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.

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.

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

The original article can be found online.

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.

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.

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.

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.

Lipohypertrophy in China: Prevalence, Risk Factors, Insulin Consumption, and Clinical Impact.

BACKGROUND: Lipohypertrophy (LH) is a complication of insulin therapy. We assessed LH prevalence, risk factors, insulin usage, and clinical and health economic effects in China. METHODS: In four cities, 401 adult patients injecting insulin ≥1 year were surveyed for diabetes/insulin injection history and practices, pen needle reimbursement (PNR), and health resource utilization, followed by structured examination and HbA1c testing. Differences between those with and without LH were evaluated by Student's t-test or the Wilcoxon rank sum test. Insulin costs were calculated. RESULTS: Patients were 59.6 ± 11.5 years old; 50% male; 93.5% type 2 diabetes. LH prevalence was 53.1%. Compared to those without LH, patients with LH had higher body mass index (BMI; 26 vs. 24.8 kg/m2) and HbA1c (8.2% vs. 7.7% [66 vs. 61 mmol/mol]), took 11 IU (0.13 IU/kg or 31.7%) more insulin costing $1.4 versus $1.0 (RMB 9.5 vs. 6.8) daily, reused PNs more times, and had less PNR (all P ≤ 0.003). LH patients correctly rotated injection sites less often (67.6% vs. 92.3%, P < 0.0001). By stepwise logistic regression, BMI, needle reuse frequency, and PNR remained modestly associated with LH prevalence (odds ratios [OR] <1.9; P ≤ 0.03); weight-adjusted insulin dose and incorrect site rotation showed ORs of nearly 7 and 8.4, respectively (P ≤ 0.001). Extrapolated to 9 million insulin-injecting patients in China and adjusted for therapy adherence, LH-related excess annual insulin consumption cost is estimated at nearly $297 million (RMB 2 billion). CONCLUSIONS: LH is common in China and associated with worse glycemic control, despite nearly one-third greater insulin consumption, with large cost implications. Proper injection technique education may reduce LH prevalence.

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.

Adherence to Insulin Pen Therapy Is Associated with Reduction in Healthcare Costs Among Patients with Type 2 Diabetes Mellitus.

BACKGROUND: Type 2 diabetes mellitus is a chronic metabolic disorder that poses a significant economic burden on the US healthcare system associated with direct and indirect medical costs, loss of productivity, and premature mortality. OBJECTIVES: To determine whether increased adherence to therapy among patients with type 2 diabetes who use an insulin pen is associated with reduced healthcare costs, and to describe the overall healthcare costs of patients with type 2 diabetes. METHODS: This retrospective claims database analysis used the Truven Health MarketScan Commercial and Medicare Supplemental databases to identify patients diagnosed with type 2 diabetes with at least 1 insulin pen prescription claim between January 2006 and September 2010. Insulin pen adherence was measured using the medication possession ratio (MPR). The cost outcomes included all-cause and type 2 diabetes-related costs by type of service (ie, inpatient, outpatient medical, outpatient pharmacy), which were calculated in 2011 US dollars. Insulin adherence and overall healthcare costs were evaluated over the 12-month postindex period. RESULTS: A total of 32,361 patients met the study inclusion criteria, with an average MPR of 0.63 (standard deviation [SD], 0.29). Overall, patients with type 2 diabetes who used an insulin pen had an average annual healthcare cost of $19,612, which was driven by inpatient costs (37.2%) and outpatient pharmacy costs (24.4%). There is a significant difference in the average annual per-patient healthcare expenditures between the least adherent group (MPR <0.20; 11.0% of patients) and the most adherent group (MPR >0.80; 34.6% of patients) $26,310 versus $23,839, respectively (P = .007). Patients with the greatest insulin adherence had higher overall pharmacy costs than patients with the lowest insulin adherence ($10,174 vs $5395, respectively; P <.001). CONCLUSIONS: The total healthcare expenditures of patients with type 2 diabetes who utilized insulin pens decreased with improvement in adherence, suggesting that higher rates of medication adherence may present an opportunity to curb healthcare costs in insulin pen users. The average sample MPR for our study population was 0.63 (SD, 0.29), indicating that insulin adherence continues to be a challenge for successful diabetes management. More research is needed to better characterize the relationship between medication adherence and healthcare costs among insulin users with type 2 diabetes and to identify the key drivers of adherence among this patient group.

Safety and efficacy of insulin therapy delivered via a 4mm pen needle in obese patients with diabetes.

OBJECTIVE: To determine whether insulin delivered via a 4-mm × 32-gauge pen needle (PN) provides equivalent glycemic control as 8-mm × 31-gauge and 12.7-mm × 29-gauge PNs in obese (body mass index ≥30) patients with diabetes. PATIENTS AND METHODS: This prospective, multicenter, randomized, open-label, 2-period, crossover, equivalence, home-based study was conducted from October 26, 2010, through May 31, 2012. After a 3-week wash-in period, eligible patients aged 18 to 80 years with a hemoglobin A1c (HbA1c) level of 5.5% to 9.5% (37-80 mmol/mol) were randomized to compare either 4- vs 8-mm PNs or 4- vs 12.7-mm PNs, using each of the 2 assigned PNs for 12 weeks in random order. The primary outcome was change in HbA1c level, with equivalence limits of ±0.4%. RESULTS: The 274 patients randomized (mean ± SD age, 56.7±11.0 years) had a mean ± SD body mass index of 37.0±6.1 (range, 29.1-59.9) and took up to 350 U of insulin daily; 226 patients were included in the modified intention-to-treat analysis. Mean (95% CI) changes in HbA1c levels with the 4-mm PN were -0.08% (-0.21 to 0.06) and -0.10% (-0.19 to 0.00) vs the 8- and 12.7-mm PNs, respectively, within equivalence margins. The 4-mm PN was less painful than the larger PNs (P<.05), with similar leakage rates reported (4.1%-4.3%). Patients preferred the 4-mm PN over the 12.7-mm PN (P<.05) but not significantly vs the 8-mm PN. There were no differences between PNs in insulin doses and hypoglycemic or hyperglycemic adverse event rates. CONCLUSION: The 4-mm × 32-gauge PN provides equivalent glycemic control as 8- and 12.7-mm PNs in obese patients with diabetes, with less pain and no increase in leakage. Shorter PNs should be considered in all insulin-requiring patients with diabetes, including those who are obese. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01231984.

Glycemic control, reported pain and leakage with a 4 mm × 32 G pen needle in obese and non-obese adults with diabetes: a post hoc analysis.

OBJECTIVE: The shortest pen needle (PN) for subcutaneous insulin therapy is 4 mm. Clinicians may hesitate to use it in obese patients. We report a post hoc analysis of a previously published study of the 4 mm × 32 G PN, evaluating responses in obese (≥30 kg/m(2)) and non-obese (<30 kg/m(2)). METHODS: Subjects (BMI 20 to 49 kg/m(2), 52% obese) with diabetes used 4 mm × 32 G PNs and either 5 mm or 8 mm PNs (both 31 G) in two, 3-week treatment periods in a randomized noninferiority cross-over trial. Percentage absolute change in fructosamine (%â”‚Δ Fru│) was the primary endpoint. Equivalent glycemic control was defined as %â”‚Δ Fru│ within 20% (including 95% CI). The impact of obesity on change in fructosamine, pain and reported insulin leakage from the skin is described. CLINICAL TRIAL REGISTRATION: Clinicaltrials.gov - identifier: NCT00928057. LIMITATIONS: This report is a post hoc analysis of two BMI subgroups resulting in smaller sample sizes. RESULTS: Of 168 who completed the study, 163 were included in the fructosamine analyses - 83 and 80 in the 4/5 mm and 4/8 mm groups, respectively. For the 4/5 mm group, mean BMI ± SD in non-obese and obese groups were 25.9 ± 2.3 and 35.0 ± 4.9 kg/m(2), respectively; 4/8 mm group 25.2 ± 2.6 and 35.6 ± 4.2 kg/m(2). BMI group was not significant for %â”‚Δ Fru│ for either 4/5 mm or 4/8 mm. Between BMI groups, the difference of the means in %â”‚Δ Fru│ was 0.4% (4/5 mm) and 0.3% (4/8 mm). The 4 mm PN was significantly less painful in all subject groups, except non-obese in 4/5 mm. Regardless of needle size, obese subjects reported more leakage events. For both BMI groups, there were fewer total reported leakage events when using the 4 mm vs 5 mm and 8 mm needles. CONCLUSIONS: The 4 mm pen needle provided equivalent glycemic control in both obese and non-obese patients compared to 5 mm and 8 mm needles with no increase in reports of skin leakage, in this post-hoc analysis. These findings should be confirmed in a prospective randomized controlled trial.

Comparative glycemic control, safety and patient ratings for a new 4 mm x 32G insulin pen needle in adults with diabetes.

OBJECTIVE: Pen needles (PN) for subcutaneous insulin therapy have become smaller; 5 mm PNs are now the shortest in use. We evaluated the safety, efficacy and patient ratings of a new 4 mm x 32 gauge (G) PN. RESEARCH DESIGN AND METHODS: Subjects with type 1 and type 2 diabetes and HbA1c 5.5% to 9.5% participated in a randomized non-inferiority cross-over trial, at four U.S. centers. Subjects used 4 mm x 32G PNs and either 5 mm x 31G PNs (4/5 mm) or 8 mm x 31G PNs (4/8 mm) in two, 3-week treatment periods; order of needle use was controlled. Subjects were either 'low dose' or 'regular dose' users (highest single insulin dose

Skin and subcutaneous adipose layer thickness in adults with diabetes at sites used for insulin injections: implications for needle length recommendations.

OBJECTIVE: During subcutaneous insulin therapy, inadvertent intramuscular (IM) injections may increase pain and/or adversely affect glucose control. The most appropriate needle length for patients depends on skin thickness (ST) and the distance to muscle fascia. ST and subcutaneous adipose layer thickness (SCT) were measured in adults with diabetes. RESEARCH DESIGN AND METHODS: A total of 388 US adults with diabetes (in three BMI subgroups: <25, 25-29.9, and >or=30 kg/m(2)) with diverse demographic features were evaluated. Each subject had ultrasound measurements of ST and SCT at four injection sites. RESULTS: Subjects had BMI 19.4-64.5 kg/m(2), age 18-85 years; 40% Caucasian, 25% Asian, 16% Black, 14% Hispanic; 28% type 1 diabetes. Mean ST (+/-95% CI) was: arm 2.2 mm (2.2, 2.3), thigh 1.9 mm (1.8, 1.9), abdomen 2.2 mm (2.1, 2.2) and buttocks 2.4 mm (2.4, 2.5). Multivariate analyses showed body site, gender, BMI, and race are statistically significant factors for ST but effects were small. Thigh ST was <0.6 mm thinner than the buttocks. Differences of 10 kg/m(2) account for 0.2 mm ST variation. Mean SCT was: arm 10.8 mm (10.2, 11.3), thigh 10.4 mm (9.8, 10.9), abdomen 13.9 mm (13.2, 17.7) and buttocks 15.4 mm (14.7, 16.2). Females had 5.1 mm greater SCT. Differences of 10 kg/m(2) account for 4 mm SCT variation. ADVERSE EVENTS: A few mild hypo- or hyperglycemia events, unrelated to study procedure, were detected and treated before subject discharge from study visits. LIMITATIONS: Only adults in the US were studied; some measurements could not be obtained on every subject, at every injection site. CONCLUSIONS: Injection site ST does not differ by clinically significant degrees in demographically diverse adults with diabetes; SCT has a wider range. Needles >or=8 mm, inserted perpendicularly, may frequently enter muscle in limbs of males and those with BMI <25 kg/m(2). With 90 degrees insertion, needles 4-5 mm enter the subcutaneous tissue with minimal risk of IM injection in virtually all adults. These data will assist recommending appropriate length needles for subcutaneous insulin injections in adults.