Open-source automated insulin delivery systems, commonly referred to as do-it-yourself automated insulin delivery systems, are examples of user-driven innovations that were co-created and supported by an online community who were directly affected by diabetes. Their uptake continues to increase globally, with current estimates suggesting several thousand active users worldwide. Real-world user-driven evidence is growing and provides insights into safety and effectiveness of these systems. The aim of this consensus statement is two-fold. Firstly, it provides a review of the current evidence, description of the technologies, and discusses the ethics and legal considerations for these systems from an international perspective. Secondly, it provides a much-needed international health-care consensus supporting the implementation of open-source systems in clinical settings, with detailed clinical guidance. This consensus also provides important recommendations for key stakeholders that are involved in diabetes technologies, including developers, regulators, and industry, and provides medico-legal and ethical support for patient-driven, open-source innovations.

Department of Diabetes and Endocrinology Guy's and St Thomas' Hospital NHS Trust London UK; Department of Diabetes King's College London London UK; Institute of Diabetes Endocrinology and Obesity King's Health Partners London UK

Department of Paediatric Endocrinology and Diabetes Charité Universitätsmedizin Berlin Berlin Germany

Department of Paediatric Endocrinology and Diabetes Charité Universitätsmedizin Berlin Berlin Germany; Institute of Medical Informatics Charité Universitätsmedizin Berlin Berlin Germany; Berlin Institute of Health Berlin Germany

Department of Pediatrics University Hospital Motol Prague Czech Republic

Department of Psychology University of Copenhagen Copenhagen Denmark; La Trobe Rural Health School La Trobe University Bendigo VIC Australia

Diabeter Center for Pediatric and Adult Diabetes Care and Research Rotterdam Netherlands

Integrated Diabetes Services Wynnewood PA USA

Muscle Health Research Centre York University Toronto ON Canada

Stanford Diabetes Research Center Stanford University School of Medicine Stanford University Stanford CA USA

Steno Diabetes Center Copenhagen Gentofte Denmark

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Lancet Diabetes Endocrinol. 2022 Jan;10(1):e1. doi: 10.1016/S2213-8587(21)00324-7. PubMed

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Lal RA, Ekhlaspour L, Hood K, Buckingham B. Realizing a closed-loop (artificial pancreas) system for the treatment of type 1 diabetes. Endocr Rev 2019; 40: 1521–46. PubMed PMC

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: 11–19. PubMed PMC

Salehi P, Roberts AJ, Kim GJ. Efficacy and safety of real-life usage of MiniMed 670G automode in children with type 1 diabetes less than 7 years old. Diabetes Technol Ther 2019; 21: 448–51. PubMed

Garg SK, Weinzimer SA, Tamborlane WV, et al. Glucose outcomes with the in-home use of a hybrid closed-loop insulin delivery system in adolescents and adults with type 1 diabetes. Diabetes Technol Ther 2017; 19: 155–63. PubMed PMC

Forlenza GP, Ekhlaspour L, Breton M, et al. Successful at-home use of the tandem control-IQ artificial pancreas system in young children during a randomized controlled trial. Diabetes Technol Ther 2019; 21: 159–69. PubMed PMC

Schoelwer MJ, Robic JL, Gautier T, et al. Safety and efficacy of initializing the control-IQ artificial pancreas system based on total daily insulin in adolescents with type 1 diabetes. Diabetes Technol Ther 2020; 22: 594–601. PubMed

Brown SA, Kovatchev BP, Raghinaru D, et al. Six-month randomized, multicenter trial of closed-loop control in type 1 diabetes. N Engl J Med 2019; 381: 1707–17. PubMed PMC

Tauschmann M, Thabit H, Bally L, et al. Closed-loop insulin delivery in suboptimally controlled type 1 diabetes: a multicentre, 12-week randomised trial. Lancet 2018; 392: 1321–29. PubMed PMC

Ekhlaspour L, Nally LM, El-Khatib FH, et al. Feasibility studies of an insulin-only bionic pancreas in a home-use setting. J Diabetes Sci Technol 2019; 13: 1001–07. PubMed PMC

El-Khatib FH, Balliro C, Hillard MA, et al. Home use of a bihormonal bionic pancreas versus insulin pump therapy in adults with type 1 diabetes: a multicentre randomised crossover trial. Lancet 2017; 389: 369–80. PubMed PMC

Thabit H, Hartnell S, Allen JM, et al. Closed-loop insulin delivery in inpatients with type 2 diabetes: a randomised, parallel-group trial. Lancet Diabetes Endocrinol 2017; 5: 117–24. PubMed

Stewart ZA, Wilinska ME, Hartnell S, et al. Closed-loop insulin delivery during pregnancy in women with type 1 diabetes. N Engl J Med 2016; 375: 644–54. PubMed

Lum J, Bailey R, Barnes-Lomen V, et al. A real-world prospective study of the safety and effectiveness of the loop open source automated insulin delivery system. Diabetes Technol Ther 2021; 23: 367–75. PubMed PMC

Shepard JA, Breton M, Nimri R, et al. User and healthcare professional perspectives on do-it-yourself artificial pancreas systems: a need for guidelines. J Diabetes Sci Technol 2020; published online October 1. PubMed PMC

Melmer A, Züger T, Lewis DM, Leibrand S, Stettler C, Laimer M. Glycaemic control in individuals with type 1 diabetes using an open source artificial pancreas system (OpenAPS). Diabetes Obes Metab 2019; 21: 2333–37. PubMed

Petruzelkova L, Soupal J, Plasova V, et al. Excellent glycemic control maintained by open-source hybrid closed-loop AndroidAPS during and after sustained physical activity. Diabetes Technol Ther 2018; 20: 744–50. PubMed

Braune K, O’Donnell S, Cleal B, et al. Real-world use of do-it-yourself artificial pancreas systems in children and adolescents with type 1 diabetes: online survey and analysis of self-reported clinical outcomes. JMIR Mhealth Uhealth 2019; 7: e14087. PubMed PMC

Hng TM, Burren D. Appearance of do-it-yourself closed-loop systems to manage type 1 diabetes. Intern Med J 2018; 48: 1400–04. PubMed

Jennings P, Hussain S. Do-it-yourself artificial pancreas systems: a review of the emerging evidence and insights for healthcare professionals. J Diabetes Sci Technol 2020; 14: 868–77. PubMed PMC

Lewis D, Leibrand S. Real-world use of open source artificial pancreas systems. J Diabetes Sci Technol 2016; 10: 1411. PubMed PMC

Lewis D History and perspective on DIY closed looping. J Diabetes Sci Technol 2019; 13: 790–93. PubMed PMC

Litchman ML, Lewis D, Kelly LA, Gee PM. Twitter analysis of #OpenAPS DIY artificial pancreas technology use suggests improved A1C and quality of life. J Diabetes Sci Technol 2019; 13: 164–70. PubMed PMC

Marshall DC, Holloway M, Korer M, Woodman J, Brackenridge A, Hussain S. Do-It-yourself artificial pancreas systems in type 1 diabetes: perspectives of two adult users, a caregiver and three physicians. Diabetes Ther 2019; 10: 1553–64. PubMed PMC

Cleal B, Braune K, O’donnell S, et al. 78-LB: detailing the experiences of people with diabetes using do-it-yourself artificial pancreas systems—qualitative analysis of responses to open-ended items in an international survey. Diabetes 2019; 68 (suppl 1): 78–LB.

Braune K, Gajewska KA, Thieffry A, et al. Why #wearenotwaiting-motivations and self-reported outcomes among users of open-source automated insulin delivery systems: multinational survey. J Med Internet Res 2021; 23: e25409. PubMed PMC

Wu Z, Luo S, Zheng X, et al. Use of a do-it-yourself artificial pancreas system is associated with better glucose management and higher quality of life among adults with type 1 diabetes. Ther Adv Endocrinol Metab 2020; 11: 2042018820950146. PubMed PMC

D+B Rechtsanwälte Berlin. Gutachten Looper. July 30, 2018. https://www.deutsche-diabetes-gesellschaft.de/fileadmin/user_upload/06_Gesundheitspolitik/03_Veroeffentlichungen/02_Looper_Gutachten/Gutachten_D_B_Looper_u__berarbeitet__30.7.2018_.pdf (accessed June 27, 2020).

Diabetes Australia. Position statement: people with type 1 diabetes and DIY diabetes technology solutions. August 22, 2018. https://static.diabetesaustralia.com.au/s/fileassets/diabetes-australia/ee67e929-5ffc-411f-b286-1ca69e181d1a.pdf (accessed June 27, 2020).

Juvenile Diabetes Research Foundation UK. JDRF UK’s position statement on type 1 diabetes ‘DIY technologies’. February 19, 2019. https://jdrf.org.uk/about-us/position-statements-reports/position-statements/jdrfs-uk-position-statement-on-type-1-diabetes-diytechnologies (accessed June 27, 2020).

Diabetes UK. Do it yourself (DIY) closed loop for people living with type 1 diabetes: position statement (January 2020). Jan 15, 2020. https://www.diabetes.org.uk/resources-s3/2020-01/DIY%20closed%20looping%20for%20Type%201%20diabetes%20position%20statement.pdf? (accessed June 27, 2020).

Steno Diabetes Center Copenhagen. Guidelines for the use of unauthorized do-it-yourself (DIY) medical technologies for the treatment of diabetes. May 20, 2019. https://www.sdcc.dk/presse-ognyheder/nyheder/Documents/SDCC%20guidelines%20for%20DIY%20medical%20systems-english-version-200519.pdf (accessed June 27, 2020).

Gawrecki A, Klupa T, Araszkiewicz A, et al. Utilization of do-it-yourself artificial pancreas systems in the management of patients with type 1 diabetes: a position statement of the Pump School Education Initiative by Diabetes Poland. Pol Arch Intern Med 2019; 129: 141–2. PubMed

Duke MD, Fredlock AA. Do-it-yourself (DIY) systems in diabetes: a family and provider perspective. J Diabetes Sci Technol 2020; 14: 917–21. PubMed PMC

Wilmot EG, Danne T. DIY artificial pancreas systems: the clinician perspective. Lancet Diabetes Endocrinol 2020; 8: 183–85. PubMed

Crabtree TSJ, Choudhary P, Hammond P, Lumb A, McLay A, Wilmot EG. Health-care professional opinions of DIY artificial pancreas systems in the UK. Lancet Diabetes Endocrinol 2020; 8: 186–87. PubMed

Shaw D, Crabtree TSJ, Hammond P, McLay A, Wilmot EG. The DIY artificial pancreas system: an ethical dilemma for doctors. Diabet Med 2020; 37: 1951–53. PubMed

Barnard KD, Ziegler R, Klonoff DC, et al. Open source closed-loop insulin delivery systems: a clash of cultures or merging of diverse approaches? J Diabetes Sci Technol 2018; 12: 1223–26. PubMed PMC

Heinemann L, Lange K. ‘Do it yourself’ (DIY)-automated insulin delivery (AID) systems: current status from a German point of view. J Diabetes Sci Technol 2019; 14: 1028–34. PubMed PMC

de Bock M The ‘do it yourself’ type 1 diabetes dilemma for medical practitioners. Intern Med J 2019; 49: 559–61. PubMed

Asarani NAM, Reynolds AN, Elbalshy M, et al. Efficacy, safety, and user experience of DIY or open-source artificial pancreas systems: a systematic review. Acta Diabetol 2021; 58: 539–47. PubMed

Crocket H Peer Mentoring in the do-it-yourself artificial pancreas system community. J Diabetes Sci Technol 2020; 14: 1022–27. PubMed PMC

Toffanin C, Kozak M, Sumnik Z, Cobelli C, Petruzelkova L. In Silico Trials of an Open-Source Android-Based Artificial Pancreas: A New Paradigm to Test Safety and Efficacy of Do-It-Yourself Systems. Diabetes Technol Ther 2020; 22: 112–20. PubMed

Lal RA, Maikawa CL, Lewis D, et al. Full closed loop open-source algorithm performance comparison in pigs with diabetes. Clin Transl Med 2021; 11: e387. PubMed PMC

Gawrecki A, Zozulinska-Ziolkiewicz D, Michalak MA, et al. Safety and glycemic outcomes of do-it-yourself AndroidAPS hybrid closed-loop system in adults with type 1 diabetes. PLoS One 2021; 16: e0248965. PubMed PMC

Burnside M, Lewis D, Crocket H, et al. CREATE (Community deRivEd AutomaTEd insulin delivery) trial. Randomised parallel arm open label clinical trial comparing automated insulin delivery using a mobile controller (AnyDANA-loop) with an open-source algorithm with sensor augmented pump therapy in type 1 diabetes. J Diabetes Metab Disord 2020; 19: 1–15. PubMed PMC

Tidepool. Tidepool documents and disclosures: regulatory. October 29, 2011. https://www.tidepool.org/documents (accessed June 27, 2020).

Choi SB, Hong ES, Noh YH. Open artificial pancreas system reduced hypoglycemia and improved glycemic control in patients with type 1 diabetes. Diabetes 2018; 67 (suppl 1): 964–P.

Provenzano V, Guastamacchia E, Brancato D, et al. Closing the loop with OpenAPS in people with type 1 diabetes—experience from Italy. Diabetes 2018; 67 (suppl 1): 993–P.

Wilmot EG, Langeland L, Mclay A, Taylor N, Idris IR. 1067-P: open source artificial pancreas system (APS) vs. combination insulin pump with flash glucose monitoring in adults with type 1 diabetes: an observational study. Diabetes 2019; 68 (suppl 1): 1067–P.

Koutsovasilis A, Sotiropoulos A, Antoniou A, Kordinas V, Papadaki D, Peppas T. 1065-P: the effect of a closed-loop insulin delivery system on glycemic control in type 1 diabetes. Diabetes 2019; 68 (suppl 1): 1065–P.

Bazdarska Y, Iotova V, Mladenov V, et al. Advantages from ‘do-it-yourself’ loops among children and adolescents in Varna’s Diabetes Center. Scr Sci Med 2019; 51: 54–61.

Jeyaventhan R, Gallen G, Choudhary P, Hussain S. A real-world study of user characteristics, safety and efficacy of open-source closed-loop systems and Medtronic 670G. Diabetes Obes Metab 2021; 23: 1989–94. PubMed

Klonoff DC, Gutierrez A, Fleming A, Kerr D. Real-world evidence should be used in regulatory decisions about new pharmaceutical and medical device products for diabetes. J Diabetes Sci Technol 2019; 13: 995–1000. PubMed PMC

Lal RA, Basina M, Maahs DM, Hood K, Buckingham B, Wilson DM. One year clinical experience of the first commercial hybrid closed-loop system. Diabetes Care 2019; 42: 2190–96. PubMed PMC

Look H Tidepool intends to deliver Loop as a supported, FDA-regulated mobile app in the App Store. October 9, 2018. https://www.tidepool.org/blog/tidepool-delivering-loop (accessed June 28, 2020).

Look H Medtronic collaborates on Tidepool Loop. June 8, 2019. https://www.tidepool.org/blog/tidepool-loop-medtronic-collaboration (accessed June 28, 2020).

US Food and Drug Administration. FDA warns against the use of unauthorized devices for diabetes management. May 17, 2019. https://www.fda.gov/news-events/press-announcements/fda-warns-against-use-unauthorized-devices-diabetes-management (accessed June 28, 2020).

US Food and Drug Administration. Correspondence generator. March 27, 2018. https://www.accessdata.fda.gov/cdrh_docs/pdf17/DEN170088.pdf (accessed Feb 17, 2021).

Walsh J, Roberts R, Heinemann L. Confusion regarding duration of insulin action: a potential source for major insulin dose errors by bolus calculators. J Diabetes Sci Technol 2014; 8: 170–78. PubMed PMC

Lal R, Quinlan A, Desborough L, Nykaza E. Optimizing formulas for basal, carb ratio and sensitivity factor for predictive controllers: lessons learned from Loop. The Official Journal of Advanced Technologies & Treatments for Diabetes Conference; June 2–5, 2021. (abstr O008/#282).

Nathan DM, Genuth S, Lachin J, et al. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med 1993; 329: 977–86. PubMed

Hidefjäll P, Berg L. Patient controlled, off-label use of continuous glucose monitoring: real-world medical costs and effects of patient controlled sensor augmented pump therapy in adult patients type 1 diabetes. J Diabetes Sci Technol 2021; 15: 575–81. PubMed PMC

Litchman ML, Wawrzynski SE, Woodruff WS, Arrington JB, Nguyen QC, Gee PM. Continuous glucose monitoring in the real world using photosurveillance of #Dexcom on Instagram: exploratory mixed methods study. JMIR Public Health Surveill 2019; 5: e11024. PubMed PMC

Pease A, Lo C, Earnest A, Kiriakova V, Liew D, Zoungas S. The efficacy of technology in type 1 diabetes: a systematic review, network meta-analysis, and narrative synthesis. Diabetes Technol Ther 2020; 22: 411–21. PubMed

Skorobogatov S Deep dip teardown of tubeless insulin pump. arXiv 2017; published online September 18. 10.17863/CAM.23096 (preprint). DOI

EUR-Lex. Directive 2009/24/EC of the European Parliament and of the Council of 23 April 2009 on the legal protection of computer programs. April 23, 2009. https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=CELEX%3A32009L0024 (accessed Dec 20, 2020).

van den Boom L, Karges B, Auzanneau M, et al. Temporal Trends and contemporary use of insulin pump therapy and glucose monitoring among children, adolescents, and adults with type 1 diabetes between 1995 and 2017. Diabetes Care 2019; 42: 2050–56. PubMed

Elleri D, Allen JM, Nodale M, et al. Automated overnight closed-loop glucose control in young children with type 1 diabetes. Diabetes Technol Ther 2011; 13: 419–24. PubMed

Forlenza GP, Raghinaru D, Cameron F, et al. Predictive hyperglycemia and hypoglycemia minimization: in-home double-blind randomized controlled evaluation in children and young adolescents. Pediatr Diabetes 2018; 19: 420–28. PubMed PMC

Young-Hyman D, de Groot M, Hill-Briggs F, Gonzalez JS, Hood K, Peyrot M. Psychosocial care for people with diabetes: a position statement of the American Diabetes Association. Diabetes Care 2016; 39: 2126–40. PubMed PMC

Sherr JL, Tauschmann M, Battelino T, et al. ISPAD clinical practice consensus guidelines 2018: diabetes technologies. Pediatr Diabetes 2018; 19 (suppl 27): 302–25. PubMed

Naranjo D, Suttiratana SC, Iturralde E, et al. What end users and stakeholders want from automated insulin delivery systems. Diabetes Care 2017; 40: 1453–61. PubMed PMC

Tanenbaum ML, Adams RN, Hanes SJ, et al. Optimal use of diabetes devices: clinician perspectives on barriers and adherence to device use. J Diabetes Sci Technol 2017; 11: 484–92. PubMed PMC

Tanenbaum ML, Hanes SJ, Miller KM, Naranjo D, Bensen R, Hood KK. Diabetes device use in adults with type 1 diabetes: barriers to uptake and potential intervention targets. Diabetes Care 2017; 40: 181–87. PubMed PMC

Quintal A, Messier V, Rabasa-Lhoret R, Racine E. A critical review and analysis of ethical issues associated with the artificial pancreas. Diabetes Metab 2019; 45: 1–10. PubMed PMC

Barnard KD, Wysocki T, Allen JM, et al. Closing the loop overnight at home setting: psychosocial impact for adolescents with type 1 diabetes and their parents. BMJ Open Diabetes Res Care 2014; 2: e000025. PubMed PMC

Weissberg-Benchell J, Hessler D, Polonsky WH, Fisher L. Psychosocial Impact of the bionic pancreas during summer camp. J Diabetes Sci Technol 2016; 10: 840–44. PubMed PMC

Iturralde E, Tanenbaum ML, Hanes SJ, et al. Expectations and attitudes of individuals with type 1 diabetes after using a hybrid closed loop system. Diabetes Educ 2017; 43: 223–32. PubMed PMC

Farrington C, Stewart ZA, Barnard K, Hovorka R, Murphy HR. Experiences of closed-loop insulin delivery among pregnant women with type 1 diabetes. Diabet Med 2017; 34: 1461–69. PubMed

Hendrieckx C, Poole LA, Sharifi A, et al. “It is definitely a game changer”: a qualitative study of experiences with in-home overnight closed-loop technology among adults with type 1 diabetes. Diabetes Technol Ther 2017; 19: 410–16. PubMed

Barnard KD, Wysocki T, Thabit H, et al. Psychosocial aspects of closed- and open-loop insulin delivery: closing the loop in adults with type 1 diabetes in the home setting. Diabet Med 2015; 32: 601–08. PubMed

Farrington C, Stewart Z, Hovorka R, Murphy H. Women’s Experiences of day-and-night closed-loop insulin delivery during type 1 diabetes pregnancy. J Diabetes Sci Technol 2018; 12: 1125–31. PubMed PMC

Lawton J, Blackburn M, Rankin D, et al. Participants’ experiences of, and views about, daytime use of a day-and-night hybrid closed-loop system in real life settings: longitudinal qualitative study. Diabetes Technol Ther 2019; 21: 119–27. PubMed PMC

Young AJ, Thabit H, Heller SR, et al. Holistic impact of closed-loop technology on people with type 1 diabetes. J Diabetes Sci Technol 2015; 9: 932–33. PubMed PMC

Lemieux P, Yamamoto JM, Donovan LE. Do-it-yourself artificial pancreas system use in pregnant women with type 1 diabetes in a real-world setting: 2 case reports. Can J Diabetes 2021; published online January 20. doi:10.1016/j.jcjd.2021.01.006 PubMed DOI

Lind M, Pivodic A, Svensson A-M, Ólafsdóttir AF, Wedel H, Ludvigsson J. HbA1c level as a risk factor for retinopathy and nephropathy in children and adults with type 1 diabetes: Swedish population based cohort study. BMJ 2019; 366: l4894. PubMed PMC

Beck RW, Bergenstal RM, Riddlesworth TD, et al. Validation of time in range as an outcome measure for diabetes clinical trials. Diabetes Care 2019; 42: 400–05. PubMed PMC

Battelino T, Danne T, Bergenstal RM, et al. Clinical targets for continuous glucose monitoring data interpretation: recommendations from the International Consensus on Time in Range. Diabetes Care 2019; 42: 1593–603. PubMed PMC

Foster NC, Beck RW, Miller KM, et al. State of type 1 diabetes management and outcomes from the T1D exchange in 2016–2018. Diabetes Technol Ther 2019; 21: 66–72. PubMed PMC

Jovanovic L, Knopp RH, Brown Z, et al. Declining insulin requirement in the late first trimester of diabetic pregnancy. Diabetes Care 2001; 24: 1130–36. PubMed

Murphy HR. Continuous glucose monitoring targets in type 1 diabetes pregnancy: every 5% time in range matters. Diabetologia 2019; 62: 1123–28. PubMed PMC

Hussain S, Choudhary P, Hopkins D. Type 1 diabetes and fasting in Ramadan: time to rethink classification of risk? Lancet Diabetes Endocrinol 2020; 8: 656–58. PubMed

Lee JM, Newman MW, Gebremariam A, et al. Real-World use and self-reported health outcomes of a patient-designed do-it-yourself mobile technology system for diabetes: lessons for mobile health. Diabetes Technol Ther 2017; 19: 209–19. PubMed

Riddell MC, Gallen IW, Smart CE, et al. Exercise management in type 1 diabetes: a consensus statement. Lancet Diabetes Endocrinol 2017; 5: 377–90. PubMed

Zaharieva DP, Messer LH, Paldus B, O’Neal DN, Maahs DM, Riddell MC. Glucose control during physical activity and exercise using closed loop technology in adults and adolescents with type 1 diabetes. Can J Diabetes 2020; 44: 740–49. PubMed

Braune K, May A, Thurm U. Safe and Successful completion of a half marathon by an adult with type 1 diabetes using a personalized open source artificial pancreas system. J Diabetes Sci Technol 2020; 14: 1137–38. PubMed PMC

A narrative commentary about interoperability in medical devices and data used in diabetes therapy from an academic EU/UK/US perspective

Are all HCL systems the same? long term outcomes of three HCL systems in children with type 1 diabetes: real-life registry-based study