Erratum: Home use of a bihormonal bionic pancreas versus insulin pump therapy in adults with type 1 diabetes: a multicentre randomised crossover trial (The Lancet (2017) 389(10067) (369–380)(S0140673616325673)(10.1016/S0140-6736(16)32567-3));Home use of a bihormonal bionic pancreas versus insulin pump therapy in adults with type 1 diabetes: a multicentre randomised crossover trial

The Lancet

Volumn 389, Issue 10067, 2017, Pages 369-380

  El Khatib, Firas H ^a   Balliro, Courtney ^b   Hillard, Mallory A ^b   Magyar, Kendra L ^b   Ekhlaspour, Laya ^b   Sinha, Manasi ^b   Mondesir, Debbie ^b   Esmaeili, Aryan ^b   Hartigan, Celia ^c   Thompson, Michael J ^c   Malkani, Samir ^c   Lock, J Paul ^c   Harlan, David M ^c   Clinton, Paula ^d   Frank, Eliana ^d   Wilson, Darrell M ^d   DeSalvo, Daniel ^d   Norlander, Lisa ^d   Ly, Trang ^d   Buckingham, Bruce A ^d   Diner, Jamie ^e   Dezube, Milana ^e   Young, Laura A ^e   Goley, April ^e   Kirkman, M Sue ^e   Buse, John B ^e   Zheng, Hui ^b   Selagamsetty, Rajendranath R ^a   Damiano, Edward R ^a   Russell, Steven J ^b   more..

^a Boston University   (United States)

^b MASSACHUSETTS GENERAL HOSPITAL   (United States)

^c UNIVERSITY OF MASSACHUSETTS MEDICAL SCHOOL   (United States)

^d STANFORD UNIVERSITY SCHOOL OF MEDICINE   (United States)

^e UNIVERSITY OF NORTH CAROLINA SCHOOL OF MEDICINE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

GLUCAGON; GLUCOSE; HEMOGLOBIN A1C; INSULIN; ANTIDIABETIC AGENT; HORMONE;

ADULT; ARTICLE; ARTIFICIAL PANCREAS; BIHORMONAL BIONIC PANCREAS; BODY MASS; CLINICAL ARTICLE; CLINICAL OUTCOME; CONTROLLED STUDY; CROSSOVER PROCEDURE; DEVICE COMPARISON; DIABETIC PATIENT; FEMALE; GLUCOSE BLOOD LEVEL; HEMOGLOBIN BLOOD LEVEL; HOME CARE; HUMAN; HYPOGLYCEMIA; INSULIN DEPENDENT DIABETES MELLITUS; INSULIN PUMP; INSULIN TREATMENT; MALE; MULTICENTER STUDY; NAUSEA; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; VISUAL ANALOG SCALE; CHEMICALLY INDUCED; CLINICAL TRIAL; COMPARATIVE STUDY; INSULIN INFUSION; METABOLISM; MIDDLE AGED; PHYSIOLOGIC MONITORING; YOUNG ADULT;

ADULT; BIONICS; BLOOD GLUCOSE; CROSS-OVER STUDIES; DIABETES MELLITUS, TYPE 1; FEMALE; GLUCAGON; HORMONES; HUMANS; HYPOGLYCEMIA; HYPOGLYCEMIC AGENTS; INSULIN; INSULIN INFUSION SYSTEMS; MALE; MIDDLE AGED; MONITORING, PHYSIOLOGIC; NAUSEA; PANCREAS, ARTIFICIAL; YOUNG ADULT;

EID: 85008213258     PISSN: 01406736     EISSN: 1474547X     Source Type: Journal    
DOI: 10.1016/S0140-6736(16)32594-6     Document Type: Erratum

References (47)

1. 1 The Diabetes Control and Complications Trial Research Group. 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 329 (1993), 977–986.
2. 2 Writing Team for the Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications Research Group. Effect of intensive therapy on the microvascular complications of type 1 diabetes mellitus. JAMA 287 (2002), 2563–2594.
3. 3 Nathan, DM, Cleary, PA, Backlund, JY, et al. Intensive diabetes treatment and cardiovascular disease in patients with type 1 diabetes. N Engl J Med 353 (2005), 2643–2653.
4. 4 Petitti, DB, Klingensmith, J, Bell, RA, et al., SEARCH for Diabetes in Youth Study Group. Glycemic control in youth with diabetes: the SEARCH for Diabetes in Youth Study. J Pediatr 155 (2009), 668–672.
5. 5 Tamborlane, RW, Bergenstal, RM, Miller, KM, DuBose, SN, Hall, CA, T1D Exchange Clinic Network. The T1D Exchange Clinic Registry. J Clin Endocrinol Metab 97 (2012), 4383–4389.
6. 6 Wood, JR, Miller, KM, Maahs, DM, et al. T1D Exchange Clinic Network. Most youth with type 1 diabetes in the T1D Exchange Clinic Registry do not meet American Diabetes Association or International Society for Pediatric and Adolescent Diabetes clinical guidelines. Diabetes Care 36 (2013), 2035–2037.
7. 7 The Diabetes Control and Complications Trial Research Group. Hypoglycemia in the Diabetes Control and Complications Trial. Diabetes 46 (1997), 271–286.
8. 8 Leese, GP, Wang, J, Broomhall, J, Frequency of severe hypoglycemia requiring emergency treatment in type 1 and type 2 diabetes: a population-based study of health service resource use. Diabetes Care 26 (2003), 1176–1180.
9. 9 Cengiz, E, Xing, D, Wong, JC, et al. T1D Exchange Clinic Network. Severe hypoglycemia and diabetic ketoacidosis among youth with type 1 diabetes in the T1D Exchange Clinic Registry. Pediatr Diabetes 14 (2013), 447–454.
10. 10 Weinstock, RS, Xing, D, Maahs, DM, et al. T1D Exchange Clinic Network. Severe hypoglycemia and diabetic ketoacidosis in adults with type 1 diabetes: results from the T1D Exchange Clinic Registry. J Clin Endocrinol Metab 98 (2013), 3411–3419.
11. 11 Cryer, PE, Davis, SN, Shamoon, H, Hypoglycemia in diabetes. Diabetes Care 26 (2003), 1902–1912.
12. 12 El-Khatib, FH, Jiang, J, Damiano, ER, Adaptive closed-loop control provides blood-glucose regulation using dual subcutaneous insulin and glucagon infusion in diabetic swine. J Diabetes Sci Technol 1 (2007), 181–192.
13. 13 El-Khatib, FH, Jiang, J, Damiano, ER, A feasibility study of bihormonal closed-loop blood-glucose control using dual subcutaneous infusion of insulin and glucagon in ambulatory diabetic swine. J Diabetes Sci Technol 3 (2009), 789–803.
14. 14 El-Khatib, FH, Russell, SJ, Nathan, DM, Sutherlin, RG, Damiano, ER, A bi-hormonal closed-loop blood glucose control device for type 1 diabetes. Sci Transl Med, 2, 2010, 27ra27.
15. 15 Russell, SJ, El-Khatib, FH, Nathan, DM, Magyar, KL, Jiang, J, Damiano, ER, Blood glucose control in type 1 diabetes with a bihormonal bionic endocrine pancreas. Diabetes Care 11 (2012), 2148–2155.
16. 16 El-Khatib, FH, Russell, SJ, Magyar, KL, et al. Autonomous and continuous adaptation of a bihormonal bionic pancreas in adults and adolescents with type 1 diabetes. J Clin Endocrinol Metab 99 (2014), 1701–1711.
17. 17 Russell, SJ, El-Khatib, FH, Sinha, M, et al. Outpatient glycemic control with a bionic pancreas in type 1 diabetes. N Engl J Med 371 (2014), 313–325.
18. 18 Russell, SJ, Hillard, MA, Balliro, C, et al. Day and night glycaemic control with a bionic pancreas versus conventional insulin pump therapy in preadolescent children with type 1 diabetes: a randomised crossover trial. Lancet Diabetes Endocrinol 4 (2016), 233–243.
19. 19 Russell, SJ, Progress of artificial pancreas devices towards clinical use: the first outpatient studies. Curr Opin Endocrinol Diabetes Obes 22 (2015), 106–111.
20. 20 Kovatchev, BP, Renard, E, Cobelli, C, et al. Safety of outpatient closed-loop control: first randomized crossover trials of a wearable artificial pancreas. Diabetes Care 37 (2014), 1789–1796.
21. 21 Ly, TT, Roy, A, Grosman, B, et al. Day and night closed-loop control using the integrated Medtronic hybrid closed-loop system in type 1 diabetes at diabetes camp. Diabetes Care 38 (2015), 1–8.
22. 22 Del Favero, S, Boscari, F, Messori, M, et al. Randomized summer camp crossover trial in 5- to 9-year-old children: outpatient wearable artificial pancreas is feasible and safe. Diabetes Care 39 (2016), 1180–1185.
23. 23 Leelarathna, L, Dellweg, S, Mader, JK, et al. Day and night home closed-loop insulin delivery in adults with type 1 diabetes: three-center randomized crossover study. Diabetes Care 37 (2014), 1931–1937.
24. 24 Tauschmann, M, Allen, JM, Wilinska, ME, et al. Day-and-night hybrid closed-loop insulin delivery in adolescents with type 1 diabetes: a free-living, randomized clinical trial. Diabetes Care 39 (2016), 1168–1174.
25. 25 Thabit, H, Tauschmann, M, Allen, JM, et al. Home use of an artificial beta cell in type 1 diabetes. N Engl J Med 373 (2015), 2129–2140.
26. 26 van Bon, AC, Luijf, YM, Koebrugge, R, et al. Feasibility of a portable bihormonal closed-loop system to control glucose excursions at home under free-living conditions for 48 hours. Diabetes Tech Ther 16 (2014), 131–136.
27. 27 Blauw, H, van Bon, AC, Koops, R, DeVries, JH, Performance and safety of an integrated bihormonal artificial pancreas for fully automated glucose control at home. Diabetes Obes Metab 18 (2016), 671–677.
28. 28 Dexacom. Dexcom G4 Platinum user's guide, chapter 2.3 contraindications: Dexcom 2013. http://www.dexcom.com/sites/dexcom.com/files/dexcom-g4-platinum/ifu/dexcom-g4-platinum-ifu.pdf (accessed April 1, 2014).
29. 29 Maahs, DM, DeSalvo, D, Pyle, L, et al. Effect of acetaminophen on CGM glucose in an outpatient setting. Diabetes Care 38 (2015), e158–e159.
30. 30 Nathan, DM, Kuenen, J, Borg, R, Zheng, H, Schoenfeld, D, Heine, RJ, A1c-derived average glucose study group, translating the A1C assay into estimated average glucose values. Diabetes Care 31 (2008), 1473–1478.
31. 31 O'Riordan, SM, Danne, T, Hanas, R, Peters, CJ, Hindmarsh, P, Paediatric estimated average glucose in children with type 1 diabetes. Diabet Med 31 (2014), 36–39.
32. 32 American Diabetes Association. Standard of medical care in diabetes. Diabetes Care 36:suppl 1 (2013), S11–S66.
33. 33 Molnar, GD, Taylor, WF, Ho, MM, Day-to-day variation of continuously monitored glycaemia: a further measure of diabetic instability. Diabetologia 8 (1972), 342–348.
34. 34 Russell, SJ, Beck, RW, Design considerations for artificial pancreas pivotal studies. Diabetes Care 39 (2016), 1161–1167.
35. 35 Miller, KM, Foster, NC, Beck, RW, et al., for the T1D Exchange Clinic Network. Current state of type 1 diabetes treatment in the US: updated data from the T1D Exchange clinic registry. Diabetes Care 38 (2015), 971–978.
36. 36 Willi, SM, Miller, KM, DiMeglio, LA, et al., T1D Exchange Clinic Network. Racial–ethnic disparities in management and outcomes among children with type 1 diabetes. Pediatrics 135 (2015), 424–434.
37. 37 Haidar, A, Legault, L, Matteau-Pelletier, L, 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 3 (2015), 595–604.
38. 38 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 101 (2016), 214–223.
39. 39 Basu, A, Veettil, S, Dyer, R, Peyser, T, Basu, R, Direct evidence of acetaminophen interference with subcutaneous glucose sensing in humans: a pilot study. Diabetes Technol Ther 18:suppl 2 (2016), 43–47.
40. 40 McGarraugh, G, The chemistry of commercial continuous glucose monitors. Diabetes Technol Ther 11:suppl 1 (2009), S17–S24.
41. 41 Diabetes Daily. A look at Dexcom's upcoming 6th & 7th generation CGM tech. https://www.diabetesdaily.com/blog/a-look-at-dexcoms-upcoming-6th-7th-generation-cgm-tech-284530/ (accessed Oct 30, 2016).
42. 42 Cersosima, E, Cummins, MJ, Kinzell, JH, et al. A phase 2 comparative safety PK/PD study of stable non-aqueous glucagon (g-Pen) vs. Lilly glucagon for treatment of severe hypoglycemia. Diabetes, 63(suppl 1A), 2014 1-LB.
43. 43 Haymond, MW, Redondo, MJ, McKay, S, et al. Nonaqueous, mini-dose glucagon for treatment of mild hypoglycemia in adults with type 1 diabetes: a dose-seeking study. Diabetes Care 39 (2016), 465–468.
44. 44 Xeris Pharmaceuticals. Pipeline. http://www.xerispharma.com/pipeline (accessed Sept 22, 2016).
45. 45 Zealand Pharma. Dasiglucagon (ZP4207) for multiple-dose with potential as an important component in an artificial pancreas. http://www.zealandpharma.com/portfolio/proprietary-pipeline/glucagon-multiple-dose-version-zp4207 (accessed Sept 22, 2016).
46. 46 ADOCIA. BioChaperone® human glucagon. http://www.adocia.fr/WP/products/biochaperone-human-glucagon/ (accessed Sept 22, 2016).
47. 47 Taleb, N, Haidar, A, Messier, V, Gingras, V, Legault, L, Rabasa-Lhoret, R, Glucagon in artificial pancreas systems: potential benefits and safety profile of future chronic use. Diabetes Obes Metab, 2016, 10.1111/dom.12789 published online Sept 15.