{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,12]],"date-time":"2026-03-12T04:21:01Z","timestamp":1773289261344,"version":"3.50.1"},"reference-count":39,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2019,12,11]],"date-time":"2019-12-11T00:00:00Z","timestamp":1576022400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2019,12,11]],"date-time":"2019-12-11T00:00:00Z","timestamp":1576022400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["npj Digit. Med."],"abstract":"<jats:title>Abstract<\/jats:title><jats:p>Do-it-yourself automated insulin delivery systems for people living with type 1 diabetes use commercially available continuous glucose sensors and insulin pumps linked by unregulated open source software. Uptake of these systems is increasing, with growing evidence suggesting that positive glucose outcomes may be feasible. Increasing interest from people living with, or affected by, type 1 diabetes presents challenges to healthcare professionals, device manufacturers and regulators as the legal, governance and risk frameworks for such devices are not defined. We discuss the data, education, policy, technology and medicolegal obstacles to wider implementation of DIY systems and outline the next steps required for a co-ordinated approach to reducing variation in access to a technology that has potential to enable glucose self-management closer to target.<\/jats:p>","DOI":"10.1038\/s41746-019-0202-1","type":"journal-article","created":{"date-parts":[[2019,12,11]],"date-time":"2019-12-11T12:44:58Z","timestamp":1576068298000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":23,"title":["Open source automated insulin delivery: addressing the challenge"],"prefix":"10.1038","volume":"2","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-3525-3633","authenticated-orcid":false,"given":"Nick","family":"Oliver","sequence":"first","affiliation":[]},{"given":"Monika","family":"Reddy","sequence":"additional","affiliation":[]},{"given":"Claire","family":"Marriott","sequence":"additional","affiliation":[]},{"given":"Tomas","family":"Walker","sequence":"additional","affiliation":[]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2493-1304","authenticated-orcid":false,"given":"Lutz","family":"Heinemann","sequence":"additional","affiliation":[]}],"member":"297","published-online":{"date-parts":[[2019,12,11]]},"reference":[{"key":"202_CR1","unstructured":"Diabetes U. K. DIY Closed Loop for people living with type 1 diabetes Position Statement. Available at: https:\/\/www.diabetes.org.uk\/resources-s3\/2019-08\/DIY-closed-looping-for-Type-1-diabetes-position-statement.pdf. (Accessed 16th Sep 2019)."},{"key":"202_CR2","unstructured":"People with type 1 diabetes and Do It Yourself (DIY) technology solutions. Diabetes Australia (2019). Available at: https:\/\/static.diabetesaustralia.com.au\/s\/fileassets\/diabetes-australia\/ee67e929-5ffc-411f-b286-1ca69e181d1a.pdf. (Accessed 5th Mar 2019)."},{"key":"202_CR3","unstructured":"JDRF\u2019s UK Position Statement on type 1 diabetes \u2018DIY\u2019 technologies. JDRF UK (2019). Available at: https:\/\/jdrf.org.uk\/about-us\/position-statements-reports\/position-statements\/jdrfs-uk-position-statement-on-type-1-diabetes-diy-technologies\/. (Accessed 5th Mar 2019)."},{"key":"202_CR4","unstructured":"Ypsomed partners with JDRF to develop new open technologies for next-generation automated insulin delivery (AID) systems. Available at: https:\/\/www.jdrf.org\/press-releases\/ypsomed-partners-with-jdrf-to-develop-new-open-technologies-for-next-generation-automated-insulin-delivery-aid-systems\/. (Accessed 21st Mar 2019)."},{"key":"202_CR5","doi-asserted-by":"publisher","first-page":"1411","DOI":"10.1177\/1932296816665635","volume":"10","author":"D Lewis","year":"2016","unstructured":"Lewis, D. & Leibrand, S. Real-World use of open source artificial pancreas systems. J. Diabetes Sci. Technol. 10, 1411 (2016).","journal-title":"J. Diabetes Sci. Technol."},{"issue":"4","key":"202_CR6","doi-asserted-by":"publisher","first-page":"790","DOI":"10.1177\/1932296818808307","volume":"13","author":"Dana Lewis","year":"2018","unstructured":"Lewis, D. History and Perspective on DIY Closed Looping. J. Diabetes Sci. Technol. (2018). https:\/\/doi.org\/10.1177\/1932296818808307.","journal-title":"Journal of Diabetes Science and Technology"},{"issue":"2","key":"202_CR7","doi-asserted-by":"publisher","first-page":"164","DOI":"10.1177\/1932296818795705","volume":"13","author":"Michelle L. Litchman","year":"2018","unstructured":"Litchman, M. L., Lewis, D., Kelly, L. A. & Gee, P. M. Twitter Analysis of #OpenAPS DIY Artificial Pancreas Technology Use Suggests Improved A1C and Quality of Life. J. Diabetes Sci. Technol. (2018). https:\/\/doi.org\/10.1177\/1932296818795705.","journal-title":"Journal of Diabetes Science and Technology"},{"key":"202_CR8","doi-asserted-by":"publisher","first-page":"332","DOI":"10.1016\/S2213-8587(16)30397-7","volume":"5","author":"C Farrington","year":"2017","unstructured":"Farrington, C. Hacking diabetes: DIY artificial pancreas systems. Lancet Diabetes Endocrinol. 5, 332 (2017).","journal-title":"Lancet Diabetes Endocrinol."},{"issue":"10","key":"202_CR9","doi-asserted-by":"publisher","first-page":"2333","DOI":"10.1111\/dom.13810","volume":"21","author":"Andreas Melmer","year":"2019","unstructured":"Melmer, A. et al. Glycemic Control in Individuals with Type 1 Diabetes Using an Open Source Artificial Pancreas System (OpenAPS). Diabetes, Obes. Metab. dom. 13810 (2019). https:\/\/doi.org\/10.1111\/dom.13810.","journal-title":"Diabetes, Obesity and Metabolism"},{"key":"202_CR10","unstructured":"The Open Project. Available at: https:\/\/open-diabetes.eu\/. (Accessed 16th Sep 2019)."},{"key":"202_CR11","doi-asserted-by":"publisher","first-page":"533","DOI":"10.1177\/1932296817730083","volume":"12","author":"D Lewis","year":"2018","unstructured":"Lewis, D. Setting expectations for successful artificial pancreas\/hybrid closed loop\/automated insulin delivery adoption. J. Diabetes Sci. Technol. 12, 533\u2013534 (2018).","journal-title":"J. Diabetes Sci. Technol."},{"key":"202_CR12","unstructured":"OpenAPS Data Commons. Available at: https:\/\/openaps.org\/outcomes\/data-commons\/. (Accessed 14th Mar 2019)."},{"key":"202_CR13","doi-asserted-by":"publisher","first-page":"1270","DOI":"10.2337\/diacare.26.4.1270","volume":"26","author":"S Gudbjornsdottir","year":"2003","unstructured":"Gudbjornsdottir, S. The National Diabetes Register in Sweden. Diabetes Care 26, 1270\u20131276 (2003).","journal-title":"Diabetes Care"},{"key":"202_CR14","unstructured":"FDA Warns People with Diabetes and Health Care Providers Against the Use of Devices for Diabetes Management Not Authorized for Sale in the United States: FDA Safety Communication. Available at: https:\/\/www.fda.gov\/medical-devices\/safety-communications\/fda-warns-people-diabetes-and-health-care-providers-against-use-devices-diabetes-management-not. (Accessed 25th July 2019)."},{"key":"202_CR15","first-page":"1","volume":"8","author":"HJ Curtis","year":"2018","unstructured":"Curtis, H. J. & Goldacre, B. OpenPrescribing: Normalised data and software tool to research trends in English NHS primary care prescribing 1998\u20132016. BMJ Open 8, 1\u201310 (2018).","journal-title":"BMJ Open"},{"key":"202_CR16","doi-asserted-by":"publisher","first-page":"719","DOI":"10.1111\/jep.12703","volume":"23","author":"L Perry","year":"2017","unstructured":"Perry, L. et al. Supporting patients with type 1 diabetes using continuous subcutaneous insulin infusion therapy: difficulties, disconnections, and disarray. J. Eval. Clin. Pract. 23, 719\u2013724 (2017).","journal-title":"J. Eval. Clin. Pract."},{"key":"202_CR17","doi-asserted-by":"publisher","first-page":"1277","DOI":"10.1177\/1932296816646798","volume":"10","author":"S James","year":"2016","unstructured":"James, S., Perry, L., Gallagher, R. & Lowe, J. Diabetes Educators\u2019 intended and reported use of common diabetes-related technologies: discrepancies and dissonance. J. Diabetes Sci. Technol. 10, 1277\u20131286 (2016).","journal-title":"J. Diabetes Sci. Technol."},{"key":"202_CR18","doi-asserted-by":"publisher","first-page":"746","DOI":"10.1136\/bmj.325.7367.746","volume":"325","author":"DS Group","year":"2002","unstructured":"Group, D. S. Training in flexible, intensive insulin management to enable dietary freedom in people with Type 1 diabetes: dose adjustment for normal eating (DAFNE) randomized controlled trial. BMJ 325, 746 (2002).","journal-title":"BMJ"},{"key":"202_CR19","unstructured":"NICE. NG17: Type 1 diabetes in adults: diagnosis and management. 1\u201385 (2015)."},{"key":"202_CR20","doi-asserted-by":"publisher","first-page":"S38","DOI":"10.2337\/dc18-S004","volume":"41","author":"D Care","year":"2018","unstructured":"Care, D. & Suppl, S. S. Lifestyle management: standards of medical care in Diabetes 2018. Diabetes Care 41, S38\u2013S50 (2018).","journal-title":"Diabetes Care"},{"key":"202_CR21","doi-asserted-by":"publisher","first-page":"3922","DOI":"10.1210\/jc.2016-2534","volume":"101","author":"AL Peters","year":"2016","unstructured":"Peters, A. L. et al. Diabetes technology-continuous subcutaneous insulin infusion therapy and continuous glucose monitoring in adults: an endocrine society clinical practice guideline. J. Clin. Endocrinol. Metab. 101, 3922\u20133937 (2016).","journal-title":"J. Clin. Endocrinol. Metab."},{"key":"202_CR22","doi-asserted-by":"publisher","first-page":"75","DOI":"10.1111\/pedi.12762","volume":"19","author":"H Phelan","year":"2018","unstructured":"Phelan, H. et al. ISPAD Clinical Practice Consensus Guidelines 2018: diabetes education in children and adolescents. Pediatr. Diabetes 19, 75\u201383 (2018).","journal-title":"Pediatr. Diabetes"},{"key":"202_CR23","doi-asserted-by":"publisher","first-page":"1","DOI":"10.3310\/pgfar02050","volume":"2","author":"S Heller","year":"2014","unstructured":"Heller, S. et al. Improving management of type 1 diabetes in the UK: the Dose Adjustment For Normal Eating (DAFNE) programme as a research test-bed. A mixed-method analysis of the barriers to and facilitators of successful diabetes self-management, a health economic analys. Program. Grants Appl. Res. 2, 1\u2013188 (2014).","journal-title":"Program. Grants Appl. Res."},{"key":"202_CR24","doi-asserted-by":"publisher","first-page":"1407","DOI":"10.1001\/jama.2016.11708","volume":"316","author":"RM Bergenstal","year":"2016","unstructured":"Bergenstal, R. M. et al. Safety of a hybrid closed-loop insulin delivery system in patients with type 1 diabetes. JAMA 316, 1407 (2016).","journal-title":"JAMA"},{"issue":"11","key":"202_CR25","doi-asserted-by":"publisher","first-page":"1617","DOI":"10.1111\/dme.13766","volume":"35","author":"R. Perera","year":"2018","unstructured":"Perera, R., Oliver, N., Wilmot, E. & Marriott, C. Variations in access to and reimbursement for continuous glucose monitoring systems for people living with Type 1 diabetes across England. Diabet. Med. 0\u20133 (2018). https:\/\/doi.org\/10.1111\/dme.13766.","journal-title":"Diabetic Medicine"},{"key":"202_CR26","unstructured":"arXiv.org. Available at: arXiv.org. (Accessed 5th Mar 2019)."},{"key":"202_CR27","unstructured":"bioRxiv.org. Available at: www.biorxiv.org. (Accessed 5th Mar 2019)."},{"key":"202_CR28","doi-asserted-by":"publisher","first-page":"44","DOI":"10.1177\/193229680900300106","volume":"3","author":"BP Kovatchev","year":"2009","unstructured":"Kovatchev, B. P., Breton, M., Man, C. D. & Cobelli, C. In silico preclinical trials: a proof of concept in closed-loop control of type 1 diabetes. J. Diabetes Sci. Technol. 3, 44\u201355 (2009).","journal-title":"J. Diabetes Sci. Technol."},{"key":"202_CR29","doi-asserted-by":"publisher","first-page":"31","DOI":"10.1055\/a-0801-1112","volume":"14","author":"L Heinemann","year":"2019","unstructured":"Heinemann, L. & Lange, K. Do it yourself (DIY) Automated Insulin Delivery (AID) Systems: Stand der Dinge. Diabetologie 14, 31\u201343 (2019).","journal-title":"Diabetologie"},{"key":"202_CR30","unstructured":"iCGM Definition. Available at: https:\/\/www.accessdata.fda.gov\/cdrh_docs\/pdf17\/DEN170088.pdf. (Accessed 5th Mar 2019)."},{"key":"202_CR31","unstructured":"ACE insulin pump definition. Available at: https:\/\/www.accessdata.fda.gov\/cdrh_docs\/pdf18\/DEN180058.pdf. (Accessed 5th Mar 2019)."},{"key":"202_CR32","unstructured":"These Hackers Made an App that Kills to Prove a Point. Available at: https:\/\/www.wired.com\/story\/medtronic-insulin-pump-hack-app\/. (Accessed 7th Aug 2019)."},{"key":"202_CR33","unstructured":"MINIMEDTM 508 AND MINIMEDTM PARADIGMTM SERIES INSULIN PUMPS SECURITY BULLETIN. Available at: https:\/\/global.medtronic.com\/xg-en\/product-security\/security-bulletins\/minimed-508-paradigm.html. (Accessed 7th Aug 2019)."},{"key":"202_CR34","unstructured":"Tidepool intends to deliver Loop as a supported, FDA-regulated mobile app in the App Store. Available at: https:\/\/tidepool.org\/blog\/tidepool-delivering-loop. (Accessed 13th Mar 2019)."},{"key":"202_CR35","first-page":"dc181444","volume":"42","author":"RM Bergenstal","year":"2018","unstructured":"Bergenstal, R. M. et al. Validation of time in range as an outcome measure for diabetes clinical trials. Diabetes Care 42, dc181444 (2018).","journal-title":"Diabetes Care"},{"key":"202_CR36","doi-asserted-by":"publisher","first-page":"155","DOI":"10.2337\/dc16-2215","volume":"40","author":"IHS Group","year":"2017","unstructured":"Group, I. H. S. Glucose Concentrations of Less Than 3.0\u2009mmol\/L (54 mg\/dL) Should Be Reported in Clinical Trials: A Joint Position Statement of the American Diabetes Association and the European Association for the Study of Diabetes: Table 1. Diabetes Care 40, 155\u2013157 (2017).","journal-title":"Diabetes Care"},{"key":"202_CR37","unstructured":"MHRA Medical Device Advrese Incident Reporting. Available at: https:\/\/yellowcard.mhra.gov.uk\/devices\/. (Accessed 13th Mar 2019)."},{"key":"202_CR38","unstructured":"EUDAMED: European Database on Medical Devices. Available at: http:\/\/ec.europa.eu\/idabc\/en\/document\/2256\/5637.html. (Accessed 21st Mar 2019)."},{"key":"202_CR39","unstructured":"MAUDE - Manufacturer and User Facility Device Experience. Available at: https:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfmaude\/search.cfm. (Accessed 13th Mar 2019)."}],"container-title":["npj Digital Medicine"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.nature.com\/articles\/s41746-019-0202-1.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/www.nature.com\/articles\/s41746-019-0202-1","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/www.nature.com\/articles\/s41746-019-0202-1.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2022,12,17]],"date-time":"2022-12-17T18:35:53Z","timestamp":1671302153000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.nature.com\/articles\/s41746-019-0202-1"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2019,12,11]]},"references-count":39,"journal-issue":{"issue":"1","published-online":{"date-parts":[[2019,12]]}},"alternative-id":["202"],"URL":"https:\/\/doi.org\/10.1038\/s41746-019-0202-1","relation":{},"ISSN":["2398-6352"],"issn-type":[{"value":"2398-6352","type":"electronic"}],"subject":[],"published":{"date-parts":[[2019,12,11]]},"assertion":[{"value":"16 September 2019","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"14 November 2019","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"11 December 2019","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"N.O. has received honoraria for speaking, and research funding for investigator-initiated studies from Dexcom; has received honoraria for participation in advice boards, and research funding from Roche Diabetes Care GmbH. M.R. has received research funding for an investigator-initiated study from Dexcom. C.M. is an employee of Roche Diabetes Care. T.W. is an employee of Dexcom. L.H. is a shareholder at Profil Institut f\u00fcr Stoffwechselforschung, Neuss, Germany and ProSciento, San Diego, US. He is a member of a number of advisory boards for companies developing novel diagnostic and therapeutic options for diabetes therapy (Becton Dickinson, Lifecare, Sanofi, Roche Diabetes Care).","order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"124"}}