A Call-to-Action to Eliminate Barriers to Accessing Automated Insulin Delivery Systems for People with Type 1 Diabetes

Abstract

We are issuing this call-to-action to the diabetes community (health care providers [HCPs], people with type 1 diabetes [PwT1D] and their caregivers, and payers) to fully recognize and implement the advances made over the last 10+ years in automated insulin delivery (AID) systems. Pivotal trials and real-world data provide robust and compelling evidence for the benefits of using AID systems, going beyond those of continuous glucose monitors (CGM) when added to a regimen of multiple daily insulin (MDI) injections and/or conventional pump therapy (with or without concomitant CGM).

CGM Is Not Enough

The development of CGM represents one of the major advances in diabetes management by providing more complete glucose information and peace of mind with respect to hypoglycemia. However, CGM when added to a regimen of MDI injections is insufficient for many people to achieve the goals of time-in-range (TIR) of >70% and HbA1c <7% with low time-below-range (TBR) of <4% that have been adopted and recommended by the diabetes community.^1,2 This is exemplified by the DIAMOND trial, which found that while the addition of CGM to an MDI regimen substantially increases TIR compared with Self Monitoring of Blood Glucose (SMBG), it does so to 51% (from a baseline of 41%) and reduces mean adjusted HbA1c by 0.6% from a baseline of 8.6% after 24 weeks.³ An HbA1c of <7% was achieved by only 18% of participants in the DIAMOND trial. Notably, the time-above-range (TAR; >180 mg/dL) remained high at 44% (goal <25%), resulting in more than 74 hours per week of hyperglycemia. These outcomes have been replicated using a variety of sensors and across different age-groups.^4

–8

AID Provides Clinically Superior Glycemic Outcomes Compared with CGM plus MDI

The pivotal trials of AID systems^9

–15 and the real-world data from thousands of individuals^16

–21 using commercially available AID systems demonstrate that these systems safely achieve TIRs of 65%–80% in children and adults across all age-groups in both registration and real-life studies. While direct comparison of pivotal trials is not appropriate and even comparing real-world observational trials with thousands of patients is challenging, at a high level, the overall evidence demonstrates that the differences in TIR between MDI plus CGM versus AID systems range from 20% to 30%. Given the general relationship of TIR to HbA1c,^22,23 this difference translates into a 1.5%–2.4% difference in HbA1c. The TAR in users of CGM plus MDI is substantially higher than the consensus guideline recommendation of <25%, while most AID studies meet or are just above these goals. AID is an example of an intervention in patients with T1D in which the efficacy demonstrated in clinical trials has been confirmed when translated into clinical practice. As researchers and clinicians, we see the effectiveness of AID in our clinical practices and recognize access to the pump and CGM devices as the main barrier to achieving this benefit.

The Goal in 2025 and Beyond: Improve Lives of People with T1D by Reducing the Burden of Disease and Reduce Hyperglycemia Without Increasing Hypoglycemia

The foundational learnings from the landmark Diabetes Control and Complications Trial (DCCT) are that hyperglycemia is the major cause of micro- and macrovascular complications in type 1 diabetes.²⁴ More recently, the blood glucose monitoring data of participants in the DCCT have been converted to TIR and demonstrate the same curvilinear relationship of TIR to retinopathy and nephropathy.²⁵ The rate of severe hypoglycemia in the DCCT trial (DCCT and DCCT Hypo) was high (61.2 episodes per 100 patient-years).²⁴ With AID use, severe hypoglycemia is rare in pivotal trials and real-world evidence demonstrates that TBR is well below 4%. On the contrary, the TAR remains >25% in many studies, while the time-in-tight range, that is, normoglycemia, is at best 55%–60%.²⁶ In addition to the known relationship between hyperglycemia and micro- and macrovascular complications, recent evidence points to the danger of hyperglycemia in children including impairment of working special memory loss^27,28 and cognitive impairment.²⁹ Finally, the burden of diabetes management is substantially reduced for AID users and their caregivers by virtue of the automation of insulin delivery.

What Do Professional Organizations and Payers Say?

Professional organizations and subject matter experts recognize the benefits of AID systems.^29

–35 The American Diabetes Association’s Standards of Medical Care in Diabetes—2025 states, “AID systems AID systems should be the preferred insulin delivery method to improve glycemic outcomes and reduce hypoglycemia and disparities in youth and adults with type 1 diabetes.”³¹ Barriers to access AID continue to exist. Cost and access are being mitigated by the National Institute of Clinical Excellence’s decision to provide funding for AID systems to all PwT1Ds in the United Kingdom.^36,37 HCP-created barriers for AID (must know carbohydrate counting, very high HbA1c, be familiar with technology, use CGM first) are belied by recent evidence.^38

–42 These barriers and others exemplify the implicit unconscious racial/ethnic biases about who can effectively use these systems.⁴³ Reducing these barriers requires the commitment and action of everyone in the diabetes community to ensure that every PwT1D is offered an AID system, thereby enabling them to make a decision that is right for them.

Call-to-Action

We recommend that the following model language be incorporated into current and future guidelines promulgated by professional societies and government agencies:

The standard of care for glycemic management in youth and adults with T1D is an AID system. Accordingly:

All PwT1D and other patients with insulin-dependent diabetes must be given a choice to use an AID system at the time of diagnosis or as soon after diagnosis as possible.

The reason(s) for not giving a choice of using an AID system should be documented in the medical record.

The choice of device should be made based on the individual’s circumstances, preferences, and needs.

National health care systems should prioritize the provision of unfettered access to AID systems to democratize the known benefits of AID systems.

Call-to-Action Individual Endorsers

Halis K. Akturk, MD, Harpreet Bajaj, MD, Tadej Battelino, MD, Katrien Benhalima, MD, Richard M. Bergenstal MD, Emanuele Bosi, MD, Antonio Ceriello, MD, Manoj Chawla, MD, Alice G. Cheng, MD, Pratik Choudhary, MD, Ignacio Conget, MD, Martin De Bock, MD, Asma Deeb, MD, Osagie Ebekozien, MD, Nancy Elbarbary, MD, Gregory Forlenza, MD, Denise Franco, MD, Daphne Gardner Tan Su-Lyn, MD, Satish Garg, MD, Ana Maria Gomez, MD, Bruno Grassi Corrales, MD, Irl B. Hirsch, MD, Alicia Jenkins, MD, Tim Jones, MD, Shashank Joshi, MD, Partha Kar, MD, Francine Kaufman, MD, Jothydev Kesavadev, MD, Tomasz Klupa, MD, Lori Laffel, MD, Warren Lee, MD, David Maahs, MD, Julia Mader, MD, Chantal Mathieu, MD, Viswanathan Mohan, MD, Sun Joon Moon, MD, Medha Munshi, MD, Kirsten Norgaard, MD, David O’Neal, MD, Bruce Perkins, MD, Sarit Polsky, MD, Jane Reusch, MD, Banshi Saboo, MD, Antonio Saleme, MD, Peter Schwarz, MD, Viral Shah, MD, Jennifer Sherr, MD, Carol Wysham, MD, Fabian Yap Kok Peng, MD, and Muhammad Yazid Jalaludin, MD.

Call-to-Action Organizational Endorsers

Breakthrough T1D (formerly Juvenile Diabetes Researh Foundation {JDRF}), Advanced Technologies & Treatments for Diabetes (ATTD), Diabetes India, International Diabetes Federation (IDF), International Society for Pediatric and Adolescent Diabetes (ISPAD), and T1D Exchange.

Footnotes

Acknowledgments

The authors are indebted to Robert A. Vigersky for his tireless efforts in uniting them to produce a document reflecting global expert opinion about AID so that the doors will be open for all people with T1D to access the most effective treatment for their condition.

Author Disclosure Statement

H.K.A.: received grant payments for research from the following companies: Boehringer Ingelheim Pharmaceuticals, Inc, Abbott Diabetes Care, AbbVie Inc, Covance Inc, Dexcom, Inc, Eli Lilly and Company, Madrigal Pharmaceuticals, Inc, Medtronic, Novo Nordisk, MannKind, Carmot, Quintiles, Akero, 89bio, Inc, Viking Therapeutics, Barbara Davis Center for Diabetes, PPD, Zydus, Kowa Pharmaceuticals America Inc, Insulet Corporation, and VtV Therapeutics LLC. H.B.: Advisory Panel or Consultant: AstraZeneca, Boehringer Ingelheim, Eli Lilly, Janssen, Merck, and Sanofi; Research Support: AstraZeneca, Eli Lilly, Janssen, Merck, Novo Nordisk, Pfizer, Regeneron, Sanofi, and Takeda; Speaker’s Bureau or fees: Abbott, AstraZeneca, Bayer, Boehringer Ingelheim, Eli Lilly, Janssen, Merck, Novo Nordisk, and Sanofi. T.B.: served on advisory panels of Novo Nordisk, Sanofi, Eli Lilly, Boehringer, Medtronic, Abbott, and Indigo Diabetes; T.B. received honoraria for participating on the speaker’s bureaux of Eli Lilly, Novo Nordisk, Medtronic, Abbott, Sanofi, Dexcom, Aventis, Astra Zeneca, and Roche; T.B.’s Institution received research grant support from Abbott, Medtronic, Novo Nordisk, Sanofi, Novartis, Sandoz, and Zealand Pharma, Slovenian Research and Innovation Agency, the National Institutes of Health, and the European Union, all outside of the submitted study; T.B. is supported in part by the Slovenian Research and Innovation Agency grant # P3-0343. K.B.: reports research funding and receipt of study devices from Medtronic for the investigator-initiated CRISTAL study; receipt of study devices from Dexcom for the investigator-initiated GLORIA study; receipt of study medication from Novo Nordisk for the investigator-initiated SERENA study; and consulting fees from AstraZeneca and Lilly and served on the Speaker’s Bureau for Novo Nordisk, AstraZeneca, and Mundipharma. R.M.B.: has received research support, has acted as a consultant, or has been on the scientific advisory board for Abbott Diabetes Care, Ascensia, Bigfoot Biomedical, Inc., CeQur, DexCom, Eli Lilly, Embecta, Hygieia, Insulet, Medtronic, Novo Nordisk, Onduo, Roche Diabetes Care, Tandem Diabetes Care, Sanofi, United Healthcare, Vertex Pharmaceuticals, and Zealand Pharma; R.M.B.’s employer, nonprofit HealthPartners Institute, contracts for his services, and he receives no personal income for any of implementation. Funding/Support for these activities: E.B.: reports advisory board and/or speaker consultant fees from Abbott Diabetes Care, AstraZeneca, Eli Lilly, Novartis, Roche, and Sanofi and nonfinancial support from Medtronic. A.C.: has received honoraria from AstraZeneca, Berlin Chemie, Merck, Novo Nordisk, and Roche Diagnostics; A.C. has received consulting fees from AstraZeneca, Bayer, Elsevier, Roche Diagnostics, Sevier, and Theras; A.C. has participated on advisory boards for Eli Lilly and Roche Diagnostics. M.C.: reports having speaker contracts with Novo Nordisk, Sanofi, Biocon, Cipla, USV Ltd., and Abbott. A.G.C.: has been paid consultant to Federation Bio. P.C.: received personal fees from Abbott, Medtronic, Dexcom, Insulet, Glooko, Novo Nordisk, Sanofi, Lilly, and Vertex. S.F.: is a shareholder of Diabeloop and has been a consultant for Diabeloop. I.C.: reported receiving lecturing and consulting fees from Medtronic Inc., Bayer AG, GlaxoSmithKline, Eli Lilly & Co., Novo-Nordisk A/S, Sanofi-Aventis, Novartis, Astra Zeneca, and MSD. M.d.B.: has received honoraria from Dexcom Inc. and is a current member of the New Zealand Advisory Board for Dexcom Inc. A.D.: takes part on the Medtronic Advisory Board. O.E.: is the PI for research projects funded through his institution by Dexcom, Eli Lilly, and Medtronic; O.E. is a member of the Medtronic Diabetes Health Inequity Advisory Board. G.F.: conducts research sponsored by Medtronic, Dexcom, Abbott, Tandem, Insulet, Beta Bionics, Lilly, and Sequel and has been a speaker/consultant/ad board member for Medtronic, Dexcom, Abbott, Tandem, Insulet, Beta Bionics, Lilly, and Sequel. D.G.: has served on Medtronic Advisory Panels. S.G.: reports consultant fees from Medtronic, Novo Nordisk, Zealand, Lifescan, Roche, and Lilly and research grants through the University of Colorado from Lilly, Novo Nordisk, Medtronic, Dexcom, T1D Exchange, Helmsley Trust, NIDDK, and JDRF. A.M.G.: received speaker’s fees from Novo Nordisk, Elli Lilly, Boehringer Ingelheim, Abbott, and Medtronic. I.B.H.: reports consulting for Abbott Diabetes Care, Roche, Hagar, and Vertex and research support from MannKind, Dexcom, and Tandem Diabetes Care. A.J.: Has received research support from Medtronic, Sanofi, Abbott Laboratories, and Mylan and has served on advisory boards for Medtronic, Sanofi, and Abbott Diabetes Care. F.K.: employee of Senseonics Inc., manufacturer of Eversense. T.K.: speaker’s honorarium: Eli Lilly, Sanofi, Novo Nordisk, Ascensia, Abbott, Roche, Medtronic, Boehringer Ingelheim, Bioton, and Servier; Advisory Panel: Eli Lilly, Sanofi, Boehringer Ingelheim, Ascensia, and Abbott; Research Support: Medtronic. L.L.: has served as an advisor for Boehringer Ingelheim, Janssen, Medtronic, Provention Bio, Sanofi, Sequel, Mannkind, Tandem Diabetes Care, and Vertex. D.M.: has had research support from the NIH, JDRF, NSF, and the Leona M. and Harry B. Helmsley Charitable Trust; his institution has had research support from Medtronic, Dexcom, Insulet, Bigfoot Biomedical, Tandem, and Roche; and has consulted for Abbott, Aditxt, the Leona M. and Harry B. Helmsley Charitable Trust, Lifescan, Mannkind, Sanofi, Novo Nordisk, Eli Lilly, Medtronic, Insulet, Dompe, and Biospex. J.M.: member in the advisory boards of Abbott Diabetes Care, Becton-Dickinson/Embecta, Biomea Fusion, Eli Lilly, Medtronic, Novo Nordisk, Pharmasens, Roche Diabetes Care, Sanofi, and Viatris; received speaker honoraria from Abbott Diabetes Care. C.M.: serves or has served on the advisory panel for Novo Nordisk, Sanofi, Eli Lilly and Company, Novartis, Boehringer Ingelheim, Roche, Medtronic, Imcyse, Insulet, and Vertex; Financial compensation for these activities has been received by KU Leuven; KU Leuven has received research support for C.M. from Medtronic, Imcyse, Novo Nordisk, Sanofi, and ActoBio Therapeutics; C.M. serves or has served on the Speaker’s Bureau for Novo Nordisk, Sanofi, Eli Lilly and Company, Medtronic, and Boehringer Ingelheim; financial compensation for these activities has been received by KU Leuven; C.M. is the president of EASD; all external support of EASD is to be found on . M.M.: consultant for Sanofi and Abbott. K.N.: serves as an advisor to Medtronic, Abbott, Convatec, and Novo Nordisk; owns shares in Novo Nordisk; has received research grants to the institution from Novo Nordisk, Zealand Pharma, Dexcom, and Medtronic; and has received fees for speaking from Medtronic and Novo Nordisk. D.O.: has served on advisory boards for Abbott Laboratories, Medtronic, Merck Sharp & Dohme, Novo Nordisk, Roche, and Sanofi; received research support from Medtronic, Novo Nordisk, Roche, Eli Lilly and Company, and Sanofi; and received travel support from Novo Nordisk and Merck Sharp & Dohme; B.P.: has received honoraria for educational events from Medtronic, Novo Nordisk, Sanofi, Insulet, and Abbott; his research institute has received funding from BMO Bank of Montreal and Novo Nordisk for research support; he has served as an advisor to Boehringer Ingelheim, Sanofi, Insulet, Abbott, and Vertex. S.P.: was a contributing writer for diaTribe, was on the Medical Advisory Board for Medtronic MiniMed, Inc; has received research funding from Dexcom, Inc., Eli Lilly, JDRF, Leona & Harry Helmsley Charitable Trust, NIDDK, and Sanofi US Services; and has received research support from Diasome Pharmaceuticals, Medtronic MiniMed, Inc., and Sanofi US Services. A.S.: consultant for Novo Nordisk and Elly Lilly. P.S.: advisor for the Emperra GmbH. V.S.: institute receives research support from Dexcom, Alexion, JDRF, and NIH; V.S. has received honoraria from Sanofi, NovoNordisk, Lilly, Tandem Diabetes Care, Dexcom, Insulet, Embecta, and Ascensia Diabetes Care for speaking, consulting, or advisory work. J.S.: reports serving, or having served, on advisory panels for Bigfoot Biomedical, Cecelia Health, Insulet Corporation, Medtronic Diabetes, StartUp Health Diabetes Moonshot, and Vertex and having served as a consultant to Abbott Diabetes, Bigfoot Biomedical, Insulet, Medtronic Diabetes, and Zealand; Yale School of Medicine has received research support for J.S. from Abbott Diabetes, Jaeb Center for Health Research, JDRF, Insulet, Medtronic, NIH, and Provention Bio, Inc. C.W.: research funding to institution: Novo Nordisk, Eli Lilly, Bayer, Corcept Speaker’s Bureau: Novo Nordisk, Eli Lilly Advisory Board: Abbott, Cequr, Novo Nordisk. F.Y.K.P.: received reimbursement for speaking at conferences sponsored by companies selling nutritional products. M.Y.J.: is a consultant for Merck Sharp & Dhome, expert panel member, and has received research grants; consultant and expert panel member for GLP1 analog research and speaker for Novo Nordisk.

Funding Information

No funding was received for this article.

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