Results of a randomized controlled trial demonstrating the clinical value of utilizing retail pharmacists to improve injection site rotation with the novel SiteSmartTM pen needle system are presented in the poster session at the 2020 Association of Diabetes Care and Education Specialists annual conference.
MONTREAL, Aug. 18, 2020 /CNW Telbec/ – Montmed Inc, a company dedicated to transforming the utility of insulin pen needles from sole delivery of insulin to a clinical tool to help achieve superior clinical and financial outcomes, presented new data at the 2020 Association of Diabetes Care and Education Specialists (ADCES) annual conference (#ADCES20), August 13th – 16th being held virtually.
Montmed has developed SiteSmart™, a novel pen needle system designed to favour adherence to a healthy injection site rotation regimen. Each package of SiteSmart™ contains 100 insulin pen needles distinctively marked with 4 colors, along with educational messages and an association tool labeled directly on the packaging that allows the user to simply and easily create a personalized structured injection site rotation plan, in which each of the four colors of pen needle is associated with a distinct injection area, seamlessly instructing the insulin user where to inject at each injection.
Additional data from the randomized control trial (RCT) by Berard, et al demonstrated how pharmacists, using the novel SiteSmart pen needle system, are an untapped and pragmatic resource to improve injection site rotation practices amongst insulin users, which can lead to superior glycemic management as well as lessen the financial burdens resulting from lack of injection site rotation.
Sixteen pharmacists located in 14 pharmacies enrolled 203 adults using daily insulin into this 30-day study. Pharmacists completed questionnaires at the beginning and conclusion of the study. Insulin users were randomized to use either their usual pen needles or the SiteSmart™ pen needle system. At study completion, pharmacists’ knowledge of lipohypertrophy rose from 53 to 94%, their confidence in educating on proper site rotation and comfort level in pen needle selection both increased from 31 to 94%. At the study end, more than 90% of the pharmacists reported counseling insulin users more frequently on proper injection site rotation.
“Our study showed that, with minimal training, retail pharmacists, using the novel SiteSmart™ pen needle system, have the potential to improve injection site rotation amongst insulin users, which should reduce the incidence of lipohypertrophy and its associated clinical and financial impact”, said Lori Berard, Nurse, CDE, “I believe this is an easily-implemented intervention by retail pharmacists, that doesn’t add any cost to the healthcare system, and that can help deliver superior clinical and health-care outcomes in diabetes. As only 15-20% of patients living with diabetes see a diabetes educator, pharmacist can play a critical role in ensuring optimal injection technique through this intervention” Berard added.
“These results are very exciting for community pharmacists who are the most accessible health care professional and often see their patients more than any other health care provider – especially for a chronic disease like diabetes. Pharmacists can provide many opportunities to improve health outcomes in their patients and identifying ways to provide value to patients that can integrate into normal pharmacist workflow are ideal. The Sitesmart™ pen needle system enables community pharmacists to provide a concise, yet impactful clinical educational intervention for their patients who use insulin which is proven to improve adherence to a key clinical recommendation. The Sitesmart intervention is a great example of how a simple community pharmacy led intervention can have a significant impact on the care of patients living with diabetes and injecting insulin”, Said Shelita Dattani, Bsc. Pharm., PharmD., pharmacist and educator.
Sitesmart™ pen needle system: A very appealing solution to a clear unmet medical need
Additionally, Montmed and dQ&A, a diabetes market research company, presented a second poster at ADCES20, highlighting the findings from a survey of 414 Diabetes Care and Education Specialists (DCES) who counsel insulin users. Diabetes Care and Education Specialists were asked questions relating to injection site rotation and their intent to recommend the Sitesmart product concept to their patients. 85% of respondents rated injection site rotation as important, whilst, only 14% reported being satisfied with currently available tools and methods to help people adhere to and maintain a healthy site rotation routine, calculated as a percent of respondents rating a 9 or a 10 on a 10-point scale. This clearly highlights the unmet need for a simple tool that can help teach and ensure adherence to healthy injection site rotation. Respondents were then provided with an unbranded neutral description of the SiteSmart™ pen needle system concept and asked about their likelihood to recommend it to their insulin using population using a 4-point scale (extremely likely, likely, likely not, definitely not). Sixty-four percent (64%) of respondents stated that they would definitely recommend the Sitesmart pen needle system to their patients using pens to inject insulin, whilst 33% stated that they would likely recommend the product to their insulin using patients for a total of 97% of respondents, showing the appeal for the Sitesmart pen needle solution. Perhaps the most interesting finding was that 87% of Diabetes Care and Education Specialists perceived the value of the Sitesmart pen needle system that enables injection site rotation as “more valuable” or “much more valuable” compared to any potential improvements in the technical attributes of the actual pen needle (eg. size, length, gauge, base, bevel, etc.).
“These results clearly validate the need for and the appeal of our solution to fill an important unmet medical need. These data add to the body of evidence that SiteSmart™ has the potential to transform the utility of an insulin pen needle from a simple delivery device, to a clinically valuable tool that improves diabetes outcomes, at no additional cost to the health care system”, said Amir Farzam, President and CEO, Montmed.
Globally, hundreds of millions of people live with diabetes. It is estimated that more than 40 million people take insulin to manage their blood glucose levels and prevent long-term diabetes associated complications. Insulin users inject insulin anywhere from 1 to 6 or more times daily. This daily repeated administration of exogenous insulin, a growth hormone, combined with the repeated trauma of needle micro-injury, can lead to a serious complication called lipohypertrophy. Lipohypertrophy is observed in as high as 65% of insulin users, defined as an abnormal accumulation of fat underneath the surface of the skin1. Lipohypertrophy has been shown to have important repercussions on glycemic control, such as an elevation in HbA1C, increased glucose variability, increased unexplained hypoglycemia as well as an increase in insulin requirements2. Studies also indicate that the most important risk factor for the development of lipohypertrophy is a failure to rotate injection sites3. As such, using a proper injection site rotation routine is a key recommendation worldwide.
Montmed has developed SiteSmart™, a pen needle system that brings clinical value by helping insulin users seamlessly adopt a healthy site rotation routine, which can reduce the risk of lipohypertrophy and help improve insulin action. The SiteSmart™ package contains 100 insulin pen needles distinctively marked with 4 colors (4X25), along with an association tool labeled directly on the packaging and on a web app, that allow the user to create a personalized structured injection site rotation plan, in which each of the four colors of pen needle is associated with an injection area. Once the plan is developed by the insulin user or with the help of a health care professional, the user simply picks a pen needle in the box, and injects in the area corresponding to color of the pen needle on his /her plan. And that’s it! No tracking, no logging, no need to remember where the last injection was given. The simplicity of SiteSmart™ makes it easy for any insulin user to get the most out of their insulin by integrating a healthy injection site rotation routine without adding to the cognitive burden associated with diabetes management. The SiteSmart™ packaging also serves as a counseling tool to favor a rapid and concise educational intervention on site rotation by health care professionals, including prescribers, diabetes educators, and retail pharmacists. SiteSmart™: Change Colour, Change Site®.
Blanco M, et al. Prevalence and risk factors of lipohypertrophy in insulin-injecting patients with diabetes. Diabetes Metab. 2013;39(5)445-53. doi: 10.1016/j.diabet.2013.05.006.
Frid A, et al. Worldwide Injection techniques questionnaire study. Mayo Clinic Proc. 2016;91(9):1212-1223. doi: 10.1016/j.mayocp.2016.06.011.
Forum for Injection Techniques (FIT). http://fit4diabetes.com
For further information: Montmed, Media Contact: firstname.lastname@example.org, 514-6951222