Closed-loop control in insulin pumps for type-1 diabetes mellitus: safety and efficacy

References

• 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(14):977–986. Epub 1993/09/30. PubMed PMID: 8366922.
   PubMed Web of Science ®Google Scholar
• Dovc K, Boughton C, Tauschmann M, et al. Young children have higher variability of insulin requirements: observations during hybrid closed-loop insulin delivery. Diabetes Care. 2019;42(7):1344–1347. Epub 2019/06/22. PubMed PMID: 31221700; PubMed Central PMCID: PMCPMC6609966.
   PubMed Web of Science ®Google Scholar
• Ruan Y, Thabit H, Leelarathna L, et al. Variability of insulin requirements over 12 weeks of closed-loop insulin delivery in adults with type 1 Diabetes. Diabetes Care. 2016;39(5):830–832. Epub 2016/03/12. PubMed PMID: 26965717.
   PubMed Web of Science ®Google Scholar
• Miller KM, Foster NC, Beck RW, et al. Current state of type 1 diabetes treatment in the U.S.: updated data from the T1D exchange clinic registry. Diabetes Care. 2015;38(6):971–978. Epub 2015/05/23. PubMed PMID: 25998289.
   PubMed Web of Science ®Google Scholar
• Boughton CK, Hovorka R. Is an artificial pancreas (closed-loop system) for Type 1 diabetes effective? Diabet Med. 2019;36(3):279–286. Epub 2018/09/06. PubMed PMID: 30183096.
   PubMed Web of Science ®Google Scholar
• Tauschmann M, Hovorka R. Technology in the management of type 1 diabetes mellitus - current status and future prospects. Nat Rev Endocrinol. 2018;14(8):464–475. Epub 2018/06/28. PubMed PMID: 29946127.
   PubMed Web of Science ®Google Scholar
• Forlenza GP, Li Z, Buckingham BA, et al. Predictive low-glucose suspend reduces hypoglycemia in adults, adolescents, and children with type 1 diabetes in an at-home randomized crossover study: results of the PROLOG trial. Diabetes Care. 2018;41(10):2155–2161. PubMed PMID: 30089663.
   PubMed Web of Science ®Google Scholar
• Bergenstal RM, Klonoff DC, Garg SK, et al. Threshold-based insulin-pump interruption for reduction of hypoglycemia. N Engl J Med. 2013;369(3):224–232. Epub 2013/06/25. PubMed PMID: 23789889.
   PubMed Web of Science ®Google Scholar
• 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(3):420–428. PubMed PMID: 29159870.
   PubMed Web of Science ®Google Scholar
• Spaic T, Driscoll M, Raghinaru D, et al. Predictive hyperglycemia and hypoglycemia minimization: in-home evaluation of safety, feasibility, and efficacy in overnight glucose control in type 1 diabetes. Diabetes Care. 2017;40(3):359–366. Epub 2017/01/20. PubMed PMID: 28100606; PubMed Central PMCID: PMCPMC5319476.
   PubMed Web of Science ®Google Scholar
• Hovorka R, Kumareswaran K, Harris J, et al. Overnight closed loop insulin delivery (artificial pancreas) in adults with type 1 diabetes: crossover randomised controlled studies. BMJ. 2011;342:d1855. Epub 2011/04/16. PubMed PMID: 21493665; PubMed Central PMCID: PMCPMC3077739.
   PubMedGoogle Scholar
• Hovorka R, Elleri D, Thabit H, et al. Overnight closed-loop insulin delivery in young people with type 1 diabetes: a free-living, randomized clinical trial. Diabetes Care. 2014;37(5):1204–1211. Epub 2014/04/24. PubMed PMID: 24757227; PubMed Central PMCID: PMCPMC3994941.
   PubMed Web of Science ®Google Scholar
• Clarke WL, Anderson S, Breton M, et al. Closed-loop artificial pancreas using subcutaneous glucose sensing and insulin delivery and a model predictive control algorithm: the Virginia experience. J Diabetes Sci Technol. 2009;3(5):1031–1038. Epub 2010/02/11. PubMed PMID: 20144416; PubMed Central PMCID: PMCPMC2769907.
   PubMedGoogle Scholar
• Nimri R, Muller I, Atlas E, et al. MD-Logic overnight control for 6 weeks of home use in patients with type 1 diabetes: randomized crossover trial. Diabetes Care. 2014;37(11):3025–3032.
   PubMed Web of Science ®Google Scholar
• Phillip M, Battelino T, Atlas E, et al. Nocturnal glucose control with an artificial pancreas at a diabetes camp. N Engl J Med. 2013;368(9):824–833. Epub 2013/03/01. PubMed PMID: 23445093.
   PubMed Web of Science ®Google Scholar
• Kropff J, Del Favero S, Place J, et al. 2 month evening and night closed-loop glucose control in patients with type 1 diabetes under free-living conditions: a randomised crossover trial. Lancet Diabetes Endocrinol. 2015;3(12):939–947.
   PubMed Web of Science ®Google Scholar
• 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(6):1001–1007. Epub 2019/09/01. PubMed PMID: 31470740; PubMed Central PMCID: PMCPMC6835195.
   PubMedGoogle Scholar
• Breton MD, Chernavvsky DR, Forlenza GP, et al. Closed-loop control during intense prolonged outdoor exercise in adolescents with type 1 diabetes: the artificial pancreas ski study. Diabetes Care. 2017;40(12):1644–1650. Epub 2017/09/01. PubMed PMID: 28855239; PubMed Central PMCID: PMCPMC5711335.
   PubMed Web of Science ®Google Scholar
• Lal RA, Ekhlaspour L, Hood K, et al. Realizing a closed-loop (Artificial Pancreas) system for the treatment of type 1 diabetes. Endocr Rev. 2019;40(6):1521–1546. Epub 2019/07/06. PubMed PMID: 31276160; PubMed Central PMCID: PMCPMC6821212.
   PubMed Web of Science ®Google Scholar
• Ekhlaspour L, Forlenza GP, Chernavvsky D, et al. Closed loop control in adolescents and children during winter sports: use of the tandem control-IQ AP system. Pediatr Diabetes. 2019;20(6):759–768. Epub 2019/05/18. PubMed PMID: 31099946; PubMed Central PMCID: PMCPMC6679803.
   PubMed Web of Science ®Google Scholar
• Bekiari E, Kitsios K, Thabit H, et al. Artificial pancreas treatment for outpatients with type 1 diabetes: systematic review and meta-analysis. BMJ. 2018;361:k1310. Epub 2018/04/20. PubMed PMID: 29669716; PubMed Central PMCID: PMCPMC5902803.
   PubMed Web of Science ®Google Scholar
• Weisman A, Bai J-W, Cardinez M, et al. Effect of artificial pancreas systems on glycaemic control in patients with type 1 diabetes: a systematic review and meta-analysis of outpatient randomised controlled trials. Lancet Diabetes Endocrinol. 2017;5(7):501–512.
   PubMed Web of Science ®Google Scholar
• Pickup JC. Is insulin pump therapy effective in type 1 diabetes? Diabet Med. 2019;36(3):269–278. Epub 2018/08/12. PubMed PMID: 30098219.
   PubMed Web of Science ®Google Scholar
• Misso ML, Egberts KJ, Page M, et al. Continuous subcutaneous insulin infusion (CSII) versus multiple insulin injections for type 1 diabetes mellitus. Cochrane Database Syst Rev. 2010;(1):CD005103. Epub 2010/01/22. DOI:10.1002/14651858.CD005103.pub2. PubMed PMID: 20091571.
   PubMed Web of Science ®Google Scholar
• Johnson SR, Cooper MN, Jones TW, et al. Long-term outcome of insulin pump therapy in children with type 1 diabetes assessed in a large population-based case-control study. Diabetologia. 2013;56(11):2392–2400. Epub 2013/08/22. PubMed PMID: 23963323.
   PubMed Web of Science ®Google Scholar
• Dovc K, Battelino T. Evolution of diabetes technology. Endocrinol Metab Clin N Am. 2019. DOI:10.1016/j.ecl.2019.10.009
   PubMed Web of Science ®Google Scholar
• Danne T, Nimri R, Battelino T, et al. International consensus on use of continuous glucose monitoring. Diabetes Care. 2017;40(12):1631–1640. Epub 2017/11/23. PubMed PMID: 29162583; PubMed Central PMCID: PMCPMC6467165.
   PubMed Web of Science ®Google Scholar
• Shah VN, Laffel LM, Wadwa RP, et al. Performance of a factory-calibrated real-time continuous glucose monitoring system utilizing an automated sensor applicator. Diabetes Technol Ther. 2018;20(6):428–433. Epub 2018/06/21. PubMed PMID: 29923775; PubMed Central PMCID: PMCPMC6422005.
   PubMed Web of Science ®Google Scholar
• Thabit H, Hovorka R. Coming of age: the artificial pancreas for type 1 diabetes. Diabetologia. 2016;59(9):1795–1805. Epub 2016/07/02. PubMed PMID: 27364997; PubMed Central PMCID: PMCPMC4969330.
   PubMed Web of Science ®Google Scholar
• Pinsker JE, Lee JB, Dassau E, et al. Randomized crossover comparison of personalized MPC and PID control algorithms for the artificial pancreas. Diabetes Care. 2016;39(7):1135–1142. Epub 2016/06/12. PubMed PMID: 27289127; PubMed Central PMCID: PMCPMC4915560.
   PubMed Web of Science ®Google Scholar
• Atlas E, Nimri R, Miller S, et al. Logic artificial pancreas system: a pilot study in adults with type 1 diabetes. Diabetes Care. 2010;33(5):1072–1076.
   PubMed Web of Science ®Google Scholar
• Beck RW, Connor CG, Mullen DM, et al. The fallacy of average: how using HbA1c alone to assess glycemic control can be misleading. Diabetes Care. 2017;40(8):994–999. PubMed PMID: 28733374; PubMed Central PMCID: PMCPMC5521971.
   PubMed Web of Science ®Google Scholar
• 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(3):400–405. PubMed PMID: WOS:000459181200020.
   PubMed Web of Science ®Google Scholar
• 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(8):1593–1603. Epub 2019/06/10. PubMed PMID: 31177185; PubMed Central PMCID: PMCPMC6973648.
   PubMed Web of Science ®Google Scholar
• Medtronic. CALIBRATING YOUR SENSOR - device: miniMed™ 670G insulin pump (MMT-1780K). 2020 Feb 13. Available from: http://www.medtronicdiabetes.com/customer-support/minimed-670g-system-support/cgm-calibrating
   Google Scholar
• 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(3):155–163. PubMed PMID: WOS:000396223600005 Pivotal Trial.
   PubMed Web of Science ®Google Scholar
• Bergenstal RM, Garg S, Weinzimer SA, et al. Safety of a hybrid closed-loop insulin delivery system in patients with type 1 diabetes. JAMA. 2016;316(13):1407–1408. Epub 2016/09/16. PubMed PMID: 27629148.
   PubMed Web of Science ®Google Scholar
• Akturk HK, Giordano D, Champakanath A, et al. Long-term real-life glycemic outcomes with hybrid closed-loop system when compared with sensor-augmented pump therapy in patients with type 1 diabetes. Diabetes Obes Metab. 2019. Epub 2019/12/04. DOI:10.1111/dom.13933. PubMed PMID: 31789447.
   Web of Science ®Google Scholar
• 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):11–19. PubMed PMID: 30585770; PubMed Central PMCID: PMCPMC6350071.
   PubMed Web of Science ®Google Scholar
• 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(8):448–451. Epub 2019/06/06. PubMed PMID: 31166801.
   PubMed Web of Science ®Google Scholar
• de Bock M, McAuley SA, Abraham MB, et al. Effect of 6 months hybrid closed-loop insulin delivery in young people with type 1 diabetes: a randomised controlled trial protocol. BMJ Open. 2018;8(8):e020275. Epub 2018/08/15. PubMed PMID: 30104309; PubMed Central PMCID: PMCPMC6091910.
   PubMedGoogle Scholar
• Medtronic Diabetes. Multi-center trial in adult and pediatric patients with type 1 diabetes using hybrid closed loop system and control at home. NIH US National Library of Medicine - ClinicalTrials.gov; 2019 Jan 23. Available from: https://clinicaltrials.gov/ct2/show/NCT02748018?term=Medtronic&recrs=abdf&cond=Type+1+Diabetes&draw=2&rank=7
   Google Scholar
• Lee MH, Vogrin S, Paldus B, et al. Glucose control in adults with type 1 diabetes using a Medtronic prototype enhanced-hybrid closed-loop system: A feasibility study. Diabetes Technol Ther. 2019;21(9):499–506. Epub 2019/07/03. PubMed PMID: 31264889.
   PubMed Web of Science ®Google Scholar
• FDA authorizes first interoperable, automated insulin dosing controller designed to allow more choices for patients looking to customize their individual diabetes management device system. 2019 Jan 5. Available from: https://www.fda.gov/news-events/press-announcements/fda-authorizes-first-interoperable-automated-insulin-dosing-controller-designed-allow-more-choices
   Google Scholar
• Anderson SM, Raghinaru D, Pinsker JE, et al. Multinational home use of closed-loop control is safe and effective. Diabetes Care. 2016;39(7):1143–1150. Epub 2016/05/22. PubMed PMID: 27208316; PubMed Central PMCID: PMCPMC5876016.
   PubMed Web of Science ®Google Scholar
• Kovatchev B, Cheng P, Anderson SM, et al. Feasibility of long-term closed-loop control: A multicenter 6-month trial of 24/7 automated insulin delivery. Diabetes Technol Ther. 2017;19(1):18–24. Epub 2016/12/17. PubMed PMID: 27982707.
   PubMed Web of Science ®Google Scholar
• Kovatchev BP, Kollar L, Anderson SM, et al. Evening and overnight closed-loop control versus 24/7 continuous closed-loop control for type 1 diabetes: a randomised crossover trial. Lancet Digit Health. 2020;2(2):E64–E73. PubMed PMID: WOS:000525879600010.
   PubMedGoogle Scholar
• Kovatchev B, Anderson SM, Raghinaru D, et al. Randomized controlled trial of mobile closed-loop control. Diabetes Care. 2020;43:607–615. Epub 2020/01/16. PubMed PMID: 31937608.
   Web of Science ®Google Scholar
• 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(18):1707–1717. Epub 2019/10/17. PubMed PMID: 31618560.
   PubMed Web of Science ®Google Scholar
• Brown S, Raghinaru D, Emory E, et al. First look at control-IQ: a new-generation automated insulin delivery system. Diabetes Care. 2018;41(12):2634–2636. Epub 2018/10/12. PubMed PMID: 30305346; PubMed Central PMCID: PMCPMC6245207.
   PubMed Web of Science ®Google Scholar
• JDRF. World’s first artificial pancreas app licensed for people with type 1 diabetes in the UK. 2020 June 6. Available from: https://jdrf.org.uk/news/worlds-first-artificial-pancreas-app-licensed-for-people-with-type-1-diabetes-in-the-uk/
   Google Scholar
• Bally L, Thabit H, Kojzar H, et al. Day-and-night glycaemic control with closed-loop insulin delivery versus conventional insulin pump therapy in free-living adults with well controlled type 1 diabetes: an open-label, randomised, crossover study. Lancet Diabetes Endocrinol. 2017;5(4):261–270.
   PubMed Web of Science ®Google Scholar
• Tauschmann M, Allen JM, Wilinska ME, et al. Home use of day-and-night hybrid closed-loop insulin delivery in suboptimally controlled adolescents with type 1 diabetes: A 3-week, free-living, randomized crossover trial. Diabetes Care. 2016;39(11):2019–2025. Epub 2016/09/11. PubMed PMID: 27612500; PubMed Central PMCID: PMCPMC5079605.
   PubMed Web of Science ®Google Scholar
• Tauschmann M, Allen JM, Nagl K, et al. Home use of day-and-night hybrid closed-loop insulin delivery in very young children: a multi-center, 3-week, randomized trial. Diabetes Care. 2019;42(4):594–600. PubMed PMID: WOS:000461816500025.
   PubMed Web of Science ®Google Scholar
• Thabit H, Tauschmann M, Allen JM, et al. Home use of an artificial beta cell in type 1 diabetes. N Engl J Med. 2015;373(22):2129–2140. Epub 2015/09/18. PubMed PMID: 26379095; PubMed Central PMCID: PMCPMC4697362.
   PubMed Web of Science ®Google Scholar
• 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(10155):1321–1329. Epub 2018/10/08. PubMed PMID: 30292578; PubMed Central PMCID: PMCPMC6182127.
   PubMed Web of Science ®Google Scholar
• Hovorka R Closed loop from onset in type 1 diabetes (CLOuD) - NCT02871089: clinical Trials.gov. 2019 [cited 2020 Feb 13]. Available from: https://clinicaltrials.gov/ct2/show/NCT02871089?term=cloud&cond=Diabetes&draw=2&rank=1
   Google Scholar
• JCfHR. Day and night closed-loop in young people with type 1 diabetes (DAN05) - NCT02925299: clinical Trials.gov. 2020 Feb 13. Available from: https://clinicaltrials.gov/ct2/show/NCT02925299?term=dan05&cond=Diabetes&draw=2&rank=1
   Google Scholar
• Hovorka R The artificial pancreas in very young children with T1D (KidsAP02) - NCT03784027: clinical Trials.gov. 2019 [cited 2020 Feb 13]. Available from: https://clinicaltrials.gov/ct2/show/NCT03784027?term=kidsap02&cond=Diabetes&draw=2&rank=1
   Google Scholar
• Hovorka R 24/7 closed-loop in older subjects with type 1 diabetes (DAN06) - NCT04025762: clinical Trials.gov. 2019 [cited 2020 Feb 13]. Available from: https://clinicaltrials.gov/ct2/show/NCT04025762?term=camaps+fx&cond=Diabetes&draw=2&rank=3
   Google Scholar
• Hovorka R Closing the loop in adults with type 1 diabetes under free living conditions (AP@Home04_P3) - NCT04055480: clinical Trials.gov. 2020 [cited 2020 Feb 13]. Available from: https://clinicaltrials.gov/ct2/show/NCT04055480?term=Hovorka+closed+loop&cond=Diabetes&draw=2&rank=5
   Google Scholar
• Benhamou PY, Huneker E, Franc S, et al. Customization of home closed-loop insulin delivery in adult patients with type 1 diabetes, assisted with structured remote monitoring: the pilot WP7 diabeloop study. Acta Diabetol. 2018;55(6):549–556. Epub 2018/03/10. PubMed PMID: 29520615.
   PubMed Web of Science ®Google Scholar
• Diabeloop SA Who can use the DBLG1 system? 2019 [cited 2020 Jan 15]. Available from: https://support.diabeloop.com/hc/en-us/articles/360024497034-Who-can-use-the-DBLG1-System
   Google Scholar
• Benhamou P, Franc S. Closed-loop insulin delivery in adults with type 1 diabetes in real-life conditions: a 12-week multicentre, open-label randomised controlled crossover trial. Lancet Digital Health. 2019;1:e17-e25.
   PubMedGoogle Scholar
• Centre d’Etudes et de Recherche pour l’Intensification du Traitement du Diabète. Safety assessment of DBLUS system in adolescent and adult patients with type 1 diabetes and assessment of its clinical efficacy (DIABELOOP SP8) (DIABELOOP SP8) - NCT04190277: clinical Trials.gov. 2019 [cited 2020 Feb 13]. Available from: https://clinicaltrials.gov/ct2/show/NCT04190277?term=diabeloop&cond=Diabetes&draw=2&rank=1
   Google Scholar
• Centre d’Etudes et de Recherche pour l’Intensification du Traitement du Diabète. Diabeloop for kids (DBL4K) - NCT03671915: clinical Trials.gov. 2019 [cited 2020 Feb 13]. Available from: https://clinicaltrials.gov/ct2/show/NCT03671915?term=diabeloop&cond=Diabetes&draw=2&rank=5
   Google Scholar
• Buckingham BA, Forlenza GP, Pinsker JE, et al. Safety and feasibility of the OmniPod hybrid closed-loop system in adult, adolescent, and pediatric patients with type 1 diabetes using a personalized model predictive control algorithm. Diabetes Technol Ther. 2018;20(4):257–262. PubMed PMID: 29431513; PubMed Central PMCID: PMCPMC5910038.
   PubMed Web of Science ®Google Scholar
• Sherr JL, Buckingham BA, Forlenza GP, et al. Safety and performance of the omnipod hybrid closed-loop system in adults, adolescents, and children with type 1 diabetes over 5 days under free-living conditions. Diabetes Technol Ther. 2019;22(3):174–184. Epub 2019/10/10. PubMed PMID: 31596130; PubMed Central PMCID: PMCPMC7047109.
   PubMed Web of Science ®Google Scholar
• Insulet C Prepivotal Omnipod Horizon™ automated glucose control system - NCT04176731: clinical Trials.gov. 2020 [cited 2020 Feb 13]. Available from: https://clinicaltrials.gov/ct2/show/NCT04176731?term=Insulet&cond=Diabetes&draw=2&rank=7
   Google Scholar
• Insulet C Pivotal Omnipod Horizon™ automated glucose control system - NCT04196140: clinical Trials.gov. 2020 [cited 2020 Feb 13]. Available from: https://clinicaltrials.gov/ct2/show/NCT04196140?term=Insulet&cond=Diabetes&draw=2&rank=6
   Google Scholar
• Jaeb Centre for Health Research. The insulin-only bionic pancreas pivotal trial - NCT04200313: clinical Trials.gov. 2020 [cited 2020 Feb 13]. Available from: https://clinicaltrials.gov/ct2/show/NCT04200313?term=ilet&cond=Diabetes&draw=2&rank=3
   Google Scholar
• Loop. LoopDocs. 2020 Jan 06. Available from: https://loopkit.github.io/loopdocs/operation/algorithm/overview/
   Google Scholar
• TidePool.org. TidePool delivering loop. 2020 Jan 04. Available from: https://www.tidepool.org/blog/tidepool-delivering-loop
   Google Scholar
• Snider C Tidepool Loop, one year in: A development update. 2020 [cited 2020 Feb 13]. Available from: https://www.tidepool.org/blog/tidepool-loop-development-update?mkt_tok=eyJpIjoiWlRCaE16RmxPR0V6WXpWaCIsInQiOiJSN2lyalpyMXRWRDA3NGVTWVYwUnMzM0UyUzJLYytheGVjSHVxOUJnM1wvbEVTOERVcWNodmx6UmVFRU1ERXlOUEdnS21uNTl1ZXdITGl3U2swd0ZMR2Q4UFVGU3FcL2JkNGVIT1N0Wkpudm4wRVlqRXhiNXVYTlU5ZUhXWm5GTlZvIn0%3D
   Google Scholar
• 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. 2019;1932296819894296. Epub 2019/12/19. DOI:10.1177/1932296819894296. PubMed PMID: 31847570.
   Google Scholar
• Weinzimer SA, Steil GM, Swan KL, et al. Fully automated closed-loop insulin delivery versus semiautomated hybrid control in pediatric patients with type 1 diabetes using an artificial pancreas. Diabetes Care. 2008;31(5):934–939.
   PubMed Web of Science ®Google Scholar
• Forlenza GP, Cameron FM, Ly TT, et al. Fully closed-loop multiple model probabilistic predictive controller artificial pancreas performance in adolescents and adults in a supervised hotel setting. Diabetes Technol Ther. 2018;20(5):335–343. PubMed PMID: 29658779; PubMed Central PMCID: PMCPMC5963546.
   PubMed Web of Science ®Google Scholar
• Dovc K, Piona C, Yesiltepe Mutlu G, et al. Faster compared with standard insulin aspart during day-and-night fully closed-loop insulin therapy in type 1 diabetes: a double-blind randomized crossover trial. Diabetes Care. 2019. Epub 2019/10/03. DOI:10.2337/dc19-0895. PubMed PMID: 31575640.
   Web of Science ®Google Scholar
• Cameron FM, Ly TT, Buckingham BA, et al. Closed-loop control without meal announcement in type 1 diabetes. Diabetes Technol Ther. 2017;19(9):527–532. Epub 2017/08/03. PubMed PMID: 28767276; PubMed Central PMCID: PMCPMC5647490.
   PubMed Web of Science ®Google Scholar
• Dassau E, Zisser H, Harvey RA, et al. Clinical evaluation of a personalized artificial pancreas. Diabetes Care. 2013;36(4):801–809. Epub 2012/11/30. PubMed PMID: 23193210; PubMed Central PMCID: PMCPMC3609541.
   PubMed Web of Science ®Google Scholar
• Beato-Vibora PI, Arroyo-Diez FJ. New uses and formulations of glucagon for hypoglycaemia. Drugs Context. 2019;8:212599. Epub 2019/08/14. PubMed PMID: 31402931; PubMed Central PMCID: PMCPMC6675539.
   PubMedGoogle Scholar
• 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(10067):369–380.
   PubMed Web of Science ®Google Scholar
• Haidar A, Rabasa-Lhoret R, Legault L, et al. Single- and dual-hormone artificial pancreas for overnight glucose control in type 1 diabetes. J Clin Endocrinol Metab. 2016;101(1):214–223. Epub 2015/11/03. PubMed PMID: 26523526.
   PubMed Web of Science ®Google Scholar
• Blauw H, van Bon AC, Koops R, et al., consortium obotP. Performance and safety of an integrated bihormonal artificial pancreas for fully automated glucose control at home. Diabetes Obes Metab. 2016;18(7):671–677. PubMed PMID: 26996542; PubMed Central PMCID: PMCPMC5111773.
   PubMed Web of Science ®Google Scholar
• Haidar A, Tsoukas MA, Bernier-Twardy S, et al. A novel dual-hormone insulin-and-pramlintide artificial pancreas for type 1 diabetes: a randomized controlled crossover trial. Diabetes Care. 2020;43:597–606. Epub 2020/01/25. PubMed PMID: 31974099.
   PubMed Web of Science ®Google Scholar
• Gingras V, Taleb N, Roy-Fleming A, et al. The challenges of achieving postprandial glucose control using closed-loop systems in patients with type 1 diabetes. Diabetes Obes Metab. 2018;20(2):245–256. Epub 2017/07/05. PubMed PMID: 28675686; PubMed Central PMCID: PMCPMC5810921.
   PubMed Web of Science ®Google Scholar
• Lal RA, Basina M, Maahs DM, et al. One year clinical experience of the first commercial hybrid closed-loop system. Diabetes Care. 2019;42(12):2190–2196. Epub 2019/09/25. PubMed PMID: 31548247; PubMed Central PMCID: PMCPMC6868462.
   PubMed Web of Science ®Google Scholar
• FDA authorizes first fully interoperable continuous glucose monitoring system, streamlines review pathway for similar devices. 2018 [cited 2020 Jan 4]. Available from: https://www.fda.gov/news-events/press-announcements/fda-authorizes-first-fully-interoperable-continuous-glucose-monitoring-system-streamlines-review
   Google Scholar
• Kimbell B, Rankin D, Ashcroft NL, et al. What training, support, and resourcing do health professionals need to support people using a closed-loop system? A qualitative interview study with health professionals involved in the closed loop from onset in type 1 diabetes (CLOuD) trial. Diabetes Technol Ther. 2020;22(6). Epub 2020/02/13. DOI:10.1089/dia.2019.0466. PubMed PMID: 32048877.
   PubMed Web of Science ®Google Scholar
• Musolino G, Dovc K, Boughton CK, et al. Reduced burden of diabetes and improved quality of life: experiences from unrestricted day-and-night hybrid closed-loop use in very young children with type 1 diabetes. Pediatr Diabetes. 2019;20(6):794–799. Epub 2019/05/30. PubMed PMID: 31140654; PubMed Central PMCID: PMCPMC6771658.
   PubMed Web of Science ®Google Scholar
• Weissberg-Benchell J, Hessler D, Fisher L, et al. Impact of an automated bihormonal delivery system on psychosocial outcomes in adults with type 1 diabetes. Diabetes Technol Ther. 2017;19(12):723–729. Epub 2017/11/07. PubMed PMID: 29106311.
   PubMed Web of Science ®Google Scholar
• Farrington C, Stewart Z, Hovorka R, et al. Women’s experiences of day-and-night closed-loop insulin delivery during type 1 diabetes pregnancy. J Diabetes Sci Technol. 2018;12(6):1125–1131. Epub 2018/10/06. PubMed PMID: 30288999; PubMed Central PMCID: PMCPMC6232744.
   PubMedGoogle Scholar
• 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(3):119–127. PubMed PMID: WOS:000463914500004.
   PubMed Web of Science ®Google Scholar