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• W4296027135 abstract "Diabetes Technology & TherapeuticsVol. 25, No. 1 EditorialFree AccessHybrid Closed-Loop Systems to Date: Hype Versus RealityLaurel H. Messer and Cari BergetLaurel H. MesserAddress correspondence to: Laurel H. Messer, PhD, RN, CDCES, Barbara Davis Center for Diabetes, University of Colorado Anschutz Medical Campus, 1775 Aurora Court, Aurora, CO 80045, USA E-mail Address: [email protected]Barbara Davis Center for Diabetes, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA.College of Nursing, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA.Search for more papers by this author and Cari BergetBarbara Davis Center for Diabetes, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA.Search for more papers by this authorPublished Online:27 Dec 2022https://doi.org/10.1089/dia.2022.0375AboutSectionsPDF/EPUB Permissions & CitationsPermissionsDownload CitationsTrack CitationsAdd to favorites Back To Publication ShareShare onFacebookTwitterLinked InRedditEmail In 2017, the first hybrid closed-loop (HCL) system entered the market, sparking hope for a diabetes care revolution: “Eliminate hypoglycemia!” and “Set it and forget it!” Although this wave of expectation was to be anticipated with this major paradigm shift, the diabetes community found relief as we developed a firmer grasp on the true promises and challenges of HCL. Multiple studies have confirmed the safety and efficacy of HCL in populations as young as 2 years old through older adults1–10; however, glycemic control on HCL systems is not perfect and users still struggle with the challenges of living with diabetes, although perhaps with less burden.It is a timely moment to revisit HCL expectations,11 as two new systems have recently become commercially available: the Minimed 780G (markets outside of United States) and the Omnipod 5 (U.S. market). With each new device, the cycle of unrealistic and realistic expectations starts again, a process known as the Hype Cycle (Fig. 1).12FIG. 1. The Hype Cycle, with blunting over time (dotted line).The Hype Cycle models progression of expectations with new technology, starting with a steep peak of inflated expectations, driven by the human attraction to novelty, social contagion, and quick heuristic decision-making.13 This is followed by rapid descent into a “trough of disillusionment,” where expectations are at nadir. A gradual increase on the hyperbolic “slope of enlightenment” follows and then stabilizes into a realistic “plateau of productivity.” The Hype Cycle, which may apply to people with diabetes and clinicians alike, coincides nicely with the innovation diffusion model,14 which maps how new technologies are adapted at different rates by different types of people. The two models are likely related, with “innovators” carrying inflated expectations only to drive opinion down to the trough of disillusionment when expectations are not met. “Early adopters” may be drivers of the slope of enlightenment, preparing the way for “late adopters” to make decisions based on the plateau of realistic expectations.Our experience indicates the following as the “plateau of realistic expectations” for HCL: 1) HCL systems can improve glycemic control for most people.This is intentionally vague, as it is not realistic to promise HCL users a specific time in range or hemoglobin A1c (HbA1c). Improved glycemic control can mean many things: reduced hypoglycemia, increased time in range, or blunted glycemic variability. It is worth noting that glycemic outcomes depend heavily on the user's baseline glycemic profile and clinical characteristics,15,16 both of which are narrowly defined in clinical trials and sometimes absent in large real-world data sets.There are several studies that report high Time in Range (70–180 mg/dL, TIR) achieved by HCL systems in the absence of information on baseline TIR, the largest predictor of achieved TIR, and without age context, another predictor of TIR.15,17,18 Interpreting these particular results for clinical relevancy is impractical, because the reader does not know who might expect to achieve these results. The lack of baseline characteristics further limits the ability to compare the data with any other system or study, because we do not know how much impact the HCL had on the results. There are no current head-to-head comparisons of glycemic outcomes between devices, which puts the burden on the scientific community to be judicious with how we compare systems. Current real-world evidence suggests that most HCL systems can improve TIR by between 9% and 12%, which equates to a reduction in HbA1c of 0.5%–1.0% (5.5–11 mmol/mol),19–21 with smaller improvements for those with higher baseline TIR.15,17,18,22–25HCL systems may not improve glycemia for users with very high time in range and low hypoglycemia but may help them maintain tight glycemia with less effort. Ironically, many “innovators” who are among the first to trial new HCL systems are disappointed in the results for this very reason—they are already meeting or surpassing glycemic targets with their current regimen. Their disappointments, although valid, may not represent the experience of the majority. 2) The best HCL system is the one the person wants to use.All systems have the potential to be beneficial if the person with diabetes is willing to use it. The decision to use a device emerges from the balance of benefits and burdens.26 If the perceived benefits of using a device outweigh the burdens, the person will continue to use it.27,28 To the point aforementioned, it is not worth splitting hairs over which HCL system produces the best glycemic outcomes—they have all performed well and demonstrate similar outcomes within their respective study populations.Instead, the most relevant questions when choosing the best HCL system relate to whether the person can afford the device on an ongoing basis, how well they can incorporate the system into their lifestyle, and the benefits and burdens they experience when using the device. An HCL algorithm makes 0% impact on glycemic control when not being used. Diabetes care is a marathon, not a sprint, and choosing the HCL system that will promote consistent enduring wear is the best choice for the person with diabetes. 3) Optimizing HCL therapy usually means intensifying meal insulin doses.All HCL systems to date require that the user deliver bolus insulin for meals. Evidence suggests that regardless of the HCL system, strengthening I:C ratios helps to improve glycemic outcomes.29–31 All HCL systems use total daily insulin to scale insulin adjustments to varying degrees. This means that intensifying bolus settings and increasing frequency of meal and/or correction boluses will have two synergistic effects: lowering the glucose in the moment and training the algorithm to work with loosened constraints. Although each system has different tunable parameters,32 every system to date allows for I:C ratio adjustments. This paradigm may change in the future, especially as systems rely less on users delivering meal bolus doses. 4) Control what you can: Nuances of algorithm actions are not as important as diabetes self-management behaviors.Each algorithm has proprietary ways to adjust insulin to bring glucose levels to target and analyzing minute-by-minute algorithm decisions is not likely to be productive. These are not in the user's control. The adage of “missing the forest for the trees” is apropos, where the overall forest relates to user burden and sustained glycemic improvements. A HCL user may benefit more from adjusting tunable parameters and focusing on diabetes care behaviors, such as bolusing, than analyzing the algorithmic play-by-play.The Hype Cycle may blunt over time, the unrealistic expectations of the 670G not likely to haunt the 780G or the Omnipod 5 to the same degree. However, these lessons bear repeating. New resources and professional knowledge may help blunt this cycle. Diabetes Care and Education Specialists have created the Identity-Configure-Collaborate model to promote shared decision-making related to diabetes technologies.33 Web-based resources such as Diabeteswise.org and PantherProgram.orghelp tease apart similarities and differences between systems for providers and people with diabetes. Realistic expectations can help guide choices with current and near-future systems—although further down the road of automated insulin delivery, new lessons will emerge.Roy Amara, a technology researcher, scientist, and futurist, noted, “We tend to overestimate the effect of a technology in the short run and underestimate the effect in the long run.”34 The impact of HCL for persons with diabetes will likely bear long-lasting improvements to diabetes care, making it worth filtering through the momentary hype.Authors' ContributionsL.H.M. wrote the first draft of this article. C.B. edited and approved the article.Author Disclosure StatementL.H.M. has received speaking/consulting honoraria from Tandem Diabetes, Dexcom, Inc., Capillary Biomedical, and Lilly. Her institution receives research/project grants from Medtronic, Tandem Diabetes, Beta Bionics, Dexcom, Abbott, and Insulet Corp. C.B. has received speaking/consulting honoraria from Insulet Corporation and Dexcom, Inc. Her institution receives research/project grants from Medtronic, Tandem Diabetes, Beta Bionics, Dexcom, Abbott, and Insulet Corp.Funding InformationThere was no funding for this article.References1. Forlenza GP, Pinhas-Hamiel O, Liljenquist DR, et al. Safety evaluation of the MiniMed 670G system in children 7–13 years of age with type 1 diabetes. Diabetes Technol Ther 2019;21(1):11–doi: 10.1089/dia.2018.0264 Link, Google Scholar2. Garg SK, Weinzimer SA, Tamborlane WV, et al. 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Google ScholarFiguresReferencesRelatedDetailsCited byOne-Year Follow-Up of Advanced Hybrid Closed-Loop System in Adults with Type 1 Diabetes Previously Naive to Diabetes Technology: The Effect of Switching to a Calibration-Free Sensor Bartłomiej Matejko, Anna Juza, Beata Kieć-Wilk, Katarzyna Cyranka, Sabina Krzyżowska, Ohad Cohen, Maciej T. Malecki, and Tomasz Klupa31 July 2023 | Diabetes Technology & Therapeutics, Vol. 25, No. 8 Volume 25Issue 1Jan 2023 InformationCopyright 2023, Mary Ann Liebert, Inc., publishersTo cite this article:Laurel H. Messer and Cari Berget.Hybrid Closed-Loop Systems to Date: Hype Versus Reality.Diabetes Technology & Therapeutics.Jan 2023.91-94.http://doi.org/10.1089/dia.2022.0375Published in Volume: 25 Issue 1: December 27, 2022Online Ahead of Print:October 4, 2022Online Ahead of Editing: September 15, 2022PDF download" @default.
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