Diabetes Ther (2017) 8:637–657 DOI 10.1007/s13300-017-0243-x ORIGINAL RESEARCH Indian Injection Technique Study: Population Characteristics and Injection Practices Sanjay Kalra . Ambrish Mithal . Rakesh Sahay . Mathew John . A. G. Unnikrishnan . Banshi Saboo . Sujoy Ghosh . Debmalya Sanyal . Laurence J. Hirsch . Vandita Gupta . Kenneth W. Strauss Received: December 19, 2016 / Published online: March 13, 2017 Ó The Author(s) 2017. This article is published with open access at Springerlink.com ABSTRACT Results: Mean HbA1c was 8.6. BMI values in India were 1.5–3 units lower than in ROW Introduction: It was estimated that 3.2 million depending on patient group, meaning the risk Indians with diabetes injected insulin in 2010, of intramuscular (IM) injections is high in but little is known about the techniques used. India. The mean total daily dose (TDD) of Methods: In 2015 we conducted an injection insulin was lower in every category of Indian technique questionnaire (ITQ) survey through- patient than in ROW, perhaps reflecting the out India involving 1011 patients. Indian values lower BMI. Needle reuse, whether with pens or were compared with those from 41 other syringes, is much higher in India than ROW and countries participating in the ITQ, known here so is the number of times the needle is used. The as rest of world (ROW). majority (56.8%) of Indian insulin users per- formed only 2 injections/day as opposed to ROW where 45% of patients performed at least 4 injections/day. Indian patients inject insulin Enhanced content To view enhanced content for this in the thighs more often than patients in ROW, article go to http://www.medengine.com/Redeem/ a site where IM injections are more risky. Many A2F7F0605653FD50. patients do not have proper access to sharps S. Kalra B. Saboo Bharti Hospital, Kunjpura Road, Karnal, India Diacare-Diabetes Care & Hormone Clinic, 1 & 2 Gandhi Park Society, Nehrunagar Cross Roads, A. Mithal Ambavadi, Ahmedabad, Gujarat, India Medanta the Medicity, CH Baktawar Singh Road, Sector 38, Gurgaon, Haryana, India S. Ghosh AMRI Medical Centre Kolkata, No. 97 A, Southern R. Sahay Avenue, Above Maruti Showroom, Opposite Lake Osmania Medical College, Turrebaz Khan Rd, Stadium, Kolkata, West Bengal, India Esamiya Bazaar, Koti, Hyderabad, Telangana, India D. Sanyal M. John KPC Medical College and Hospital, Raja Subodh Providence Endocrine & Diabetes Specialty Centre, Chandra Mullick Road, Jadavpur, Near Jadavpur TC 1/2138, Near GG Hospital, Murinjapalam, Railway Station, Kolkata, West Bengal, India Thiruvanthapuram, Kerala, India L. J. Hirsch A. G. Unnikrishnan BD Diabetes Care, 1 Becton Dr. MC 378, Franklin Chellaram Diabetes Institute, Pune-Bangalore, NH4, Lakes, New Jersey, USA Bavdhan, Pune, Maharashtra, India 638 Diabetes Ther (2017) 8:637–657 containers or have other risk factors that could (Table 1). This is one of the largest surveys of its lead to blood-borne pathogen spread. More kind ever performed in diabetes and provides than 60% of used sharps in India go into the landmark data on Indian injectors. The rubbish, with nearly 12% not even having the English-language versions of the questionnaire minimum protection of a cap. (nurse and patient forms) used in India can be Discussion: The shortest needles are very com- found at http://www.fitter4diabetes.com. ITQ mon in India; however, the level of needle reuse findings were used to formulate and publish is high. Multiple daily injections therapy is not new insulin delivery guidelines both on a as common in India as ROW. More focus needs worldwide basis [5, 6] and for India [7]. to be given to dwell times under the skin, reconstitution of cloudy insulins, skinfolds, and safe sharps disposal. METHODS The ITQ questionnaire consisted of an initial Keywords: Infusions; Injections; Insulin; participant section (administered by an experi- Lipodystrophy; Lipohypertrophy; Needles; enced diabetes nurse) followed by a section Needlestick; Subcutaneous completed by the nurse after an injection was observed and a meticulous examination made INTRODUCTION of all injection sites. The objectives of this questionnaire were The International Diabetes Federation (IDF) published statistics showing that India has the • To understand the epidemiologic profiles of second highest number of persons with diabetes the major insulin injection parameters (69.1 million) than any other country except • To determine the major causes of variability China [1]. This equates to a prevalence of 8.7% in injection technique, their ranking, and of the total adult population aged 20–79 years. their interactions In 2010 it was estimated that 3.2 million Indians • To query the participants’ perception of the with diabetes injected insulin [2], a figure that injection process, the psychological barriers, has risen significantly over the last 6 years and is and aids projected to rise dramatically over coming dec- ades. However, surprisingly little was known Besides participant demographic informa- and nothing has been published about the tion, the following key insulin injection techniques used by Indian insulin users when parameters were queried by the questionnaire: giving injections until the present study. Current practice: Injection device and needle From February 2014 until June 2015 the length, number of injections/day, choice of insulin injection technique questionnaire (ITQ) injection site, use and characteristics of skin- survey was conducted on a worldwide basis folds (pinch-up), needle entry angle, size of among 13,289 patients from 425 centers in 42 injecting zone, site rotation, disinfecting prior countries [3, 4]. One of the principal countries to injecting, dwell time of needle under the participating in the ITQ was India, with an skin, site inspection by health care professional input of 1011 patients from 20 centers repre- (HCP), needle reuse, sharps disposal, injection senting all the major regions of the country through clothing; Observed anomalies at injection sites: insulin leakage, bruising, lipoatrophy, lipohypertrophy (LH), inflammation, pain; V. Gupta Knowledge about injections: identity of teacher, BD Diabetes Care, BD, 6th Floor Signature Tower-B, themes covered in education, adequacy of the South City I, NH 8, Gurgaon, Haryana, India coverage of these themes, desire for more K. W. Strauss (&) knowledge. Blood glucose anomalies: episodes of BD Diabetes Care, POB 13, Erembodegem-Dorp 86, hypo- and hyperglycemia, hospitalizations for 9320 Erembodegem, Belgium hypoglycemia, diabetic ketoacidosis (DKA), e-mail: [email protected] Diabetes Ther (2017) 8:637–657 639 glucose variability, and unexpected hypo- clinic were accessioned. Injections were per- glycemia. Safety: needlestick injuries, risk factors formed with an insulin pen or syringe or both, for blood-borne infections, and disposal habits and participants gave verbal consent to partici- for used sharps. pate. A total of 1011 Indian participants with Validation: In 2013 the 2008 version of the diabetes who had both patient and nurse forms ITQ was reviewed and rewritten by a group of filled out were included in the ITQ database. HCPs who had attended the TITAN meeting [8]. We recognize the importance of rural vs The new version, the fourth generation, was then urban setting, availability of health care sent to a group of 18 leading endocrinologist and resources, and economic standing of patients in diabetes educators throughout their world for influencing outcomes. However, we elected not their comment. Further revisions were made. to capture detailed socioeconomic data in an Then the newest version was validated in Mon- already lengthy study. Though we do not have treal, Canada with a group of persons with dia- data on exact place of residence, we do know betes mellitus (DM) who were multilingual. A that the majority of centers who performed the total of eight languages were represented. These survey in India were in urban areas and it may patients were assessed on their understanding of be necessary to extend this study to rural areas. each question and of the translations into vari- All results from the ITQ survey data are ous languages. Finally after further revision the available in an interactive form on Tableau 2014 ITQ was validated by the Forum for Injec- Public Adam Young’s Profile website [9]. All tion Technique (FIT) board of the UK and Ireland, differences we present are significant at a a group of nurse specialists who had participated p value of less than 0.5. In a survey with such a in the previous ITQs. large number of subjects (n = 1011) even slight Participating centers (Table 1) were required differences generally reach statistical signifi- to understand and agree with the questions cance, often with p values as low as less than posed in the questionnaire and to recruit 0.001. Hence our comments are based not only approximately 25 subjects/center within the on statistical tests but on the practical and allotted time frame. Subjects were not placed at clinical significance of each finding. any risk by the study, therapy decisions were SPSS software was used to perform the data not based on it, and no financial compensation analysis. Descriptive statistics, frequencies, and was offered for participation. For these reasons rankings were obtained. Chi-squared analysis was signed informed consent was not sought. performed where appropriate for contingency Subject identity was kept confidential at all tables. Log linear analysis and ANOVA were used times and the study was conducted according to for the analysis of individual parameters, and GCP and the Helsinki accords. No partici- multiple regression and correlation analysis were pant-identifying information was made available used for multiparametric analysis. Two-tailed tests to the sponsor and participants were informed were used in all analyses. Initially results from each that their care would not be affected in any way of the 42 countries were analyzed independently by their participation. They were not put at risk in and only when the distributions of key demo- any way by the study and were not paid to par- graphic parameters (age, sex, BMI, and duration of ticipate.