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Introduction The aim of this randomized controlled trial was to assess the impact of providing intensive injection technique (IT) education to patients routinely injecting insulin into sites of lipohypertrophy (LH). Methods Between November 2016 and May 2018, insulin-injecting patients with LH treated at Tianjin Metabolism Hospital (a public tertiary medical institution), Tianjin, China, were included in a 6-month prospective randomized controlled trial and randomized into either the intervention (the IT-education group) or the control (control group) arm. The control and IT-education groups were seen by different groups of trained nurses on different clinic days. IT education emphasized moving injections to normal tissue sites, within-and between-site injection rotation, an initial reduction of insulin total daily dose (TDD), and stopping needle reuse. Needles were provided to the IT group, while controls acquired needles in their usual way. Differences in changes in glycated hemoglobin (HbA1c) and insulin TDD were the primary and main secondary endpoints, respectively. Results The control (n = 104) and IT-education (N = 106) groups had similar demographic parameters (97% with type 2 diabetes) and baseline IT behavior. HbA1c reduction was similar in the IT-education and control group in the intention-to-treat (ITT) analysis (6-month between-group difference 0.16% [1.7 mmol/mol], 95% confidence interval [CI] − 0.11, 0.43 [− 1.2, 4.7]; p = 0.239) but was significant by the per-protocol (PP) analysis (difference 0.31% [3.4 mmol/mol], 95% CI 0.02, 0.60 [0.2, 6.6]; p = 0.038). Changes in TDD insulin in the IT-education group were approximately − 7 and − 8 IU by the ITT and PP analyses, respectively, versus − 1 IU (nonsignificant) in the controls (both between-group differences p ≤ 0.05). Despite the study design, IT education “contamination” (unplanned adoption of IT-intervention behaviors) was documented in 63 control patients. By post hoc analyses, HbA1c in “contaminated” controls decreased by 0.70% (7.7 mmol/mol) vs. 0.20% (2.2 mmol/mol) in “non-contaminated’ patients (p = 0.019) at 6 months. Conclusions Proper IT, including learning to not inject into sites of LH, proper within- and between site rotation, needle reuse reduction, and the use of 4-mm, 32-G needles in Chinese patients injecting into sites of LH enables a safe reduction of TDD insulin while maintaining overall glycemic control. Trial Registration Trial registration: ChiCTR-IOR-16009270 in the Chinese Clinical Trials Registry. Supplementary Information The online version contains supplementary material available at 10.1007/s13300-021-01013-1.

Approximately 9 million people in China use insulin but little is known of their injection techniques (IT). Our aim was to understand IT in China via direct examination and a detailed survey. Injection Technique Questionnaire (ITQ) results of 3853 patients from 20 representative centers in China were compared with the Rest of World (ROW). Insulin pens are used by 92% of Chinese insulin injectors, with > 3/4 using 4- or 5-mm pen needles. This is consistent with Chinese BMI values (and thus subcutaneous fat thickness) being lower than in ROW, raising the risk of IM (intramuscular) injections with longer needles. Total daily insulin dose is ~ 33 IU in China vs. 45 IU elsewhere. Lipohypertrophy (LH) rates are lower than in ROW, but still found in at least 25% of Chinese patients. Patients apparently do not realize they have LH or are unaware of the hazards of injecting into LH since many of them do so, and those who do use a mean of 11 IU more of insulin than non-LH patients. This incremental insulin use possibly costs the Chinese health care service around 2 billion RMB annually. Needle reuse is also frequent in China (78% vs. 48% ROW), and the high cost of pen needles is the main reason patients cite for reusing (25% use a single needle > 10×). This study reveals many areas in which Chinese professionals and patients can optimize injection practices and thereby improve outcomes and reduce costs. The official guidelines of the Chinese Diabetes Society, based on the FITTER recommendations, offer a roadmap for reaching this goal. BD Diabetes Care. Plain language summary available for this article.

Introduction The 2015 Insulin Injection Technique Questionnaire survey involving 13,289 patients included 898 (6.8%) patients in the pediatric age range (≤ 18 years). Methods The younger patients included in the questionnaire survey were grouped according to age: Group 1 (G1), 0–6 years, n = 85; Group 2(G2), 7–13, n = 423; Group 3 (G3), 14–18, n = 390. The injection technique was evaluated by means of a questionnaire and nurse assessment. Results Nurses found lipohypertrophy at injection sites in 41.3, 45.2, and 47.3% of patients in G1, G2, and G3, respectively. Unexpected hypoglycemia was common, ranging from 23.8 to 48.1% of patients, and glucose variability was even more common (61.0% in G1, 45.9% in G2, and 52.5% in G3); both conditions were associated with lipohypertrophy. While increasing numbers of patients were using the recommended 4-mm needles, large percentages still used longer ones (33.3% in G1, 45.9% in G2, and 61.5% in G3). The reuse of needles was also common, ranging from 21.1 to 32.5% in the three age groups. Excessive reuse, defined as using a single needle more than five times, was reported by 9.4–21.8% of patients in the three age group. The percentages of patients who had not received any injection training in the last 12 months ranged from 21.2 to 26.8% in the three groups. Conclusion Implications of our study are as follows: (1) pediatric patients should use 4-mm pen needles or 6-mm syringes (inserted at a 45° angle); (2) patients aged ≤ 6 years should always inject into a raised skin fold regardless of which device is used; (3) all patients should rotate sites and use needles only once to avoid lipohypertrophy. Funding Becton–Dickinson (BD) diabetes care.

Background: Lipohypertrophy (LH) is highly prevalent and is potentially harmful to insulin-injecting patients. Methods: In this study, we assessed the impact of injection technique (IT) education, including use of a 4-mm pen needle on insulin-treated patients with clinically observed LH in a randomized, controlled, prospective multicenter study in France with follow-up of 6 months. Intensive education and between-visit reinforcement were given to the intervention group. Control patients received similar messages at study outset. Results: A total of 123 patients were recruited (age 52.1 ± 15.7 years; men 70.7%; body mass index >30 kg/m2: 34.2%; type 1: 53.7%; years with diabetes mellitus: 18.1 ± 10.5), of which 109 patients were included in the final analysis. The intervention group (n = 53) showed a significant decrease of total daily dose of insulin (average at baseline: 54.1 IU) at 3 months (T-3) and 6 months (T-6), reaching just over 5 IU versus baseline (P = 0.035). Corresponding, although not significant, decreases occurred in controls (n = 56); between-group differences were not significant. There were significant decreases in HbA1c (up to 0.5%) at T-3 and T-6 in both groups, with no significant differences between groups. A significant number of intervention patients improved their IT habits; about half achieved ideal IT habits by T-3 versus a quarter of control patients. By T-6, 2/3 of intervention patients achieved either ideal or acceptable IT habits, while only 1/3 of control patients did. Conclusions: Our intervention was effective in both study arms, however, to a greater degree and more rapidly in the intervention group. Widespread application of this intervention could be highly cost-effective.

Introduction Using the Indian and rest of world (ROW) injection technique questionnaire (ITQ) data, we address key insulin injection complications. Methods In 2015 we conducted an ITQ survey throughout India involving 1011 patients. Indian values were compared with those from 41 other countries participating in the ITQ, known here as ROW. Results More than a quarter of Indian insulin users described lesions consistent with lipohypertrophy (LH) at their injection sites and approximately 1 in 5 were found to have LH by the examining nurse (using visual inspection and palpation). Just over half of Indian injectors report having pain on injection. Of these, 4 out of 5 report having painful injections only several times a month or year (i.e., not with every injection). Doctors and diabetes educators in India (as opposed to nurses) have a larger role in teaching patients how to inject than they do in ROW. Despite this specialized approach, a very high percentage of patients report that they have not been trained (at least cannot remember being trained) in a wide range of essential injection topics. Only about 30% of Indian injectors get their sites checked at least annually, with nearly a third only having sites checked when they specifically complained and nearly 4 out of 10 never having had their sites checked. Conclusion Indian HCPs can clearly do a better job covering all the vital topics essential to proper injection habits.

IN BRIEF To be consistently effective, insulin must be delivered into subcutaneous tissue. If insulin is delivered intramuscularly, its uptake and action become variably faster, leading to suboptimal, inconsistent glucose control. The best strategy to avoid intramuscular injection is to use the shortest needles available. Injection sites should be rotated systematically to prevent lipohypertrophy, which also substantially affects insulin uptake and action. New evidence-based insulin delivery recommendations are available, and awareness of them should lead to more effective use of insulin therapy, improved clinical outcomes, and considerable cost savings.

Rationale: LH is a common local complication of insulin injection. We conducted a 6-month prospective RCT to assess effects of intensive IT training vs. usual care on HbA1c, TDD insulin, LH lesions, injection behavior and BG variability. Methods: Adult subjects injecting into LH lesions were randomized to usual care (N=104), or intensive IT training (N=106): stop LH injections, lower TDD insulin 10-20%, properly rotate injections within and between sites, and reduce needle reuse. The 2 groups saw different study staff to avoid injection practice contamination in Controls. Results: Subjects were well matched for (mean ± SD) insulin injection duration (7.0 ± 5.0 years); HbA1c (8.5 ± 1.1%); TDD insulin (46.2 ± 21.2 IU); LH lesion count (1.9 ± 0.4), strict correct site rotation (2.9%), and factors such as age, BMI, needle reuse (% and frequency), daily number and sites of injections. Subjects did not perform adequate SBGM to assess BG variability. Due to protocol non-adherence (not lowering TDD in initial IT subjects), and injection behavior contamination in 63 Controls, both ITT and Per Protocol (PP) results are shown. Conclusion: Intensive IT training in subjects who inject into LH lesions can safely lower HbA1c even as TDD insulin is reduced. Conduct of LH RCTs with behavioral education is difficult for both investigators and subjects. Control contamination is likely multi-factorial. Disclosure L. Chen: Research Support; Self; Becton, Dickinson and Company. Q. Xing: Research Support; Self; Becton, Dickinson and Company. J. Li: Research Support; Self; Becton, Dickinson and Company. J. Zhou: Research Support; Self; Becton, Dickinson and Company. Y. Yuan: Employee; Self; Becton, Dickinson and Company. H. Xu: Employee; Self; Becton, Dickinson and Company. Y. Wan: Employee; Self; Becton, Dickinson and Company. B.K. Pflug: Employee; Self; Becton, Dickinson and Company. K. Strauss: Employee; Self; Becton, Dickinson and Company. L. Hirsch: Employee; Self; Becton, Dickinson and Company. Stock/Shareholder; Self; Merck & Co., Inc. Funding Becton, Dickinson and Company

From February 1, 2014, through June 30, 2015, 13,289 insulin-injecting patients from 423 centers in 42 countries took part in one of the largest surveys ever performed in diabetes. The goal was to assess patient characteristics, as well as historical and practical aspects of their injection technique. Results show that 4- and 8-mm needle lengths are each used by nearly 30% of patients and 5- and 6-mm needles each by approximately 20%. Higher consumption of insulin (as measured by total daily dose) is associated with having lipohypertrophy (LH), injecting into LH, leakage from the injection site, and failing to reconstitute cloudy insulin. Glycated hemoglobin values are, on average, 0.5% higher in patients with LH and are significantly higher with incorrect rotation of sites and with needle reuse. Glycated hemoglobin values are lower in patients who distribute their injections over larger injection areas and whose sites are inspected routinely. The frequencies of unexpected hypoglycemia and glucose variability are significantly higher in those with LH, those injecting into LH, those who incorrectly rotate sites, and those who reuse needles. Needles associated with diabetes treatment are the most commonly used medical sharps in the world. However, correct disposal of sharps after use is critically suboptimal. Many used sharps end up in public trash and constitute a major accidental needlestick risk. Use of these data should stimulate renewed interest in and commitment to optimizing injection practices in patients with diabetes.

Many primary care professionals manage injection or infusion therapies in patients with diabetes. Few published guidelines have been available to help such professionals and their patients manage these therapies. Herein, we present new, practical, and comprehensive recommendations for diabetes injections and infusions. These recommendations were informed by a large international survey of current practice and were written and vetted by 183 diabetes experts from 54 countries at the Forum for Injection Technique and Therapy: Expert Recommendations (FITTER) workshop held in Rome, Italy, in 2015. Recommendations are organized around the themes of anatomy, physiology, pathology, psychology, and technology. Key among the recommendations are that the shortest needles (currently the 4-mm pen and 6-mm syringe needles) are safe, effective, and less painful and should be the first-line choice in all patient categories; intramuscular injections should be avoided, especially with long-acting insulins, because severe hypoglycemia may result; lipohypertrophy is a frequent complication of therapy that distorts insulin absorption, and, therefore, injections and infusions should not be given into these lesions and correct site rotation will help prevent them; effective long-term therapy with insulin is critically dependent on addressing psychological hurdles upstream, even before insulin has been started; inappropriate disposal of used sharps poses a risk of infection with blood-borne pathogens; and mitigation is possible with proper training, effective disposal strategies, and the use of safety devices. Adherence to these new recommendations should lead to more effective therapies, improved outcomes, and lower costs for patients with diabetes. (C) 2016 Mayo Foundation for Medical Education and Research.

Introduction Approximately 9 million people in China use insulin but little is known of their injection techniques (IT). Our aim was to understand IT in China via direct examination and a detailed survey. Methods Injection Technique Questionnaire (ITQ) results of 3853 patients from 20 representative centers in China were compared with the Rest of World (ROW). Results Insulin pens are used by 92% of Chinese insulin injectors, with > 3/4 using 4- or 5-mm pen needles. This is consistent with Chinese BMI values (and thus subcutaneous fat thickness) being lower than in ROW, raising the risk of IM (intramuscular) injections with longer needles. Total daily insulin dose is ~ 33 IU in China vs. 45 IU elsewhere. Lipohypertrophy (LH) rates are lower than in ROW, but still found in at least 25% of Chinese patients. Patients apparently do not realize they have LH or are unaware of the hazards of injecting into LH since many of them do so, and those who do use a mean of 11 IU more of insulin than non-LH patients. This incremental insulin use possibly costs the Chinese health care service around 2 billion RMB annually. Needle reuse is also frequent in China (78% vs. 48% ROW), and the high cost of pen needles is the main reason patients cite for reusing (25% use a single needle > 10×). Conclusion This study reveals many areas in which Chinese professionals and patients can optimize injection practices and thereby improve outcomes and reduce costs. The official guidelines of the Chinese Diabetes Society, based on the FITTER recommendations, offer a roadmap for reaching this goal. Funding BD Diabetes Care. Plain Language Summary Plain language summary available for this article.

Background In 2014–2015, the largest international survey of insulin injection technique in patients with diabetes taking insulin was conducted in 42 countries, totaling 13,289 participants. In Brazil, patients from five public health centers were included. This study aims to evaluate insulin injection technique in Brazilian patients and compare results with Latin America (LatAm) and World data. Methods The insulin Injection Technique Questionnaire (ITQ) survey consisted of an initial patient section (questions applied by an experienced nurse), followed by observation of injection technique and examination of the injection sites by the health care professional. Results In Brazil, 255 patients were evaluated: 25% had type 1 diabetes mellitus (T1DM) and 75% had T2DM. In this study, 79% of patients injected less than 4 times a day, and 17.3% used insulin pens, compared to 28% in LatAm and 86% worldwide. Syringes were used by 78% of patients in Brazil, compared to 65% in LatAm and 10% globally. Differences in needle length were substantial—nearly 64% in Brazil inject with 8 mm length needle compared to 48% in LatAm and 27% worldwide. Additionally, 48% of patients in Brazil skip doses, 80% reuse pen needles and 57% reuse syringes with 27% having lipohypertrophy by exam. Conclusion Brazilian patients use syringes more and pens less, inject with larger needles and have more lipohypertrophy when compared to Latin America and World data. Their re-use of needles and syringes is also high. This study showed that in Brazil, teaching of proper injection technique has to be more widespread, and more intensive during diabetes educational sessions, and the type of delivered supplies must be updated to smaller, shorter needles preferred by patients, in order to facilitate adherence to treatment. From the ITQ, we conclude that there are many aspects of insulin injection technique that may be improved in Brazil.

This communication highlights the unique features of insulin injection technique in the paediatric age group. It describes the anatomical, neurodevelopmental and psychosocial characteristics of children and adolescents of various age groups. These are correlated to highlight 'best practices' or 'injection manner' which diabetes care providers and care givers should observe, in order to achieve a 'happy' and healthy insulin injection experience for the child. The softer side of paediatric insulin injection technique adds to existing guidelines on insulin delivery. It encourages research on the special needs and challenges of children and adolescents living with diabetes.

Introduction: Using the Turkish and rest of world (ROW) Injection Technique Questionnaire (ITQ) data we address key insulin injection complications. Methods: Summarized in first ITQ paper. Results: Nearly one-third of Turkish insulin users described lesions consistent with lipohypertrophy (LH) at heir injection sites and 27.4% were found to have LH by the examining nurse (using visual inspection and palpation). LH lesions in the abdomen and thigh of Turkish patients are slightly smaller than those measured in ROW but more than half of Turkish patients who have LH continue to inject into them at least daily. More than a quarter of Turkish patients have frequent unexplained hypoglycemia and nearly 2 out of 5 have glycemic variability, both of which have been linked to the presence of LH and the habit of injecting into it. Nearly half of Turkish injectors report having pain on injection. Of these, just over half report having painful injections only several times a month or year (i.e., not with every injection). In Turkey the diabetes nurse has by far the major role in teaching patients how to inject. Nearly 40% of Turkish injectors get their sites checked at least annually, and a larger roportion than ROW had received recent (within the last 12 months) instruction on how to inject properly. Conclusion: Turkish patients and professionals have clearly made progress in injection technique, but there are still considerable challenges ahead which the new Turkish guidelines will help address., BD Diabetes Care

Resume En milieu hospitalier, les Accidents d’Exposition au Sang (AES) comportent un risque important de contamination virale accidentelle touchant les personnels de sante. Les injections d’insuline, notamment avec les stylos, constituent une source majeure d’exposition. La legislation a, ainsi, evolue dans le sens d’une mise a disposition des personnels exposes d’aiguilles de securite. L’objectif de cette etude etait d’evaluer l’aptitude a la fonction de securite de l’aiguille BD AutoShield ™ Duo, lors de la mise en place de son usage en milieu hospitalier. Dans quatre unites hospitalieres de diabetologie, apres une formation initiale, 33 infirmier(e)s ont utilise durant 3 semaines des aiguilles de securite en remplacement du materiel non securise anterieur, pour effectuer chacun au moins 30 injections d’insuline. L’utilite, la perception de securite, et les proprietes de l’aiguille de securite, ont ete evaluees par les utilisateurs comparativement au precedent materiel. Les infirmiers se declaraient majoritairement (88 %) preoccupes par les AES ; 82 % disaient en avoir observe, et 46 % s’etre deja eux-memes piques. Des resultats nuances etaient observes concernant l’utilite percue de l’aiguille de securite dans les phases initiales de l’injection, n’exposant pas aux AES. L’utilite maximale (> 75 % des investigateurs) etait observee pour les operations suivant l’injection : retrait de l’aiguille, devissage, elimination ; 82 % des investigateurs se disaient prets a utiliser la nouvelle aiguille dans leur future pratique quotidienne. Introduit dans les nouvelles normes europeennes, l’usage des aiguilles de securite apparait comme un progres important pour la protection des personnels soignants dans les unites hospitalieres. Bien que modifiant les habitudes et necessitant une formation specifique, elle apporte une securite reelle dans les phases suivant l’injection, qui exposent aux AES potentiellement contaminants.

Eine der haufigsten Komplikationen bei subkutanen Insulininjektionen ist die Lipodystrophie, die sich meistens als Lipohypertrophie manifestiert. Die Pravalenz bei den injizierenden Patienten kann bis zu 64% betragen und auch bei Insulininfusion haufig auftreten [1, 2, 3]. Die zum Teil deutlich ungunstigen Auswirkungen von Insulininjektionen in Lipohypertrophien konnen bei Einhaltung einfacher Masnahmen verhindert werden.

Introduction It was estimated that 3.2 million Indians with diabetes injected insulin in 2010, but little is known about the techniques used. Methods In 2015 we conducted an injection technique questionnaire (ITQ) survey throughout India involving 1011 patients. Indian values were compared with those from 41 other countries participating in the ITQ, known here as rest of world (ROW). Results Mean HbA1c was 8.6. BMI values in India were 1.5–3 units lower than in ROW depending on patient group, meaning the risk of intramuscular (IM) injections is high in India. The mean total daily dose (TDD) of insulin was lower in every category of Indian patient than in ROW, perhaps reflecting the lower BMI. Needle reuse, whether with pens or syringes, is much higher in India than ROW and so is the number of times the needle is used. The majority (56.8%) of Indian insulin users performed only 2 injections/day as opposed to ROW where 45% of patients performed at least 4 injections/day. Indian patients inject insulin in the thighs more often than patients in ROW, a site where IM injections are more risky. Many patients do not have proper access to sharps containers or have other risk factors that could lead to blood-borne pathogen spread. More than 60% of used sharps in India go into the rubbish, with nearly 12% not even having the minimum protection of a cap. Discussion The shortest needles are very common in India; however, the level of needle reuse is high. Multiple daily injections therapy is not as common in India as ROW. More focus needs to be given to dwell times under the skin, reconstitution of cloudy insulins, skinfolds, and safe sharps disposal.

Introduction Lipohypertrophy (LH) is one of the most common complications of insulin therapy. We conducted a prospective study in 18 UK centres to assess the impact of a targeted LH intervention on a range of clinical, biological and socio-economic parameters. Methods Seventy-five insulin-injecting patients were recruited randomly and were followed prospectively for 3–6 months, with results compared to baseline values. Interventions included the use of an intensive education program and a switch to a 4 mm pen needle. Results At all injection sites LH decreased significantly by the end of the study, either disappearing completely or shrinking by approximately 50% from its original diameter. Injections into LH decreased by more than 75% by the end. Most patients were not correctly rotating injection sites at the beginning but by the end most were, by a 5-fold margin. Only 1/3 of our subjects used the 4 mm needle at the beginning of the study, however, virtually all did by study end. The mean HbA1c improved by more than 4 mmol/L and there were significantly lower levels of unexpected hypoglycaemia and glucose variability. Total daily doses of insulin dropped by an average of 5.6 IU by study end. Conclusions We believe the impressive clinical improvements seen with training to prevent LH can be achieved by wide adoption of the interventions outlined in this study.

Background Children who inject insulin need clear guidelines as to the length of needle best for them. We studied the distance from surface to muscle in children in order to make needle choices which are evidence-based. Methods One hundred one children with type 1 diabetes were divided into three groups according to age: 2–6, 7–13, and 14–17 yr. The thickness of skin and subcutaneous (SC) tissue was measured by ultrasound in all injection sites. Results Skin thickness varied from 1.58 mm in the arm of the youngest children to 2.29 mm in the buttocks of the adolescents. Values decreased progressively based on age (2–6 < 7–13 < 14–17) and on body site (arm

Aim With the June 2010 publication of EU Council Directive 2010/32/EU scrutiny is now being focused on the safety and protection of diabetes nurses. Methods We used a questionnaire to study the frequency and risks of Needlestick Injuries (NSI) associated with diabetic injections in European hospitals. 634 nurses participated from 13 western European countries and Russia. Results When patients with diabetes who self-inject at home are hospitalized injections are given always by the staff in 31% of cases, by the patients themselves where possible in 33%, initially by staff, then the patient takes over in 12% and both staff and patient throughout the stay in 21%. 86% of nurses said their hospitals had a written policy on the prevention of NSI but, where it was available, only 56% were familiar with it. 67% of the nurses had not attended any training on the prevention of NSI and only 13% had attended one in the last year. 7.1% of nurses report recapping needles and 5.9% report storing unprotected needles temporarily on a tray, trolley or cart. 32% of nurses report suffering a NSI while giving a diabetic injection at some point in the past. 29.5% of NSI occurred while recapping a used needle. 57% of nurses unscrew pen needles using their own fingers. In 80% cases the source patient's identity was known and the sharp item was "contaminated" (known previous percutaneous exposure to patient) in almost half the cases (43%). NSIs were reported to the proper authorities in only 2/3 of cases. Conclusion Our study shows that frequent NSI occur in European nurses treating people with diabetes in hospital settings. These injuries are a source of possible infection despite the small size of diabetes needles. The introduction of safety-engineered medical devices has been shown to reduce the risk of injury. A new European Directive that has now come into force specifically stipulates that wherever there is risk of sharps injury, the user and all healthcare workers must be protected by adequate safety precautions, including the use of "medical devices incorporating safety-engineered protection mechanisms".

Background: In Giarre, Sicily, we have created a diabetes center in which the medical center and exercise gym share the same physical space. When a patient leaves the doctor’s office he/she immediately enters a functioning gym. In the present paper, we report on our experiences with this integrated medical/exercise approach. Methods: Exercise, and the subsequent achievement of physical conditioning, is a cornerstone of treatment for metabolic syndrome and Type 2 diabetes. We initiate each patient on a tailored, phased, and sustainable exercise program administered by experts in sport, diet, and behavioral change with the immediate support of a range of medical disciplines. Results: More than 1100 patients have joined our program since its inception in 2005, with 180 passing through the center each day. Measurable and sustainable improvements in cardiovascular conditioning, quality of life indices, blood glucose control, and weight have been documented. The financial structure permits patients of all socioeconomic strata to access the service. Discussion: We believe that health care workers should teach by doing, and exercise is best taught by doing activities that the patients should do using the same facilities as the instructors. We target one of the most difficult patient groups, people with metabolic syndrome or Type 2 diabetes, and we ask them to do one of the hardest things in life: change it radically at a relatively advanced age by beginning to exercise regularly. Our approach appears to be unique in the world. We invite others who may have similar experiences to share their knowledge with us.

The first Injection Technique workshop brought together endocrinologists and injection experts from around the world in Strasbourg in 1997. From its work came groundbreaking recommendations which advanced best practices in areas such as the use of a skin fold when injecting. The second Injection Technique workshop, with an expanded format including nurses and diabetes educators, took place in Barcelona in 2000. The initial stimulus to use shorter injecting needles can be said to date from this meeting. The third Injection Technique workshop was held in Athens in September 2009 and involved 127 experts from across the globe. After a comprehensive review of all publications since 2000 as well as several unpublished studies, the attendees divided into smaller groups to debate and draft new injecting recommendations based on the new data and their collective experience. This paper summarizes all the formal presentations given at this practical consensus workshop. (C) 2010 Elsevier Masson SAS. All rights reserved.

Background: The efficacy of injection therapy in diabetes depends on correct injection technique and, to provide patients with guidance in this area, we must understand how they currently inject. Methods: From September 2008 to June 2009, 4352 insulin-injecting Type 1 and Type 2 diabetic patients from 171 centers in 16 countries were surveyed regarding their injection practices. Results: Overall, 3.6% of patients use the 12.7-mm needle, 1.8% use the 12-mm needle, 1.6% use the 10-mm needle, 48.6% use the 8-mm needle, 15.8% use the 6-mm needle, and 21.6% use the 5-mm needle; 7% of patients do not know what length of needle they use. Twenty-one percent of patients admitted injecting into the same site for an entire day, or even a few days, a practice associated with lipohypertrophy. Approximately 50% of patients have or have had symptoms suggestive of lipohypertrophy. Abdominal lipohypertrophy seems to be more frequent in those using the two smaller injection size areas, and less frequent in those using larger areas. Nearly 3% of patients reported always injecting into lipohypertrophic lesions and 26% inject into them sometimes. Of the 65% of patients using cloudy insulins (e.g. NPH), 35% do not remix it before use. Conclusions: It is clear from the latest survey that we have improved in certain areas, but that, in others, we have either not moved at all or our efforts have not yielded the results we expected. The results of the present survey are available online on a country-by-country and question-by-question basis at http://www.titan-workshop.org.

Background: Peripheral intravenous catheters are among the most widely used medical devices in the world. European patients are increasingly aware of the risk of health care associated infections and the role catheters play in their facilitation. Aims: We intend to show that European health care providers are increasingly aware of the occupational risks of bloodborne infections such as HIV and hepatitis which can be transmitted by the needles from catheters and that the political will is building to take action to ensure safer devices are provided. Methods: We review the wide variety of peripheral intravenous catheters which are specially engineered to reduce these risks. Results: Available safety devices include spring-loaded retractable needles, guards that shield the dangerous tips and closed, needle-free access valves for intravenous sets. Conlusions: It is no longer necessary for patients and professionals to take risks to health and life when solutions which minimize these risks are at hand.

Aim. A large pan-European epidemiologic survey of insulin injection techniques was performed in order to determine the epidemiologic profile by centre, country and continent of major issues surrounding insulin injection. Methods. European insulin-injecting, type 1 or 2 diabetes patients, using insulin for at least 6 months via an insulin pen or syringe; 22 sites in seven countries, 1002 patients in total, 51% female, 58% type 1. Results. Nearly 70% of patients inject using a pinch-up and this practice is associated with improved HbA1c. Thirty per cent of patients reported having lipohypertrophy. Concurrent nurse evaluation found the prevalence to be 27%. Independent risk factors for lipohypertrophy were found to be failure by the patients to check injection sites regularly, failure to rotate sites and longer duration of DM. Less than 50% of patients reported that they were taught about lipohypertrophy. Needles were used 3.3 times on average in Europe, with wide variation by country. Male sex, type 1 diabetics, a high daily number of injections and the use of the 12.7 mm length needle were factors associated with high needle reuse. Needle reuse, even more than once, increased the risk of lipohypertrophy by 31%. Nearly half of patients dispose of their needles directly into the trash after protecting the needle (recapping or clipping). Alarmingly, 22% dispose directly into the trash without protection. Conclusion. There is a considerable way to go in ensuring optimal insulin injection practices. The issues raised by this study must be addressed by focused and intensive HCP efforts. Copyright © 2002 John Wiley & Sons, Ltd.

Diabetes nurses and observant patients have long known that the technique of injection is critical to the successful use of insulin, but the medical community at large and most insulin-injecting patients remain unaware of the hows and whys of proper technique. The Second Injection Technique Workshop, held in Barcelona, brought together over 90 injection experts from across Europe and the world. This paper highlights major findings in this emerging field as well as practical guidelines and recommendations. Epidemiologic findings on current injection practice are presented and areas meriting future study are outlined. Copyright © 2002 John Wiley & Sons, Ltd.

Purpose: The purpose of the study is to assess whether proper Injection Technique (IT) is associated with improved glucose control over a three month period. Methods: Patients (N = 346) with diabetes from 18 ambulatory centers throughout northern Italy who had been injecting insulin ≥ four years answered a questionnaire about their IT. The nurse then examined the patient's injection sites for the presence of lipohypertrophy (LH), followed by an individualized training session in which sub-optimal IT practices highlighted in the questionnaire were addressed. All patients were taught to rotate sites correctly to avoid LH and were begun on 4 mm pen needles to avoid intramuscular (IM) injections. They were instructed not to reuse needles. Results: Nearly 49% of patients were found to have LH at study entry. After three months, patients had mean reductions in HbA1c of 0.58% (0.50%–0.66%, 95% CI), in fasting blood glucose of 14 mg/dL (10.2–17.8 mg/dL, 95% CI) and in total daily insulin dose of 2.0 IU (1.4–2.5 IU, 95% CI) all with p

The aim of the present study was to assess the interlaboratory reproducibility of the FACSCount system for the enumeration of peripheral blood (PB) CD4(+) T-cells. In each of the seven participating centers, both previously stained and unstained PB samples (n = 49) were received and either analyzed or stained and then analyzed. Interlaboratory reproducibility was checked in two different groups of centers (n = 3 and n = 4) where the study was performed in parallel. In addition, both the intralaboratory precision and accuracy of this system were analyzed in comparison with results obtained with conventional flow cytometry. Accordingly, upon comparing both methods, a high degree of correlation was observed in the total number of CD3(+) T-cells (coefficient of correlation of 0.9750 +/- 0.0184, slope of the best linear fit: 0. 9214 +/- 0.0311, y-intercept of 12 +/- 47) as well as in the number of CD3(+)/CD4(+) (coefficient of correlation of 0.9794 +/- 0.1457, slope of the best linear fit: 0.9463 +/- 0.0753, y-intercept of -11 +/- 36) and CD3(+)/CD8(+) (coefficient of correlation of 0.9728 +/- 0.0192, slope of the best linear fit: 0.9682 +/- 0.0735, y-intercept of 7 +/- 95) major subsets. In addition, low coefficients of variation (CV) were obtained for replicates, indicating the method's high degree of accuracy. The present study shows that with respect to the interlaboratory reproducibility reported for most techniques used for the enumeration of PB CD4(+) T-cells, the FACSCount system results in data with much lower coefficients of variance (CVs) (mean CV of less than 10%). Upon measuring the impact on results of different variables associated with either sample preparation or data acquisition and analysis, our study clearly shows that data acquisition and analysis does not influence the results by increasing variability since the coefficients of variation obtained for samples prepared in the same laboratory under the same conditions and read in different laboratories with different instruments were identical to those obtained for the replicates of the same samples read in each individual center. In contrast, interlaboratory variability, although low, significantly increased when sample preparation was carried out in different laboratories, suggesting that pipetting still represents the major source of variability in the FACSCount system.

Staged Diabetes Management (SDM) is a disease state management programme, that was developed by the International Diabetes Center, Minneapolis, USA. Its primary aim is to achieve near-normal to normal blood glucose control in all patients with diabetes, using community involvement and simple, complete clinical pathways. SDM contains methods of diagnosis, an overview of therapy, practice guidelines, and specific detailed treatment protocols (decision paths) for type 1 and type 2 diabetes and gestational diabetes (GDM). Formal training in SDM was conducted for participating physicians and nurses, including an introduction to the philosophy and approach of SDM, provision of the materials and elucidation of the expected goals and results. After training and implementation, a series of trials were performed to determine the effectiveness of SDM in improving diabetes care in this region. The trial results evaluated the overall influence of SDM on such clinical parameters as HbA1c and fasting blood glucose, to assess the appropriateness of treatment modalities and timing of therapeutic choices, eg minimal delay to choice of appropriate stage. The introduction of the SDM programme led to significant reductions of HbA1c and fasting and postprandial blood sugar, without hypoglycaemia, in a representative group of people with type 1 diabetes. In patients with type 2 diabetes, significant reductions of HbA1c, fasting and postprandial blood glucose without hypoglycaemia or weight-gain was achieved. To our knowledge, this is one of the first times that these goals have been achieved in people with type 1 diabetes, without hypoglycaemia, and in type 2 diabetes, without weight-gain. Using SDM we achieved 100% screening of 500 women referred for evaluation of menopausal symptoms. Approximately 5% of peri- and post-menopausal women were found to have frank diabetes (type 2) and an additional 8% had impaired glucose tolerance. Using the SDM programme, tight metabolic control in pregnant women with type 1 diabetes decreased the incidence of serious complications, eg urinary tract infections and pre-eclampsia, particularly in the critical last few weeks before delivery. We found a decrease in the incidence of serious neonatal complications in the SDM group — lower levels of: neonatal death (none seen in the SDM group); fetal congenital malformations; hypoglycaemia and respiratory distress syndrome. With respect to GDM, screening of pregnant women and proper treatment using SDM resulted in lower pregnancy and neonatal complication rates as well as fewer Caesarean sections. The success of these early pilot studies has led to a training programme that aims to introduce SDM to up to 500 primary care providers per year throughout Poland. Once trained, a larger more definitive multi-centre study of the effects of SDM will be needed to confirm the earlier findings.

Forty diabetes experts — among them investigators who have studied insulin injections for many years — gathered in Strasbourg, France for the first International Insulin Injection Technique Workshop. The objectives of the Workshop were to present known data on injection technique and to outline the future directions of clinical and basic research in this area, in order to define guidelines on injections techniques at the end of the Workshop.

�䀆e results showed that nearly two-thirds (64.4%) of patients had LH. �䀆ere was a strong relationship between the presence of LH and non-rotation of sites, with correct rotation technique having the strongest protective value against LH. Of the patients who correctly rotated sites, only 5% had LH while, of the patients with LH, 98% either did not rotate sites or rotated incorrectly (7). Also, 39.1% of patients with LH had unexplained hypoglycaemia and 49.1% had glycaemic variability compared with only 5.9% and 6.5%, respectively, in those without LH. LH was also related to needle reuse, with risk increasing sgnficantly when needles were used more than five times.

The major lymphocyte subsets in the peripheral blood were assessed in 120 children 6-13 years old living on areas that received high levels of radioactivity as fallout after the Chernobyl nuclear power plant accident. Seventy-one of the children were suffering from recurrent respiratory disease (RRDC) and 49 were not (non-RRDC). As controls, a total of 87 RRDC and non-RRDC living on noncontaminated areas were evaluated. We did not find significant differences in major lymphocyte subsets between the values in non-RRDC living on radionuclide-contaminated areas and noncontaminated areas. However, RRDC living on radionuclide-contaminated areas had a significantly lower percentage of CD3+ T and CD3+CD4+ T-helper/ inducer cells compared to control RRDC. Furthermore, the decrease in percentage of CD3+CD4+ cells was more profound in RRDC living in radiation-contaminated settlements with an average summary dose (ASD) Cs-137(134) and Sr-90 for the population1.0 mSv than in RRDC living in contaminated settlements with an ASD Cs-137(134) and Sr-901.0 mSv. These data indicated that long-time exposure to small doses of radiation could affect the immune system in children living around Chernobyl.

Healthy HIV–positive regular donors of plasma in a programme of passive immunotherapy for AIDS patients were studied over a period of about two years. None developed symptoms of clinical progression; most seemed to make substantial gains of CD4 cells by comparison with asymptomatic individuals who were not donating. The effects of donation did not seem to diminish with repetition, and donor CD4 counts tended towards stabilizing within normal limits. Asymptomatic HIV–positive individuals were compared immunologically with ‘normals’ and people with AIDS, using a battery of 25 measurements on peripheral blood. The immunological profiles of donor and non–donor asymptomatics, indistinguishable at the start, became dissimilar: donors' profiles resembled AIDS less, non–donors became less like ‘normal’ and a few non–donor results could not be distinguished from AIDS. Improvement in the CD4 counts and amelioration of the immunological profile in donors provide prima facie evidence that plasmapheresis may be therapeutic for asymptomatic HIV–positive people. Further studies are justified.

With the FACSCount TM flow cytometer, counts of CD4, CD8 and CD3 lymphocytes and CD4/CD8 ratios were performed in a rural hospital in Tanzania. A total of 168 subjects (21 HIV-1 seropositive and 147 HIV-1 seronegative) were tested as part of a population-based serosurvey and AIDS education programme; 134 other subjects were hospitalized patients who had signs and symptoms suggestive of AIDS (69 HIV-1 seropositive and 65 HIV-seronegative). Mean values for the 147 HIV-1 seronegative subjects from the local population were 980 CD4 cells (95% CI 930, 1031), 598 CD8 cells (560, 635) and CD4/CD8 ratio 1.78 (1.68, 1.89). Seropositive subjects from the local population had significantly lower CD4 cell counts, higher CD8 counts and a lower CD4/CD8 ratio. CD4 cells were significantly lower and CD8 cells significantly higher in HIV-1 seropositive hospital patients compared to HIV-1 seronegative patients. However, 23 (35%) seronegative hospital patients had CD4 counts lower than 600. These results establish baseline values for the lymphocyte subsets in this population and indicate that this technique can be used in remote areas to monitor progress of HIV-infected individuals.

The new Quality Control Program in Immunophenotyping for Central Europe (CEQUAL) was created in 1993. Its first formal send-around proficiency exercise, consisting of a stained stabilised preparation of leukocytes, took place in November 1993. Forty-one laboratories from Slovakia, Poland, Hungary, and the Czech Republic participated. Eighty-three percent of member laboratories returned results and list mode files. The results for each cell population were evaluated for central tendencies, variability, and overall distribution patterns. Extreme outliers were identified and list mode files reviewed for clues to the aberrerant values. When found these reasons were communicated back to member labs. When extreme outlier values were removed, all coefficient of variations (CVs) for lymphocyte populations were below 10%, except for NK cells, which had a CV of 14.8%. In future send-arounds, unstained and pathologic specimens will be used. This CEQUAL program is the first to function on such a broad international basis.

The relationship between CD8 lymphocyte phenotypic alterations and virological parameters was studied in 47 asymptomatic subjects with human immunodeficiency virus type 1 (HIV-1) infection and CD4 T cell counts above 400/microliters. CD8 subsets were examined by means of three-color flow cytometry, using an extensive panel of monoclonal antibody combinations. Virological parameters were measured by both end-point dilution culture of peripheral blood mononuclear cells (PBMCs) and plasma and branched-DNA (bDNA) signal amplification of plasma HIV RNA. Whereas HIV-infected patients had a near-normal CD4 cell count (mean, 782 cells/microliter), several subsets of activated CD8 cells were markedly expanded relative to values in 23 HIV-seronegative controls. The PBMC cultures were positive in 38 cases and plasma HIV RNA was detected in 31. The percentage of CD4 cells correlated negatively with both cellular viremia and plasma HIV RNA levels. Conversely, a positive correlation was observed between viral load and the percentage of CD8 cells. Among CD8 lymphocytes, the CD38+CD8 and HLA-DR+CD8 subsets correlated best with viral load. Three-color analysis showed that the subpopulations involved in this relationship were CD38+HLA-DR+, CD38+CD28-, HLA-DR+CD28+, HLA-DR+CD57-, CD38+CD57-, CD38+CD45RO+, and HLA-DR+CD45RO+. Our data provide the first evidence that viral load correlates with subsets of activated CD8 lymphocytes in asymptomatic HIV-infected subjects who have near-normal numbers of CD4 lymphocytes.

It is widely believed that multiple sclerosis is a T-cell mediated autoimmune disease associated with abnormalities in immunoregulation. This large, prospective study evaluated the lymphocyte immunophenotypic profile of 246 MS patients, divided clinically into a remitting/relapsing group (n = 176) and a progressive group (n = 70), and compared their results to those of 117 healthy controls. All patients were found to have significantly elevated percentage and absolute numbers of IL2R(+)CD3(+) cells as well as depressed percentages of CD45RA(+)CD4(+) cells. However, when the factor of treatment with cyclophosphamide (CY) versus no treatment or treatment with other agents was used to group patients, dramatic declines in both percentages and absolute numbers of CD45RA(+) CD4(+) cells were discovered. These declines were associated specifically with CY and could be explained by this factor independent of the clinical state of the patient. The effects were seen in patients undergoing current treatment or in those exposed to CY in the near or remote past. These findings highlight the confounding effect of specific treatments on the immune profile of MS patient groups and suggest that there may be important implications for cellular function and clinical outcome in these and other patient groups.

EU legislation to reduce needlestick injury and consequent infections will come into force in May 2013. The law will oblige healthcare organisations to take measures to prevent needlestick injuries to staff, and strongly recommends the use of safety-engineered medical devices. Some healthcare organisations have already converted to using safety devices, recognising the need to improve staff safety, reduce the cost of treating injured workers, and avoid expensive legal actions. The main focus of the directive seems to be on safety-engineered devices for blood collection and infusion, as healthcare organisations often ignore or see the risk of injections into tissue as minimal. There is still a need for further education on the risks of injection. This article reviews a number of commonly held views regarding the risk of needlestick injury and discusses whether the statements are supported by the evidence.

Flow cytometry and monoclonal antibodies are promising tools for HLA-antigen detection. Previous approaches have been hampered by the lack of a carefully standardized system for calibration and sample analysis. A new system for HLA-B27 screening was developed using a FACScan flow cytometer, software for automated calibration and analysis, calibration beads, and the anti-HLA-B27-FITC/anti-Leu4-PE (CD3) monoclonal antibodies. The median fluorescence channel result for the HLA-B27-FITC signal of CD3+ T lymphocytes is compared to a decision marker. Values lower than this threshold are read as HLA-B27 negative and those above are recommended for retesting with the classic microcytotoxicity assay on the presumption of HLA-B27 positivity. The anti-HLA-B27 antibody reacts with all six HLA-B27 subtypes and shows a weaker binding to HLA-B7. The screening test results were compared with those from the microcytotoxicity assay for HLA-typing in studies involving several European centers. The observed sensitivity was 100% (95% Cl:98.6-100) and the specificity was 97.4% (95% Cl: 96.4-98.3). Other performance studies verified the reproducibility and reliability of results obtained with the screening system.

A reference range for lymphocyte populations, with particular emphasis on T lymphocyte subsets, was obtained for normal individuals covering age cohorts from birth through adulthood. This report confirms and extends findings from a developmental reference range published earlier (1). Absolute numbers of WBC, lymphocytes, and T, B, and NK subsets decline significantly during childhood. However, differences in the rate of decline of certain lymphocyte subsets leads to discordance between absolute numbers and percentages. Those lymphocyte subsets which decline less rapidly with age than the total lymphocyte count will show an increase in percentage, whereas those which decline more rapidly will show further declines in percentage values. T cell percentages were seen to increase over time whereas B cell percentages decline. Markers of immaturity such as CD45RA on CD4 cells and CD38 on CD8 cells declined in both percentages and absolute numbers. Activation markers, such as HLA-DR on CD8 cells and IL2-R on CD3 cells, increased in percentages with time but changed inconsistently in cell number from infancy to adulthood. These findings extend the lymphocyte reference range to markers thought to be informative in various disease states, including HIV infection.