Companion Medical is pleased to announce the publication of The Reference Guide to Integrate Smart Insulin Pens into Data-Driven Diabetes Care and Education Services released as a sponsored supplement to the August 2020 issue of The Diabetes Educator (TDE), a journal of the Association of Diabetes Care and Education Specialists (ADCES) (1). The 20-page Reference Guide was authored by Hope Warshaw, RD, MMSc, BC-ADM, CDCES, Hope Warshaw Associates, Diana Isaacs, PharmD, BCPT, BC-ADM, BCACP, CDCES, Cleveland Clinic and Janice MacLeod, MA, RD, CDCES, FADCES, Companion Medical.
The Reference Guide provides an in-depth overview of a new category of insulin delivery referred to as smart insulin pen systems, including information about how these integrated insulin delivery systems can reduce many of the challenges of rapid-acting insulin injection therapy by enabling easier and more accurate dose recording, dose calculations and sharing of diabetes management data with clinicians. The Reference Guide notes that fewer than 30% of individuals with Type 1 diabetes and less than 1% of individuals with insulin requiring type 2 diabetes are using smart insulin pump systems with the vast majority instead relying on injection therapy. As we approach the 100-year anniversary of the discovery of insulin, authors emphasize, it is imperative that every person requiring insulin be able to make an informed decision regarding the method of insulin delivery that is best for them and that regardless of their choice they have the smart dosing capability now available through smart insulin pumps and finally with smart insulin pens.
RoadMap to Smart Insulin Pens
The Reference Guide describes a Roadmap to Smart Insulin Pens that Warshaw developed and published with Dr. David Kerr, Sansum Diabetes Research Center, in a May 2019 Endocrine Today publication on smart insulin pens (2). This is a particularly useful concept as it helps define where products currently are in the development process as well as future development potential. The Reference Guide notes that Companion Medical’s InPen is the first FDA-cleared, Stage 4 Smart Insulin Pen system available in the United States. Future Stage 5 Smart Insulin Pens offering advanced decision support are currently under development.
It is noted in the Reference Guide that the American Diabetes Association (ADA) 2020 Standards of Medical Care in Diabetes include smart insulin pens in their recommendations in chapter 7, Technology in Diabetes. The standards indicate that smart pens may be useful for some patients to help with dose capture and dosing recommendations as well as titrating insulin doses further stating that individuals choosing to use bolus calculators use those that are FDA approved (3).
Hallmarks of a Data-Driven Practice Model: Identify, Configure, Collaborate
The Reference Guide is an important foundational piece providing the diabetes care and education specialist a comprehensive toolkit for integrating smart insulin pens into clinical practice and highlights new roles for diabetes care and education specialists in leading the care team in providing data-driven care and education services. Authors note that these new roles are in keeping with the 2019 ADCES Project Vision, a framework to promote expanded roles for diabetes care and education specialists as healthcare systems and the diabetes care ecosystem transforms (4). Diabetes care and education specialists can position themselves to be the experts, or technology champions, that build data-driven diabetes care and education services in a variety of practice settings.
The Reference Guide is organized around the Hallmarks of a Data-Driven Practice Model, recently adopted by ADCES and included in their recent Perspectives in Practice publication, A Framework for Optimizing Technology-Enabled Diabetes and Cardiometabolic Care and Education: The Role of the Diabetes Care and Education Specialist (5). In the Reference Guide each hallmark or pillar (Identify, Configure, Collaborate) is defined then illustrated with helpful tables, figures and interviews with three clinicians who have embraced this approach in their practice.
The Reference Guide notes that increasingly people with diabetes are using a growing array of connected devices such as glucose monitoring devices, smart insulin delivery systems, fitness trackers, food databases, blood pressure and heart rate monitors among others. Combining diabetes-related data from multiple sources enables people with diabetes to more easily share their data with their clinical team and to collaboratively use the data to optimize the care plan. Authors illustrate that the Insights by InPen™ data management report integrates data from the Dexcom® G5® and Dexcom G6® Continuous Glucose Monitors (CGM), from Bluetooth-enabled blood glucose meters and other health data through Apple Health. The insulin dose data tracked by the InPen can also be viewed in the Dexcom CLARITY® report and in the Tidepool and Glooko data-management platforms. The Reference Guide provides an annotated guide to using the Insights by InPen integrated data management report with details about key clinical considerations. These reports are sent directly through the InPen app by the person with diabetes wirelessly to their clinical care team. Having access to integrated data reports enables remote patient monitoring and facilitates virtual care approaches increasingly vital to diabetes care models.
The Reference Guide provides a comprehensive case study illustrating a new diabetes counseling strategy, DATAA, recently published in yet another ADCES Perspectives in Practice publication, Technology Integration: The Role of the Diabetes Care and Education Specialist in Practice also appearing in the August 2020 TDE issue (6). This approach was developed by Isaacs and her writing group from the ADCES Technology Work Group tasked with writing the piece. The DATAA counseling strategy includes:
Data – access data from the person with diabetes’ connected devices (with their consent)
Assess Safety – Look for and resolve Time Below Range (hypoglycemia) first as a top safety priority
Time In Range – Focus on the positive by looking for times of day or days of week when Time In Range is highest; discuss ways to replicate success
Areas to Improve – Note times of day or days of week when Time Above Range (hyperglycemia) is more significant; discuss ways to resolve, e.g. missed or late doses, inconsistent response to a particular meal dose, etc.
Action Plan – Collaboratively develop an action plan that empowers the person with diabetes to move forward successfully
It is important to note that since having integrated injection dose data is new to the care team it is vital to develop a workflow to ensure that the data is consistently used with individuals using smart insulin pen systems. The authors introduce the Receive-Review-Respond model that helps practice stakeholders ask and answer the right questions to help establish a rigorous process for data incorporation.
Authors challenge readers to step up and lead their health care teams to embrace these new tools along with evolving payment and care models and to endeavor to develop person-centric approaches to address the unmet needs of their diabetes population including those on insulin injection therapy, improving access, reach and effectiveness of their services.
Click here for the supplement!
About the author
Janice MacLeod, MA, RD, CDCES, FADCES
Head of Clinical Advocacy, Companion Medical
Janice leads clinical advocacy at Companion Medical partnering with professional organizations and thought leaders in diabetes, digital health and practice transformation to establish smart insulin pens as a standard of care for individuals on injection therapy. Previously Janice served as the Director, Clinical Innovation for Welldoc and at Johnson & Johnson Diabetes Care in a variety of roles including as Clinical Affairs Manager, and as Senior Medical Science Liaison. Janice has spent many years in clinical practice as a diabetes dietitian and certified diabetes care & education specialist at University of Maryland in Baltimore, MD and Carilion Health System in Roanoke, VA. Janice has served as both author and editor for multiple publications, contributed to book and curriculum manuals on diabetes, and has developed numerous continuing education programs and presentations in the areas of diabetes nutrition, glucose monitoring, digital health, and practice transformation.
- Warshaw H, Isaacs D, MacLeod J. Reference Guide to Integrate Smart Insulin Pens Into Data-Driven Diabetes Care and Education Services. TDE Supplement, 2020;46(suppl 4):S3-S20.
- Kerr D, Warshaw H. Smart Insulin Pens Will Address Critical Unmet Needs for People with Diabetes Using Insulin. Endocrine Today, 2019;17(5):21-22
- American Diabetes Association. 7. Diabetes technology: Standards of medical care in diabetes – 2020. Diabetes Care. 2020;43:(Supp 1):S77–S88.
- Association of Diabetes Care & Education Specialists. AADE rebrands as Association of Diabetes Care & Education Specialists. https://www.diabeteseducator.org/news-and-publications/press-releases/press-releases/2020/01/22/aade-rebrands-as-association-of-diabetes-care-education-specialists. Accessed August 17, 2020.
- Greenwood D, et al. A Framework for Optimizing Technology-Enabled Diabetes and Cardiometabolic Care and Education: The Role of the Diabetes Care and Education Specialist. TDE, 2020;46(4):315-322
- Isaacs D, et al. Technology Integration: The Role of the Diabetes Care and Education Specialist in Practice. TDE, 2020;46(4):323-334.