Injection Techniques Questionnaire (ITQ) WorldWide Results Needle Gauge

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1 Injection Techniques Questionnaire (ITQ) WorldWide Results Needle Gauge

2 BACKGROUND

3 All needles are at least twice as long as the skin is thick

4

5 More than twice as long

6 31G =.26mm Surface = 1 A = π x r 2

7 More than 70% greater area 29G =.34mm 31G =.26mm Surface X 1,71 Surface = 1 A = π x r 2

8 Centre for Sensory-Motor Interaction, Denmark: Egekvist H, Bjerring P, Arendt-Nielson L. Pain and mechanical injury to human skin following needle insertions. European Journal of Pain. 3:41-49, 1999

9

10 Results: penetration force

11 GAUGE

12 GAUGE

13 SPEED

14 SPEED

15 SPEED

16 SPEED

17 ANGLE

18 Pain

19 30G: 0,3112mm 31G:0,2604mm 32G:0,2350mm Surface X 1,76 Surface X 1,23 Surface = 1

20

21

22 STUDY OBJECTIVES Compare four different pen needle types THIN Wall 31Gx8mm vs normal Wall 31Gx8mm THIN Wall 31Gx5mm vs normal Wall 31Gx6mm Evaluate comfort and pain perception by using TW vs normal Wall pen needles

23 Rate pain perception on: the penetration of pen needle into skin With Normal Wall With Thin Wall no answer 1% no answer 1% not at all painful 19% not at all painful 70% hardly painful 57% painful 19% hardly painful 27% very painful 3% painful 2% extremely painful 2%

24 24

25 Bench testing The penetration force in a skin substitute was on average 23 % lower with the 5-bevel pen needles vs similar 3-bevel pen needles,

26

27 Make IT Easy Extra Thin-Wall Pen Needle Clinical Study Results Michael Gibney

28 NEXT Clinical Study - Results

29 What can we say based on these studies? The pain of an injection is reduced by: A smaller gauge needle An extra-thin wall A 5-bevel tip More rapid insertion

30 DESCRIPTIVE STATISTICS

31 What needle gauge did nurses observe? NEEDLE GAUGE % as per Nurse

32 How is Gauge associated with Needle Length? (both Nurse-Observed; results as %) Gauge NEEDLE LENGTH mm mm mm mm

33 Gauge Percentages by Country (1) Country USA Canada Russia South Africa Netherlands Belgium France Spain Italy Switzerland Austria

34 Gauge Percentages by Country (2) Country UK Denmark Sweden Poland Germany Perú Mexico Argentina Brazil Chile Colombia

35 Gauge Percentages by Country (3) Country Venezuela Malaysia Australia Indonesia Philippines Singapore S. Korea China Turkey India Ireland

36 Gauge Percentages by Country (4) Country Finland Czech Republic Nicaragua Taïwan Saudi Arabia United Arab Emirates TOTAL

37 COMPARATIVE STATISTICS: DEMOGRAPHICS

38 Is Needle Gauge associated with Diabetes Type? Needle Gauge T1DM DM type % 3.0% 12.0% 44.8% 40.3% T2DM % 3.0% 13.6% 49.3% 34.1% p = 0.076

39 Is needle gauge associated with age category of respondent? Needle Gauge Adult % 2.8% 14.3% 49.5% 33.5% Adolescent Respondent % 1.2% 9.3% 42.9% 46.6% Child % 6.5% 5.8% 35.7% 51.9% 3 rd Party % 13.0% 7.7% 17.2% 62.1% p < 0.000

40 COMPARATIVE STATISTICS: ASSOCIATIONS

41 Is Needle Gauge associated with patient-reported LH? Gauge Lipohypertrophy Yes Lipos (patient reported) more frequent with largest diameter gauge, p = No % 62.7% % 69.7% % 66.4% % 71.1%

42 Is Needle Gauge associated with Nurse-Observed LH? Gauge Lipohypertrophy Yes Lipos (Nurse-Observed) more frequent with largest diameter gauge, p < No % 63.2% % 68.8% % 66.3% % 72.2%

43 Is Gauge associated to Pen Needle Reuse (patient reported)? Needle Gauge Yes Reuse % 48.0% 52.8% 54.8% 45.1% No % 52.0% 47.2% 45.2% 54.9% Less PN reuse with 32 gauge, p < 0.000

44 Is Gauge associated to Pen Needle Reuse (nurse reported)? Needle Gauge Yes Reuse % 35.7% 54.0% 57.4% 44.6% No % 64.3% 46.0% 42.6% 55.4% Less PN reuse with 32 gauge, p < 0.000

45 Is Gauge associated to Syringe Reuse? Needle Gauge Yes Reuse % 28.1% 45.6% 48.3% 24.4% No % 71.9% 54.4% 51.7% 75.6% Less syringe reuse with 32 gauge, p < 0.000

46 Is Needle Gauge associated with pain? Needle Gauge Yes Pain % 48.4% 49.3% 52.5% 50.4% No % 51.6% 50.7% 47.5% 49.6% At 29G are we at pain-detection threshold?, p = 0.304

47 30G: 0,3112mm 31G:0,2604mm 32G:0,2350mm Surface X 1,76 Surface X 1,23 Surface = 1

48 Is Needle Gauge associated with bleeding? Needle Gauge Yes Pain % 52.6% 57.7% 58.4% 53.9% No % 47.4% 42.3% 41.6% 46.1% p = 0.013

49 Is Needle Gauge associated with Leaking from Site? Needle Gauge Yes Leaking from Site % 35.1% 35.2% 36.6% 38.4% No % 64.9% 64.8% 63.4% 61.6% p = 0.370

50 Is Needle Gauge associated with Hypoglycemia? Needle Gauge Yes Hypos % 56.7% 55.9% 57.2% 55.7% No % 43.3% 44.1% 42.8% 44.4% p = 0.743

51 Is Needle Gauge associated with Correct Rotation? Needle Gauge Yes Correct Rotation % 52.1% 68.7% 70.0% 73.9% No % 47.9% 31.3% 30.0% 26.1% p < 0.000

52 Conclusions (1) Needle gauge over the last decade has shifted significantly towards lower diameters (31 and 32G) This shift has tracked the move to shorter needle lengths, although not as dramatically. There is still a great deal of country variation in the distribution of different needle gauges. Adolescents and children use the thinnest gauge (32G) more frequently than adults.

53 Conclusions (2) For unknown reasons LH seems to be less frequent with 32G than the other gauges. Correspondingly, needle reuse seems to be lower with this gauge, while correct rotation seems to increase in frequency as the gauge thins. 32G needles are associated with less bleeding, but there are no apparent differences in injection pain, hypoglycemia or leaking from the site as a function of needle gauge. It may be that at or near 29G we reach the threshold for pain detection in the majority of patients.

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