Shining the Spotlight on Multiple Daily Insulin Therapy: Real-World Evidence of the InPen Smart Insulin Pen.

Objective: Connected insulin pens are creating opportunities for the millions of individuals with diabetes using multiple daily injections (MDI) therapy across the globe. Continuous glucose monitoring (CGM) data from connected insulin pens are revealing gaps and opportunities to significantly improve care for this population. In this article, we report real-world findings of the InPen™ smart insulin pen paired with CGM (InPen system), used by persons with type 1 diabetes (T1D) and type 2 diabetes (T2D). Methods: A retrospective cohort analysis was conducted with the real-world data collected from the InPen system of individuals (N = 3793 with T1D, N = 552 with T2D, and N = 808 unidentified) who used the system from January 01, 2020, to December 31, 2021. Diabetes management (e.g., missed and mistimed insulin dosing, mismatched food intake, and correction dose delivery) and glycemic outcomes were assessed. Results: In the overall and T1D populations, a dosing frequency of ≥3 doses per day and a missed dose frequency of <20% was associated with improved glycemia. In adults with T2D, missing <20% of doses was the significant factor determining improved glycemia. Conclusion: This analysis, integrating data from a smart insulin pen and CGM, provides insights into the impact of dosing behavior on glycemic outcomes and informs counseling strategies for the diabetes care team, through technologically advanced insulin management for those using MDI therapy.

Potential cost savings in the United States from a reduction in sensor-detected severe hypoglycemia among users of the InPen smart insulin pen system.

BACKGROUND: Severe hypoglycemia is a significant barrier to optimizing insulin therapy in both type 1 and type 2 diabetes and places a burden on the US health care system because of the high costs of hypoglycemia-related health care utilization. OBJECTIVE: To compare the frequency of sensor-detected severe hypoglycemic events (SHEs) among a population of continuous glucose monitoring (CGM) users on insulin therapy after initiation of the InPen smart insulin pen (SIP) system and to estimate the potential hypoglycemia-related medical cost savings across a population of SIP users. METHODS: SIP users of all ages with type 1 or type 2 diabetes were required to have at least 90 days of SIP use with a connected CGM device. The last 14 days of sensor glucose (SG) data within the 30-day period prior to the start of SIP use ("pre-SIP") and the last 14 days of SG data, along with the requirement of at least 1 bolus entry per day within the 61- to 90-day period after SIP start ("post-SIP"), were analyzed. Sensor-detected SHEs (defined as ≥10 minutes of consecutive SG readings at <54 mg/dL) were determined. Once factored, the expected medical intervention rates and associated costs were calculated. Intervention rates and costs were obtained from the literature. RESULTS: There were 1,681 SIP + CGM users from March 1, 2018, to April 30, 2021. The mean number of sensor-detected SHEs per week declined from 0.67 in the pre-SIP period to 0.58 in the post-SIP period (P = 0.008), which represented a 13% reduction. Assuming a range of 5%-25% of all sensor-detected SHEs resulted in a clinical event, the estimated cost reduction associated with reduced SHEs was $12-$59 and $110-$551 per SIP user per month and per year, respectively. For those aged at least 65 years, there were 166 SIP+CGM users and the reduction in the mean number of sensor-detected SHEs per week between the pre-SIP and post-SIP periods was 31%. CONCLUSIONS: Use of the SIP system with a connected CGM is associated with reduced sensor-detected severe hypoglycemia, which may result in significant cost savings. DISCLOSURES: Albert Chien, Glen Im, Kael Wherry, Janice MacLeod, and Robert A Vigersky are employees of Medtronic; Sneha Thanasekaran and Angela Gaetano were affiliated with Medtronic while doing this research. The submitted work did not involve study subject recruitment, enrollment, or participation in a trial and did not fall under human subject protection requirements (per the Department of Health and Human Services CFR Part 46) necessitating Internal Review Board approval or exemption.

A Review of Precision Insulin Management With Smart Insulin Pens: Opening Up the Digital Door to People on Insulin Injection Therapy.

Although advances in insulin therapy and delivery have been made, global evidence indicates sub-optimal glycemic management in people on insulin therapy with either type 1 diabetes (T1D) or type 2 diabetes (T2D). In this review, we discuss connected insulin pens that include tracking insulin pens (TIPs) and smart insulin pens (SIPs) and caps, as approaches to improving mean glucose or time in range while minimizing exposure to hypoglycemia or time below range (TBR) in people with diabetes (PwD) on multiple daily injection (MDI) therapy. We discuss various factors offered by SIPs that can facilitate precision insulin management, that is, delivering the right dose at the right time. These factors include the automatic recording of insulin dose size and delivery time; differentiating prime from therapy doses; active insulin tracking; dose calculators that provide individualized dosing recommendations; alerts for missed doses (ie, rapid-acting or long-acting insulin), insulin temperature, and insulin age monitoring; and integrated data reports for the clinical care team. A data-driven approach to care is critical to precision insulin management and includes helping PwD make informed choices regarding their preferred method of insulin delivery and ensuring insulin delivery technology tools are configured for their personal therapy plan. The data-driven approach involves developing a plan for ongoing collaborative use of the resulting data with their care team that may include adjusting insulin regimen and optimizing the care plan on a timely basis. We conclude with a list of practice protocols that are needed to support data-driven precision insulin management. This review includes a summary of research including various stages of connected insulin pens and caps.

Building a Data-Driven Multiple Daily Insulin Therapy Model Using Smart Insulin Pens.

A growing suite of connected devices including Bluetooth or cellular-enabled glucose monitoring devices, smart insulin pens, pumps, fitness trackers, blood pressure, and heart rate and weight monitors present a golden opportunity to build a data-driven clinical practice model including remote monitoring capability and virtual care. This paper will discuss this approach using diabetes as a case study and smart insulin pens as a use case. As payment and practice approaches evolve, there is growing interest from both patients and their health care teams in virtual care made possible by remote monitoring capability. Here, we will define the category of smart insulin pens, describe the hallmarks of a data-driven practice model, and delineate the steps to take to incorporate remote monitoring capability with smart insulin pens into diabetes care for injection therapy patients.

2017 National Standards for Diabetes Self-Management Education and Support.

PURPOSE: The purpose of this study is to review the literature for Diabetes Self-Management Education and Support (DSMES) to ensure the National Standards for DSMES (Standards) align with current evidence-based practices and utilization trends. METHODS: The 10 Standards were divided among 20 interdisciplinary workgroup members. Members searched the current research for diabetes education and support, behavioral health, clinical, health care environment, technical, reimbursement, and business practice for the strongest evidence that guided the Standards revision. RESULTS: Diabetes Self-Management Education and Support facilitates the knowledge, skills, and ability necessary for diabetes self-care as well as activities that assist a person in implementing and sustaining the behaviors needed to manage their condition on an ongoing basis. The evidence indicates that health care providers and people affected by diabetes are embracing technology, and this is having a positive impact of DSMES access, utilization, and outcomes. CONCLUSION: Quality DSMES continues to be a critical element of care for all people with diabetes. The DSMES services must be individualized and guided by the concerns, preferences, and needs of the person affected by diabetes. Even with the abundance of evidence supporting the benefits of DSMES, it continues to be underutilized, but as with other health care services, technology is changing the way DSMES is delivered and utilized with positive outcomes.

The Reference Guide to Integrate Smart Insulin Pens Into Data-Driven Diabetes Care and Education Services.

PURPOSE: More than 7 million Americans who have diabetes use insulin therapy. The majority continue to use syringes and vials or traditional insulin pens to deliver their insulin doses. Using these tools to deliver insulin presents numerous challenges for both the person with diabetes and their clinicians. This article provides an in-depth introduction to a new category of insulin delivery devices and integrated management systems, referred to as smart insulin pens. The article includes information about how these integrated insulin delivery systems can reduce many of the challenges of rapid-acting insulin dosing via injection by enabling easier and more accurate dose recording, dose calculations, and sharing of diabetes management data with clinicians. This article also discusses new roles for diabetes care and education specialists in diabetes data-driven care and practice and addresses how smart insulin pens represent one of many newer digital diabetes management tools that can assist people with diabetes and their clinicians to optimally achieve and deliver quality, data-driven diabetes care. CONCLUSIONS: Newer and simplified insulin delivery devices with their integrated management systems, such as smart insulin pens, have the potential to minimize the challenges and complexities associated with insulin injection therapy while also providing people with diabetes and their clinicians more complete and integrated data in easily transmitted reports that support more efficient data analysis.

2017 National Standards for Diabetes Self-Management Education and Support.

PURPOSE: The purpose of this study is to review the literature for Diabetes Self-Management Education and Support (DSMES) to ensure the National Standards for DSMES (Standards) align with current evidence-based practices and utilization trends. METHODS: The 10 Standards were divided among 20 interdisciplinary workgroup members. Members searched the current research for diabetes education and support, behavioral health, clinical, health care environment, technical, reimbursement, and business practice for the strongest evidence that guided the Standards revision. RESULTS: Diabetes Self-Management Education and Support facilitates the knowledge, skills, and ability necessary for diabetes self-care as well as activities that assist a person in implementing and sustaining the behaviors needed to manage their condition on an ongoing basis. The evidence indicates that health care providers and people affected by diabetes are embracing technology, and this is having a positive impact of DSMES access, utilization, and outcomes. CONCLUSION: Quality DSMES continues to be a critical element of care for all people with diabetes. The DSMES services must be individualized and guided by the concerns, preferences, and needs of the person affected by diabetes. Even with the abundance of evidence supporting the benefits of DSMES, it continues to be underutilized, but as with other health care services, technology is changing the way DSMES is delivered and utilized with positive outcomes.

2017 National Standards for Diabetes Self-Management Education and Support.

PURPOSE: The purpose of this study is to review the literature for Diabetes Self-Management Education and Support (DSMES) to ensure the National Standards for DSMES (Standards) align with current evidence-based practices and utilization trends. METHODS: The 10 Standards were divided among 20 interdisciplinary workgroup members. Members searched the current research for diabetes education and support, behavioral health, clinical, health care environment, technical, reimbursement, and business practice for the strongest evidence that guided the Standards revision. RESULTS: Diabetes Self-Management Education and Support facilitates the knowledge, skills, and ability necessary for diabetes self-care as well as activities that assist a person in implementing and sustaining the behaviors needed to manage their condition on an ongoing basis. The evidence indicates that health care providers and people affected by diabetes are embracing technology, and this is having a positive impact of DSMES access, utilization, and outcomes. CONCLUSION: Quality DSMES continues to be a critical element of care for all people with diabetes. The DSMES services must be individualized and guided by the concerns, preferences, and needs of the person affected by diabetes. Even with the abundance of evidence supporting the benefits of DSMES, it continues to be underutilized, but as with other health care services, technology is changing the way DSMES is delivered and utilized with positive outcomes.

Success of nutrition-therapy interventions in persons with type 2 diabetes: challenges and future directions.

A systematic review was conducted by the Academy of Nutrition and Dietetics to determine the evidence for the effectiveness of individualized nutrition therapy provided by a dietitian nutritionist and evidence-based (EB) nutrition-therapy interventions in adults with diabetes. This article briefly reviews the systematic process used and summarizes the effectiveness evidence and intervention recommendations. In persons with type 2 diabetes (T2D), 18 studies met study criteria for the effectiveness question. A 0.3%-2.0% decrease from baseline in glycated hemoglobin was reported at 3 months in 13 study arms, a 0.3%-1.8% decrease at 6 months in 12 study arms, a 0.3%-1.6% decrease at 12 months with ongoing support in six study arms, and a 0.6%-1.8% decrease at >12 months in four study arms. An initial series of encounters with follow-up visits and implementation of a variety of nutrition-therapy interventions, all of which reduced energy intake, were reported. Nutrition therapy also significantly decreased doses or number of glucose-lowering medications used and resulted in improvements in quality of life. Mixed effects on cardiovascular risk factors and body weight were reported. Fourteen questions were identified related to nutrition-therapy interventions. A total of 38 studies met study criteria for the nutrition-intervention questions, from which 30 conclusion statements and 19 nutrition-practice guideline recommendations for T2D were written. Three additional NPG recommendations for T2D were written based on evidence reviewed by the American Diabetes Association. The 22 nutrition-intervention recommendations for T2D are summarized. How to implement nutrition-practice guideline recommendations effectively by health care providers and individuals with T2D remains challenging. Of importance, it is recognized that identifying and integrating EB digital health-technology tools into clinical practice are major challenges for future management of diabetes, self-management education, and support.

2017 National Standards for Diabetes Self-Management Education and Support.

Purpose The purpose of this study is to review the literature for Diabetes Self-Management Education and Support (DSMES) to ensure the National Standards for DSMES (Standards) align with current evidence-based practices and utilization trends. Methods The 10 Standards were divided among 20 interdisciplinary workgroup members. Members searched the current research for diabetes education and support, behavioral health, clinical, health care environment, technical, reimbursement, and business practice for the strongest evidence that guided the Standards revision. Results Diabetes Self-Management Education and Support facilitates the knowledge, skills, and ability necessary for diabetes self-care as well as activities that assist a person in implementing and sustaining the behaviors needed to manage their condition on an ongoing basis. The evidence indicates that health care providers and people affected by diabetes are embracing technology, and this is having a positive impact of DSMES access, utilization, and outcomes. Conclusion Quality DSMES continues to be a critical element of care for all people with diabetes. The DSMES services must be individualized and guided by the concerns, preferences, and needs of the person affected by diabetes. Even with the abundance of evidence supporting the benefits of DSMES, it continues to be underutilized, but as with other health care services, technology is changing the way DSMES is delivered and utilized with positive outcomes.

2017 National Standards for Diabetes Self-Management Education and Support.

This article was copublished in Diabetes Care 2017;40:1409-1419 and The Diabetes Educator 2017;43:449-464 and is reprinted with permission. The previous version of this article, also copublished in Diabetes Care and The Diabetes Educator, can be found at Diabetes Care 2012;35:2393-2401 (https://doi.org/10.2337/dc12-1707).

2017 National Standards for Diabetes Self-Management Education and Support.

Purpose The purpose of this study is to review the literature for Diabetes Self-Management Education and Support (DSMES) to ensure the National Standards for DSMES (Standards) align with current evidence-based practices and utilization trends. Methods The 10 Standards were divided among 20 interdisciplinary workgroup members. Members searched the current research for diabetes education and support, behavioral health, clinical, health care environment, technical, reimbursement, and business practice for the strongest evidence that guided the Standards revision. Results Diabetes Self-Management Education and Support facilitates the knowledge, skills, and ability necessary for diabetes self-care as well as activities that assist a person in implementing and sustaining the behaviors needed to manage their condition on an ongoing basis. The evidence indicates that health care providers and people affected by diabetes are embracing technology, and this is having a positive impact of DSMES access, utilization, and outcomes. Conclusion Quality DSMES continues to be a critical element of care for all people with diabetes. The DSMES services must be individualized and guided by the concerns, preferences, and needs of the person affected by diabetes. Even with the abundance of evidence supporting the benefits of DSMES, it continues to be underutilized, but as with other health care services, technology is changing the way DSMES is delivered and utilized with positive outcomes.