Current Medical Research & Opinion 0300-7995 doi:10.1185/03007995.2014.895711
2014, 1–7
Article ST-0433.R1/895711 All rights reserved: reproduction in whole or part not permitted
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Original article Insulin pen injection technique survey in patients with type 2 diabetes in mainland China in 2010
Jiajia Ji Nanjing University of Chinese Medicine, Nanjing, PR China
Qingqing Lou Jiangsu Province Hospital on Integration of Chinese and Western Medicine, Nanjing University of Chinese Medicine, Nanjing, PR China Address for correspondence: Qingqing Lou J MSN RN AAPN, Diabetes Nurse Specialist, Director of Health Education, Jiangsu Province Hospital on integration of Chinese and Western Medicine, Nanjing University of Chinese Medicine, #100 Hongshan Road, Qixia District Nanjing, PR 210028, China. [email protected] Keywords: Diabetes – Injection – Insulin – Lipohypertrophy
Abstract Objective: The efficacy of injection therapy in diabetes depends on correct injection technique. To provide patients with guidance in this area and help patients inject themselves correctly, we must understand how they currently inject; therefore, the purpose of this study was to assess the current situation of insulin injection technique in patients with diabetes in mainland China. Design and methods: From October 2010 to November 2010, a cross-sectional survey of 380 diabetes patients from 20 centers in mainland China was conducted regarding their daily insulin pen injection practice. Results: Overall, 35.26% of patients had lipohypertrophy; 58.68% of patients had bleeding and bruising, and abdominal lipohypertrophy at injection sites. Bleeding and bruising were more frequent. We found a significant relationship between the frequency of a single needle reuse and lipohypertrophy (r ¼ 0.426, P ¼ 0.000). In addition, there was a significant relationship between the frequency of daily insulin injection and lipohypertrophy (r ¼ 0.146, P ¼ 0.004), between rolling the pen while pulling out the needle after injection and lipohypertrophy ( 2 ¼ 7.355, P ¼ 0.007). Bleeding and bruising at injection sites were found to be related to HbA1c levels (r ¼ 0.151, P ¼ 0.003).
Accepted: 3 February 2014; published online: 10 March 2014 Citation: Curr Med Res Opin 2014; 1–7
Limitations: A few limitations linked with this survey should be noted. Because of the limited budget, the ultrasound was not used to evaluate lipodystrophy and the photographs of lipodystrophy were not taken. On the other hand, specific size of lipodystrophy and the cost of insulin wastage were not evaluated. Furthermore, the population of this survey is limited, and it was only done in general hospitals and not in community hospitals, therefore, a larger study sample is advisable. Conclusions: The insulin injection skill of patients with diabetes in mainland China was poor, and the incidence of lipohypertrophy, bleeding, and needle reuse was high. Frequency of daily insulin injection and needle reuse may relate to the incidence of lipohypertrophy and bleeding. The bleeding and bruising at the injection sites may be associated with suboptimal absorption of injected insulin. Improved education in optimal insulin injection technique, including reducing needle reuse and correct rotation of injection sites should be emphasized.
Introduction With economic development, the aging of society, and lifestyle change, the incidence of diabetes in China has been dramatically increased. Data showed that the age-adjusted prevalence of diabetes in adults over the age of 20 in China was up to 9.7% in 20081. There is a high prevalence of diabetes in China and the ! 2014 Informa UK Ltd www.cmrojournal.com
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rate of well controlled blood glucose is low. The 1998– 2006 China Diabetes (DiabCare-China) survey shows that in China only 26.8% of patients with diabetes have ideal glycemic control (HbA1c 6.5%), and the number of patients with HbA1c 48% reached as high as 28.3%. Insulin therapy is powerful to diabetes patients, yet among the patients on insulin, only 37% of them have achieved ideal glycemic control2. Nowadays, insulin use in patients with diabetes is gradually increasing. About 61.53% of Chinese patients with type 2 diabetes are on insulin3. However, according to ISIS Diabetic Therapy Monitor PhVI 2002 American Diabetes Association guidelines, glycemic control of diabetes patients with insulin therapy is worse than those with oral medical therapy. The HbA1c of diabetes patients with insulin therapy is approximately 8.25%, while the HbA1c of diabetes patients with oral medical therapy is approximately 7.43%. Poor injection technique is an important reason for blood glucose that is not well controlled. Injection technique plays an important role in blood glucose control. Incorrect insulin injection technique on a global scale is a common phenomenon4, such as incorrect rotation of the injection site and needle reuse. These problems, to some degree, affected the effect of insulin therapy, eventually leading to poor glucose control. Compared with insulin syringe, insulin pen devices are more convenient to carry, less painful, and have less leakage from injection sites5,6. A survey conducted in 2008 and 2009 in China7 shows that 2.7% of the study population were using a syringe alone and 91.7% were using a pen device. So the insulin pens are widely used in China, and it is important to learn how well the patients give insulin injection to themselves. Therefore, we conducted a multi-center, cross-sectional survey in mainland China, so as to find problems with insulin pen injection technique in patients with diabetes to provide information for diabetes educators to tailor their education programs and make them more practical.
Patients and methods Research design We conducted this survey from October 2010 to November 2010. The survey was a cross-sectional, multiple center design to obtain detailed information in a sample of Chinese diabetes patients. Patients visiting clinics meeting the inclusion criteria were asked to participate in the study. The inclusion criteria were: (1) type 2 diabetes patients; (2) aged 20–65 years; (3) body mass index (BMI) between 18.5 and 29.9 kg/m2; (4) had been on insulin and used an insulin pen for at least 3 months; (5) a single insulin dose of 40 IU (patients with diabetes in China are slimmer than those in western countries, with 2
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BMI from 20.52 to 24.498–11, and their insulin resistance is relatively lower; therefore, the single dosage of the majority of patients who are on insulin is usually less than 40 IU). Patients whose insulin is injected by someone else; patients with pregnancy, breast-feeding, planning to have a baby; patients with coagulopathy, serious complication, such as cardiovascular disease, end stage renal disease; and patients with severe retinopathy or other eye problems that impair their visual function, or cognitive dysfunction were excluded from the study. This study was given permission to proceed by the local ethics committee, and all patients involved with the study gave written informed consent prior to joining.
Methods The survey included demographic data, lab values (HbA1c and blood glucose), and a questionnaire to assess patients’ injection skill and their knowledge with regard to insulin injection. The demographic data and HbA1c were drawn from patients’ medical records within 3 months. A questionnaire was obtained by a face to face interview between a trained nurse and the patient. All questionnaires were checked for quality and completeness of information; missing data were highlighted and went back for correction. The assessment of insulin injection technique is described below: (1) Assessing injection device and needle length, the number of injections per day, the injection sites where using the skin fold technique (pinch-up) and rotation, needle entry angle, the size of the area disinfected prior to injection, the time the needle remains under skin, needle reuse, sharps disposal, how to pull out the needle after injection. (2) ‘Observing at injection sites’ including insulin leakage, bleeding and bruising, lipohypertrophy at injection sites. The data on lipohypertrophy were obtained through visual examination and palpation by nurses. Nurses from the centers were trained on how to assess bleeding, bruising, and lipohypertrophy (by both observation and palpation) at injection sites before participating in the study.
Statistical analysis Data was analyzed by SPSS 16.0 software package. Twotailed tests were used in all analyses. Statistical analyses were undertaken to determine the response distribution, to calculate frequency, mean statistical description, percentages, and correlation, according to the original data type. Spearman correlation was used to analyze the association between the frequency of needle reuse, the frequency of daily insulin injection and lipohypertrophy, between the www.cmrojournal.com ! 2014 Informa UK Ltd
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frequency of bleeding and bruising at injection sites and HbA1c levels, and so on. Potential differences in pen needle reuse (yes or no) and lipohypertrophy present (yes or no), or rolling the pen while pulling out the needle after injection (yes or no) and lipohypertrophy present (yes or no) were analyzed using chi square. Statistical comparisons were considered significant when P was 50.05.
Patient characteristics Table 1 shows the number of participants and demographic data for the subjects inducted into the study. In total, 380 patients completed the study and their data were analyzed. The sample is made up of 50% men and 50% of women. Two overlapping peaks can be seen in the age distribution (Figure 1): a sharp peak between 52 and 58 years of age, and another peak around 62 years of age. BMI were 23.23 2.30. The mean time on insulin was 3.62 years. Mean HbA1c of 435 participants was 8.06 3.66. In the present study, 16.58%, 62.11%, 7.63%, and 13.68% of participants required one, two, three and four injections per day, respectively. In addition, we found that there was a significant relationship between the frequency of insulin injection per day and lipohypertrophy (r ¼ 0.146, P ¼ 0.004), and between the frequency of insulin injection per day and needle reuse (r ¼ 0.292, P ¼ 0.000).
Needle length All of the study population were using a pen device. Overall, 18.95% of patients were using the 8 mm needle, 72.63% were using the 5 mm needle, 4.74% were using the 6 mm needle, 2.63% were using 8 mm plus 5 mm needle, and 1.05% of patients did not know what length of needles they were using (Table 2). There was no significant correlation between the length of the needle used and insulin leakage (P ¼ 0.056), the presence of lipohypertrophy (P ¼ 0.388), the presence of bleeding and bruising at injection sites (P ¼ 0.709) or HbA1c levels (P ¼ 0.091). Mean (SD) HbA1c of the patients was 8.06 3.66. There was no significant correlation between HbA1c and the presence of lipohypertrophy (P ¼ 0.602).
Injecting practice Insulin injection sites are usually the upper arm and the lateral areas of the thigh, buttocks, and abdomen. Site rotation includes rotating the injection of insulin to all four anatomical areas and rotating within one area, and consecutive insulin injections should be at least one inch apart from the last injection point. It is reported that 92.11% of participants rotated the injection site, of which 36% reported that they rotated the four anatomical 60
Mean = 54.56 Std. Dev. = 8.652 N = 380
50
Table 1. Characteristics of the studied diabetes patients with insulin therapy, n ¼ 380. Characteristics
Age Sex Female Male Weight (kg) BMI (kg/m2) 18.5–23.9 24.0–26.9 27.0–29.9 Waist circumference (cm) Systolic blood pressure (mmHg) Diastolic blood pressure (mmHg) Hemoglobin A1c Fasting blood glucose (mmol/L) Prandial blood glucose (mmol/L) Duration of insulin (years) Average single insulin dose (IU) (minimal dosage 2 IU; maximal dosage 40 IU) Frequency of injections per day 1 2 3 4
n or mean standard
40 Frequency
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Results
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30
54.56 8.65 20
190 190 64.32 9.31 23.23 2.30 293 63 24 84.96 1.06 125.64 14.47 77.27 8.96 8.06 3.66 7.55 2.27 10.85 3.49 3.62 4.08 15.65 6.45 2.18 0.87 63 236 29 52
10
0 20.00
30.00
40.00
50.00
60.00
70.00
Figure 1. Age distribution of the study population. The mean (SD) age of 380 participants was 54.56 8.652 years. Table 2. Lengths of needles used. Lengths of needles used 8 mm 5 mm 6 mm Either 8 mm or 5 mm needle used other
n (%) 72 (18.95) 276 (72.63) 18 (4.74) 10 (2.63) 4 (1.05)
BMI, body mass index; n, number of subjects.
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Table 3. Preparation before insulin injections.
Table 4. Problems with the injection process.
Variables Insulin injection after disinfection (the alcohol) being dried Priming before injection Understand the proper way to pinch the skin Check insulin dose before injection Check the liquid before injection Pinch the skin 5 mm needle use only 6 mm needle use only 8 mm needle use only
N
Yes (%)
380
296 (77.89)
380 380 380 380
274 (72.11) 218 (57.37) 346 (91.05) 292 (76.84)
276 18 72
172 (62.32) 12 (66.67) 51 (70.83)
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N, number of subjects.
areas, such as from the abdomen to outer thighs or to the buttocks; 80% reported that they rotated within one area, such as the abdomen; 16% reported that they rotated both among the four anatomical areas and within each area.
Preparation before insulin injections Most patients usually do not require a skin fold at the injection angle of 90 using shorter (4 mm or 5 mm) needles12–15 (Table 3), but when they use long (8 mm) needles, patients need to pinch the skin or inject at 45 to reduce the risk of intramuscular injection16,17 (Table 3). Most of the participants in this survey lifted a skin fold before injecting, but many patients used the ‘pinch up’ inappropriately. It was found that only 57.37% of the participants understood the proper way to pinch the skin. A total of 62.32% of patients who used the 5 mm needle also pinched their skin; 34.62% of patients who used other needles didn’t pinch their skin. When participants were asked whether they prime before injection, 72.11% of subjects answered ‘Yes’. All participants cleaned their injection sites with 75% alcohol; 77.89% of them started to inject insulin after the alcohol was dry.
Variables Rolling to pull out the needle after injection Yes No Leakage at the injection site Yes No Bleeding at the injection site Yes No After injection, the time (s) the pen needle under the skin 10 s After injection, how to dispose of needles Leave with the pen Needles back to the needle cap to be used again Needles discarded after back to the needle cap After the injection, back to the needle cap and then remove the needle Yes No
N (M SD)
%
67 313
17.63 82.37
169 211
44.47 55.53
197 183 11.62 10.28
51.84 48.16
282
74.21
279 50
73.42 13.16
51
13.42
277 103
72.89 27.11
M, mean; N, number of subjects; SD, standard deviation.
Table 5. Needle reuse. Needle replacement frequency
Every time 2–4 5–10 410
N (M SD)
%
9.19 9.295 33 116 129 102
8.68 30.53 33.95 26.84
M, mean; N, number of subjects; SD, standard deviation.
If they rolled the needles while they pulled them out they were more likely to have lipohypertrophy.
Needle reuse Problems with the injection process A total of 74.21% of participants kept the pen needle under skin for 10 seconds (Table 4). There was no relationship found between the time that the needle was kept under the skin and the degree of leakage from the site (P ¼ 0.074). However, the time that the pen needle was left under the skin was found to be related to HbA1c levels (r ¼ 0.117, P ¼ 0.022). It means that the longer the pen needle was left under the skin, the more precisely insulin was injected into the body, and the better glycemic control could be achieved. A total of 17.63% of participants roll the needles while they pull out the needles from the skin after finishing injection and there was a significant relationship between rolling to pull out the needle after injection and lipohypertrophy ( 2 ¼ 7.355, P ¼ 0.007). 4
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The mean (SD) number of per needle uses was 9.19 9.30 (Table 5). Specifically, 8.68% of participants used a pen needle only once; 30.53% used it two, three, or four times; 33.95% used it between five and ten times; and 26.84% used it more than ten times. We found a significant relationship between needle reuse and lipohypertrophy (r ¼ 0.426, P ¼ 0.000). When participants were grouped into binary groups (pen needle reuse, yes or no; and lipohypertrophy present, yes or no), we found a significant relationship between needle reuse and lipohypertrophy ( 2 ¼ 8.478, P ¼ 0.004). These data suggests that if participants reuse pen needles, they have more chance of having lipohypertrophy. When participants were asked why they reused needles, the most frequent responses were because of the convenience and saving money. www.cmrojournal.com ! 2014 Informa UK Ltd
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In the survey, pen needle reuse was not associated with worse HbA1c (P ¼ 0.48), or bleeding and bruising at the injection sites (P ¼ 0.188). When participants were asked how they disposed of needles after injection, it was found that the needle was attached to the pen devices between injections in 73.42% of the cases. Only 13.16% of subjects removed the needles from the pen devices and needles were put back to the needle cap to be used again; 13.42% disposed of used needles into specific sharps containers or into the rubbish after recapping. In addition, 17.63% of participants were found rolling to pull out the needle after injection (Table 4).
Injection complications Lipohypertrophy was found in 35.26% of the participants at their injection sites after an assessment of observation and palpitation by a diabetes nurse (Table 6); 1.32% had lipohypotrophy; 58.68% had bleeding and bruising at their injection sites. There is a significant relationship between needle reuse and the presence of lipohypertrophy (r ¼ 0.426, P ¼ 0.000). Most of the complications such as lipohypertrophy occurred within the abdomen area. Many participants reported injection complications at multiple sites. Nearly 44.47% of participants observed leakage of insulin from their pen needles after injection. There was no relationship between insulin leakage and the length of the needles (P ¼ 0.056), or the HbA1c (P ¼ 0.151). A total of 58.68% of participants reported have bleeding and bruising at injection sites after injection. Bleeding and bruising at injection sites was not found to be related to pen needle reuse (P ¼ 0.290) or the length of the needle (P ¼ 0.248). Bleeding and bruising at injection sites were found to be related to HbA1c levels (r ¼ 0.151, P ¼ 0.003). In other words, those who sometimes or often bled had higher mean HbA1c levels than those who never did.
Table 6. Local skin complications and HbA1c. Skin complications Lipohypertrophy Yes No Lipoatrophy Yes No Bleeding Yes No
n
%
HbA1c
134 246
35.26 64.74
7.87 1.53 8.17 4.41
6 374
1.58 98.42
8.8 2.60 8.05 3.68
223 157
58.68 41.32
7.98 4.55 8.19. 1.74
Z/ 2
P value
0.522
0.602
1.036
0.300
8.567
0.003
Numbers add up to more than 380 because of the use of multiple sites. n, number of subjects.
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Discussion In the survey, the mean (SD) frequency of pen needle reuse is high (9.19 9.30) and pen needle reuse increases the risk of lipohypertrophy. This is in agreement with the study conducted in 2008–2009 in multiple countries7. So decreasing the frequency of needle reuse is generally felt to be an appropriate intervention, even if not completely effective in every case18,19. People with diabetes who are injecting insulin should also be taught not to inject into lipohypertrophic lesions, especially if they are doing so just because it hurts less19. In this survey, 72.63% were using the 5 mm needle, 4.74% were using the 6 mm needle, 2.63% were using 8 mm plus 5 mm needles, and 1.05% of patients did not know what length of needles they were using. The percentage using 5 mm is high in China, because needles 8 mm, inserted perpendicularly, may frequently enter muscle in the limbs of males and those with BMI 525 kg/m2. The BMI of patients with diabetes in China is lower than in western countries8–11, and subcutaneous tissue thickness is thin (293 patients had BMI between 18.5 and 23.9 kg/m2, 63 patients had BMI between 24.0 and 26.9 kg/m2, and 24 patients had BMI between 27.0 and 29.9 kg/m2 in this survey). The 5 mm needle is safe for children and thin adults, for it is not likely to be injected into muscles with such short length. The short needle is correlated with reduced pain and minimal leakage20. This may explain why the 5 mm needle is widely used in Chinese patients with diabetes. In addition, in this survey it was found that 17.63% of the patients tended to roll the needle while pulling it out after injection, and if participants rolled to pull out the needle after injection the prevalence of lipohypertrophy increased. Rolling to pull out the needle after injection might be unconscious behavior, and is associated with lack of education. Most of the participants in the present survey injected with a lifted skin fold, but many subjects used the ‘pinch up’ inappropriately. Injections into the abdomen in people with a BMI 425 kg/m2, especially when using a needle 56 mm long, usually do not require a skin fold to prevent intramuscular injection. However, injections into the thigh in slim people should always be made with a pinch up regardless of needle length, except with 5 mm or shorter needle. There is often so little subcutaneous tissue in the outer thigh that pinching up is the only way to reduce intramuscular injection. However, when a 5 mm needle is used, a skin fold is not usually required to prevent intramuscular injection. Mostly participants actually pinch up with almost equal frequency in the abdomen and thigh, which indicates they still do not understand the rationale behind the technique. Many of the same principles regarding abdominal injections apply to the buttocks, and those Insulin pen injection technique survey Ji &
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regarding the thigh apply to the arm. However, the arm is an especially challenging place to pinch up, because this maneuver must be performed with the fingers of the same arm that is being injected (while the injecting device is being held in the other hand). Recent guidelines for self-injections state unequivocally that the arm should not be used21,22. It was found in our study that only 57.37% of the participants understood the proper way to pinch the skin. A correct pinch up should be held for at least 5 s after the injection to give the insulin time to disperse throughout the subcutaneous tissue7. Releasing the pinch earlier increases the risk of insulin leakage from the site and of pushing the needle into muscle. Ideally, and for the same reasons, the skin fold should only be released when the needle is removed from the skin, a practice currently observed by only a minority of participants. Finally, a correct pinch up is made with the thumb and index (and sometimes the third) finger, and not the whole hand. The latter technique risks lifting the entire muscle, thereby promoting intramuscular injection23. Participants keep the pen needle under the skin for 10 s24,25, and then it decreases the occurring of leakage from the pen device. This raises concern about the quality of the medical supervision for insulin injections that participants are receiving, especially given the high prevalence of insulin leakage from the sites. In this survey, the frequency of bleeding and bruising at injection sites after injection is positively correlated with HbA1c. Lower frequency of bleeding and bruising might positively impact on HbA1c. This may relate to malabsorption of insulin in the bleeding area, and the poor absorption of insulin can lead to worse HbA1c. Inspecting the injected site not only discovers and treats these conditions, but also sends an important message to the people who give injections to themselves that they should pay particular attention to these vital signs, and that improving the practice of injecting is a cost-effective method for optimizing the benefits from the agent injected. The disposal of used needles needs improving. Sharps containers should be provided to all people injecting, along with clear guidance on the locations and procedures for the disposal of filled containers. It is clear that we are not covering many of the key educational topics adequately, because so many participants do not know how to dispose of the sharp needles. Whether they have simply forgotten them or whether the topics were not ever covered is beside the point. Until people who are injecting understand these best practices and why they yield benefits, we are obliged to repeat the message or recast it in forms that can be better understood and acted upon. 6
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Table 7. Comparison between surveys. 2008–20097
Items
No. participants No. participating centers Mean age of participants (years) Mean body mass index (kg/m2) Mean HbA1c (%) Participants reporting four or more injections/day (%) Participants using an insulin pen (%) Participants using 8 mm needles (%) Participants using needles 58 mm (%) Injection site (%) Abdomen Thigh Buttocks Arm Participants injecting using pinch up (%) Prevalence of occasional bleeding (%) Prevalence of lipohypertrophy (%) Mean no. times a single needle used Disposal of needles into the rubbish with recapping (%) Participants desiring more knowledge regarding injection technique (%)
2441 91 43.9 27 8.2 51.9
2010 in China 380 54.56 23.23 8.06 13.68
93.2 56.5 37.5
100 18.95 81.05
86 63 21 32 72.6 60 53 3.2 97.8
92.89 24.21 5 22.89 63.16 51.84 15.79 9.19 13.42
17
51.58
No., number of subjects.
Comparison of findings from the surveys in 2008–2009 in multiple countries and 2010 in China Table 7 compares salient parameters from the two surveys. The first data column gives results from the 2008–2009 survey7, the second column lists results from the 2010 survey in China. The scale of these two surveys was different in terms of participant numbers, and all the data collected in our survey had a higher mean age (43.90 in 2008–2009 vs 54.56 in 2010), a higher prevalence of the use of58 mm needles (37.5% in 2008–2009 vs 81.05% in 2010), a lower percentage of four daily injections (51.9% in 2008–2009 vs 13.68% in 2010), less pinching technique used while injecting (72.6% in 2008–2009 vs 63.16% in 2010), and lower presence of bleeding and bruising at injection sites (60% in 2008–2009 vs 51.84% in 2010). Furthermore, the mean HbA1c value is lower (8.2% in 2008–2009 vs 8.06% in 2010); however, there was more reuse of needles on average (3.2 in 2008–2009 vs 9.19 in 2010). Compared with insulin syringe, insulin pen devices are more convenient to carry, less painful, and have less leakage from injection sites, so Chinese patients widely use insulin pens. Of the study population in 2008–2009 China, 2.7% were using a syringe alone and 91.7% were using a pen device. Overall, 0.6% of patients were using the 12.7 mm needle, 28.2% were using the 8 mm needle, 1.5% of patients were using the 6 mm needle, 49.6% were using the 5 mm needle, and the rest of the patients did not www.cmrojournal.com ! 2014 Informa UK Ltd
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know what length of needle they were using7. In our survey, 18.95% of patients use the 8 mm needle, 72.63% use the 5 mm needle, 4.74% use the 6 mm needle, and 2.63% of patients do not know what length of needle they use. Thus, in China, participants have moved to pens as their devices of choice, as well as to move away from the use of longer needles towards the use of shorter ones, but the appropriate disposal of sharps has not improved. A few limitations linked with this survey should be noted. Because of the limited budget, the ultrasound was not used to evaluate lipodystrophy and photographs of lipodystrophy were not taken. On the other hand, specific size of lipodystrophy and the cost of insulin wastage were not evaluated. Furthermore, the population of this survey is limited, and it was only done in general hospitals and not in community hospitals; therefore, a larger sample of study is advisable.
Conclusions The insulin injection skill of patients with diabetes in mainland China was poor, and the incidence of lipohypertrophy, bleeding, and needle reuse were high. Frequency of daily insulin injection and needle reuse may relate to the incidence of lipohypertrophy and bleeding. The bleeding and bruising at the injection sites may be associated with suboptimal absorption of injected insulin. Improved education in optimal insulin injection technique, including reducing needle reuse and correct rotation of injection sites, should be emphasized.
Transparency Declaration of funding This paper was sponsored by Becton Dickinson Company, Franklin Lakes, NJ, USA. Declaration of financial/other relationships J.J. and Q.L. have disclosed that they have no significant relationships with or financial interests in any commercial companies related to this study or article. CMRO peer reviewers may have received honoraria for their review work. The peer reviewers on this manuscript have disclosed that they have no relevant financial relationships. Acknowledgments The authors sincerely thank the participants, nurses, and the other investigators in the 20 centers in mainland China, and Becton Dickinson Company for their support.
References 1. Yang W, Lu J, Weng J, et al. Prevalence of diabetes among men and women in China. N Engl J Med 2010;362:1090-101
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2. Pan C, Yang W, Jia W, et al. Management of Chinese patients with type 2 diabetes, 1998–2006: the Diabcare-China surveys. Curr Med Res Opin 2009;25:39-45 3. Guo X, Yuan L, Lou Q, et al. A nationwide survey of diabetes education, selfmanagement and glycemic control in patients with type 2 diabetes in China. Chin Med J 2012;125:4175-80 4. Frid A, Hirsch L, Gaspar R, et al. The Third Injection Technique Workshop In Athens (TITAN). Diabetes Metab 2010;36:s19-29 5. Pfu¨tzner A, Bailey T, Campos C, et al. Accuracy and preference assessment of prefilled insulin pen versus vial and syringe with diabetes patients, caregivers, and healthcare professionals. Curr Med Res Opin 2013;29:475-81 6. Fry A. Insulin delivery device technology 2012: where are we after 90 years? J Diabetes Sci Technol 2012;6:947-53 7. De Coninck C, Frid A, Gaspar R, et al. Results and analysis of the 2008–2009 Insulin Injection Technique Questionnaire survey. J Diabetes 2010;2:168-79 8. Shi YF, Shao XY, Lou QQ, et al. Study on female sexual dysfunction in type 2 diabetic Chinese women. Biomed Environ Sci 2012;25:557-61 9. Kong L, Cai Y, Mei G, et al. Psychological status and diabetes-related distress of Chinese type 1 diabetes patients in Jiangsu province, China. J Biomed Res 2013;27:380-5 10. Wang Q, Huang R, Yu B, et al. Higher fetal insulin resistance in Chinese pregnant women with gestational diabetes mellitus and correlation with maternal insulin resistance. PLOS One 2013;8:e59845 11. Guo XH, Yuan L, Lou QQ, et al. A nationwide survey of diabetes education, self-management and glycemic control in patients with type 2 diabetes in China. Chin Med J (Engl) 2012;125:4175-80 12. Birkebaek N, Solvig J, Hansen B, et al. A 4mm needle reduces the risk of intramuscular injections without increasing backflow to skin surface in lean diabetic children and adults. Diabetes Care 2008;22:e65 13. Gibney MA, Arce CH, Byron KJ, et al. Skin and subcutaneous adipose layer thickness in adults with diabetes at sites used for insulin injections: implications for needle length recommendations. Curr Med Res Opin 2010;26:1519-30 14. Hirsch L, Klaff L, Bailey T, et al. Comparative glycemic control, safety and patient ratings for a new 4 mm\32G insulin pen needle in adults with diabetes. Curr Med Res Opin 2010;26:1531-41 15. Kreugel G, Keers JC, Jongbloed A, et al. The influence of needle length on glycemic control and patient preference in obese diabetic patients. Diabetes 2009;58:A117 16. Schwartz S, Hassman D, Shelmet J, et al. A multicenter, open-label, randomized, two-period crossover trial comparing glycemic control, satisfaction, and preference achieved with a 31 gauge 6mm needle versus a 29 gauge 12.7mm needle in obese patients with diabetes mellitus. Clin Ther 2004;26:1663-78 17. Frid A, Linde´n B. Where do lean diabetics inject their insulin? A study using computed tomography. BMJ 1986;292:1638 18. Hauner H, Stockamp B, Haastert B. Prevalence of lipohypertrophy in insulintreated diabetic patients and predisposing factors. Exp Clin Endocrinol Diabetes 1996;104:106-10 19. Young RJ, Hannan WJ, Frier BM, et al. Diabetic lipohypertrophy delays insulin absorption. Diabetes Care 1984;7:479-80 20. Hofman PL, Derraik JG, Pinto TE, et al. Defining the ideal injection techniques when using 5-mm needles in children and adults. Diabetes Care 2010;33:1940-4 21. Danish Nurses Organization. Evidence-based Clinical Guidelines for Injection of Insulin for Adults with Diabetes Mellitus, 2nd edn. Copenhagen, Denmark: DNO, 2006 22. Association for Diabetescare Professionals (EADV). Guideline: The Administration of Insulin with the Insulin Pen. Utrecht, Netherlands: EADV, 2008 23. Strauss K. Insulin injection techniques. Pract Diabetes Int 1998;15:181-4 24. Annersten M, Frid A. Insulin pens dribble from the tip of the needle after injection. Pract Diabetes Int 2000;17:109-11 25. Rissler J, Jørgensen C, Rye Hansen M, et al. Evaluation of the injection force dynamics of a modified prefilled insulin pen. Expert Opin Pharmacother 2008;9:2217-22
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Article ST-0433.R1/895711 All rights reserved: reproduction in whole or part not permitted
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Original article Insulin pen injection technique survey in patients with type 2 diabetes in mainland China in 2010
Jiajia Ji Nanjing University of Chinese Medicine, Nanjing, PR China
Qingqing Lou Jiangsu Province Hospital on Integration of Chinese and Western Medicine, Nanjing University of Chinese Medicine, Nanjing, PR China Address for correspondence: Qingqing Lou J MSN RN AAPN, Diabetes Nurse Specialist, Director of Health Education, Jiangsu Province Hospital on integration of Chinese and Western Medicine, Nanjing University of Chinese Medicine, #100 Hongshan Road, Qixia District Nanjing, PR 210028, China. [email protected] Keywords: Diabetes – Injection – Insulin – Lipohypertrophy
Abstract Objective: The efficacy of injection therapy in diabetes depends on correct injection technique. To provide patients with guidance in this area and help patients inject themselves correctly, we must understand how they currently inject; therefore, the purpose of this study was to assess the current situation of insulin injection technique in patients with diabetes in mainland China. Design and methods: From October 2010 to November 2010, a cross-sectional survey of 380 diabetes patients from 20 centers in mainland China was conducted regarding their daily insulin pen injection practice. Results: Overall, 35.26% of patients had lipohypertrophy; 58.68% of patients had bleeding and bruising, and abdominal lipohypertrophy at injection sites. Bleeding and bruising were more frequent. We found a significant relationship between the frequency of a single needle reuse and lipohypertrophy (r ¼ 0.426, P ¼ 0.000). In addition, there was a significant relationship between the frequency of daily insulin injection and lipohypertrophy (r ¼ 0.146, P ¼ 0.004), between rolling the pen while pulling out the needle after injection and lipohypertrophy ( 2 ¼ 7.355, P ¼ 0.007). Bleeding and bruising at injection sites were found to be related to HbA1c levels (r ¼ 0.151, P ¼ 0.003).
Accepted: 3 February 2014; published online: 10 March 2014 Citation: Curr Med Res Opin 2014; 1–7
Limitations: A few limitations linked with this survey should be noted. Because of the limited budget, the ultrasound was not used to evaluate lipodystrophy and the photographs of lipodystrophy were not taken. On the other hand, specific size of lipodystrophy and the cost of insulin wastage were not evaluated. Furthermore, the population of this survey is limited, and it was only done in general hospitals and not in community hospitals, therefore, a larger study sample is advisable. Conclusions: The insulin injection skill of patients with diabetes in mainland China was poor, and the incidence of lipohypertrophy, bleeding, and needle reuse was high. Frequency of daily insulin injection and needle reuse may relate to the incidence of lipohypertrophy and bleeding. The bleeding and bruising at the injection sites may be associated with suboptimal absorption of injected insulin. Improved education in optimal insulin injection technique, including reducing needle reuse and correct rotation of injection sites should be emphasized.
Introduction With economic development, the aging of society, and lifestyle change, the incidence of diabetes in China has been dramatically increased. Data showed that the age-adjusted prevalence of diabetes in adults over the age of 20 in China was up to 9.7% in 20081. There is a high prevalence of diabetes in China and the ! 2014 Informa UK Ltd www.cmrojournal.com
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rate of well controlled blood glucose is low. The 1998– 2006 China Diabetes (DiabCare-China) survey shows that in China only 26.8% of patients with diabetes have ideal glycemic control (HbA1c 6.5%), and the number of patients with HbA1c 48% reached as high as 28.3%. Insulin therapy is powerful to diabetes patients, yet among the patients on insulin, only 37% of them have achieved ideal glycemic control2. Nowadays, insulin use in patients with diabetes is gradually increasing. About 61.53% of Chinese patients with type 2 diabetes are on insulin3. However, according to ISIS Diabetic Therapy Monitor PhVI 2002 American Diabetes Association guidelines, glycemic control of diabetes patients with insulin therapy is worse than those with oral medical therapy. The HbA1c of diabetes patients with insulin therapy is approximately 8.25%, while the HbA1c of diabetes patients with oral medical therapy is approximately 7.43%. Poor injection technique is an important reason for blood glucose that is not well controlled. Injection technique plays an important role in blood glucose control. Incorrect insulin injection technique on a global scale is a common phenomenon4, such as incorrect rotation of the injection site and needle reuse. These problems, to some degree, affected the effect of insulin therapy, eventually leading to poor glucose control. Compared with insulin syringe, insulin pen devices are more convenient to carry, less painful, and have less leakage from injection sites5,6. A survey conducted in 2008 and 2009 in China7 shows that 2.7% of the study population were using a syringe alone and 91.7% were using a pen device. So the insulin pens are widely used in China, and it is important to learn how well the patients give insulin injection to themselves. Therefore, we conducted a multi-center, cross-sectional survey in mainland China, so as to find problems with insulin pen injection technique in patients with diabetes to provide information for diabetes educators to tailor their education programs and make them more practical.
Patients and methods Research design We conducted this survey from October 2010 to November 2010. The survey was a cross-sectional, multiple center design to obtain detailed information in a sample of Chinese diabetes patients. Patients visiting clinics meeting the inclusion criteria were asked to participate in the study. The inclusion criteria were: (1) type 2 diabetes patients; (2) aged 20–65 years; (3) body mass index (BMI) between 18.5 and 29.9 kg/m2; (4) had been on insulin and used an insulin pen for at least 3 months; (5) a single insulin dose of 40 IU (patients with diabetes in China are slimmer than those in western countries, with 2
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BMI from 20.52 to 24.498–11, and their insulin resistance is relatively lower; therefore, the single dosage of the majority of patients who are on insulin is usually less than 40 IU). Patients whose insulin is injected by someone else; patients with pregnancy, breast-feeding, planning to have a baby; patients with coagulopathy, serious complication, such as cardiovascular disease, end stage renal disease; and patients with severe retinopathy or other eye problems that impair their visual function, or cognitive dysfunction were excluded from the study. This study was given permission to proceed by the local ethics committee, and all patients involved with the study gave written informed consent prior to joining.
Methods The survey included demographic data, lab values (HbA1c and blood glucose), and a questionnaire to assess patients’ injection skill and their knowledge with regard to insulin injection. The demographic data and HbA1c were drawn from patients’ medical records within 3 months. A questionnaire was obtained by a face to face interview between a trained nurse and the patient. All questionnaires were checked for quality and completeness of information; missing data were highlighted and went back for correction. The assessment of insulin injection technique is described below: (1) Assessing injection device and needle length, the number of injections per day, the injection sites where using the skin fold technique (pinch-up) and rotation, needle entry angle, the size of the area disinfected prior to injection, the time the needle remains under skin, needle reuse, sharps disposal, how to pull out the needle after injection. (2) ‘Observing at injection sites’ including insulin leakage, bleeding and bruising, lipohypertrophy at injection sites. The data on lipohypertrophy were obtained through visual examination and palpation by nurses. Nurses from the centers were trained on how to assess bleeding, bruising, and lipohypertrophy (by both observation and palpation) at injection sites before participating in the study.
Statistical analysis Data was analyzed by SPSS 16.0 software package. Twotailed tests were used in all analyses. Statistical analyses were undertaken to determine the response distribution, to calculate frequency, mean statistical description, percentages, and correlation, according to the original data type. Spearman correlation was used to analyze the association between the frequency of needle reuse, the frequency of daily insulin injection and lipohypertrophy, between the www.cmrojournal.com ! 2014 Informa UK Ltd
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frequency of bleeding and bruising at injection sites and HbA1c levels, and so on. Potential differences in pen needle reuse (yes or no) and lipohypertrophy present (yes or no), or rolling the pen while pulling out the needle after injection (yes or no) and lipohypertrophy present (yes or no) were analyzed using chi square. Statistical comparisons were considered significant when P was 50.05.
Patient characteristics Table 1 shows the number of participants and demographic data for the subjects inducted into the study. In total, 380 patients completed the study and their data were analyzed. The sample is made up of 50% men and 50% of women. Two overlapping peaks can be seen in the age distribution (Figure 1): a sharp peak between 52 and 58 years of age, and another peak around 62 years of age. BMI were 23.23 2.30. The mean time on insulin was 3.62 years. Mean HbA1c of 435 participants was 8.06 3.66. In the present study, 16.58%, 62.11%, 7.63%, and 13.68% of participants required one, two, three and four injections per day, respectively. In addition, we found that there was a significant relationship between the frequency of insulin injection per day and lipohypertrophy (r ¼ 0.146, P ¼ 0.004), and between the frequency of insulin injection per day and needle reuse (r ¼ 0.292, P ¼ 0.000).
Needle length All of the study population were using a pen device. Overall, 18.95% of patients were using the 8 mm needle, 72.63% were using the 5 mm needle, 4.74% were using the 6 mm needle, 2.63% were using 8 mm plus 5 mm needle, and 1.05% of patients did not know what length of needles they were using (Table 2). There was no significant correlation between the length of the needle used and insulin leakage (P ¼ 0.056), the presence of lipohypertrophy (P ¼ 0.388), the presence of bleeding and bruising at injection sites (P ¼ 0.709) or HbA1c levels (P ¼ 0.091). Mean (SD) HbA1c of the patients was 8.06 3.66. There was no significant correlation between HbA1c and the presence of lipohypertrophy (P ¼ 0.602).
Injecting practice Insulin injection sites are usually the upper arm and the lateral areas of the thigh, buttocks, and abdomen. Site rotation includes rotating the injection of insulin to all four anatomical areas and rotating within one area, and consecutive insulin injections should be at least one inch apart from the last injection point. It is reported that 92.11% of participants rotated the injection site, of which 36% reported that they rotated the four anatomical 60
Mean = 54.56 Std. Dev. = 8.652 N = 380
50
Table 1. Characteristics of the studied diabetes patients with insulin therapy, n ¼ 380. Characteristics
Age Sex Female Male Weight (kg) BMI (kg/m2) 18.5–23.9 24.0–26.9 27.0–29.9 Waist circumference (cm) Systolic blood pressure (mmHg) Diastolic blood pressure (mmHg) Hemoglobin A1c Fasting blood glucose (mmol/L) Prandial blood glucose (mmol/L) Duration of insulin (years) Average single insulin dose (IU) (minimal dosage 2 IU; maximal dosage 40 IU) Frequency of injections per day 1 2 3 4
n or mean standard
40 Frequency
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30
54.56 8.65 20
190 190 64.32 9.31 23.23 2.30 293 63 24 84.96 1.06 125.64 14.47 77.27 8.96 8.06 3.66 7.55 2.27 10.85 3.49 3.62 4.08 15.65 6.45 2.18 0.87 63 236 29 52
10
0 20.00
30.00
40.00
50.00
60.00
70.00
Figure 1. Age distribution of the study population. The mean (SD) age of 380 participants was 54.56 8.652 years. Table 2. Lengths of needles used. Lengths of needles used 8 mm 5 mm 6 mm Either 8 mm or 5 mm needle used other
n (%) 72 (18.95) 276 (72.63) 18 (4.74) 10 (2.63) 4 (1.05)
BMI, body mass index; n, number of subjects.
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Table 3. Preparation before insulin injections.
Table 4. Problems with the injection process.
Variables Insulin injection after disinfection (the alcohol) being dried Priming before injection Understand the proper way to pinch the skin Check insulin dose before injection Check the liquid before injection Pinch the skin 5 mm needle use only 6 mm needle use only 8 mm needle use only
N
Yes (%)
380
296 (77.89)
380 380 380 380
274 (72.11) 218 (57.37) 346 (91.05) 292 (76.84)
276 18 72
172 (62.32) 12 (66.67) 51 (70.83)
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N, number of subjects.
areas, such as from the abdomen to outer thighs or to the buttocks; 80% reported that they rotated within one area, such as the abdomen; 16% reported that they rotated both among the four anatomical areas and within each area.
Preparation before insulin injections Most patients usually do not require a skin fold at the injection angle of 90 using shorter (4 mm or 5 mm) needles12–15 (Table 3), but when they use long (8 mm) needles, patients need to pinch the skin or inject at 45 to reduce the risk of intramuscular injection16,17 (Table 3). Most of the participants in this survey lifted a skin fold before injecting, but many patients used the ‘pinch up’ inappropriately. It was found that only 57.37% of the participants understood the proper way to pinch the skin. A total of 62.32% of patients who used the 5 mm needle also pinched their skin; 34.62% of patients who used other needles didn’t pinch their skin. When participants were asked whether they prime before injection, 72.11% of subjects answered ‘Yes’. All participants cleaned their injection sites with 75% alcohol; 77.89% of them started to inject insulin after the alcohol was dry.
Variables Rolling to pull out the needle after injection Yes No Leakage at the injection site Yes No Bleeding at the injection site Yes No After injection, the time (s) the pen needle under the skin 10 s After injection, how to dispose of needles Leave with the pen Needles back to the needle cap to be used again Needles discarded after back to the needle cap After the injection, back to the needle cap and then remove the needle Yes No
N (M SD)
%
67 313
17.63 82.37
169 211
44.47 55.53
197 183 11.62 10.28
51.84 48.16
282
74.21
279 50
73.42 13.16
51
13.42
277 103
72.89 27.11
M, mean; N, number of subjects; SD, standard deviation.
Table 5. Needle reuse. Needle replacement frequency
Every time 2–4 5–10 410
N (M SD)
%
9.19 9.295 33 116 129 102
8.68 30.53 33.95 26.84
M, mean; N, number of subjects; SD, standard deviation.
If they rolled the needles while they pulled them out they were more likely to have lipohypertrophy.
Needle reuse Problems with the injection process A total of 74.21% of participants kept the pen needle under skin for 10 seconds (Table 4). There was no relationship found between the time that the needle was kept under the skin and the degree of leakage from the site (P ¼ 0.074). However, the time that the pen needle was left under the skin was found to be related to HbA1c levels (r ¼ 0.117, P ¼ 0.022). It means that the longer the pen needle was left under the skin, the more precisely insulin was injected into the body, and the better glycemic control could be achieved. A total of 17.63% of participants roll the needles while they pull out the needles from the skin after finishing injection and there was a significant relationship between rolling to pull out the needle after injection and lipohypertrophy ( 2 ¼ 7.355, P ¼ 0.007). 4
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The mean (SD) number of per needle uses was 9.19 9.30 (Table 5). Specifically, 8.68% of participants used a pen needle only once; 30.53% used it two, three, or four times; 33.95% used it between five and ten times; and 26.84% used it more than ten times. We found a significant relationship between needle reuse and lipohypertrophy (r ¼ 0.426, P ¼ 0.000). When participants were grouped into binary groups (pen needle reuse, yes or no; and lipohypertrophy present, yes or no), we found a significant relationship between needle reuse and lipohypertrophy ( 2 ¼ 8.478, P ¼ 0.004). These data suggests that if participants reuse pen needles, they have more chance of having lipohypertrophy. When participants were asked why they reused needles, the most frequent responses were because of the convenience and saving money. www.cmrojournal.com ! 2014 Informa UK Ltd
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In the survey, pen needle reuse was not associated with worse HbA1c (P ¼ 0.48), or bleeding and bruising at the injection sites (P ¼ 0.188). When participants were asked how they disposed of needles after injection, it was found that the needle was attached to the pen devices between injections in 73.42% of the cases. Only 13.16% of subjects removed the needles from the pen devices and needles were put back to the needle cap to be used again; 13.42% disposed of used needles into specific sharps containers or into the rubbish after recapping. In addition, 17.63% of participants were found rolling to pull out the needle after injection (Table 4).
Injection complications Lipohypertrophy was found in 35.26% of the participants at their injection sites after an assessment of observation and palpitation by a diabetes nurse (Table 6); 1.32% had lipohypotrophy; 58.68% had bleeding and bruising at their injection sites. There is a significant relationship between needle reuse and the presence of lipohypertrophy (r ¼ 0.426, P ¼ 0.000). Most of the complications such as lipohypertrophy occurred within the abdomen area. Many participants reported injection complications at multiple sites. Nearly 44.47% of participants observed leakage of insulin from their pen needles after injection. There was no relationship between insulin leakage and the length of the needles (P ¼ 0.056), or the HbA1c (P ¼ 0.151). A total of 58.68% of participants reported have bleeding and bruising at injection sites after injection. Bleeding and bruising at injection sites was not found to be related to pen needle reuse (P ¼ 0.290) or the length of the needle (P ¼ 0.248). Bleeding and bruising at injection sites were found to be related to HbA1c levels (r ¼ 0.151, P ¼ 0.003). In other words, those who sometimes or often bled had higher mean HbA1c levels than those who never did.
Table 6. Local skin complications and HbA1c. Skin complications Lipohypertrophy Yes No Lipoatrophy Yes No Bleeding Yes No
n
%
HbA1c
134 246
35.26 64.74
7.87 1.53 8.17 4.41
6 374
1.58 98.42
8.8 2.60 8.05 3.68
223 157
58.68 41.32
7.98 4.55 8.19. 1.74
Z/ 2
P value
0.522
0.602
1.036
0.300
8.567
0.003
Numbers add up to more than 380 because of the use of multiple sites. n, number of subjects.
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Discussion In the survey, the mean (SD) frequency of pen needle reuse is high (9.19 9.30) and pen needle reuse increases the risk of lipohypertrophy. This is in agreement with the study conducted in 2008–2009 in multiple countries7. So decreasing the frequency of needle reuse is generally felt to be an appropriate intervention, even if not completely effective in every case18,19. People with diabetes who are injecting insulin should also be taught not to inject into lipohypertrophic lesions, especially if they are doing so just because it hurts less19. In this survey, 72.63% were using the 5 mm needle, 4.74% were using the 6 mm needle, 2.63% were using 8 mm plus 5 mm needles, and 1.05% of patients did not know what length of needles they were using. The percentage using 5 mm is high in China, because needles 8 mm, inserted perpendicularly, may frequently enter muscle in the limbs of males and those with BMI 525 kg/m2. The BMI of patients with diabetes in China is lower than in western countries8–11, and subcutaneous tissue thickness is thin (293 patients had BMI between 18.5 and 23.9 kg/m2, 63 patients had BMI between 24.0 and 26.9 kg/m2, and 24 patients had BMI between 27.0 and 29.9 kg/m2 in this survey). The 5 mm needle is safe for children and thin adults, for it is not likely to be injected into muscles with such short length. The short needle is correlated with reduced pain and minimal leakage20. This may explain why the 5 mm needle is widely used in Chinese patients with diabetes. In addition, in this survey it was found that 17.63% of the patients tended to roll the needle while pulling it out after injection, and if participants rolled to pull out the needle after injection the prevalence of lipohypertrophy increased. Rolling to pull out the needle after injection might be unconscious behavior, and is associated with lack of education. Most of the participants in the present survey injected with a lifted skin fold, but many subjects used the ‘pinch up’ inappropriately. Injections into the abdomen in people with a BMI 425 kg/m2, especially when using a needle 56 mm long, usually do not require a skin fold to prevent intramuscular injection. However, injections into the thigh in slim people should always be made with a pinch up regardless of needle length, except with 5 mm or shorter needle. There is often so little subcutaneous tissue in the outer thigh that pinching up is the only way to reduce intramuscular injection. However, when a 5 mm needle is used, a skin fold is not usually required to prevent intramuscular injection. Mostly participants actually pinch up with almost equal frequency in the abdomen and thigh, which indicates they still do not understand the rationale behind the technique. Many of the same principles regarding abdominal injections apply to the buttocks, and those Insulin pen injection technique survey Ji &
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regarding the thigh apply to the arm. However, the arm is an especially challenging place to pinch up, because this maneuver must be performed with the fingers of the same arm that is being injected (while the injecting device is being held in the other hand). Recent guidelines for self-injections state unequivocally that the arm should not be used21,22. It was found in our study that only 57.37% of the participants understood the proper way to pinch the skin. A correct pinch up should be held for at least 5 s after the injection to give the insulin time to disperse throughout the subcutaneous tissue7. Releasing the pinch earlier increases the risk of insulin leakage from the site and of pushing the needle into muscle. Ideally, and for the same reasons, the skin fold should only be released when the needle is removed from the skin, a practice currently observed by only a minority of participants. Finally, a correct pinch up is made with the thumb and index (and sometimes the third) finger, and not the whole hand. The latter technique risks lifting the entire muscle, thereby promoting intramuscular injection23. Participants keep the pen needle under the skin for 10 s24,25, and then it decreases the occurring of leakage from the pen device. This raises concern about the quality of the medical supervision for insulin injections that participants are receiving, especially given the high prevalence of insulin leakage from the sites. In this survey, the frequency of bleeding and bruising at injection sites after injection is positively correlated with HbA1c. Lower frequency of bleeding and bruising might positively impact on HbA1c. This may relate to malabsorption of insulin in the bleeding area, and the poor absorption of insulin can lead to worse HbA1c. Inspecting the injected site not only discovers and treats these conditions, but also sends an important message to the people who give injections to themselves that they should pay particular attention to these vital signs, and that improving the practice of injecting is a cost-effective method for optimizing the benefits from the agent injected. The disposal of used needles needs improving. Sharps containers should be provided to all people injecting, along with clear guidance on the locations and procedures for the disposal of filled containers. It is clear that we are not covering many of the key educational topics adequately, because so many participants do not know how to dispose of the sharp needles. Whether they have simply forgotten them or whether the topics were not ever covered is beside the point. Until people who are injecting understand these best practices and why they yield benefits, we are obliged to repeat the message or recast it in forms that can be better understood and acted upon. 6
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Table 7. Comparison between surveys. 2008–20097
Items
No. participants No. participating centers Mean age of participants (years) Mean body mass index (kg/m2) Mean HbA1c (%) Participants reporting four or more injections/day (%) Participants using an insulin pen (%) Participants using 8 mm needles (%) Participants using needles 58 mm (%) Injection site (%) Abdomen Thigh Buttocks Arm Participants injecting using pinch up (%) Prevalence of occasional bleeding (%) Prevalence of lipohypertrophy (%) Mean no. times a single needle used Disposal of needles into the rubbish with recapping (%) Participants desiring more knowledge regarding injection technique (%)
2441 91 43.9 27 8.2 51.9
2010 in China 380 54.56 23.23 8.06 13.68
93.2 56.5 37.5
100 18.95 81.05
86 63 21 32 72.6 60 53 3.2 97.8
92.89 24.21 5 22.89 63.16 51.84 15.79 9.19 13.42
17
51.58
No., number of subjects.
Comparison of findings from the surveys in 2008–2009 in multiple countries and 2010 in China Table 7 compares salient parameters from the two surveys. The first data column gives results from the 2008–2009 survey7, the second column lists results from the 2010 survey in China. The scale of these two surveys was different in terms of participant numbers, and all the data collected in our survey had a higher mean age (43.90 in 2008–2009 vs 54.56 in 2010), a higher prevalence of the use of58 mm needles (37.5% in 2008–2009 vs 81.05% in 2010), a lower percentage of four daily injections (51.9% in 2008–2009 vs 13.68% in 2010), less pinching technique used while injecting (72.6% in 2008–2009 vs 63.16% in 2010), and lower presence of bleeding and bruising at injection sites (60% in 2008–2009 vs 51.84% in 2010). Furthermore, the mean HbA1c value is lower (8.2% in 2008–2009 vs 8.06% in 2010); however, there was more reuse of needles on average (3.2 in 2008–2009 vs 9.19 in 2010). Compared with insulin syringe, insulin pen devices are more convenient to carry, less painful, and have less leakage from injection sites, so Chinese patients widely use insulin pens. Of the study population in 2008–2009 China, 2.7% were using a syringe alone and 91.7% were using a pen device. Overall, 0.6% of patients were using the 12.7 mm needle, 28.2% were using the 8 mm needle, 1.5% of patients were using the 6 mm needle, 49.6% were using the 5 mm needle, and the rest of the patients did not www.cmrojournal.com ! 2014 Informa UK Ltd
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know what length of needle they were using7. In our survey, 18.95% of patients use the 8 mm needle, 72.63% use the 5 mm needle, 4.74% use the 6 mm needle, and 2.63% of patients do not know what length of needle they use. Thus, in China, participants have moved to pens as their devices of choice, as well as to move away from the use of longer needles towards the use of shorter ones, but the appropriate disposal of sharps has not improved. A few limitations linked with this survey should be noted. Because of the limited budget, the ultrasound was not used to evaluate lipodystrophy and photographs of lipodystrophy were not taken. On the other hand, specific size of lipodystrophy and the cost of insulin wastage were not evaluated. Furthermore, the population of this survey is limited, and it was only done in general hospitals and not in community hospitals; therefore, a larger sample of study is advisable.
Conclusions The insulin injection skill of patients with diabetes in mainland China was poor, and the incidence of lipohypertrophy, bleeding, and needle reuse were high. Frequency of daily insulin injection and needle reuse may relate to the incidence of lipohypertrophy and bleeding. The bleeding and bruising at the injection sites may be associated with suboptimal absorption of injected insulin. Improved education in optimal insulin injection technique, including reducing needle reuse and correct rotation of injection sites, should be emphasized.
Transparency Declaration of funding This paper was sponsored by Becton Dickinson Company, Franklin Lakes, NJ, USA. Declaration of financial/other relationships J.J. and Q.L. have disclosed that they have no significant relationships with or financial interests in any commercial companies related to this study or article. CMRO peer reviewers may have received honoraria for their review work. The peer reviewers on this manuscript have disclosed that they have no relevant financial relationships. Acknowledgments The authors sincerely thank the participants, nurses, and the other investigators in the 20 centers in mainland China, and Becton Dickinson Company for their support.
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