Living Well Successfully managing diabetes

Transcription

1 Living Well Successfully managing diabetes with 4mm Pen Needles Helping all people live healthy lives Our most comfortable injection experience ever Successfully managing diabetes with BD Micro-Fine + 4mm Pen Needles 1

2 Contents Successfully managing diabetes with 4mm Pen Needles Helping to improve health outcomes with 4mm Pen Needles 3 Helping to improve health outcomes with BD Micro-Fine + 4mm Pen Needles 4 Understanding skin thickness 5 Understanding the subcutaneous layer thickness 6 Simplifying injection technique to help improve blood glucose control 7 Reducing the risk of intra-muscular injections 8 Maximising injection site options minimising lipos 9 Clinically proven levels of effective blood glucose control 10 People with diabetes prefer the new BD Micro-Fine + 4mm Pen Needle 11 Our most comfortable injection experience ever 12 How to find BD Micro-Fine products on GP Computer Systems DSNs tell us that their goal is to help people with diabetes successfully manage their condition through a combination of diet, exercise and drug treatments. We have identified 3 key factors that all have a significant impact on day to day success with pen injections. Factors Affecting Injection Performance Clinical Factors Skin Structure Site Rotation Injection Technique Improving Blood Glucose Control Improving Health Outcomes The new BD Micro-Fine + 4mm Pen Needle is our simplest and most comfortable injection experience ever, making it easier for you to help people with diabetes achieve effective blood glucose control. And that s a comforting thought for you too! Psychological Factors Needle Phobia Pain Patient Confusion Technological Factors Pen Needle Compatibility Thin Wall Technology Triple Bevel Geometry 2 Successfully managing diabetes with BD Micro-Fine + 4mm Pen Needles Successfully managing diabetes with BD Micro-Fine + 4mm Pen Needles 3

3 Understanding skin thickness Understanding the subcutaneous layer thickness Recent research measured skin thickness using 2D Ultrasound imaging amongst 348 people with diabetes. The sample age categories of 18-39, and years, were split by gender and ethnic background, and importantly ranged from a BMI of 19.6 to 64.5, with an average BMI of This research is the first to use a large sample size of people with diabetes specifically looking at injection sites: Body site: thigh thinnest, buttocks thickest (difference ~0.6mm) Gender: male > female ~0.3mm BMI: each 10 BMI units accounts for only ~0.2mm change The subcutaneous layer differs more widely by patient profile and injection site, increasing with BMI in all sites. The research continued to examine the thickness of the subcutaneous layer at all injection sites and across all patient types, showing statistically significant results: Body site: arms thinnest, buttocks thickest (difference ~5.2mm) Gender: female > male ~5.1mm BMI: each 10 BMI units accounts for ~4.0mm SQ change Skin thickness does not differ by a clinically significant degree in different people with diabetes (1.8mm to 2.5mm, 95% CI) skin thickness mm Skin Thickness by BMI and Injection Site 95% CI BMI <25 The SQ layer thickness varies greatly, from <8mm to >16mm. Some people with diabetes could be injecting into the intra-muscular layer with longer needles SQ thickness mm Subcutaneous Layer Thickness by BMI and Injection Site % CI BMI < arm thigh abdomen buttock > arm thigh abdomen buttock >30 4 Successfully managing diabetes with BD Micro-Fine + 4mm Pen Needles Successfully managing diabetes with BD Micro-Fine + 4mm Pen Needles 5

4 Simplifying injection technique to help improve blood glucose control Reducing the risk of intra-muscular injections Understanding skin thickness and subcutaneous layer thickness enables us to see how easy it is for injections to become intra-muscular with longer needles. With poor blood glucose control due to intra-muscular injections it is clear why a lifted skin fold has often been recommended in the past. Unfortunately research * has shown that almost two thirds of people with diabetes who inject do not use a lifted skin fold when injecting, with the subsequent increased risk of an intramuscular injection. % Using lifted skin fold technique Use lifted skin fold 41% Do not use lifted skin fold 59% Research on skin and subcutaneous layer thickness shows a dramatic reduction in the risk of an intra-muscular injection when using shorter pen needles. Our research looked at the calculated injection deposition with different pen needle lengths to measure the risk of intra-muscular injections. The calculated risk of an intra-muscular injection increases by approximately 3 fold as you progress from 4mm, 5mm, 6mm, 8mm and to 12.7mm. The risk of an intra-muscular injection is minimised with the 4mm pen needle. With a 90 insertion angle and no lifted skin fold, there is no risk of intra-dermal injections but the risk of an intra-muscular injection dramatically increases with needle length. Introducing the new BD Micro-Fine + 4mm Pen Needle our shortest, finest needle ever The incidence of an intra-muscular injection with a 12.7mm needle is 45% Calculated incidence of intra-muscular injections 15.3% Long enough to pass through the skin, with no risk of intra-dermal injection at a 90 angle. % % Short enough to inject into the subcutaneous layer, without the need for a lifted skin fold % 1.8% 0 4mm 5mm 6mm 8mm Pen needle length 6 Successfully managing diabetes with BD Micro-Fine + 4mm Pen Needles Successfully managing diabetes with BD Micro-Fine + 4mm Pen Needles 7

5 Maximising injection site options minimising lipos Clinically proven levels of effective blood glucose control Encouraging good site rotation and helping to reduce the risk of lipohypertrophy formation are important factors in successful management of diabetes through insulin and GLP-1 injection. Skin thickness and subcutaneous layer thickness research has highlighted that by using a BD 4mm pen needle, the risk of an intra-muscular injection is reduced therefore safely opening up more injection sites to the patient. And by encouraging good injection site rotation, the risk of the formation of lipos is also reduced. Without the need to teach a lifted skin fold with the 4mm needle, you will have more time to focus on site rotation and avoiding lipos. The efficacy of insulin delivery through the new BD Micro- Fine + 4mm Pen Needle has been tested in a clinical trial. The trial was designed to measure differences in fructosamine levels in the blood for patients using 4mm needles vs 5mm needles and 8mm needles. The criteria for blood glucose equivalence was an absolute difference in fructosamine of less than 20% at a 95% confidence interval. Key clinical study findings: Absolute differences: 4.93% vs 5mm needle and 5.45% vs 8mm needle Fructosamine differences were not influenced by dose of insulin or by subject BMI (40 units maximum dose of insulin used) Unexplained hypos and hypers were no more frequent with 4mm needle BD Micro-Fine + 4mm Pen Needles can help to open up injection sites with a 90 injection angle and without a lifted skin fold Skin mm thickness Subcutaneous tissue Muscle 4mm needle 4mm needle 4mm needle The 4mm pen needles showed equivalent blood glucose control compared to longer needles Absolute Difference % Fructosamine relative difference 95% CI Changing Muscle Patient Profile Thin Normal Obese Mixed Obese Android Arm Thigh Abdomen Buttocks Changing Injection Site 0 4 vs 5mm All Dose 4 vs 8mm 4 vs 5mm 4 vs 8mm 4 vs 5mm 4 vs 8mm Low Regular 8 Successfully managing diabetes with BD Micro-Fine + 4mm Pen Needles Successfully managing diabetes with BD Micro-Fine + 4mm Pen Needles 9

6 People with diabetes prefer the new 4mm Pen Needle Our most comfortable injection experience ever We all know that for some people with diabetes, the sight of a needle is enough to put them off injecting. In research 86% of people with diabetes when questioned said that they were not anxious when talking about the new BD Micro- Fine + 4mm Pen Needle. Research shows a significantly higher preference for the new BD Micro-Fine + 4mm Pen Needle compared to their currently used pen needles: More comfortable Easier to use (no lifted skin fold) Preferred by people with diabetes The pain of inserting a needle and injecting, are both factors that can cause poor injection compliance. The new BD Micro-Fine + 4mm Pen Needle has been shown in research, carried out amongst existing injectors, to be more comfortable than their current needles. Preference data for people with diabetes shows that: 94% felt only low pain when inserting the 4mm needle compared to only 74% with their current needle 96% felt no or only low pain during the injection compared to only 76% with their current needle Preference vs normal needle used Unspecified 1% Summary of pain level of first pen needle used and current pen needle on various attributes Low Pain (0-4) Moderate Pain (5-7) High Pain (8-10) Scale = Not at all painful 10 = Extremely painful No preference 12% No preference 12% 100% Pain of inserting the needle into the skin Pain of delivering insulin Prefer 4mm 66% Prefer 5mm 22% Prefer 4mm 63% Prefer 8mm 25% 80% 60% 40% 20% 4mm vs. 5mm (n=68) 4mm vs. 8mm (n=72) 0% 4mm (n=64) Current (n=129) 4mm (n=69) Current (n=140) 10 Successfully managing diabetes with BD Micro-Fine + 4mm Pen Needles Successfully managing diabetes with BD Micro-Fine + 4mm Pen Needles 11

7 How to find products on GP computer systems If you are having difficulty in finding BD Micro-Fine + products on your prescribing system, please refer to this search guide BD Micro-Fine + 4mm 4mm x 0.23mm (32G) PIP Code System TTP System One Isoft Emis Vision GPASS Seetec CrossCare Microtest (Practice Manager 2 & Evolution Practice Manager for Windows) What to search Change the search type at the top of the screen from a product search to a free text search, type in microfine and select the BD pen needle you need BD (space bar) BD BD BD BD or bd BD, bd, or microfine BD pen needles This will bring up 5mm, 8mm and 12.7mm needles only BD Micro-Fine + 5mm 5mm x 0.25mm (31G) PIP Code BD Micro-Fine + 8mm 8mm x 0.25mm (31G) PIP Code Please distribute this information where appropriate Helping all people live healthy lives * Pen Needle clinical Study conducted for BD by Bruno and Ridgeway associates Inc., Dec 2009 Comparative glycaemic control, safety and patient ratings for a new 4mm x 32G insulin pen needle in adults with diabetes. Laurence J Hirsch et al Current Medical Research & Opinion (April 2010), Vol 26 (6), Skin and subcutaneous adipose layer thickness in adults with diabetes at sites used for insulin injections: implications for needle length recommendations. Michael A Gibney et al Current Medical Research & Opinion (April 2010), Vol 26 (6), BD, BD Logo and Micro-Fine are trademarks of Becton, Dickinson and Company BD. All claims and copy are correct at the time of print, June All claims relate solely to diabetes drugs and devices currently available in the UK and Eire. Becton, Dickinson U.K. Limited. Registered in England: Registered Office: The Danby Building, Edmund Halley Road, Oxford Science Park, Oxford, Oxfordshire OX4 4DQ. BDDC June Successfully managing diabetes with BD Micro-Fine + 4mm Pen Needles BD Medical - Diabetes Care Edmund Halley Road Oxford Science Park Oxford OX4 4DQ Tel: +44 (0) Fax: +44 (0)