The Injection Technique Factor: What You Don't Know or Teach Can Make a Difference.

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.

Injection Technique Education in Patients with Diabetes Injecting Insulin into Areas of Lipohypertrophy: A Randomized Controlled Trial.

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.

Correction to: Insulin Injection Technique in China Compared with the Rest of the World.

The original article can be found online.

Pediatric Insulin Injection Technique: A Multi-Country Survey and Clinical Practice Implications.

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.

Correction to: Pediatric Insulin Injection Technique: A Multi-Country Survey and Clinical Practice Implications.

In the original publication, fourth author name was incorrectly published as Asthma Deeb in author group.

Insulin Injection Technique in China Compared with the Rest of the World.

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 available for this article.

Turkish Insulin Injection Techniques Study: Complications of Injecting Insulin Among Turkish Patients with Diabetes, Education They Received, and the Role of Health Care Professional as Assessed by Survey Questionnaire.

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 their 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 proportion 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. FUNDING: BD Diabetes Care.

Turkish Insulin Injection Technique Study: Population Characteristics of Turkish Patients with Diabetes Who Inject Insulin and Details of Their Injection Practices as Assessed by Survey Questionnaire.

INTRODUCTION: Over 7 million people in Turkey have diabetes. Of the 1 million who inject insulin little is known of their habits and injection techniques. METHODS: We conducted an Injection Technique Questionnaire (ITQ) survey throughout Turkey that involved 1376 patients from 56 centers. Turkish values were compared with those from 41 other countries participating in the ITQ, known here as Rest of World (ROW). RESULTS: The majority (50.4%) of Turkish insulin users give four injections/ day as opposed to ROW, where only 30.9% do. The abdomen is the most common injection site used by Turkish patients, but they also inject insulin in multiple body sites more often than do patients in ROW. Body mass index values in Turkey were 0.75 units higher than those in ROW as was the mean total daily dose (average daily dose [ADD]) of insulin (54.0 IU in Turkey vs. 47.4 IU in ROW). Mean glycated hemoglobin (HbA1c) in Turkey was 9.1%, which is higher than in ROW and possibly related to the higher BMI and ADD. Turkish patients use insulin analogs (short and long-acting) more frequently than do patients in ROW. The shortest pen needles (4 mm) are used by about one-third of patients in Turkey, but the longer ones (8 mm) are equally common. Needles are reused in Turkey at a rate of 3.4 injections/single needle. However, needle reuse, whether with pens or syringes, is lower in Turkey than ROW, as is the number of times a reused needle is used. More than 75% of used sharps in Turkey go into the rubbish, with nearly 6% having no protection of the tip. CONCLUSION: The continued use of 8-mm needles raises the risk of intramuscular injections in Turkish patients. Despite full reimbursement, needle reuse still remains an important issue. More focus needs to be given to dwell times under the skin, reconstitution of cloudy insulant, correct use of skin folds and safe disposal of sharps. FUNDING: BD Diabetes Care.

Indian Injection Technique Study: Injecting Complications, Education, and the Health Care Professional.

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.

Indian Injection Technique Study: Population Characteristics and Injection Practices.

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.

An Effective Intervention for Diabetic Lipohypertrophy: Results of a Randomized, Controlled, Prospective Multicenter Study in France.

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.

Worldwide Injection Technique Questionnaire Study: Population Parameters and Injection Practices.

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.

Worldwide Injection Technique Questionnaire Study: Injecting Complications and the Role of the Professional.

From February 1, 2014, through June 30, 2015, 13,289 insulin-injecting patients from 423 centers in 42 countries participated in one of the largest surveys ever performed in diabetes. The first results of this survey are published elsewhere in this issue. Herein we report that the most common complication of injecting insulin is lipohypertrophy (LH), which was self-reported by 29.0% of patients and found by physical examination in 30.8% by health care professionals (HCPs). Patients with LH consumed a mean of 10.1 IU more insulin daily than patients without LH. Glycated hemoglobin levels averaged 0.55% higher in patients with vs without LH. Lipohypertrophy was associated with higher rates of unexplained hypoglycemia and glycemic variability as well as more frequent diabetic ketoacidosis, incorrect rotation of injection sites, use of smaller injection zones, longer duration of insulin use, and reuse of pen needles (each P<.05). Routine inspection of injection sites by the HCP was associated with lower glycated hemoglobin levels, less LH, and more correct injection site rotation. Patients were also more likely to rotate correctly if they received injection instructions from their HCP in the past 6 months. Fewer than 40% of patients claimed to have gotten such instructions in the past 6 months, and 10% said that they have never received training on how to inject correctly despite injecting for a mean of nearly 9 years. Use of these data should stimulate renewed commitment to optimizing insulin injection practices.

New Insulin Delivery Recommendations.

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.

Sindrome de anticardiolipina / Anticardiolipin's syndrome

Los anticuerpos anticardiolipina han generado extraordinario interes en los utlimos anos, entre otras razones, por su asociacion con trombosis arterio-venosas recurrentes, trombocitopenia y aborto espontaneo. Presentamos el caso de un paciente con multiples y recurrentes trombosis venosas, en quien se encontraron altos titulos de anticuerpo anticardiolipina; hacemos ademas una breve revision del tema con particular atencion a su evolucion desde la descripcion del anticoagulante lupico, y discutimos la fisiopatologia, asociaciones clinicas e implicaciones terapeuticas de este interesante sindrome ahora conocido como el sindrome de anticardiolipina.