Montmed announces positive clinical trial data on SiteSmart™
Results of a randomized controlled trial presented at
Diabetes Canada's 2019 Professional Conference demonstrate the clinical value of
the novel SiteSmart™ pen needles educational concept.
MONTREAL, Oct. 4, 2019 /CNW Telbec/ - Montmed, Inc., a company dedicated to enabling people with diabetes to do more without adding to the burden of managing their diabetes, announced the presentation of positive results from a randomized controlled trial on its SiteSmart™ insulin pen needles, during an oral poster presentation at the Diabetes Canada 2019 Professional Conference, Oct 2-5, 2019. SiteSmart™ is a novel pen needle designed to favor adherence to a healthy injection site rotation regimen amongst insulin users. 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 create a personalized structured injection site rotation plan, in which each of the four colors of pen needle is associated with an injection area, seamlessly instructing the insulin user where to inject.
The data highlight the impact of SiteSmart™ on injection site rotation habits of established insulin users, as compared to the currently available conventional insulin pen needles.
In the study, 208 adult insulin users with type 1 or type 2 diabetes were randomized to either use Montmed's SiteSmart colored coded pen needles or their current, conventional pen needle for one month to evaluate the effect of SiteSmart™ on injection site rotation habits amongst established insulin users. The study also evaluated the impact of SiteSmart™ on pharmacists' knowledge and comfort in discussing injection site rotation with their patients. In this study, the sole dispensing of Montmed's SiteSmart™ by a retail pharmacist resulted in a significant improvement in injection site rotation (p=0.00546) compared to conventional pen needles, delivering a 134.7% increase in the likelihood to improve site rotation over conventional pen needle.
"These data are very exciting in that they demonstrate that a simple, yet innovative, intervention like SiteSmart™ can help insulin users easily learn and adhere to a healthy injection site rotation regimen which should, in turn, reduce the risk of lipohypertrophy and the associated impact on glucose control and insulin use," said Lori Berard, RN, CDA, Study Investigator and Chair of the Canadian Forum for Injection Techniques. "I believe this is an easily-implemented intervention that doesn't add any cost to the healthcare system, and that has the potential to deliver important clinical and health-care outcomes."
Amir Farzam, chief executive officer of Montmed, commented, "These data support our belief that SiteSmart™ has the potential to transform the utility of an insulin pen needle from a simple delivery device, to a clinically valuable tool. SiteSmart™ can play an important role in proper insulin use and diabetes control by helping insulin users easily and seamlessly integrate a healthy injection site rotation routine in their daily lives, and therefore, have an important impact on the healthcare system."
Additional results of this study looking at pharmacist's ability, level of comfort, and willingness to teach site rotation to their insulin using patients, as well as patients satisfaction using SiteSmart™ will be the subject of publication at a later date.
Globally, hundreds of millions of people live with diabetes and it is estimated that more than 40 million people depend on the daily administration of exogenous insulin to help control their blood glucose levels and prevent long-term complications associated with diabetes. Insulin users inject themselves 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, 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, proper injection site rotation is a key recommendation of diabetes guidelines worldwide.
Montmed has developed SiteSmart™, a pen needle 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™.
References1. 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.
2. 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.
3. Forum for Injection Techniques (FIT). http://fit4diabetes.com