Automated insulin delivery advancements -
This latest model of the Dexcom CGM is set to bring a significant form-factor change: a combined sensor and transmitter design. At the big JP Morgan healthcare conference in January , Dexcom CEO Kevin Sayer presented pivotal data that it had submitted to the FDA.
Notably, this latest technology outperformed the regulatory iCGM standards with better time-in-range performance of The way CGM technology is measured for accuracy is by a standard known as MARD, or Mean Absolute Relative Difference, and the G7 registered an 8.
It was very rewarding when we launched G6 to see how that changed the world. This product is going to do it again. In recent investor updates, Sayer explained that the company plans to eventually have different versions of the G7 for different groups of users.
For example, non-insulin—using type 2s or general health consumers may prefer a much simpler interface than insulin-using type 1s who have experience with CGM tech and want all the advanced alarms and tracking features. Dexcom filed the G7 with the FDA by the end of So most likely, we will see that approved before too long in and Dexcom will conduct an initial limited launch before eventually rolling the G7 out more broadly across the United States later in the year.
Made by Senseonics and sold by Ascensia Diabetes Care, the Eversense implantable CGM is a first of its kind that has been available in the United States since The next-generation version under development would allow for the same tiny sensor to be implanted for days or 6 months rather than 3.
This version will also reduce the number of fingerstick calibrations needed down from two to just one per day, according to the company. We may very well see this appear in The company submitted the Tempo Smart Button to the FDA in , as did Welldoc with its new app.
Those are still under FDA review and pending k clearance. The expectation is the system will get approval and launch in Since hitting the U. market in , this system has allowed PWDs to get a glucose reading whenever they want just by scanning the little white round sensor worn on the arm.
The Libre 2 became available in , offering optional alerts for low and high blood sugars. The mobile app was released in , which eliminated the need to scan the sensor with the handheld reader. But Libre 3 promises to elevate the tech to full-CGM functionality because it will no longer require any sensor scanning to provide real-time glucose readings.
Instead, Libre 3 generates a real-time glucose reading every minute, displaying that result on the compatible mobile app on iPhone or Android. This continuous stream of data allows optional alerts for high and low blood sugars, along with glucose results. This is a big leap forward compared to Libre 2 that still requires a confirmation scan to get a numeric reading.
Per Abbott, that is a more than 70 percent size reduction that uses 41 percent less plastic. Our experts continually monitor the health and wellness space, and we update our articles when new information becomes available.
Insulet's Omnipod 5 becomes the first commercially available Automated Insulin Delivery AID system with no tubes and smartphone control. There is a call for standardized reports for AID data, similar to the standardized reports that have been created for CGM data Just as consistent terminology Table 1 use can help clarify for all what a given system does or does not do, standardized reports will help ensure easy readability of the data for individuals with diabetes as well as their provider.
AID holds the promise to improve care for all individuals living with diabetes who require insulin. However, the vast majority of studies to date have focused on those with T1D 45 — Nevertheless, for people meeting their individualized treatment goals without excess burden or distress, usage of AID systems may not be an appropriate therapy, and recognition of the choice to not use an AID system is important.
The current evidence base is mostly built on studies where selected participants were able to engage with self-management and had received structured education or an equivalent level of support, which may impact the outcome of these studies and therefore their generalizability.
There is a need for well-conducted studies in populations who differ from those included in the studies, who may, in some cases, be most apt to benefit.
However, more data from real-world studies were published recently e. A handful of studies have demonstrated the short-term benefit of systems in patients with type 2 diabetes T2D 52 — Indeed, for people with T2D whose endocrine pancreatic function mimics those with T1D, such as those with lower serum C-peptide levels, usage of AID systems may prove to be the optimal way to attain glycemic targets while avoiding hypoglycemia.
Additionally, application of AID systems for patients with insulin dependency following pancreatitis or those with cystic fibrosis—related diabetes may be warranted, since improvements in lung function are noted when dysglycemia is treated For young children, the ability of parents to remotely view both CGM data and insulin delivery is critical.
Similarly, for older adults in assisted living facilities, such remote monitoring tools may be of great help. Additionally, in both of these circumstances, it may be best to have only basic functionality on the insulin pump itself in order to prevent errant and unwanted bolus insulin delivery.
However, as youth with diabetes achieve greater independence in their care, access to greater functionality of AID systems is likely to be appropriate over time.
Including an option for the HCP to individualize pump settings for this purpose is recommended. Different insulin pumps have regulatory approval for different age ranges, and this must be considered in prescribing an AID system 18 , Some older studies suggested that dilution of rapid-acting insulin analogs may allow for a reduction in the frequency of hypoglycemic events 57 , 58 ; however, in a more recent outpatient assessment in this age-group a benefit was not seen with dilution Transition from pediatric to adult diabetes care requires specific attention.
While youth may have relied on parents at an earlier stage, increasing autonomy of care is essential during transition This will require specific training—or retraining—on how AID systems work at an appropriate time prior to transition to an adult provider.
In patients who may experience acute metabolic events where insulin sensitivity can change rapidly e. Assessment of these situations in a standardized manner to determine safety of various devices would be prudent. Evidence is now emerging regarding use of AID systems during times where insulin action time may be changing due to reduced or changed insulin clearance e.
Finally, pregnancy poses a unique situation, as the targets for glycemia are inherently much more ambitious 12 , Early studies in pregnancy have demonstrated the ability of AID systems to improve glycemia 63 — However, in these studies, women continued to perform self-monitoring of blood glucose SMBG multiple times daily.
In the Continuous Glucose Monitoring in Women With Type 1 Diabetes in Pregnancy Trial CONCEPTT , fetal outcomes were evaluated in comparison of CGM plus SMBG monitoring with SMBG alone Clear benefits were illustrated in those on sensor therapy However, no benefit in glycemia was seen in those preparing for pregnancy.
Moreover, data on outcomes are lacking from individuals with preexisting T2D or gestational diabetes mellitus. Because pregnancy glycemic targets are currently lower than the targets allowed by most commercially available AID systems, it is important to follow glycemic guidelines for pregnant women and find the best method for achieving these outcomes in an individual patient.
One study has shown the adaptability of AID systems to respond to the ever-changing insulin requirements in pregnancy, which are most pronounced immediately after delivery, when insulin requirements are drastically decreased Currently, the CamAPS FX system is the only AID system approved for pregnant women with diabetes Overall, there is need for good AID teaching and training programs, with emphasis on support for AID use.
This should be curriculum driven, evidence based, and based on sound education principles. As previously described, there are many obvious advantages for using AID systems, but there are also some important limitations of the current and near-future AID systems.
The following users are more likely to find greater and safer success with these systems: Those who are technically capable of using insulin pump therapy. Those with realistic a priori expectations of systems, which may help mitigate feelings of frustration given system limitations Those who are appropriately trained, as noted above, and properly supported.
Ideally, they have a social environment supporting them and insurance coverage of AID systems. They also should have the ability to transmit their ongoing AID data to the health care professional team.
Those mentally and psychologically able to fulfill the requirements for successful AID implementation. People with diabetes and eating disorders or severe psychiatric comorbidities e.
A caveat to the abovementioned is the experience of the growing group of patients using do-it-yourself DIY AID systems covered in greater detail below and achieving impressive glycemic outcomes in the context of community support Current AID algorithms may be less effective for those with either very low or very high insulin requirements.
Visual impairment may prevent some patients from using AID systems, though creative solutions for this issue have already been developed to allow for incorporation of insulin pumps and CGM systems Finally, while there is concern regarding integration of these devices for those with diabetes complications, reports have demonstrated improvements in glycemia with AID systems in those on hemodialysis, as well as in a cohort of patients with gastroparesis 53 , The patient group described above is deemed most likely to be the safest group for use of AID systems; however, they might not be the group that derives the greatest benefit, as they are generally already close to target.
Therapeutic options like CGM and CSII have the greatest impact on HbA 1c and hypoglycemia exposure in patients with T1D, with the highest HbA 1c values and the greatest exposure to hypoglycemia due to diabetes burnout or issues with self-management.
Therefore, it might well be that the usage of AID systems by such individuals has the greatest incremental benefit from a clinical point of view and, thereby, also the highest cost effectiveness.
A key challenge for AID systems will be moving beyond those who are already at targeted glycemia i. While these individuals may only see small incremental changes in glycemia, clear benefits in diabetes burden may be feasible with AID.
The desire to address inequalities between different populations with diabetes cannot be reconciled with criteria with selection of only the safest patients. Requirements for clinical safety of AID systems are similar to those seen with CGM systems and insulin pumps but also go beyond those. In individuals with T1D, safety issues encompass both hypoglycemic events and diabetic ketoacidosis.
Such events can be induced by system malfunctioning e. Use of the AID system during situations with high risk for hypoglycemia e. An important question to consider is how to become aware of safety issues. Are currently implemented mechanisms to detect safety issues adequate? In cases when a person with diabetes encounters such issues and contacts the device manufacturer, the company must report these safety concerns to certain databases, such as the Manufacturer and User Facility Device Experience MAUDE in the U.
Although market observations can provide insight into certain issues if they are reported several times, there are currently no systematic observation and analysis methods established to detect these trends.
Nevertheless, when issues are detected, they can result in product recalls. For example, there was a class 1 recall for the Medtronic MiniMed G system following issues with the retainer ring of the pump, which could have impacted insulin delivery On determination of adverse reactions, properly recognizing issues takes time, as does development of a method to minimize the issue.
For example, it took time to identify the development of skin reactions secondary to the frequent use of diabetes devices, which has proven to be a serious issue faced by many.
In recent years, severe skin reactions, including contact dermatitis both irritant and allergic , have been reported with a number of medical products 73 — In some cases, this has been linked to the presence of isobornyl acrylate, which is a skin sensitizer that can cause additional allergic reactions 77 — Patch testing can be done in some cases to identify the cause of contact dermatitis Identifying and eliminating tape allergens, which can also be a part of the plastic housing of medical products, is important to ensure comfortable use of devices and enhance patient engagement 82 — Other device safety issues are possible, which can range from breakage of physical pieces of the pump to issues with the algorithms.
Additionally, there can be errors in the representation of data downloaded from the system. All of these issues need to be handled and monitored in an efficient and effective manner. Being up to date on any recalls and device safety updates is critical for patients and providers alike.
Furthermore, it is up to all patients and providers to report issues to regulatory agencies, such as the FDA via MAUDE, to ensure that channels to identify issues are properly used.
Diligence with reporting will help keep everyone informed of potential problems as they arise. Another critical issue is cybersecurity and data privacy. Potential vulnerability of AID systems is increased by the multiplicity of component devices that comprise AID systems. Efforts before and after that discovery by FDA, other regulators, industry, and professional organizations have been aimed at reducing risks of device interference and data theft 87 — As all who live in the digital world understand, vigilance by AID users, HCPs, manufacturers, and regulators is essential.
Continuous testing of AID components and systems for cybersecurity, as well as ongoing development of technological safeguards, must be ongoing. Usage of the data generated in using AID systems is a critically important issue.
Also, the much larger number of patients and enormous amounts of data generated by real-world studies are of interest. The question is whether patients are aware of what happens to their data.
Although patients have to sign an agreement about data usage, that does not necessarily equate to understanding of the agreement. In contrast, if patients are willing to donate their data for research e.
Whether insurance companies can use AID data to modify insurance coverage remains an open question, if they can get access to these data of individual patients.
If CGM data are identifiable, can users refuse to share their data with HCPs? Is there a risk to doing so? Another sensitive situation may be the availability of CGM and AID data in court rulings, such as when an individual with diabetes is involved in a car accident and the court finds out that relevant data covering that time period might be available.
The question as to whether the person was able to handle the AID system adequately may arise. Could data be downloaded to prove what occurred i. Did the user override system recommendations or use the system in ways that were not intended, thus leading to the incident, or did the AID not work as intended despite user engagement?
Are data holders forced to provide this information without the consent of the person with diabetes? Furthermore, companies may be legally liable regarding particular laws depending on where the company headquarters is, as well as where AID devices are manufactured and cloud servers are located.
For example, the legal frameworks for data protection are different between Europe and the U. In Europe, the sensitivity for data privacy is high.
Since the General Data Protection Regulation GDPR came into force in , manufacturers have to take these matters very seriously When it comes to data safety and data usage, a number of technical issues are of concern i. Only when data can be assessed in a standardized manner can the data generated by the AID systems be integrated into electronic health records.
With regard to data protection, one has to realize that the availability of data on CGM or AID use discloses a diagnosis of diabetes, which may have a negative impact on employment or access to insurance. In general, the regulation of medical devices in the U.
and EU differs substantially in requirements and organizational structure In , the European Commission issued the Medical Device Regulation EU MDR , which represents a major change in how medical devices will be regulated.
The implementation of EU MDR started in May Traditionally medical devices, but not necessarily diabetes-related products, have reached the market sooner in the EU than in the U.
The EU MDR may have the effect of reducing differences in data requirements and marketing approval times. The FDA has been highly supportive of diabetes device development through the release of clear and detailed guidance.
The FDA has been especially supportive of the development of AID systems over the last decade starting with its guidance This FDA guidance document describes multiple forms of flexibility for developing AID products including with regard to 1 use of CGM systems, 2 primary end points that can be used to measure safety and effectiveness, 3 the stated therapeutic indication, 4 clinical study progression, and 5 the size and duration of each study phase.
This guidance explicitly expresses the intent of applying the least burdensome approach to investigating and developing AIDs and making them available to patients. The FDA has also approved AID systems rapidly. Later the Libre 2 by Abbott also got this status. Importantly, this approval had the effect of changing the risk category for iCGM products from class III to class II while stipulating conditions and special controls to ensure safe interoperability.
This new provision also enables bringing future iCGM systems to market with the least burdensome requirements possible. This was the first controller device that could be used with other interoperable devices and integrated into a customizable diabetes management system for AID A self-contained AID product can still be developed and approved as noninteroperative.
Such products could require a more burdensome Premarket Approval PMA process. The EU does not have an interoperable diabetes device pathway comparable with that in the U. Technical documentation can demonstrate conformance with the essential requirements at the product or system level, but it must take into account system components and interactions used to achieve the intended purpose.
Therefore, the manufacturer of a system component defines the interoperability with other components. This results in the availability of AID system components intended to be combined only with other specified system components e.
In contrast with the FDA as the single national agency for device approval in the U. As noted above, the EU MDR brings a higher burden for the manufacturer with respect to technical documentation and clinical evaluation. It should be noted that a number of questions and issues related to AID remain to be addressed by the notified bodies and the EU Commission.
A key question with respect to the EU MDR regulation is, in what risk categories will AID systems and components be placed, class IIb or class III? Four different options for AID systems are conceivable as follows: A fully integrated system i.
A system that combines products of different manufacturers e. DIY AID systems that are built by people with diabetes using commercially available hardware combined with an algorithm downloaded from the internet, for which no regulatory approval is available.
The second and third types of AID systems might belong to a different risk class than the first. AID systems are viewed as requiring special attention, since they involve infusion of a therapeutic product, insulin, which has a narrow therapeutic index.
Such products are scrutinized more intensively. In the case where components of different manufacturers are combined i. Another question is how the safety and efficacy of the different combinations can be meaningfully demonstrated to the satisfaction of the emerging EU MDR.
Patients with diabetes will be expected to use the device according to the instructions for use provided by the manufacturer, and these instructions will need to be clear, transparent, and understandable.
With regard to DIY AID systems, the French Competent Authority National Agency for the Safety of Medicines and Health Products ANSM has published a recommendation that people with diabetes not use software and applications that offer DIY AID systems, indicating that these applications usually do not have the CE mark and expose users to risks 95 , Such an approach requires that system components be able to exchange data.
The U. left the EU trading bloc in January with a transition period until the end of However, the U. Medicines and Healthcare products Regulatory Agency MHRA has issued guidance that generally harmonizes with EU MDR requirements i.
Since 1 January , all medical devices placed on the U. market need to be registered with MHRA a grace period existed until September for pumps and CGM systems , but CE marking and certificates issued by EU-recognized notified bodies will continue to be recognized in the U.
until June Any manufacturer based outside the U. will need to appoint a single U. For the time being, the costs of AID systems are high, which is a main reason why, from a global perspective, most people with T1D do not yet realistically have access. An important factor to consider is the costs of devices, as well as coverage of devices by insurance companies, which varies widely between countries.
This means out-of-pocket costs can be vastly different, and access to particular devices may be restricted in some regions, even if the devices have achieved regulatory approval. Fortunately, use of modern diabetes technology is increasingly being covered by health care systems given the proven benefits they bring for many people with diabetes.
However, coverage includes not only the up-front costs of AID systems but also ongoing supply costs for IIS, batteries, and insulin, as well as increasing use of cell phones and adequate Wi-Fi coverage for transmitting data to health care professionals. Furthermore, AID systems require extensive use of nonmonetary resources, such as up-front education of the users.
Patients must also have access to HCPs who can support and troubleshoot a given AID system when the need arises, such as malfunction of a component or interruptions in the supply chain. In view of the costs associated with widespread use of AID systems, insurers will likely request more cost-effectiveness studies, which will also be dependent on baseline characteristics of individuals with diabetes.
Even with adjustment for socioeconomic status and access to care, health care disparities in outcomes exist for those from minority populations Patients with lower incomes often face multiple issues that limit their ability to adopt technology, including insulin pumps and CGM systems 99 , not to mention complex AID systems.
These issues include lack of consistent access to health care, insufficient or inconsistent coverage for devices, lower literacy and numeracy skills, lack of access to healthy food, psychosocial stressors, language barriers, and other issues related to social determinants of health that make diabetes management extremely challenging.
Furthermore, implicit bias may affect who is offered such devices , One interesting question to raise about AID systems is liability.
At first glance, this might be obvious. Questions to consider are as follows: How does a given AID system respond to issues and challenges? How do the algorithms implemented in the system respond to avoid too low glucose values i. How do we know if the algorithms implemented work adequately under all circumstances?
How do we hear about issues? Less than 10 years ago, upon recognition of the myriad data generated by diabetes devices and the inability to access this data in real time, efforts led by individuals with diabetes demonstrated to manufacturers that remote monitoring of CGM data was feasible.
Building on this momentum, an online community of devoted individuals whose lives were touched by diabetes sought next steps and built their own AID systems using a DIY approach The advantages of such an approach are the flexibility and rapidity with which the DIY AID systems can be adjusted to new needs and options.
For example, adaptations of algorithms allow for incorporation of insulins with improved pharmacodynamic properties.
Compared with commercial AID systems, DIY AID systems offer more tunable parameters, thus offering a truer possibility of personalized medicine.
However, the entry bar for a patient who wants to start a DIY AID system is high. This is not merely downloading an app and transitioning to AID.
In fact, creation of such systems requires extensive knowledge and frequent monitoring of diabetes therapy. Additional complications tied to DIY AID systems are differences in legalities and liabilities between different countries. For example, one of the present authors L.
described the German perspective on DIY AID systems in a recent publication Later, a letter that challenged the views expressed in the publication as not being patient centered enough was published Afterward, the reply to the letter clarified that DIY AID systems were a positive development but should be assessed with thorough scientific evaluation Recently, an international consensus statement was published detailing the current state of DIY AID systems, including a description of the systems, evidence of their use, and considerations for clinical implementation.
Further, the authors discussed both the ethical and the legal implications of system use, with the understanding that legal consequences of unregulated systems vary between jurisdictions To date, the benefits of using DIY AID systems have not been fully evaluated in randomized controlled trials, though studies are underway.
However, results of a number of real-world studies showed remarkably positive outcomes , even during pregnancy and in remarkably challenging patient situations, such as running a half-marathon , Overall, DIY AID systems represent a useful tool to learn about how an optimal AID system might operate.
Although there is the need for rigorous devotion and intent focus on details in operating DIY AID systems, there is a lot to learn from the users of such systems. If a provider is asked by an individual with diabetes about using a DIY AID system, the provider should act as follows: The provider should tell the individual that these systems are not approved by regulatory agencies i.
The provider should tell the individual that although these systems cannot be prescribed by a provider, and the patient assumes responsibility for their use, the provider can make recommendations regarding patient safety and assist with developing a backup plan in case the system fails.
It should be noted that these recommendation are somewhat country specific, depending on the legal framework in the given country. The question of liability becomes exponentially larger in considering DIY AID systems. Since these systems are created by the user through the bridging of different system components, who is liable should a system malfunction occur?
We outline a list of considerations for regulatory agencies, manufacturing companies, international and national professional societies, funding bodies, researchers, health care professionals, and people with diabetes to take into careful consideration. These can be categorized into the following themes: More systematic and structured guidelines for AID systems usage 1 a—c and 3 d and e in consensus report recommendations , below.
Improved consistency and accessibility of safety reports 2 a , b , and d. Greater investment in collecting of clinical data to provide evidence for or against use of AID systems 4 a and b and 5 a and b.
Increased accessibility for all consumer populations to use AID systems confidentially and securely 2 c , g , and h and 3 c. Increased communication and cooperation across stakeholder groups 1 d — g , 2 e and f , 3 a and b , 6 a—e , and 7 a—c.
Regulatory agencies should: Harmonize their activities. Provide a regulatory pathway with clear steps and guidance on how to obtain approval for future AID systems. Construct guidance for conducting both pivotal trials of new devices and postmarketing trials with a focus on evidence regarding how to assess safety and efficacy of systems.
Postmarket studies and registry data may elucidate evidence on effectiveness of systems. Foster a commitment to conduct long-term studies of AID systems to evaluate persistence of glycemic benefits and to explore how this may translate into rates of long-term complications of diabetes.
Determine methods to evaluate DIY AID systems in larger-scale real-world observational and clinical settings. Create, publicize, and maintain a single publicly accessible international database of available AID systems. Mandate that device manufacturers provide information on the population studied in pivotal trials and any updates based on real-world studies that may highlight the clinical data regarding who would derive most benefit from the product.
Manufacturing companies should: Comply with regulations, industry standards, and best practices established for AID systems. Create training modules that are readily available and written at an accessible reading level to ensure these modules will meet the needs of individuals with diabetes.
Assess the usability of device interfaces, with the goal of creating user-friendly platforms for all demographic groups. Further, it should be possible to personalize the interfaces with real-time insights and suggestions for individual users.
Cooperate with academic and health care professionals to provide balanced and adequate information both to providers and patients with diabetes.
Package output data from devices in standardized formats for ease of access, and potentially integration, in electronic health records. Provide users the option to submit their data, including demographic information, anonymously, which will provide real-world metrics of device use to be monitored and reported annually.
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Read more about insulin. artificial pancreas.
The second Goal alignment and motivation development insuoin been, finally, broad Automated insulin delivery advancements of telemedicine due to Automafed of such visits during the COVID pandemic. Herbal extract recipes allows Herbal extract recipes more efficient management for Automated insulin delivery advancements who have the ability insuulin use insuin access technology — not givens, of course, in our dysfunctional iinsulin care delivery system. Insulin advancemdnts has changed dramatically advancemnets the days when Grunberger Herbal extract recipes his grandfather sterilize a glass syringe and steel needle, which had to be sharpened daily to lessen the pain of animal-derived insulin injections. Currently, the InPen Companion Medical is the only smart insulin pen available in the U. The pen, which transmits dosing data with Bluetooth technology and allows for programming of carbohydrate ratios and sensitivity factors, has simplified management for clinicians, Grunberger said. A fully closed-loop insulin delivery system, sometimes called an artificial pancreas, remains out of reach today; however, hybrid closed-loop systems have helped simplify care for people with type 1 diabetes, even though carbohydrates must still be entered manually before a meal, Grunberger said. market: proportional-integral derivative control, or PID; model predictive control, or MPC; and fuzzy logic control, or FL.Automated insulin delivery advancements -
With increasing use of cloud-based automatic data uploading to servers, the need to educate and encourage patients to manually transmit data from their devices to the cloud is reduced. However, in the present landscape, some systems still require manual, cumbersome data-handling procedures by patients or HCPs , and operating system updates can affect the ability of medical devices to transfer data for analysis; thus, clinical practices need to account for the time required into clinical workflow.
Data from other systems can be readily accessed by clinicians if permission is granted by users in real time via dedicated password-protected websites. While the ability to remotely monitor CGM data has transformed how HCPs and caregivers can be involved in the care of those with diabetes thus increasing support connectivity , power outages and server failures may lead to data disruptions that can impact an enormous number of patients Contingency plans for how such lapses in data transfer will be managed may help to mitigate the fear of consequences, especially for pediatric populations.
Undoubtedly, the AID systems that are commercially available, as well as those that are in late phases of clinical development, are by no means perfect, and manufacturers of these AID systems have already announced successor products to overcome some of the limitations present with currently available products.
Explaining the nuances of the CGM system used for AID may help patients with diabetes in selecting the system that best suits them Points of discussion include whether finger-stick calibrations are necessary, as well as the expected duration of glucose sensor wear.
Additionally, with the advent of remote data monitoring, understanding the data-sharing capabilities of AID systems is crucial. Sharing features may include only CGM data or additional data regarding insulin delivery. These features may be used by a caregiver, such as a parent of a young child; family member of a senior; or the person with diabetes who prefers using their smartphone to check their data on a more regular basis rather than assessing information from the insulin pump itself.
It is important to recognize that in devising a treatment plan, providers should work together with patients and their caregivers to broach the topic of AID systems. Using a structured method to review currently available AID systems will lay the framework upon which patients with diabetes can choose what features are most important to them.
This shared decision-making will lead to successful integration of therapy into the care plan. Having the key AID data and action plan automatically available in the electronic health record would also facilitate coordination of care across a team of health care professionals supporting patients on AID systems.
In the European Union EU and other countries outside the U. Although access to an AID system may be less physician restricted in the U.
and more determined by insurance coverage or ability to meet costs, a methodical approach to system selection is still needed.
Overall, the approval and reimbursement process of AID systems varies considerably between countries. Thus, it will be imperative to have software updates of hardware to ensure continued access to the latest technologies. Paramount in the transition to using AID systems is setting realistic expectations of what the available systems can and cannot do.
For example, with hybrid AID systems, the timing of meal bolusing should ideally occur prior to eating and with accurate assessment of carbohydrate content, with consideration also of the impact of the meal composition e. While future iterations of AID systems may allow for automatic detection of meal-related glycemic excursions, first-generation AID systems need meal announcements by the user.
Accurate and well-timed bolusing will clearly minimize postprandial glycemic excursions and increase TIR. In some systems, delayed meal dosing can result in hypoglycemia because of the overlap between insulin given automatically by the AID system in response to the postprandial glycemic excursion and the relative overbolusing of giving a delayed full meal bolus.
If bolusing postprandially, some patients may need to reduce the meal bolus to account for the insulin already provided by the AID system. Patients are also expected to announce any upcoming physical activity to avoid hypoglycemia.
Concern exists that patients transitioning to AID systems may become less skilled in dosing insulin as they rely more heavily on their technology. Thus, it will be essential that patients, as well as providers, understand that like any technology, components of AID systems can fail. When hyperglycemia occurs, patients may need to return to fundamental diabetes management, such as assessing ketones and considering whether an IIS occlusion or failure has led to the hyperglycemia.
They will need clear instructions on how to restore normoglycemia, even possibly returning to conventional continuous subcutaneous insulin infusion CSII or insulin injection therapy so preprogrammed basal rates are used and appropriate correction doses can be administered.
Contingency planning should include access to batteries, charging cables, IIS, reservoirs, a vial of insulin, syringes or insulin pens and needles , a glucose meter and test strips, glucagon, ketone test strips, and a backup glucose sensor and transmitter for the CGM system. In addition, a plan for transition to insulin injection therapy, as well as a supply of unexpired insulin pens or vials with rapid-acting and long-acting insulins, should be available for use until a replacement for the AID system is available.
It is also critical to consider potential disruption in availability of supplies, as has been noted during the coronavirus disease era. For example, if there is a supply issue with glucose sensors or transmitters, if the sensors or transmitters do not last for their intended duration of time, or if there is a change in insurance plans and a prior authorization is required, individuals with diabetes may find themselves running out of supplies.
Furthermore, traveling can be exceptionally challenging, especially if key components break unexpectedly. Thus, it is essential to always have a backup subcutaneous insulin therapy plan, as described above.
Devices that require charging through USB electric cable can be difficult to charge in certain regions e. Medical imaging can also be a challenge because certain scans e.
IIS can stay in place, but removing the glucose sensor can be a problem if sensors are in short supply. However, the recommendations for removing CGM systems are based on caution, largely in the absence of data from device testing under these conditions. In at least one simulation it was found that CGM can stay in place during radiographic and MRI procedures 38 , Discussions regarding treatment of hypoglycemic events in patients using an AID system need to highlight that since basal insulin will be suspended, fewer carbohydrates will need to be consumed to return to euglycemia.
Even though hypoglycemia can be corrected with fewer carbohydrates, people with diabetes need to be educated to overcome fear of hypoglycemia and avoid overcorrecting hypoglycemia, which often causes hyperglycemia with the use of AID systems.
Also, AID users have noticed anecdotally that the AID system assumes that the person with diabetes is still in a state of hypoglycemia with delivery suspension long after the hypoglycemia has been corrected with rapid-acting glucose, and people with diabetes find themselves experiencing hyperglycemia 30—40 min after having corrected hypoglycemia even if they use fewer carbs.
Since AID systems increase insulin delivery based on elevated glucose levels, patients may find they are limited in the manual correction bolus that can be given. Helping patients understand that this is due to insulin being proactively delivered by the AID system may help minimize frustration in the initial transition period.
Educating patients with diabetes on AID system functionality and how to determine whether insulin delivery is being increased or suspended may allow for trust to be established with this automated process. Indeed, for those who have achieved targeted glycemia with traditional CSII or multiple daily insulin injections, delegating the decision-making process to this new technology may be difficult.
Education also needs to focus on the different modes that these AID systems have. The most common feature allows the AID algorithm to adapt, for example, to exercise. Alternatively, overnight algorithms may allow some systems to tighten targets, thereby allowing for more aggressive insulin delivery.
As commercial AID systems become more widely used, education regarding what to do with an urgent question will be crucial. There should be a clear distinction between technical support delivered by the manufacturer and clinical support delivered by the clinical support team.
Such a helpline should be staffed by people with specific diabetes experience, i. Most practices do not have the capacity to provide this level of support, especially where general practitioners may treat those with diabetes due to the limited number of subspecialists in a region. An additional level of complexity with technical support arises with multiple manufacturers contributing to a given AID system.
For example, in the case of an unknown failure of an AID system built using components from different manufacturers, who should be contacted? Calls must be promptly answered, and multiple language options based on regional need should be easily chosen.
Those employed to answer calls must be familiar with the given AID system so they can support the patient with most, if not all, questions regarding system use. The questions asked by the call center staff must be simple and nonconfrontational, as individuals with lower literacy, numeracy, and technical skills may not be able to provide detailed information.
The most common concern that may arise could be whether the AID system or one of its components needs to be replaced. Trained call-line workers will need to help patients troubleshoot a given situation, help them check and change the pump settings, and potentially provide authorization for new components of the AID system to be sent if it is deemed that the current system is not functioning as intended.
Potential AID system issues may include repeated loss of data transfer from the transmitter of the CGM system or an insulin pump that has a cracked screen. However, this requires that the patient have the choice of different AID systems available in the country and through the health care system.
Just as CSII offers a plethora of options of different insulin pumps, IIS, and other components, it is anticipated that a number of AID systems will be commercially available in the not-too-distant future.
Paramount to having an open dialogue with the patient in considering therapeutic options is presenting information in a standardized and adequate manner.
Ideally, the patient would have the chance to evaluate different AID systems before making a decision for a given system. With certain differences in technology and handling of AID systems currently available, a systematic approach for defining how each advanced diabetes technology works has been proposed.
A: Adjust—How can the user adjust insulin delivery, which parameters can be adjusted to influence insulin delivery during automation, and which parameters are fixed?
With conventional CSIIs, the same parameters for system setup are held constant across a range of devices; however, this does not hold true for AID systems.
Two approaches exist for AID targets: a treat-to-target AID system that has a singular set point e. Conversely, for treat-to-range systems there are CGM values between which the system tries to maximize the TIR e. Thus, the first step may be understanding which type of target a given AID system uses, followed by assessment of the threshold at which these targets are set.
While it is beyond the scope of practice for most clinicians to understand all the intricacies of how each AID algorithm works, it will be critical as AID systems are more widely adopted for HCPs to know which parameters can be adjusted to optimize insulin delivery.
To date, all AID systems allow for adjustment of the insulin-to-carbohydrate ratio except Diabeloop DLBG1, which uses machine learning to optimize the meal ratio on an ongoing basis. Some of the newer AID systems on the market will give automated correction boluses, while others may not.
The strategy for determining the dose allowed to be given by automated correction, as well as the frequency with which these autocorrections can be provided, will differ by system.
Indeed, without comprehension of what parameters are adjustable, some clinicians may alter settings that have no impact on AID, thereby increasing frustration of both patients and providers in their experience with the product.
With commercialization of AID systems, companies should seek to include materials that clearly delineate the settings that can be adjusted. Companies should also provide clinical scenarios to highlight when such optimization would be needed and how to successfully implement the changes.
Providers will need to inform patients of when AID systems may automatically revert to manual mode i. Thus, it is a good practice to update these manual settings intermittently while patients are using AID systems, as overall insulin needs may be changing, particularly in the pediatric population.
Should such features not be available, it may be critical to consider altering the low-glucose thresholds and predictive low alerts when not using the AID feature so that the patient with diabetes can manually respond to the hypoglycemic event.
It may not be prudent to continue with AID in certain situations, and patients may be instructed to revert to conventional CSII. These situations include illness, when there may be temporarily increased insulin resistance and elevated glucose levels, as well as reduction in oral intake and ketosis without elevated glucose levels.
Resolution of ketones will be contingent on increased insulin delivery; however, this may not be possible if a patient is solely relying on the AID system. Likewise, should a clinical situation arise in which treatment necessitates use of systemic steroids, it is possible that the AID system does not respond rapidly enough to account for the increased insulin requirements often necessitated with steroids.
Finally, the lower targets needed in pregnancy may not be achievable on an AID system. Given that AID systems are new in diabetes care and subject to ongoing rapid development, many practitioners may not be fully aware of how to teach individuals with diabetes how to use them. As a result, manufacturers may need to provide training either directly to patients or diabetes care and education specialists or by means of online videos.
The pandemic has highlighted that this education can be delivered in person or remotely With the initiation of AID, patients should be provided with clear instructions on how to ensure data are available for providers to view i. Particularly during early use, providers will need to take a more proactive approach than with previous nonintegrated insulin pumps.
Although teaching tools for medical devices like AID systems include user guides, these are often not easy to read.
They are hundreds of pages long, and the chances that patients and even HCPs will read them are slim. In the case of troubleshooting, often it is not easy to find appropriate support. Many learn from videos, which, if available, are often very helpful.
However, such teaching tools need to be available in multiple languages, created for learners of all skill levels, and sensitive to the inclusion of people from varying ethnicities. Communication with the HCP may be through the use of interpreter services in case of language barriers.
Undoubtedly, there will be a steep learning curve as use of AID systems becomes more prevalent. Patient acceptance and safety will come through education and adjustments to ensure safe use.
For people with diabetes whose management strategies have been primarily focused on permissive hyperglycemia, the return to more targeted glucose levels may lead to the sensation of hypoglycemia. Instructions on this phenomenon and encouragement that the threshold for symptoms will be lowered may help patients adapt to this transitional period as they initiate AID therapy.
Providers will need to understand how to access data so that dose optimization on AID systems can be made. They may need to assure they have programs installed for local uploading of devices in their offices.
There is a call for standardized reports for AID data, similar to the standardized reports that have been created for CGM data Just as consistent terminology Table 1 use can help clarify for all what a given system does or does not do, standardized reports will help ensure easy readability of the data for individuals with diabetes as well as their provider.
AID holds the promise to improve care for all individuals living with diabetes who require insulin. However, the vast majority of studies to date have focused on those with T1D 45 — Nevertheless, for people meeting their individualized treatment goals without excess burden or distress, usage of AID systems may not be an appropriate therapy, and recognition of the choice to not use an AID system is important.
The current evidence base is mostly built on studies where selected participants were able to engage with self-management and had received structured education or an equivalent level of support, which may impact the outcome of these studies and therefore their generalizability.
There is a need for well-conducted studies in populations who differ from those included in the studies, who may, in some cases, be most apt to benefit. However, more data from real-world studies were published recently e. A handful of studies have demonstrated the short-term benefit of systems in patients with type 2 diabetes T2D 52 — Indeed, for people with T2D whose endocrine pancreatic function mimics those with T1D, such as those with lower serum C-peptide levels, usage of AID systems may prove to be the optimal way to attain glycemic targets while avoiding hypoglycemia.
Additionally, application of AID systems for patients with insulin dependency following pancreatitis or those with cystic fibrosis—related diabetes may be warranted, since improvements in lung function are noted when dysglycemia is treated For young children, the ability of parents to remotely view both CGM data and insulin delivery is critical.
Similarly, for older adults in assisted living facilities, such remote monitoring tools may be of great help. Additionally, in both of these circumstances, it may be best to have only basic functionality on the insulin pump itself in order to prevent errant and unwanted bolus insulin delivery.
However, as youth with diabetes achieve greater independence in their care, access to greater functionality of AID systems is likely to be appropriate over time. Including an option for the HCP to individualize pump settings for this purpose is recommended. Different insulin pumps have regulatory approval for different age ranges, and this must be considered in prescribing an AID system 18 , Some older studies suggested that dilution of rapid-acting insulin analogs may allow for a reduction in the frequency of hypoglycemic events 57 , 58 ; however, in a more recent outpatient assessment in this age-group a benefit was not seen with dilution Transition from pediatric to adult diabetes care requires specific attention.
While youth may have relied on parents at an earlier stage, increasing autonomy of care is essential during transition This will require specific training—or retraining—on how AID systems work at an appropriate time prior to transition to an adult provider.
In patients who may experience acute metabolic events where insulin sensitivity can change rapidly e. Assessment of these situations in a standardized manner to determine safety of various devices would be prudent. Evidence is now emerging regarding use of AID systems during times where insulin action time may be changing due to reduced or changed insulin clearance e.
Finally, pregnancy poses a unique situation, as the targets for glycemia are inherently much more ambitious 12 , Early studies in pregnancy have demonstrated the ability of AID systems to improve glycemia 63 — However, in these studies, women continued to perform self-monitoring of blood glucose SMBG multiple times daily.
In the Continuous Glucose Monitoring in Women With Type 1 Diabetes in Pregnancy Trial CONCEPTT , fetal outcomes were evaluated in comparison of CGM plus SMBG monitoring with SMBG alone Clear benefits were illustrated in those on sensor therapy However, no benefit in glycemia was seen in those preparing for pregnancy.
Moreover, data on outcomes are lacking from individuals with preexisting T2D or gestational diabetes mellitus. Because pregnancy glycemic targets are currently lower than the targets allowed by most commercially available AID systems, it is important to follow glycemic guidelines for pregnant women and find the best method for achieving these outcomes in an individual patient.
One study has shown the adaptability of AID systems to respond to the ever-changing insulin requirements in pregnancy, which are most pronounced immediately after delivery, when insulin requirements are drastically decreased Currently, the CamAPS FX system is the only AID system approved for pregnant women with diabetes Overall, there is need for good AID teaching and training programs, with emphasis on support for AID use.
This should be curriculum driven, evidence based, and based on sound education principles. As previously described, there are many obvious advantages for using AID systems, but there are also some important limitations of the current and near-future AID systems.
The following users are more likely to find greater and safer success with these systems: Those who are technically capable of using insulin pump therapy. Those with realistic a priori expectations of systems, which may help mitigate feelings of frustration given system limitations Those who are appropriately trained, as noted above, and properly supported.
Ideally, they have a social environment supporting them and insurance coverage of AID systems. They also should have the ability to transmit their ongoing AID data to the health care professional team. Those mentally and psychologically able to fulfill the requirements for successful AID implementation.
People with diabetes and eating disorders or severe psychiatric comorbidities e. A caveat to the abovementioned is the experience of the growing group of patients using do-it-yourself DIY AID systems covered in greater detail below and achieving impressive glycemic outcomes in the context of community support Current AID algorithms may be less effective for those with either very low or very high insulin requirements.
Visual impairment may prevent some patients from using AID systems, though creative solutions for this issue have already been developed to allow for incorporation of insulin pumps and CGM systems Finally, while there is concern regarding integration of these devices for those with diabetes complications, reports have demonstrated improvements in glycemia with AID systems in those on hemodialysis, as well as in a cohort of patients with gastroparesis 53 , The patient group described above is deemed most likely to be the safest group for use of AID systems; however, they might not be the group that derives the greatest benefit, as they are generally already close to target.
Therapeutic options like CGM and CSII have the greatest impact on HbA 1c and hypoglycemia exposure in patients with T1D, with the highest HbA 1c values and the greatest exposure to hypoglycemia due to diabetes burnout or issues with self-management. Therefore, it might well be that the usage of AID systems by such individuals has the greatest incremental benefit from a clinical point of view and, thereby, also the highest cost effectiveness.
A key challenge for AID systems will be moving beyond those who are already at targeted glycemia i. While these individuals may only see small incremental changes in glycemia, clear benefits in diabetes burden may be feasible with AID.
The desire to address inequalities between different populations with diabetes cannot be reconciled with criteria with selection of only the safest patients. Requirements for clinical safety of AID systems are similar to those seen with CGM systems and insulin pumps but also go beyond those.
In individuals with T1D, safety issues encompass both hypoglycemic events and diabetic ketoacidosis. Such events can be induced by system malfunctioning e. Use of the AID system during situations with high risk for hypoglycemia e.
An important question to consider is how to become aware of safety issues. Are currently implemented mechanisms to detect safety issues adequate? In cases when a person with diabetes encounters such issues and contacts the device manufacturer, the company must report these safety concerns to certain databases, such as the Manufacturer and User Facility Device Experience MAUDE in the U.
Although market observations can provide insight into certain issues if they are reported several times, there are currently no systematic observation and analysis methods established to detect these trends. Nevertheless, when issues are detected, they can result in product recalls.
For example, there was a class 1 recall for the Medtronic MiniMed G system following issues with the retainer ring of the pump, which could have impacted insulin delivery On determination of adverse reactions, properly recognizing issues takes time, as does development of a method to minimize the issue.
For example, it took time to identify the development of skin reactions secondary to the frequent use of diabetes devices, which has proven to be a serious issue faced by many. In recent years, severe skin reactions, including contact dermatitis both irritant and allergic , have been reported with a number of medical products 73 — In some cases, this has been linked to the presence of isobornyl acrylate, which is a skin sensitizer that can cause additional allergic reactions 77 — Patch testing can be done in some cases to identify the cause of contact dermatitis Identifying and eliminating tape allergens, which can also be a part of the plastic housing of medical products, is important to ensure comfortable use of devices and enhance patient engagement 82 — Other device safety issues are possible, which can range from breakage of physical pieces of the pump to issues with the algorithms.
Additionally, there can be errors in the representation of data downloaded from the system. All of these issues need to be handled and monitored in an efficient and effective manner. Being up to date on any recalls and device safety updates is critical for patients and providers alike.
Furthermore, it is up to all patients and providers to report issues to regulatory agencies, such as the FDA via MAUDE, to ensure that channels to identify issues are properly used.
Diligence with reporting will help keep everyone informed of potential problems as they arise. Another critical issue is cybersecurity and data privacy. Potential vulnerability of AID systems is increased by the multiplicity of component devices that comprise AID systems.
Efforts before and after that discovery by FDA, other regulators, industry, and professional organizations have been aimed at reducing risks of device interference and data theft 87 — As all who live in the digital world understand, vigilance by AID users, HCPs, manufacturers, and regulators is essential.
Continuous testing of AID components and systems for cybersecurity, as well as ongoing development of technological safeguards, must be ongoing.
Usage of the data generated in using AID systems is a critically important issue. Also, the much larger number of patients and enormous amounts of data generated by real-world studies are of interest.
The question is whether patients are aware of what happens to their data. Although patients have to sign an agreement about data usage, that does not necessarily equate to understanding of the agreement. In contrast, if patients are willing to donate their data for research e. Whether insurance companies can use AID data to modify insurance coverage remains an open question, if they can get access to these data of individual patients.
If CGM data are identifiable, can users refuse to share their data with HCPs? Is there a risk to doing so?
Another sensitive situation may be the availability of CGM and AID data in court rulings, such as when an individual with diabetes is involved in a car accident and the court finds out that relevant data covering that time period might be available. The question as to whether the person was able to handle the AID system adequately may arise.
Could data be downloaded to prove what occurred i. Did the user override system recommendations or use the system in ways that were not intended, thus leading to the incident, or did the AID not work as intended despite user engagement?
Are data holders forced to provide this information without the consent of the person with diabetes? Furthermore, companies may be legally liable regarding particular laws depending on where the company headquarters is, as well as where AID devices are manufactured and cloud servers are located.
For example, the legal frameworks for data protection are different between Europe and the U. In Europe, the sensitivity for data privacy is high. Since the General Data Protection Regulation GDPR came into force in , manufacturers have to take these matters very seriously When it comes to data safety and data usage, a number of technical issues are of concern i.
Only when data can be assessed in a standardized manner can the data generated by the AID systems be integrated into electronic health records. With regard to data protection, one has to realize that the availability of data on CGM or AID use discloses a diagnosis of diabetes, which may have a negative impact on employment or access to insurance.
In general, the regulation of medical devices in the U. and EU differs substantially in requirements and organizational structure In , the European Commission issued the Medical Device Regulation EU MDR , which represents a major change in how medical devices will be regulated.
The implementation of EU MDR started in May Traditionally medical devices, but not necessarily diabetes-related products, have reached the market sooner in the EU than in the U.
The EU MDR may have the effect of reducing differences in data requirements and marketing approval times. The FDA has been highly supportive of diabetes device development through the release of clear and detailed guidance. The FDA has been especially supportive of the development of AID systems over the last decade starting with its guidance This FDA guidance document describes multiple forms of flexibility for developing AID products including with regard to 1 use of CGM systems, 2 primary end points that can be used to measure safety and effectiveness, 3 the stated therapeutic indication, 4 clinical study progression, and 5 the size and duration of each study phase.
This guidance explicitly expresses the intent of applying the least burdensome approach to investigating and developing AIDs and making them available to patients.
The FDA has also approved AID systems rapidly. Later the Libre 2 by Abbott also got this status. Importantly, this approval had the effect of changing the risk category for iCGM products from class III to class II while stipulating conditions and special controls to ensure safe interoperability.
This new provision also enables bringing future iCGM systems to market with the least burdensome requirements possible. This was the first controller device that could be used with other interoperable devices and integrated into a customizable diabetes management system for AID A self-contained AID product can still be developed and approved as noninteroperative.
Such products could require a more burdensome Premarket Approval PMA process. The EU does not have an interoperable diabetes device pathway comparable with that in the U.
Technical documentation can demonstrate conformance with the essential requirements at the product or system level, but it must take into account system components and interactions used to achieve the intended purpose.
Therefore, the manufacturer of a system component defines the interoperability with other components. This results in the availability of AID system components intended to be combined only with other specified system components e. In contrast with the FDA as the single national agency for device approval in the U.
As noted above, the EU MDR brings a higher burden for the manufacturer with respect to technical documentation and clinical evaluation.
It should be noted that a number of questions and issues related to AID remain to be addressed by the notified bodies and the EU Commission. A key question with respect to the EU MDR regulation is, in what risk categories will AID systems and components be placed, class IIb or class III?
Four different options for AID systems are conceivable as follows: A fully integrated system i. A system that combines products of different manufacturers e. DIY AID systems that are built by people with diabetes using commercially available hardware combined with an algorithm downloaded from the internet, for which no regulatory approval is available.
The second and third types of AID systems might belong to a different risk class than the first. AID systems are viewed as requiring special attention, since they involve infusion of a therapeutic product, insulin, which has a narrow therapeutic index.
Such products are scrutinized more intensively. In the case where components of different manufacturers are combined i. Another question is how the safety and efficacy of the different combinations can be meaningfully demonstrated to the satisfaction of the emerging EU MDR.
Patients with diabetes will be expected to use the device according to the instructions for use provided by the manufacturer, and these instructions will need to be clear, transparent, and understandable.
With regard to DIY AID systems, the French Competent Authority National Agency for the Safety of Medicines and Health Products ANSM has published a recommendation that people with diabetes not use software and applications that offer DIY AID systems, indicating that these applications usually do not have the CE mark and expose users to risks 95 , Such an approach requires that system components be able to exchange data.
The U. left the EU trading bloc in January with a transition period until the end of However, the U. Medicines and Healthcare products Regulatory Agency MHRA has issued guidance that generally harmonizes with EU MDR requirements i. Since 1 January , all medical devices placed on the U.
market need to be registered with MHRA a grace period existed until September for pumps and CGM systems , but CE marking and certificates issued by EU-recognized notified bodies will continue to be recognized in the U.
until June Any manufacturer based outside the U. will need to appoint a single U. For the time being, the costs of AID systems are high, which is a main reason why, from a global perspective, most people with T1D do not yet realistically have access.
An important factor to consider is the costs of devices, as well as coverage of devices by insurance companies, which varies widely between countries. This means out-of-pocket costs can be vastly different, and access to particular devices may be restricted in some regions, even if the devices have achieved regulatory approval.
Fortunately, use of modern diabetes technology is increasingly being covered by health care systems given the proven benefits they bring for many people with diabetes.
However, coverage includes not only the up-front costs of AID systems but also ongoing supply costs for IIS, batteries, and insulin, as well as increasing use of cell phones and adequate Wi-Fi coverage for transmitting data to health care professionals.
Furthermore, AID systems require extensive use of nonmonetary resources, such as up-front education of the users. Patients must also have access to HCPs who can support and troubleshoot a given AID system when the need arises, such as malfunction of a component or interruptions in the supply chain.
In view of the costs associated with widespread use of AID systems, insurers will likely request more cost-effectiveness studies, which will also be dependent on baseline characteristics of individuals with diabetes. Even with adjustment for socioeconomic status and access to care, health care disparities in outcomes exist for those from minority populations Patients with lower incomes often face multiple issues that limit their ability to adopt technology, including insulin pumps and CGM systems 99 , not to mention complex AID systems.
These issues include lack of consistent access to health care, insufficient or inconsistent coverage for devices, lower literacy and numeracy skills, lack of access to healthy food, psychosocial stressors, language barriers, and other issues related to social determinants of health that make diabetes management extremely challenging.
Furthermore, implicit bias may affect who is offered such devices , One interesting question to raise about AID systems is liability. At first glance, this might be obvious.
Questions to consider are as follows: How does a given AID system respond to issues and challenges? How do the algorithms implemented in the system respond to avoid too low glucose values i. How do we know if the algorithms implemented work adequately under all circumstances?
How do we hear about issues? Less than 10 years ago, upon recognition of the myriad data generated by diabetes devices and the inability to access this data in real time, efforts led by individuals with diabetes demonstrated to manufacturers that remote monitoring of CGM data was feasible.
Building on this momentum, an online community of devoted individuals whose lives were touched by diabetes sought next steps and built their own AID systems using a DIY approach The advantages of such an approach are the flexibility and rapidity with which the DIY AID systems can be adjusted to new needs and options.
For example, adaptations of algorithms allow for incorporation of insulins with improved pharmacodynamic properties. Compared with commercial AID systems, DIY AID systems offer more tunable parameters, thus offering a truer possibility of personalized medicine.
However, the entry bar for a patient who wants to start a DIY AID system is high. This is not merely downloading an app and transitioning to AID. In fact, creation of such systems requires extensive knowledge and frequent monitoring of diabetes therapy.
Additional complications tied to DIY AID systems are differences in legalities and liabilities between different countries. For example, one of the present authors L. described the German perspective on DIY AID systems in a recent publication Later, a letter that challenged the views expressed in the publication as not being patient centered enough was published Afterward, the reply to the letter clarified that DIY AID systems were a positive development but should be assessed with thorough scientific evaluation Recently, an international consensus statement was published detailing the current state of DIY AID systems, including a description of the systems, evidence of their use, and considerations for clinical implementation.
Further, the authors discussed both the ethical and the legal implications of system use, with the understanding that legal consequences of unregulated systems vary between jurisdictions To date, the benefits of using DIY AID systems have not been fully evaluated in randomized controlled trials, though studies are underway.
However, results of a number of real-world studies showed remarkably positive outcomes , even during pregnancy and in remarkably challenging patient situations, such as running a half-marathon , Overall, DIY AID systems represent a useful tool to learn about how an optimal AID system might operate.
Although there is the need for rigorous devotion and intent focus on details in operating DIY AID systems, there is a lot to learn from the users of such systems. If a provider is asked by an individual with diabetes about using a DIY AID system, the provider should act as follows: The provider should tell the individual that these systems are not approved by regulatory agencies i.
The provider should tell the individual that although these systems cannot be prescribed by a provider, and the patient assumes responsibility for their use, the provider can make recommendations regarding patient safety and assist with developing a backup plan in case the system fails.
It should be noted that these recommendation are somewhat country specific, depending on the legal framework in the given country.
The question of liability becomes exponentially larger in considering DIY AID systems. Since these systems are created by the user through the bridging of different system components, who is liable should a system malfunction occur?
We outline a list of considerations for regulatory agencies, manufacturing companies, international and national professional societies, funding bodies, researchers, health care professionals, and people with diabetes to take into careful consideration.
These can be categorized into the following themes: More systematic and structured guidelines for AID systems usage 1 a—c and 3 d and e in consensus report recommendations , below. Improved consistency and accessibility of safety reports 2 a , b , and d.
Greater investment in collecting of clinical data to provide evidence for or against use of AID systems 4 a and b and 5 a and b. Increased accessibility for all consumer populations to use AID systems confidentially and securely 2 c , g , and h and 3 c.
Increased communication and cooperation across stakeholder groups 1 d — g , 2 e and f , 3 a and b , 6 a—e , and 7 a—c. Regulatory agencies should: Harmonize their activities. Provide a regulatory pathway with clear steps and guidance on how to obtain approval for future AID systems.
Construct guidance for conducting both pivotal trials of new devices and postmarketing trials with a focus on evidence regarding how to assess safety and efficacy of systems. Postmarket studies and registry data may elucidate evidence on effectiveness of systems.
Foster a commitment to conduct long-term studies of AID systems to evaluate persistence of glycemic benefits and to explore how this may translate into rates of long-term complications of diabetes.
Determine methods to evaluate DIY AID systems in larger-scale real-world observational and clinical settings. Create, publicize, and maintain a single publicly accessible international database of available AID systems.
Mandate that device manufacturers provide information on the population studied in pivotal trials and any updates based on real-world studies that may highlight the clinical data regarding who would derive most benefit from the product.
Manufacturing companies should: Comply with regulations, industry standards, and best practices established for AID systems. Create training modules that are readily available and written at an accessible reading level to ensure these modules will meet the needs of individuals with diabetes.
Assess the usability of device interfaces, with the goal of creating user-friendly platforms for all demographic groups. Further, it should be possible to personalize the interfaces with real-time insights and suggestions for individual users.
Cooperate with academic and health care professionals to provide balanced and adequate information both to providers and patients with diabetes. Package output data from devices in standardized formats for ease of access, and potentially integration, in electronic health records.
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