ABSTRACT
Ongoing innovations in glucose monitoring, insulin delivery, and telehealth technologies have created a digital diabetes ecosystem populated by connected tools and technologies that have been shown to improve clinical outcomes, lower costs, and reduce the burden of diabetes. Advances in connected continuous glucose monitoring devices, insulin pumps, and insulin pens have led to the development of automated insulin delivery systems that modulate insulin infusion based on sensor glucose data. Similar integrations of continuous glucose monitoring and connected blood glucose meter data into “smart” pens have lessened the guesswork of intensive insulin management for individuals who prefer traditional injection therapy. A growing number of health apps that can be accessed through smartphones and wearable devices provide information and advice that support individuals in adopting healthier lifestyles. The differences in features and functionality give users the ability to select the devices that best meet their unique requirements and preferences. This article reviews the most current digital diabetes technologies and discusses how the connectivity of these tools can create an overarching architecture of feedback mechanisms that monitor an individual’s health status, motivate and enhance adherence to self-management, and provide advice and decision-support tools to clinicians as well as other members of the health care team to make living with diabetes more manageable.
Plain language summary
Advances in continuous glucose monitoring devices, insulin delivery systems, and telehealth technologies can help patients with diabetes achieve their self-management goals. Connectivity of these devices has created a diabetes ecosystem that provides immediate feedback to patients about their health status and enables health care providers to make informed decisions about therapy adjustments. The differences in features and functionality give users the ability to select the devices that best meet their unique requirements and preferences.
Implications for managed care pharmacy
This article provides information about the functionality and availability of various continuous glucose monitors, insulin delivery devices, and connected digital health apps that will aid health care providers in developing personalized treatment plans for their patients with diabetes and help managed care organizations leverage relevant data to develop population health programs to better manage patients with complex diabetes.
Continuous glucose monitors (CGMs) and other connected diabetes technologies have transformed the way individuals with type 1 diabetes (T1D) and type 2 diabetes (T2D) manage their disease.1 CGM systems typically measure interstitial glucose levels and display the current glucose level, direction, and rate of change on the patient’s smartphone or receiver. These data enable users to take immediate action to treat or prevent acute glycemic events and to make more informed decisions in their daily self-management with a simple glance/scan of their phone or receiver. As an added safety net, most CGM devices allow for users to share data with their health care team and family/caregivers. Depending on the specific brand, connected CGM sensors last 7-15 days and greatly reduce the patient burden associated with capturing these data relative to blood glucose monitoring (BGM). The data can be downloaded for retrospective analysis, enabling users and their health care team to identify problematic glycemic patterns that may indicate the need for therapy adjustments. The data also help provide guidance for optimal carbohydrate counting, calculating insulin dosages, and/or counseling in healthy lifestyle behaviors. Furthermore, retrospective data can be analyzed to assist with population health initiatives and clinical programs for managed care organizations and other payers.
Another important step was to combine CGM use with conventional insulin pump therapy. The glycemic benefits of this approach were soon demonstrated in randomized trials2 and real-world studies.3,4 More enhanced optimization of these technologies came with the development of sensor-augmented pump systems. With sensor-augmented pump systems, the sensor automatically transmits glucose data to the pump for the patient to use when adjusting insulin infusion, bolusing, and suspending insulin delivery when either hypoglycemia or anticipated hypoglycemia are detected. However, the ultimate goal of connecting CGMs with insulin pumps is the creation of a hybrid closed-loop or automated insulin delivery (AID) system, a device that attempts to mimic the body’s physiologic response to changing glucose levels.
For individuals who require intensive insulin therapy but do not wish to use an insulin pump, advances in insulin pens allow them to continue on injection therapy with “connected” insulin pens that offer connectivity with CGM and some BGM meters, built-in memory, and download capability.
Smartphone apps have also become increasingly important tools for managing diabetes. These apps present information and advice about various components of diabetes self-management, provide strategies for achieving specific goals (eg, weight loss and increased physical activity), and track progress. Personalized feedback that is continuously available has been shown to be a powerful motivator in helping individuals achieve their health objectives.5,6 Some of these apps can be connected with wearable devices, including CGMs.
In this article, we present a summary of connected current CGM sensors, AID systems, smart pens, and digital health technologies and discuss how these devices and apps come together to form a diabetes ecosystem that allows individuals with diabetes to optimize their daily self-management using a variety of digital tools that can be personalized to meet each individual’s needs and preferences. Importantly, these technologies have the potential to address many of the health disparities impacting racial and ethnic minority groups and those with lower socioeconomic status by connecting people living in underserved communities with health care providers who can deliver the expert care and support needed to manage their diabetes effectively. The goal of all stakeholders—developers, users, clinicians, health care systems, and payers—is to create an overarching architecture of feedback mechanisms that monitor an individual’s health status, motivate and enhance adherence to self-management,7,8 and provide advice and decision-support tools to clinicians and other members of the health care team to make living with diabetes more manageable.
Continuous Glucose Monitoring
Numerous studies have shown that daily use of CGMs in individuals treated with intensive and nonintensive insulin therapy regimens improves overall glycemic status4,9-23 and reduces diabetes-related events, hospitalization rates, and associated costs.15,24-27 Use of CGMs has also been shown to improve patients’ understanding of their disease and increase their engagement in daily self-management.28-31 Through ongoing advances in glucose monitoring technologies, each new generation of CGM systems continues to offer greater accuracy and includes features that promote safety, personalization, and ease of use.32 CGMs also allow for the generation of glycemic metrics for use by payers and health care accreditation organizations. For example, the National Committee for Quality Assurance recently adopted the Glucose Management Indicator (GMI), an established CGM metric,33 for use as an estimation of hemoglobin A1c in the glycemic status assessment.34 Integrated CGM sensors include the FreeStyle Libre 2, FreeStyle Libre 2 Plus, FreeStyle Libre 3, Dexcom G6, and Dexcom G7. Medtronic Guardian 4 Sensor and Medtronic Simplera Sync also connect with some Medtronic devices. Table 1 presents a summary of the key features offered by the most recent and widely used connected CGMs.
TABLE 1.
Key Features of Current Connected CGM Systems
CGM sensor | Size | Duration of wear | Range | Warm-up time | Memory storage | Device connections | Age |
---|---|---|---|---|---|---|---|
FreeStyle Libre 235-37 | 1.38 inches diameter × 0.2 inches | 14 days | 20 feet | 60 minutes | 8 hours | Abbott’s Unity Pen NovoPen 6 NovoPen Echo Plus (Europe) |
4 years3 |
FreeStyle Libre 2 Plus35 | 1.38 inches diameter × 0.2 inches | 15 days | 20 feet | 60 minutes | 8 hours | Tandem t:slim X2 pump with Control-IQ technology Omnipod 5 (CE marked in Europe) NovoPen 6 NovoPen Echo Plus (Europe) |
2 years3 |
FreeStyle Libre 335,38-41 | 0.82 inches diameter × 0.11 inches | 14 days | 33 feet | 60 minutes | 14 days | myLife CamAPS FX/YpsoPump (Europe) | 4 years3 |
Dexcom G635,38,39,42-49 | 1.8 x 1.2 × 0.6 inches | 10 days | 20 feet | 120 minutes | 3 hours | myLife CamAPS FX/YpsoPump (Europe) CamAPS FX/DANA-i pump (Europe) Tandem t:slim X2 pump with Control-IQ technology Tandem Mobi System Omnipod 5 Beta Bionics iLet Tempo NovoPen 6 NovoPen Echo Plus (Europe) Medtronic InPen |
2 years3 |
Dexcom G735,38,39,42-48,50 | 1.07 × 0.94 × 0.18 inches (without required overpatch) | 10 days with 12-hour grace period | 20 feet | 30 minutes | 24 hours | Tandem t:slim X2 pump with Control-IQ technology Omnipod 5 Beta Bionics iLet Tempo NovoPen 6 NovoPen Echo Plus (Europe) Medtronic InPen |
2 years3 |
Medtronic Guardian 451-54 | 2.6 × 2.0 × 1.5 inches | 7 days | 20 feet | 120 minutes | Not available | Medtronic 780G Medtronic InPen |
7 years3 |
Medtronic Simplera Sync55-57 (CE marked in Europe) |
1.13 × 1.13 × 0.19 inches | 7 days | 20 feet | 120 minutes | Not available | Medtronic 780G (Europe) Medtronic InPen (Europe) |
2 years3 |
CGM = continuous glucose monitor
FREESTYLE LIBRE 2 AND FREESTYLE LIBRE 2 PLUS35
The FreeStyle Libre 2 and FreeStyle Libre 2 Plus systems have similar features and functionalities. Both offer real-time, customizable alerts when programmable low and high glucose thresholds are crossed, and both are indicated for use in pregnancy by the US Food and Drug Administration (FDA).58 However, there are some differences. The FreeStyle Libre 2 is indicated for patients aged 4 years and older, with sensor wear up to 14 days, whereas the FreeStyle Libre 2 Plus is the first CGM sensor with a wear time of 15 days for both adults and children (aged 2 years and older), offering greater convenience to users (2 fewer sensors per year). The sensor connects with the Tandem t:slim X2 pump with Control-IQ technology and Omnipod 5 (CE marked in Europe only) or used as a standalone device. There are also other connections, as presented below.
FREESTYLE LIBRE 335
The FreeStyle Libre 3 system is the smallest, thinnest, and most accurate sensor available.37 It is indicated for individuals aged 4 years and older and indicated for use in pregnancy.59 This real-time CGM provides minute-to-minute glucose readings that stream directly to the user’s compatible smartphone (iOS or Android) or reader with a wear time of 14 days. Much like the FreeStyle Libre 2 CGM and FreeStyle Libre 2 Plus CGM, this sensor features customizable alerts and remote monitoring capability using the LibreLinkUp app, which allows up to 20 people to remotely track glucose data and trends from a smartphone. In select countries outside the United States, the sensor currently integrates for AID with CamDiab’s CamAPS FX mobile app in conjunction with Ypsomed’s mylife YpsoPump, but FreeStyle Libre 3 integration with other systems is planned. CamAPS FX also received FDA clearance in the United States in May 2024 for use with compatible devices.60
DEXCOM G635
The Dexcom G6 sensor is a 10-day real-time CGM that integrates with several connected insulin pens and hybrid closed-loop systems, including the Omnipod 5, Tandem t:slim X2 pump with Control-IQ technology, Tandem Mobi System, iLet Bionic Pancreas System, myLife CamAPS FX/YpsoPump (Europe), and CamAPS FX/Dana-i insulin pump (Europe). The sensor features customizable alerts and alarms for hypoglycemia and hyperglycemia for users and family/caregivers. Alert profiles can be set for different times of day and customized sounds can be set for alerts. The sensor also has remote monitoring capability with the Dexcom Share and Follow apps, with up to 10 followers.
DEXCOM G735
The Dexcom G7 is approximately 60% smaller than the previous-generation sensor (G6) and is indicated for individuals aged 2 years and older and also has an indication for use in pregnancy by the FDA.61 The sensor duration supports 10 days of use plus a 12-hour grace period and requires an “overpatch.”62 Alerts (low, high, rising/falling fast, delayed first alert [high], and urgent low soon alert) can be customized with sound options. When using the Dexcom G7 app, the Dexcom Follow app and Internet connectivity allows up to 10 people to remotely monitor glucose information and alerts. The sensor can be integrated with the Omnipod 5, Tandem t:slim X2 pump with Control-IQ technology, and iLet Bionic Pancreas System.
MEDTRONIC GUARDIAN SENSOR 451-53
The Medtronic Guardian 4 Sensor is designed to work with the Medtronic 780G system and the Medtronic InPen, which are indicated for individuals aged 7 years and older. The insulin dose and glucose reports can be sent to care partners and health care specialists. The MiniMed Mobile app displays glucose and insulin data. Users can use the CareLink Connect app to share glucose and insulin pump data with health care providers and family/caregivers.
MEDTRONIC SIMPLERA SYNC55
The Medtronic Simplera Sync features a 2-step insertion process and is approved in Europe by regulatory agencies (CE marked) and currently under FDA review. The sensor does not require overpatch and is seamlessly connected with the Medtronic InPen smart insulin pen, which provides real-time, personalized dosing guidance to help simplify diabetes management, and will connect with the Medtronic 780G system for AID in Europe. As with the Guardian 4 Sensor, users can share insulin and glucose data with health care providers and family/caregivers using the CareLink Connect app.
FUTURE DEVELOPMENTS
Ongoing advances in CGM technology may also lead to monitoring analytes to reduce the risk of diabetic emergencies and expand the use and clinical benefits of new medication classes.63 One example is the development of a first-of-its-kind dual monitoring system that will enable individuals with diabetes to continuously monitor glucose and ketone levels in one sensor.64 This may be particularly useful given recent studies that demonstrate that ketones increase sooner than glucose levels do.65 This capability is particularly important for individuals with T1D at high risk for diabetic ketoacidosis (DKA) such as insulin pump users, those who are pregnant, and those with high propensity for infection. DKA is the most frequent hyperglycemic emergency and leading cause of death in this population.66 Current methods for ketone monitoring such as using a separate blood ketone meter and urine ketone test strips have limitations (eg, increased cost and inconvenience) that significantly limit adherence to prescribed ketone monitoring regimens.67,68 Glucose monitoring alone cannot detect euglycemic DKA,67 which is a major barrier for treatment with sodium-glucose cotransporter-2 inhibitors. Although sodium-glucose cotransporter-2 (SGLT2) inhibitor therapy is not currently indicated for use in T1D,67 some clinicians prescribe these medications off label because of their cardiorenal protective qualities.69,70 Abbott Diabetes Care recently demonstrated the feasibility of this multianalyte sensor measuring glucose and ketones.71 The company recently announced plans to partner with leading insulin pump manufacturers to make the dual system interoperable with current and future insulin delivery systems.64
Automated Insulin Delivery Systems
During the past 10 years, we have seen major advances in AID technologies. Studies with various AID systems have demonstrated significant improvements in glycemic outcomes in people with T1D across all age groups, in all sexes, and regardless of diabetes duration, prior insulin delivery modality, or baseline A1c.72,73 AID systems typically use a sophisticated algorithm that continuously adjusts insulin delivery in response to CGM glucose levels, residual insulin action (ie, insulin-on-board), and other inputs, such as meal intake and exercise announcement.74 More recent AID iterations now feature algorithms that use multivariable adaptive capability based on each user’s unique glycemic response to food, physical activity, and other everyday behaviors, with some user inputs required.
Some AID systems use a predictive algorithm that automatically adjusts insulin delivery to optimize glucose control and increases the programmed basal insulin delivery rate when glucose levels are predicted to exceed a predefined upper threshold and decreases the insulin infusion rate when glucose levels are predicted to fall below the lower threshold. Additionally, many of these systems can transfer data to family/caregivers and/or health care providers. Their differences in features and functionality give potential users the ability to select the AID system that best meets their unique requirements and preferences. Table 2 presents a summary of the key features offered by the most commonly used AID systems.
TABLE 2.
Key Features of Current AID Systems
AID system | Compatible CGM | Mobile control | Set glucose target range | Customizable inputs | Preset basal insulin rates | Bolus correction delivery | Automatic data upload for remote monitoring |
---|---|---|---|---|---|---|---|
Tandem t:slim with Control-IQ38,42,43,75,76 Tandem Mobi77-79 |
Dexcom G6, G7 FreeStyle Libre 2 Plus Mobi: Dexcom G6 Dexcom G7 (announced) |
Smartphone bolusing using iOS and Android (United States only) Mobi: Lacks a built-in screen and relies on a compatible application for insulin delivery (iOS and Android) |
Target 30-minute predicted range Standard 112.5-160 mg/dL Sleep activity 112.5-120 mg/dL Exercise activity 140-160 mg/dL Target corrections to 110 mg/dL |
Timed settings: basal rate, correction factor, carbohydrate ratio, and target blood glucose. Bolus settings: insulin duration, and carbohydrates setting (on/off) Can customize low and high glucose alerts |
Can set up to 6 personal profiles with up to 16 different time segments | Automated correction boluses up to once per hour (when glucose expected to be >180 mg/dL) using predicted CGM glucose and input correction factor. Optional user-initiated correction boluses Mobi: Features an on-pump button, providing a Quick Bolus option for people to manually bolus rather than bolus from smartphone (can choose set 0.5, 1.0, 2.0, 5.0 units or 2, 5, 10, 15 grams carbohydrates) |
Insulin data shared via t:connect mobile app (United States only) Real-time glucose data shared via Dexcom Follow app (when used with Dexcom G6 or G7) |
Omnipod 538,44 |
Dexcom G6, G7 (United States) and FreeStyle Libre 2 Plus (CE marked in Europe) | Full smartphone control (Android only; iOS has FDA clearance in the United States) or controller | Target glucose customizable between 110 and 150 mg/dL (can set up to 8 glucose targets for different times of day) Activity feature target 150 mg/dL |
SmartBolus calculator uses insulin-to-carbohydrate ratios, correction factor, and duration of insulin action and aims for the target glucose value | Up to 24 segments/day in a basal program | Optional user-initiated correction boluses SmartBolus calculator delivers a correction if current glucose is higher than correct above threshold (can customize 110-200 mg/dL) |
Glooko |
Beta Bionics iLet45-48 | Dexcom G6, G7 | iLet Mobile app as a companion app | Can choose from 3 preset targets: 110 (lower),120 (usual),130 (higher) mg/dL |
Basal adjusts automatically after weight input. Announce meals with breakfast/lunch/dinner AND Less/Usual for me/More. No input for carbohydrate counting, programmed basal rate settings, insulin:carbohydrate ratios, correction factors |
Automatic after weight input | Automatic. Uses “autonomous lifelong learning” to calculate and deliver insulin doses (uses basal, correction, meal announcement) | Real-time glucose data shared via Dexcom Follow app |
Medtronic 780G38,80,81 | Guardian 4, Simplera Sync (CE marked in Europe) | View app on smartphone as secondary display | 100-120 mg/dL Temp target 150 mg/dL (no automated correction bolus) |
Can personalize glucose target (100, 110, 120 mg/dL) Can adjust the carbohydrate ratio, insulin sensitivity factor, blood glucose target, and active insulin time |
Maximum 8 patterns, up to 48 rates | Automated correction boluses (target 120 mg/dL)—up to 12/hour (every 5 minutes) | Insulin and glucose data shared via Carelink app |
myLife CamAPS FX38,39 (available in Europe) Ypsomed’s mylife YpsoPump82 |
Dexcom G6,FreeStyle Libre 3 | Full smartphone control: Android only | Default target: 104 mg/dL Customizable personal target: 80-198 mg/dL |
Predictive control: algorithm calculates insulin requirement for the next 2.5-4 hoursAdaptive model: insulin delivery is adjusted every 8-12 minutes | Two profiles (A and B), freely programmable by the user Temporary basal rate available |
Optional user-initiated correction boluses Features a “blind bolus” option with an on-pump function button |
Data uploaded to Diasend/GlookoReal-time monitoring with Companion app (up to 10 companions) and SMS |
CE = ; SMS = short message/messaging service; TDD = total daily insulin dose.
TANDEM T:SLIM WITH CONTROL-IQ TECHNOLOGY38,42,43
The Tandem Control-IQ system comprises the t:slim X2 insulin pump with Control-IQ technology and integrates with several CGM systems, including the Dexcom G6 and G7 sensors and, most recently, the FreeStyle Libre 2 Plus sensor. When treatment with the system is initiated, the sensor connects wirelessly to the Tandem t:slim X2 insulin pump, transmitting glucose data to the pump every minute with the FreeStyle Libre 2 Plus sensor and every 5 minutes with the Dexcom G6 and G7 sensors. Glucose data are displayed on the t:connect mobile app and t:slim X2 insulin pump. The newest Tandem AID system is the Tandem Mobi, which is half the size of the t:slim pump and the smallest durable AID system available in the United States.77 The Tandem Mobi is operated by Control-IQ technology and compatible with the Dexcom G6 sensor.
MEDTRONIC 780G38,80,81
The Medtronic 780G AID system with Bluetooth connects with the Guardian 4 Sensor, which allows data to be shared with family/caregivers and automatic uploading to the CareLink software. It is also CE marked in Europe to connect with the Simplera Sync CGM. The system allows users to input personalized glucose targets and automatically corrects for high glucose with auto correction boluses and basal dose adjustments.
MYLIFE CAMAPS FX APP/YPSOMED PUMP38,39
The CamAPS FX is an Android app that is used to manage glucose levels, using an advanced adaptive hybrid closed-loop approach. The app integrates with Ypsomed’s mylife YpsoPump, which can be connected to either the FreeStyle Libre 3 CGM system or Dexcom G6. The app also integrates with the DANA Diabecare RS, DANA-i insulin pump, which is compatible with the Dexcom G6. As with other systems, it allows for multiple glucose targets that can be set at different times. It is currently the only commercial AID system approved for use during pregnancy for people with T1D in Europe, but is not currently available in the United States. Users require an Android smartphone to use the system connected via Bluetooth to compatible pumps and sensors for the YpsoPump but can support both Android and iOS for the DANA-i insulin pump. It is approved for use with both rapid-acting insulin and ultra-rapid insulin. The mylife CamAPS FX app allows users’ data to be shared with up to 10 people.
OMNIPOD 538,44
Omnipod 5 is the first and only tubeless AID system and comprises the tubeless Pod enhanced with SmartAdjust Technology and the Omnipod 5 Controller with an integrated Smartbolus Calculator. The algorithm utilizes CGM data (value and trend) to predict the glucose level 60 minutes in the future and corrects every 5 minutes based on the users target glucose range. Omnipod 5 is cleared for use with the Dexcom G6 and G7 sensors in the US and is CE marked for use with the FreeStyle Libre 2 Plus sensor in Europe.
iLet BIONIC PANCREAS SYSTEM45-48
The Beta Bionics iLet Bionic Pancreas system is an AID system comprising the iLet ACE Pump, iLet Dosing Decision Software, and a Dexcom G6 or G7 CGM. Insulin dosing is initiated solely based on the user’s weight. After the user’s weight has been entered, the system runs 3 algorithms. The basal insulin controller determines basal rates every 5 minutes based on present glucose, glucose trend, and historic CGM data. The bolus correction controller takes into account the same factors and residual active insulin. The meal announcement controller algorithm determines meal bolus doses utilizing the user’s estimated meal size. The device does not utilize user-programmed basal rates, correction factors, or carbohydrate ratios, although users can choose 1 of the 3 targets for glucose.
CONNECTED INSULIN PENS
In addition to advances in AID, we have seen similar innovations in insulin injection technologies. Starting with the transition from “vial and syringe” to insulin pens in 1985, the next step was the first “smart” pen in 2007,83 which featured a memory function that automatically stores the date, time, and volume of the previous insulin dose.84,85 Further refinements led to smart pens with built-in dosage calculators that provide advice to patients regarding the insulin dosage based on their last injection, user-inputted data (eg, insulin sensitivity factor and insulin-to-carbohydrate ratio).83 The current generation of smart pens offer the same features as earlier smart pens but now have the ability to connect with CGM systems and/or BGM meters and pair with smartphone apps. Moreover, a recent systematic review showed that use of these devices improves adherence to prescribed insulin regimens with improved glycemic control and enhanced patient satisfaction.86 Two cost-effective analyses reported an association between connected pen use and potential economic benefits resulting from improved A1c87 and reduced complications.88 Chien et al showed a 13% reduction in severe hypoglycemia events within a cohort of 1,681 children and adults with T1D and T2D, resulting in an estimated cost savings ranging from $110 to $551 per user per year.89 A summary of the features and functionality of current “connected” pens is presented in Table 3.
TABLE 3.
Key Features of Current Connected Smart Pens
Device | Features | Functionality | Connectivity |
---|---|---|---|
Abbott Diabetes Care Unity90,91 |
Smart Cap Reusable Used with most commercially available rapid-acting and long-acting insulin pens |
Tracks time last dose was given Real-time hypoglycemia alerts Displays glucose range/trends over time from CGM Notifies the user of potential missed doses Determines correction and meal dose recommendations |
Pairs with Bigfoot Unity Mobile App on iOS Smartphone Syncs with glucose monitoring systems/apps:
Data can be viewed in Bigfoot Clinic Hub portal |
Novo Nordisk NovoPen 693 NovoPen Echo Plus92 (Europe) |
Smart Pen Reusable Used for rapid-acting insulin Insulin adjustments:
|
Records time, date, and insulin units Insulin data can be viewed side by side with glucose data |
Connects for smartphone and other smart devices via Near Field Communication technology Syncs with glucose monitoring systems/apps:
|
Medtronic InPen90,93,94 |
Smart Pen Reusable for 1 year Used for rapid-acting insulin delivery Doses in half-unit increments, up to 30 units at a time |
Records time and amount of insulin doses Calculates meal and correction doses based on individualized insulin therapy settings and glucose values Tracks active insulin (insulin-on-board) Sends dose reminders Monitors insulin temperature and expiration date |
Pairs with iOS and Android Smartphone App via Bluetooth Syncs with glucose monitoring systems/apps:
Allows users to share connected data reports with a health care team and family/caregivers |
Eli Lilly & Company Tempo90,95 |
Smart Diabetes Self-Management Tool (Pen + Cap + App) Reusable Tempo Smart Button attaches to disposable prefilled disposable insulin Tempo Pen for data transfer via Bluetooth to TempoSmart App Tempo Pen available with Eli Lilly–based basal and bolus insulin (Lyumjev, Basaglar, and Humalog) |
Tracks insulin dose Tracks synced health data and manually entered health data Sends medication reminders Medication coaching Real-time feedback on BGM input (not CGM) |
Pairs with iOS and Android smartphones Syncs with glucose monitoring systems and apps:
Syncs with wearable devices:
View data in Tempo Insights Portal Shares data with HCPs through clinician hub Tempo Insights |
BGM = blood glucose monitoring; CGM = continuous glucose monitor; HCP = health care practitioner.
DIGITAL HEALTH APPS
The number of smartphone users is projected to reach 6.4 billion in 2029.96
The proliferation of smartphone use has prompted the development of more than 2,200 diabetes-related mobile health apps.97 In addition to the apps that are specific to glucose monitoring and insulin delivery devices, individuals with diabetes have ready access to digital health apps that provide information, tracking, and feedback to support modification of various lifestyle behaviors such as physical activity, stress management, virtual coaching, healthy nutrition, and weight loss. In a recent systematic review of 25 studies that included 3,360 individuals with T1D, T2D, and prediabetes, use of these digital apps was associated with a significant reduction in mean A1c (−0.8%).98 Some CGM systems can be used to connect with smartphone features in visually impaired patients using voice-enabled CGM readings.99 Some of the more commonly known apps are mentioned below.
In addition to their standalone functionality, many of these apps can be connected to CGM data. This enables users to see how behavioral modifications can impact their glycemic control. For example, individuals who currently follow the WeightWatchers Diabetes-Tailored plan can now access their glucose data using the WeightWatchers app. The app captures glucose data from the FreeStyle Libre 2 and FreeStyle Libre 3 sensors. In a recent prospective, 24-week, single-arm study of 136 adults with T2D who participated in the WeightWatchers program, investigators observed a significant reduction in A1c (−0.8%) at week 24, with mean weight loss of 5.7 kg, and a significant reduction in diabetes-related distress.100 Adding CGM data to the program’s feedback loop will likely result in further improvements in weight loss and glycemic control.8
Another example is The Omada Health Program, a digital adaptation of the Diabetes Prevention Program lifestyle intervention using its own proprietary curriculum.101 In 2019, Omada Health partnered with Abbott Diabetes Care to connect the FreeStyle Libre CGM systems into its digital care program. Using this program, which is offered to employers and health plans, people with T2D are guided through a tailored curriculum that includes an online physician consultation, a prescription for the Freestyle Libre system, and delivery of a welcome kit that includes the CGM system and a wireless scale.102
Open Diabetes Ecosystem of Connected Devices and Technologies
The devices and technologies discussed in this article represent only a small portion of the numerous tools currently available to individuals with diabetes and their health care providers. Moreover, the data generated by these tools can be used by health systems, insurers, and policy-makers to assess the safety and efficacy of various therapies and treatment strategies and potentially lead to more informed, evidence-based best practices, greater efficiencies in health care resource utilization, and lower costs. The data can also help build population health programs to better manage patients with complex diabetes, thereby decreasing medical loss ratios, admission rates, length of stay, and other key performance indicators for a high-quality plan.
Moreover, use of digital technologies has the potential to improve the quality of diabetes care among racial and ethnic minority groups and individuals with lower socioeconomic status.103,104 Numerous studies have shown that the use of and/or access to digital health technologies is disproportionately low despite the disproportionately higher prevalence of diabetes, cardiovascular disease, and chronic renal disease in these populations.105-116 Studies have also shown that use of connected devices can help individuals living in lower-socioeconomic-status areas and rural communities who often have inadequate access to quality health care.105-115 Use of connected CGM sensors and insulin delivery devices can link these individuals with health care providers who are knowledgeable and experienced in using advanced digital technologies. Furthermore, the addition of more patients from racial and ethnic minority subgroups to diabetes technology clinical trials will help to better understand the specific needs of this population and accordingly improve the design and performance.117
An open diabetes ecosystem can facilitate connections between the devices and technologies and allow seamless transfer of data between all stakeholders.118 In addition to upholding health data security and privacy laws, this will require standardization of how data are reported. As demonstrated by the widespread integration of the Ambulatory Glucose Profile, a standardized, single-page CGM report,119 into most of the download software provided by most CGM manufacturers, this can be achieved. The main barrier is achieving universal interoperability between the devices and device-specific software, enabling the various products and technologies within the ecosystem to “talk” to each other, regardless of brand, without relinquishing proprietary information or methods. Solutions are currently being explored.
Another barrier is the daily challenge of entering CGM data and other health information into most electronic medical record platforms, which can be time-consuming, incomplete, and cumbersome. Re-engineering current electronic medical record systems to facilitate more efficient entry of downloaded data from connected devices and apps and then using advanced analytics and artificial intelligence capabilities to develop more robust tools for risk stratification and assessment of each patient’s health status would further support clinical decision-making.
Summary
Advances in glucose monitoring and insulin delivery technologies have driven the creation of a unified diabetes ecosystem populated with connected medical devices that have been proven safe and effective in assisting individuals with diabetes to achieve their diabetes management goals. The diversity of tools with unique features allows individuals with diabetes to choose a treatment regimen they can personalize to meet their unique needs and preferences, which is in strong alignment with recommendations from US and European medical associations.120 Although this review described the most current technologies, ongoing innovation will likely lead to additional products in the months ahead. Moving forward, the challenge will be to ensure that all individuals with diabetes have access to the tools best suited to their clinical and personal needs, regardless of race, ethnicity, or socioeconomic status.
ACKNOWLEDGMENTS
The authors thank Christopher Parkin, MS, CGParkin Communications, Inc., for providing editorial support in the development of this manuscript.
Funding Statement
This research was funded by Abbott.
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