hematoma due to frequent insulin injections in a single site. Intern Med. 2004;43:148-149. 170 de Valk H, Visser GH. Insulin during pregnancy, labour and delivery. Best Pract Res Clin Obstet Gynaecol. 2011;25:65-76. 171 Gibney MA, Aarce CH, Byron KJet al. Skin and subcutaneous adipose layer thickness in adults with diabetes at sites used for injectable therapy injections: implications for needle length recommendations. Curr Med Res Opin. 2010;26:1519-1530. 172 Laurent A, Mistretta F, Dottigioli D, et al. Echographic measurement of skin thickness in adults by high frequency ultrasound to assess the appropriate microneedle length for intradermal delivery of vaccines. Vaccine. 2007;25:6423-6430. 173 Tan CY, Statham B, Marks R, et al. Skin thickness measured by pulsed ultrasound: its reproducibility, validation and variability. Br J Dermatol. 1982;106:657-667. 174 Vora JP, Peters JR, Burch A, et al. Relationship between absorption of radiolabeled soluble insulin subcutaneous blood flow and anthropometry. Diabetes Care. 1992;15:1484-1493. 175 EU Commission for Employment, Social Affairs and Inclusion, New legislation to reduce injuries for 3.5 million healthcare workers in Europe, 8th March 2010. 176 http://www.hse.gov.uk/healthservices/ needlesticks/resources.htm) 177 EU Commission for Employment, Social Affairs and Inclusion, New legislation to reduce injuries for 3.5 million healthcare workers in Europe, 8th March 2010. 178 Article 3.2 says that where risk cannot be eliminated the employer shall take appropriate measures to minimise the risks. Appropriate measures to minimise the risks would include the provision by employers of safer needle devices. (Cf. NHS Employers, Implementation advice on sharps agreement, 12th October 2010) The Directive specifically requires: “eliminating the unnecessary use of sharps by implementing changes in practice and on the basis of the results of the risk assessment, providing medical devices incorporating safety-engineered protection mechanisms”. Council Directive 2010/32/EU, Official Journal of the European Union, L134/71 and Council Directive 2010/32/EU, Official Journal of the European Union, L134/69. 179 Adams D, Elliott TSJ. Impact of safety needle devices on occupationally acquired needle stick injuries: a fouryear prospective study. J Hosp Infect 2006;64:50- 5. 180 arantola A, Golliot F, Astagneau P, Fleury L, Brucker G, Bouvet E; CCLIN Paris- Nord Blood and Body Fluids (BBF) Exposure Surveillance Taskforce. Four-year surveillance from the Northern France network, Am J Infect Control. 2003;31:357- 63. 181 Cullen BL, Genasi F, Symington I et al. Potential for reported needlestick injury prevention among healthcare workers in NHS Scotland through safety device usage and improvement of guideline adherence: an expert panel assessment. J Hosp Infect 2006;63:445- 51. 182 Mendelson MH, Lin- Chen BY, FinkelsteinBlond L, Bailey E, Kogan G. Evaluation of a Safety IV Catheter (IVC) (Becton Dickinson, INSYTE™ AUTOGUARD™): Final Report Eleventh Annual Scientific Meeting Society for Healthcare Epidemiology of America, 2001 SHEA, Toronto, Canada. 183 Louis N, Vela G, Groupe Projet. Évaluation de l’effi cacité d’une mesure de prévention des accidents d’exposition au sang au cours du prélèvement de sang veineux. Bulletin Épidémiologique Hebdomadaire 2002;51:260- 1. 184 Lamontagne F, Abiteboul D, Lolom I, Pellissier G, Tarantola A, Descamps JM, Bouvet E. Role of safety-engineered devices in preventing needlestick injuries in 32 French hospitals. Infect Control Hosp Epidemiol 2007;28:18- 23. 185 Tuma SJ, Sepkowitz KA. Efficacy of Safetyengineered device implementation in the prevention of percutaneous injuries: a review of published studies. Clin Infect Dis 2006;42:1159- 70. 186 Sonoki K, Yoshinari M, Iwase M, Tashiro K, Iino K, Wakisaka M, et al. Regurgitation of blood into insulin cartridges in the pen-like injectors. Diabetes Care 2001;24:603- 4. 187 Adams D, Elliott TSJ. A comparative user evaluation of three needle protective devices. Br J Nurs 2003;12:470-4. 37 THE INJECTION TECHNIQUE RECOMMENDATIONS 188 Jagger J, Perry J, Gomaa A, Phillips EK. The impact of U.S. policies to protect healthcare workers from bloodborne pathogens: The critical role of safetyengineered devices. J Infect Pub Health 2008;1:62- 71. 189 Blanco M,. Hernández M.T., Strauss K,. Amaya M. Prevalence and risk factors of lipohypertrophy in insulin-injecting patients with diabetes. Diabetes & Metabolism 39 (2013) 445–453 190 Giorgio Grassi, MD, Paola Scuntero, RN , Rosalba Trepiccioni, RN,Francesca Marubbi, PhD, Kenneth Strauss, MD. Optimizing insulin injection technique and its effect on blood glucose control. Journal of Clinical & Translational Endocrinology. Journal of Clinical & Translational Endocrinology. 2014. 1: p145-150 191 Council Directive 2010/32/EU, Official Journal of the European Union, L134/71, http://eurlex.europa.eu/ LexUriServ/LexUriServ.do?uri=OJ: L:2010:134:0066:0072:EN:PDF. 192 Diabetes facts and stats. Version 4. Revised: May 2015. Next Review: September 2015. Diabetes UK. https:// www.diabetes.org.uk/Documents/ Position%20statements/Facts%20and%20 stats%20June%202015.pdf 38 DATE PUBLISHED: September 2015 * data on file Contributors NURSE CONSULTANT DIABETES, RETIRED FIT BOARD MEMBER ELAINE ADAMS CERYS AKARCA JO BAKER ISABELLE BANE RHONDA BLEAKLY SIAN BODMAN DEBBY BREWER DEBBIE CALLAND HILARY CASKEY HELEN CARTER LYNN CARTWRIGHT LINDA CLAPHAM ALISON CLARKE HEIDI CLARKE PENNY CLARKE PATRICIA CLAWSON LOUISE COLLINS MICHELE COLLOBY REBECCA COOK JANE COOK RUTH COOK PETER DAVIES CLAIRE DRAKE LESLEY DRUMMOND SIAN FITZGERALD ANNA FOLLETT MARY GLASS FIONA JAMISON SUE JONES LIZ KAMPS KIM KEAR LISA KING LESLEY LAMEN SARAH LEA JILL LITTLE BREID MCGIRR OONAGH MCGLONE DAMIEN MCHUGH HELENA MCKEEVER MARGARET MCNEILL DR. D. MILLAR JONES JANICE MOSES CAROL NAYLOR DEB NOLAN SUSAN NYIKA GEORGINA PARISI HEATHER REED SUE ROBSON SAM ROSINDALE GWENDOLINE SEWELL TERRI SHARP KATE SLOWEY ANGELA STUBBS SIMONA TULUC LOUISE TYLER CLAIRE VICK JENNI WALLACE MARINA WALSON SUE WALTERS SIAN WARD JACKIE WEBB ADELE WEST SHARON WILSON LYNDI WILTSHIRE ANDREW WOODBURN - DRAYTON LYNN WOOLWAY HILARY YULE COMMUNITY DIABETIC SPECIALIST NURSE COMMUNITY DIABETES SPECIALIST NURSE CHILDREN’S DIABETES SPECIALIST NURSE COMMUNITY DIABETES SPECIALIST NURSE DIABETES NURSE SPECIALIST LEAD NURSE DIABETES, COMMUNITY DIVISION DIABETES SPECIALIST NURSE PATHWAY LEAD DIABETES SPECIALIST NURSE DIABETES NURSE SPECIALIST DIABETES SPECIALIST NURSE PRACTICE NURSE DIABETES NURSE SPECIALIST/CENTRE MANAGER DIABETES SPECIALIST NURSE COMMUNITY DIABETIC SPECIALIST NURSE DIABETES SPECIALIST NURSE DIABETES SPECIALIST NURSE PAEDIATRIC DIABETES SPECIALIST NURSE DIABETES SPECIALIST NURSE LEAD DIABETES INPATIENT SPECIALIST NURSE LEAD DIABETES NURSE DIABETES SPECIALIST NURSE CONSULTANT IN DIABETES & ENDOCRINOLOGY CHILDREN’S DIABETES SPECIALIST NURSE LEAD DIABETES CLINICAL NURSE SPECIALIST DIABETES SPECIALIST NURSE COMMUNITY DIABETIC SPECIALIST NURSE DIABETES SPECIALIST NURSE DIABETES SPECIALIST NURSE LEAD NURSE FOR DIABETES DIABETES SPECIALIST NURSE CHILDREN’S DIABETES SPECIALIST NURSE DIABETES SPECIALIST NURSE DIABETES INPATIENT SPECIALIST NURSE & DIABETES SPECIALIST NURSE DIABETES SPECIALIST NURSE DIABETES SPECIALIST NURSE DIABETES SPECIALIST NURSE DIABETES SPECIALIST NURSE PAEDIATRIC DIABETES SPECIALIST NURSE DIABETES SPECIALIST NURSE DIABETES SPECIALIST NURSE DOCTOR/GP DIABETES SPECIALIST NURSE NURSE PRACTITIONER DIABETIC INPATIENT SPECIALIST NURSE DIABETES SPECIALIST NURSE COMMUNITY DIABETES SPECIALIST NURSE DIABETES SPECIALIST NURSE DIABETES NURSE SPECIALIST DIABETES LEAD CHAMPION FOR TORBAY & SOUTHERN DEVON TEAM LEADER/ CHILDREN’S DIABETES NURSE SPECIALIST DIABETES NURSE PRACTITIONER DIABETES SPECIALIST NURSE COMMUNITY DIABETES SPECIALIST NURSE DIABETES SPECIALIST NURSE DIABETES SPECIALIST NURSE LEAD DIABETES SPECIALIST NURSE DIABETES SPECIALIST NURSE CHILDREN’S DIABETES SPECIALIST NURSE CHILDREN’S DIABETES SPECIALIST NURSE DIABETES SPECIALIST NURSE LEAD DIABETES SPECIALIST NURSE DIABETES IN-PATIENT SPECIALIST NURSE DIABETES SPECIALIST NURSE HEAD OF DIABETES CARE ACUTE MEDICINE UNIT CHARGE NURSE DIABETES SPECIALIST NURSE DIABETES SPECIALIST NURSE DR AF T All contributors who reviewed this document were professional clinicians or people with a special interest in diabetes in the UK SU DOWN Optimising Diabetes Care www.fit4diabetes.com