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The study questionnaire was adapted from the Worldwide ITQ Study. A 50% larger sample size was needed to include the associated risk factors of lipohypertrophy this yielded a required sample size of 485 respondents.

The sample size was based on the prevalence of lipohypertrophy in the ITQ study (30.8%), yielding a sample size for this study of 323 respondents. The study respondents were recruited via systematic sampling wherein we sampled every one out of three patients who attended the clinic that day from September to November 2019 until the sample size was achieved. 14, 15 The cost of medical treatment is heavily subsidised (RM 1 for consultation, laboratory tests and drugs however, consumables such as insulin needles and glucometer test strips are not provided). Insulin-filled pen is prescribed in accordance with the national clinical practice guidelines on diabetes and insulin therapy. In the study sites, diabetes care (including insulin therapy) is delivered by a medical officer under the supervision of family medicine specialists. These study sites were selected because of convenience and logistic reasons. Four of the study sites were located in urban areas and the other two in suburban areas. The study was conducted at six public primary care clinics in central Peninsular Malaysia. In the present study, pregnant patients with diabetes were excluded. In the literature search for major studies in this field including the Worldwide ITQ Study, no study has been found to evaluate the duration of the development of lipohypertrophy after starting insulin injection therapy. This cross-sectional study was conducted among adult patients with type 1 or 2 diabetes who had been treated with insulin for at least 6 months. In view of the absence of relevant data in the Malaysian primary care setting for insulin-injecting patients with diabetes, the present study was conducted to determine the prevalence and associated factors of lipohypertrophy in this setting. 12 The ITQ study identified several risk factors of lipohypertrophy, including longer duration of insulin use, poorer glycaemic control, glycaemic variability and unexplained hypoglycaemia. In the Worldwide Injection Technique Questionnaire (ITQ) Study conducted in 42 countries involving 13,289 insulin-injecting patients, the overall prevalence of lipohypertrophy was 30.8%. Among these studies, three included patients with type 2 diabetes, 9- 11 and only one was conducted at a primary care clinic (a hospital-based study in Saudi Arabia). 8 systematically reviewed 26 palpation-based cross-sectional studies and found wide differences in the prevalence of lipohypertrophy (1.9%–73.4%). One study conducted in China has estimated that the additional insulin needed in patients with lipohypertrophy compared with those without lipohypertrophy is 15 IU per day. Insulin absorption is usually reduced or delayed, resulting in an increased requirement of the total daily dose of insulin and its associated costs.

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Lipohypertrophy has many undesirable effects, ranging from skin disfigurement to impairment of insulin absorption.

4, 5 Lipohypertrophic areas may be visible and/or palpable, and some lesions may be easily felt rather than visualised. This lesion is aggravated with needle reuse. Subsequently, lipohypertrophy forms over the trauma site over time. 4, 5 Repeated insulin injection causes microtrauma and, together with the growth-promoting effect of insulin on the repairing cell, can result in hypertrophy of adipose tissue at the trauma site. Lipohypertrophy is a thickened, rubbery lesion that is formed when injections of insulin are given repeatedly at the same location. 3 Insulin-injecting patients may develop treatment-related complications such as allergy, lipohypertrophy, hypoglycaemia and, rarely, oedema. 2 According to the Malaysian National Diabetes Registry, insulin use in primary care settings had almost doubled from 2009 to 2012 (rising from 11.7% to 21.4%). 1 In Malaysia, approximately 400,000 out of 1.6 million (25.1%) patients with known diabetes were using insulin. The National Health and Morbidity Survey 2019 indicated that the prevalence of diabetes among adults in Malaysia increased from 13.4% in 2015 to 18.3% in 2019.