1. Gregory GA, Robinson TI, Linklater SE, Wang F, Colagiuri S, de Beaufort C, et al. Global incidence, prevalence, and mortality of type 1 diabetes in 2021 with projection to 2040: a modelling study. Lancet Diabetes Endocrinol. 2022; 10:741–60.
Article
2. Foster NC, Beck RW, Miller KM, Clements MA, Rickels MR, DiMeglio LA, et al. State of type 1 diabetes management and outcomes from the T1D exchange in 2016-2018. Diabetes Technol Ther. 2019; 21:66–72.
Article
3. REPOSE Study Group. Relative effectiveness of insulin pump treatment over multiple daily injections and structured education during flexible intensive insulin treatment for type 1 diabetes: cluster randomised trial (REPOSE). BMJ. 2017; 356:j1285.
4. Alotaibi A, Al Khalifah R, McAssey K. The efficacy and safety of insulin pump therapy with predictive low glucose suspend feature in decreasing hypoglycemia in children with type 1 diabetes mellitus: a systematic review and meta-analysis. Pediatr Diabetes. 2020; 21:1256–67.
Article
5. Bosi E, Choudhary P, de Valk HW, Lablanche S, Castaneda J, de Portu S, et al. Efficacy and safety of suspend-before-low insulin pump technology in hypoglycaemia-prone adults with type 1 diabetes (SMILE): an open-label randomised controlled trial. Lancet Diabetes Endocrinol. 2019; 7:462–72.
Article
6. Nwokolo M, Hovorka R. The artificial pancreas and type 1 diabetes. J Clin Endocrinol Metab. 2023; 108:1614–23.
Article
7. Wilson LM, Jacobs PG, Riddell MC, Zaharieva DP, Castle JR. Opportunities and challenges in closed-loop systems in type 1 diabetes. Lancet Diabetes Endocrinol. 2022; 10:6–8.
Article
8. Templer S. Closed-loop insulin delivery systems: past, present, and future directions. Front Endocrinol (Lausanne). 2022; 13:919942.
Article
9. Fang Z, Liu M, Tao J, Li C, Zou F, Zhang W. Efficacy and safety of closed-loop insulin delivery versus sensor-augmented pump in the treatment of adults with type 1 diabetes: a systematic review and meta-analysis of randomized-controlled trials. J Endocrinol Invest. 2022; 45:471–81.
Article
10. Zeng B, Gao L, Yang Q, Jia H, Sun F. Automated insulin delivery systems in children and adolescents with type 1 diabetes: a systematic review and meta-analysis of outpatient randomized controlled trials. Diabetes Care. 2023; 46:2300–7.
Article
11. Weisman A, Bai JW, Cardinez M, Kramer CK, Perkins BA. 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; 5:501–12.
Article
12. Bekiari E, Kitsios K, Thabit H, Tauschmann M, Athanasiadou E, Karagiannis T, et al. Artificial pancreas treatment for outpatients with type 1 diabetes: systematic review and meta-analysis. BMJ. 2018; 361:k1310.
Article
13. Boughton CK, Allen JM, Ware J, Wilinska ME, Hartnell S, Thankamony A, et al. Closed-loop therapy and preservation of C-peptide secretion in type 1 diabetes. N Engl J Med. 2022; 387:882–93.
Article
14. Bionic Pancreas Research Group, Russell SJ, Beck RW, Damiano ER, El-Khatib FH, Ruedy KJ, et al. Multicenter, randomized trial of a bionic pancreas in type 1 diabetes. N Engl J Med. 2022; 387:1161–72.
Article
15. Bekiari E, Karagiannis T, Haidich AB, Tsapas A. Meta-analysis of artificial pancreas trials: methodological considerations. Lancet Diabetes Endocrinol. 2017; 5:685.
Article
16. Boughton CK, Hartnell S, Lakshman R, Nwokolo M, Wilinska ME, Ware J, et al. Fully closed-loop glucose control compared with insulin pump therapy with continuous glucose monitoring in adults with type 1 diabetes and suboptimal glycemic control: a single-center, randomized, crossover study. Diabetes Care. 2023; 46:1916–22.
Article
17. Mosquera-Lopez C, Wilson LM, El Youssef J, Hilts W, Leitschuh J, Branigan D, et al. Enabling fully automated insulin delivery through meal detection and size estimation using artificial intelligence. NPJ Digit Med. 2023; 6:39.
Article
18. Tsoukas MA, Majdpour D, Yale JF, Fathi AE, Garfield N, Rutkowski J, et al. A fully artificial pancreas versus a hybrid artificial pancreas for type 1 diabetes: a single-centre, open-label, randomized controlled, crossover, non-inferiority trial. Lancet Digit Health. 2021; 3:e723–32.
19. Blauw H, Onvlee AJ, Klaassen M, van Bon AC, DeVries JH. Fully closed loop glucose control with a bihormonal artificial pancreas in adults with type 1 diabetes: an outpatient, randomized, crossover trial. Diabetes Care. 2021; 44:836–8.
Article
20. Page MJ, McKenzie JE, Bossuyt PM, Boutron I, Hoffmann TC, Mulrow CD, et al. The PRISMA 2020 statement: an updated guideline for reporting systematic reviews. BMJ. 2021; 372:n71.
21. Higgins JP, Altman DG, Gotzsche PC, Juni P, Moher D, Oxman AD, et al. The Cochrane Collaboration’s tool for assessing risk of bias in randomised trials. BMJ. 2011; 343:d5928.
Article
22. Guyatt G, Oxman AD, Akl EA, Kunz R, Vist G, Brozek J, et al. GRADE guidelines: 1. introduction-GRADE evidence profiles and summary of findings tables. J Clin Epidemiol. 2011; 64:383–94.
Article
23. Klonoff DC, Wang J, Rodbard D, Kohn MA, Li C, Liepmann D, et al. A glycemia risk index (GRI) of hypoglycemia and hyperglycemia for continuous glucose monitoring validated by clinician ratings. J Diabetes Sci Technol. 2023; 17:1226–42.
24. Wan X, Wang W, Liu J, Tong T. Estimating the sample mean and standard deviation from the sample size, median, range and/or interquartile range. BMC Med Res Methodol. 2014; 14:135.
Article
25. Elbourne DR, Altman DG, Higgins JP, Curtin F, Worthington HV, Vail A. Meta-analyses involving cross-over trials: methodological issues. Int J Epidemiol. 2002; 31:140–9.
Article
26. Phillip M, Nimri R, Bergenstal RM, Barnard-Kelly K, Danne T, Hovorka R, et al. Consensus recommendations for the use of automated insulin delivery technologies in clinical practice. Endocr Rev. 2023; 44:254–80.
Article
27. Burnside MJ, Lewis DM, Crocket HR, Meier RA, Williman JA, Sanders OJ, et al. Open-source automated insulin delivery in type 1 diabetes. N Engl J Med. 2022; 387:869–81.
Article
28. Haidar A, Legault L, Matteau-Pelletier L, Messier V, Dallaire M, Ladouceur M, et al. Outpatient overnight glucose control with dual-hormone artificial pancreas, single-hormone artificial pancreas, or conventional insulin pump therapy in children and adolescents with type 1 diabetes: an open-label, randomised controlled trial. Lancet Diabetes Endocrinol. 2015; 3:595–604.
Article
29. Haidar A, Messier V, Legault L, Ladouceur M, Rabasa-Lhoret R. Outpatient 60-hour day-and-night glucose control with dual-hormone artificial pancreas, single-hormone artificial pancreas, or sensor-augmented pump therapy in adults with type 1 diabetes: an open-label, randomised, crossover, controlled trial. Diabetes Obes Metab. 2017; 19:713–20.
30. Haidar A, Rabasa-Lhoret R, Legault L, Lovblom LE, Rakheja R, Messier V, et al. Single- and dual-hormone artificial pancreas for overnight glucose control in type 1 diabetes. J Clin Endocrinol Metab. 2016; 101:214–23.
Article
31. Kariyawasam D, Morin C, Casteels K, Le Tallec C, Sfez A, Godot C, et al. Hybrid closed-loop insulin delivery versus sensor-augmented pump therapy in children aged 6-12 years: a randomised, controlled, cross-over, non-inferiority trial. Lancet Digit Health. 2022; 4:e158–68.
Article
32. Russell SJ, El-Khatib FH, Sinha M, Magyar KL, McKeon K, Goergen LG, et al. Outpatient glycemic control with a bionic pancreas in type 1 diabetes. N Engl J Med. 2014; 371:313–25.
Article
33. Thabit H, Tauschmann M, Allen JM, Leelarathna L, Hartnell S, Wilinska ME, et al. Home use of an artificial beta cell in type 1 diabetes. N Engl J Med. 2015; 373:2129–40.
Article
34. Wilson LM, Jacobs PG, Ramsey KL, Resalat N, Reddy R, Branigan D, et al. Dual-hormone closed-loop system using a liquid stable glucagon formulation versus insulin-only closed-loop system compared with a predictive low glucose suspend system: an open-label, outpatient, single-center, crossover, randomized controlled trial. Diabetes Care. 2020; 43:2721–9.
Article
35. Abraham MB, de Bock M, Smith GJ, Dart J, Fairchild JM, King BR, et al. Effect of a hybrid closed-loop system on glycemic and psychosocial outcomes in children and adolescents with type 1 diabetes: a randomized clinical trial. JAMA Pediatr. 2021; 175:1227–35.
Article
36. Choudhary P, Kolassa R, Keuthage W, Kroeger J, Thivolet C, Evans M, et al. Advanced hybrid closed loop therapy versus conventional treatment in adults with type 1 diabetes (ADAPT): a randomised controlled study. Lancet Diabetes Endocrinol. 2022; 10:720–31.
Article
37. McAuley SA, Lee MH, Paldus B, Vogrin S, de Bock MI, Abraham MB, et al. Six months of hybrid closed-loop versus manual insulin delivery with fingerprick blood glucose monitoring in adults with type 1 diabetes: a randomized, controlled trial. Diabetes Care. 2020; 43:3024–33.
38. Boscari F, Avogaro A. Current treatment options and challenges in patients with type 1 diabetes: pharmacological, technical advances and future perspectives. Rev Endocr Metab Disord. 2021; 22:217–40.
Article
39. Garcia-Tirado J, Diaz JL, Esquivel-Zuniga R, Koravi CL, Corbett JP, Dawson M, et al. Advanced closed-loop control system improves postprandial glycemic control compared with a hybrid closed-loop system following unannounced meal. Diabetes Care. 2021; dc210932.
Article
40. Kaur J, Seaquist ER. Hypoglycaemia in type 1 diabetes mellitus: risks and practical prevention strategies. Nat Rev Endocrinol. 2023; 19:177–86.
Article
41. Urakami T. The advanced diabetes technologies for reduction of the frequency of hypoglycemia and minimizing the occurrence of severe hypoglycemia in children and adolescents with type 1 diabetes. J Clin Med. 2023; 12:781.
Article
42. Kim JY, Yoo JH, Kim JH. Comparison of glycemia risk index with time in range for assessing glycemic quality. Diabetes Technol Ther. 2023; 25:883–92.
Article
43. Battelino T, Alexander CM, Amiel SA, Arreaza-Rubin G, Beck RW, Bergenstal RM, et al. Continuous glucose monitoring and metrics for clinical trials: an international consensus statement. Lancet Diabetes Endocrinol. 2023; 11:42–57.
Article
44. Eviz E, Yesiltepe Mutlu G, Karakus KE, Can E, Gokce T, Muradoglu S, et al. The advanced hybrid closed loop improves glycemia risk index, continuous glucose monitoring index, and time in range in children with type 1 diabetes: real-world data from a single center study. Diabetes Technol Ther. 2023; 25:689–96.
Article
45. Kang SL, Hwang YN, Kwon JY, Kim SM. Effectiveness and safety of a model predictive control (MPC) algorithm for an artificial pancreas system in outpatients with type 1 diabetes (T1D): systematic review and meta-analysis. Diabetol Metab Syndr. 2022; 14:187.
Article
46. Pinsker JE, Lee JB, Dassau E, Seborg DE, Bradley PK, Gondhalekar R, et al. Randomized crossover comparison of personalized MPC and PID control algorithms for the artificial pancreas. Diabetes Care. 2016; 39:1135–42.
Article
47. Lal RA, Maikawa CL, Lewis D, Baker SW, Smith AA, Roth GA, et al. Full closed loop open-source algorithm performance comparison in pigs with diabetes. Clin Transl Med. 2021; 11:e387.
Article