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Do these stats surprise you?
- Of the 1.6 million people with type 1 diabetes in the US,1 only 30 to 40 percent use a Continuous Subcutaneous Insulin Infusion (CSII) system,2 more commonly referred to as an insulin pump.
- Of the nearly 6 million people with type 2 diabetes who take insulin,2 a very small number use an insulin pump.
Until a few years ago the only ways to take insulin, other than using an insulin pump, was via traditional pens or vial and syringe. Today, there is a growing category of insulin delivery devices referred to as connected insulin delivery devices.
This article defines “connected insulin delivery devices” and provides details on currently available devices and those we can expect in the near future. The article also articulates the potential benefits of connected devices and why you may opt to use one during a particular life stage or two or continuously for many years.
Define “Connected” Devices
Traditional pens and syringes allow you to deliver insulin. That’s it. Connected devices enable insulin delivery plus have additional capabilities. Depending on the device, a connected device typically provides dosing calculations based on customized and changeable settings for all aspects of basal and bolus insulin dosing. The devices allow you to set up reminders and alerts and integrate with glucose data either through a Bluetooth Blood Glucose Monitoring (BGM) or Continuous Glucose Monitoring (CGM).
Connected devices often work in sync with a mobile app that assists with data analysis and sharing with your diabetes healthcare providers or loved ones. The forms of connected devices vary from a clip that goes on a traditional insulin pen to a so-called Smart Insulin Pen or Smart Pen Cap. Interestingly, as you peruse the resource on the various connected delivery devices, you’ll see that entities involved in this area at times initiate partnerships with others to leverage expertise and technology.
Rationale for Connected Devices
No doubt about it, taking insulin numerous times a day presents challenges and burdens which can make achieving glycemic targets no easy bullseye. These range from missed or forgotten3 and/or miscalculated boluses, to challenges with doing the mental math involved with calculating insulin doses.4,5 “Connected devices can reduce the tedious tasks of recording all diabetes data and the time-consuming task of transferring data to one’s healthcare providers,” says Colleen Miller-Owen, APRN, CDCES, Family Nurse Practitioner and Certified Diabetes Care and Education Specialist, Tampa General Medical Group, Tampa, Florida. Miller-Owens adds, “A connected device captures critical data which can easily be sent to one’s healthcare providers who can recommend dose adjustments to improve glucose metrics between visits.”
Stats from a 2020 survey conducted by the Association of Diabetes Care & Education Specialists (ADCES) and Sanofi with 700 people who take insulin showed that most people surveyed wanted a streamlined way to assemble and display all their diabetes data.6 People conjectured that having all their compiled data in an understandable format would empower them to better manage their diabetes.
For sure, insulin pump systems assist with many of the challenges and burdens noted above. But there are people who take insulin who, for various reasons, don’t want to use an insulin pump.7 In addition, there are times people may want a break from feeling tethered to their insulin delivery device. With these needs and desires in mind combined with plenty of technological ingenuity, we now have this growing cadre of connected devices. But keep in mind that while connected devices possess some of the capabilities of insulin pump systems, they simply don’t have all the bells and whistles. And this is particularly true when it comes to advanced Automated Insulin Delivery systems. For example, the connected device user can’t set various basal rates during a 24-hour period or set temporary basal rates. Nor is there the ability to set extended bolus doses.
A small review of three studies on connected devices that met the researchers’ inclusion criteria detailed several clinical benefits: a decrease in A1c, improved Time in Range (TIR), reduced hypoglycemia, fewer missed bolus doses and more accurate mealtime dosing.8 The authors concluded that this category of devices could offer the person who takes insulin a promising approach to simplifying insulin therapy.
As for recommendations from professional organizations, the American Diabetes Association (ADA) includes the mention of smart pens in their 2021 annual standards of care.9 They note these devices may be useful to help some people implement dosing recommendations and to capture dosing data. The American Association of Clinical Endocrinologist (AACE) included connected pens in their review of advanced insulin delivery devices.10 AACE concluded that these devices may assist the person who takes three or more injections a day and doesn’t want to wear an insulin pump system to optimize their insulin plan as well as to help limit insulin stacking that can result in hypoglycemia.
When to Consider a Connected Device
“If you use a traditional pen or vial and syringe to deliver multiple daily injections, consider a connected device if you consistently do one or more of the following: overthink your bolus dose decisions, consistently underthink your bolus decisions and constantly play catch-up, and/or take the same bolus dose regardless of the type and amount of food you eat and your glucose level,” says Jennifer Okemah, MS RD, BC-ADM, CDCES, Owner of Salute Nutrition, PLLC, a private practice based in Seattle that focuses on helping people with diabetes optimize their diabetes devices and data.
To when a person using an insulin pump might want to consider a connected device, Okemah says, “When their insulin pump is no longer a helpful friend but instead becomes a burden to which they no longer respond to alerts and alarms.”
How the FDA Reviews Connected Devices
Connected insulin delivery devices are generally submitted to FDA’s Center for Diagnostics and Radiological Health (CDRH) by the manufacturer as a Class II device with a 510k application, also known as a premarket notification. If the manufacturer receives a positive review, the device is “FDA-cleared.” (Learn more about FDA’s Review Processes for Medical Devices here.)
Future of Connected Devices
As time passes, technological and engineering capabilities will advance, and so will connected insulin delivery devices. As you’ll read under “what’s next,” in the table, several manufacturers shared how they anticipate their devices will evolve. It looks like we will see integration of software that offers the user greater diabetes decision-making support that, in some cases, will leverage artificial intelligence. Users will get assistance with insulin dose titration and maintaining optimal insulin doses. Based on their original intent, manufacturers hint that simplicity of use and design will continue to be their focus.
- JDRF Statistics. Type 1 diabetes facts. https://www.jdrf.org/t1d-resources/about/facts/. Accessed September 21, 2021.
- Saydah SH. Medication use and self-care practices in persons with diabetes. In: Cowie CC, Casagrande SS, Menke A, et al., eds. Diabetes in America. 3rd ed. National Institutes of Health; 2017(NIH publ. no. 17-1468).
- Randlov J, Poulsen JU. How much do forgotten insulin injections matter to hemoglobin A1C in people with diabetes? A simulation study. J Diabetes Sci Technol. 2008;2(2):229-235.
- Zaugg SD, Dogbey G, Collins K, et al. Diabetes numeracy and blood glucose control. Association with type of diabetes and source of care. Clin Diabetes. 2014;32(4):152-157.
- Cavanaugh K, Huizinga MM, Wallston KA, et al. Association of numeracy and diabetes control. Ann Intern Med. 2008;148(10):737-746.
- ADCES, Sanofi: https://www.diabeteseducator.org/docs/default-source/practice/educator-tools/sanofi-survey-2020/adces-national-diabetes-survey-results_infographic.pdf?sfvrsn=2. Accessed September 21, 2021.
- Tanenbaum ML, Hanes SJ, Miller KM, et al. Diabetes device use in adults with type 1 diabetes: barriers to uptake and potential intervention targets. Diabetes Care. 2017;40(2):181-187.
- Heinemann L, Schnell O, Gehr B, et al. Digital diabetes management: a literature review of smart insulin pens. J Diabetes Sci Technol. 2021;1-9.
- ADA The American Diabetes Association Standards of Medical Care in Diabetes – 2021. Diabetes Technology. Diabetes Care, 2021;44(S1):S85-S99,
- Grunberger G, Sherr J, Allende M, et al. American Association of Clinical Endocrinology clinical practice guideline: the use of advanced technology in the management of persons with diabetes mellitus. Endocrine Practice. 2021;27:505-537.
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Status Update: Connected Insulin Delivery Devices
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