A review of artificial pancreas technologies with an emphasis on bi-hormonal therapy

Diabetes, Obesity and Metabolism

Volumn 15, Issue 12, 2013, Pages 1065-1070

  Bakhtiani, P A ^a   Zhao, L M ^b   El Youssef, J ^a   Castle, J R ^a   Ward, W K ^a,b  

^a OREGON HEALTH AND SCIENCE UNIVERSITY   (United States)

^b LEGACY RESEARCH   (United States)

Author keywords

CSII; Diabetes complications; Glycaemic control; Insulin intensive management; Insulin pump therapy; Type 1 diabetes

Indexed keywords

GLUCAGON;

ARTIFICIAL PANCREAS; BIOENGINEERING; BLOOD GLUCOSE METER; DIABETIC PATIENT; GLUCAGON RELEASE; HORMONAL THERAPY; HUMAN; HYPOGLYCEMIA; INSULIN DEPENDENT DIABETES MELLITUS; INSULIN TREATMENT; LOW DRUG DOSE; MONITOR; REVIEW;

CSII; DIABETES COMPLICATIONS; GLYCAEMIC CONTROL; INSULIN INTENSIVE MANAGEMENT; INSULIN PUMP THERAPY; TYPE 1 DIABETES;

BLOOD GLUCOSE; DIABETES MELLITUS, TYPE 1; FORECASTING; GLUCAGON; HUMANS; HYPERGLYCEMIA; HYPOGLYCEMIA; HYPOGLYCEMIC AGENTS; INSULINS; PANCREAS, ARTIFICIAL;

EID: 84887185415     PISSN: 14628902     EISSN: 14631326     Source Type: Journal    
DOI: 10.1111/dom.12107     Document Type: Review

References (75)

1. Rewers A, Klingensmith G, Davis C et al. Presence of diabetic ketoacidosis at diagnosis of diabetes mellitus in youth: the Search for Diabetes in Youth Study. Pediatrics 2008; 121: e1258-e1266.
2. Svensson M, Eriksson JW, Dahlquist G. Early glycemic control, age at onset, and development of microvascular complications in childhood-onset type 1 diabetes: a population-based study in northern Sweden. Diabetes Care 2004; 27: 955-962.
3. Olsen BS, Johannesen J, Sjolie AK et al. Metabolic control and prevalence of microvascular complications in young Danish patients with Type 1 diabetes mellitus. Danish Study Group of Diabetes in Childhood. Diabet Med 1999; 16: 79-85.
4. The EURODIAB IDDM Complications Study Group. Microvascular and acute complications in IDDM patients: the EURODIAB IDDM Complications Study. Diabetologia 1994; 37: 278-285.
5. The Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications Research Group. Retinopathy and nephropathy in patients with type 1 diabetes four years after a trial of intensive therapy. N Engl J Med 2000; 342: 381-389.
6. Writing Team for the Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications Research Group. Sustained effect of intensive treatment of type 1 diabetes mellitus on development and progression of diabetic nephropathy: the Epidemiology of Diabetes Interventions and Complications (EDIC) study. JAMA 2003; 290: 2159-2167.
7. Kumareswaran K, Evans ML, Hovorka R. Artificial pancreas: an emerging approach to treat Type 1 diabetes. Expert Rev Med Devices 2009; 6: 401-410.
8. Lorenzi M, Bohannon N, Tsalikian E, Karam JH. Duration of type I diabetes affects glucagon and glucose responses to insulin-induced hypoglycemia. West J Med 1984; 141: 467-471.
9. Cryer PE. Hypoglycemia, functional brain failure, and brain death. J Clin Invest 2007; 117: 868-870.
10. Pickup JC, Freeman SC, Sutton AJ. Glycaemic control in type 1 diabetes during real time continuous glucose monitoring compared with self monitoring of blood glucose: meta-analysis of randomised controlled trials using individual patient data. BMJ 2011; 343: d3805.
11. Langendam M, Luijf YM, Hooft L, Devries JH, Mudde AH, Scholten RJ. Continuous glucose monitoring systems for type 1 diabetes mellitus. Cochrane Database Syst Rev 2012; 1: CD008101.
12. Holmes G, Galitz L, Hu P, Lyness W. Pharmacokinetics of insulin aspart in obesity, renal impairment, or hepatic impairment. Br J Clin Pharmacol 2005; 60: 469-476.
13. Juvenile Diabetes Research Foundation Continuous Glucose Monitoring Study Group, Tamborlane WV, Beck RW et al. Continuous glucose monitoring and intensive treatment of type 1 diabetes. N Engl J Med 2008; 359: 1464-1476.
14. Retnakaran R, Hochman J, DeVries JH et al. Continuous subcutaneous insulin infusion versus multiple daily injections: the impact of baseline A1c. Diabetes Care 2004; 27: 2590-2596.
15. Pickup J, Mattock M, Kerry S. Glycaemic control with continuous subcutaneous insulin infusion compared with intensive insulin injections in patients with type 1 diabetes: meta-analysis of randomised controlled trials. BMJ 2002; 324: 705.
16. Buse JB, Dailey G, Ahmann AA et al. Baseline predictors of A1C reduction in adults using sensor-augmented pump therapy or multiple daily injection therapy: the STAR 3 experience. Diabetes Technol Ther 2011; 13: 601-606.
17. Kadish AH. Automation control of blood sugar. I. a Servomechanism for glucose monitoring and control. Am J Med Electron 1964; 3: 82-86.
18. Albisser AM, Leibel BS. The artificial pancreas. Clin Endocrinol Metab 1977; 6: 457-479.
19. Kovatchev B. Closed loop control for type 1 diabetes. BMJ 2011; 342: 1911.
20. 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.
21. Ward WK, Castle JR, El YJ. Safe glycemic management during closed-loop treatment of type 1 diabetes: the role of glucagon, use of multiple sensors, and compensation for stress hyperglycemia. J Diabetes Sci Technol 2011; 5: 1373-1380.
22. El-Khatib FH, Russell SJ, Nathan DM, Sutherlin RG, Damiano ER. A bihormonal closed-loop artificial pancreas for type 1 diabetes. Sci Transl Med 2010; 2: 27ra27.
23. Buckingham B, Chase HP, Dassau E et al. Prevention of nocturnal hypoglycemia using predictive alarm algorithms and insulin pump suspension. Diabetes Care 2010; 33: 1013-1017.
24. Nimri R, Atlas E, Ajzensztejn M, Miller S, Oron T, Phillip M. Feasibility study of automated overnight closed-loop glucose control under MD-logic artificial pancreas in patients with type 1 diabetes: the DREAM Project. Diabetes Technol Ther 2012; 14: 728-735.
25. Weinzimer SA, Steil GM, Swan KL, Dziura J, Kurtz N, Tamborlane WV. 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: 934-939.
26. Heinemann L, Benesch C, DeVries JH. AP@home: a novel European approach to bring the artificial pancreas home. J Diabetes Sci Technol 2011; 5: 1363-1372.
27. Juvenile Diabetes Research FoundationArtificial Pancreas Consortium. Available from URL: http://jdrfconsortium.jaeb.org/ViewPage.aspx?PageName=Home. Accessed 2 September 2013.
28. The AP@home Consortium. Available from URL http://www.apathome.eu/project/consortium/. Accessed 2 October 2013.
29. Kovatchev BP, Breton M, Man CD, Cobelli C. In silico preclinical trials: a proof of concept in closed-loop control of type 1 diabetes. J Diabetes Sci Technol 2009; 3: 44-55.
30. Castle JR, Ward WK. Amperometric glucose sensors: sources of error and potential benefit of redundancy. J Diabetes Sci Technol 2010 1; 4: 221-225.
31. Fogt EJ, Dodd LM, Jenning EM, Clemens AH. Development and evaluation of a glucose analyzer for a glucose controlled insulin infusion system (Biostator). Clin Chem 1978; 24: 1366-1372.
32. 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 2007; 1: 181-192.
33. Ward W, Engle J, Duman H, Bergstrom C, Kim S, Federiuk I. The benefit of subcutaneous glucagon during closed-loop glycemic control in rats with type 1 diabetes. IEEE Sensors J 2008; 8: 88-96.
34. Hovorka R. Closed-loop insulin delivery: from bench to clinical practice. Nat Rev Endocrinol 2011; 7: 385-395.
35. Parker RS, 3rd Doyle FJ, Peppas NA. A model-based algorithm for blood glucose control in type I diabetic patients. IEEE Trans Biomed Eng 1999; 46: 148-157.
36. Steil GM, Panteleon AE, Rebrin K. Closed-loop insulin delivery-the path to physiological glucose control. Adv Drug Deliv Rev 2004; 56: 125-144.
37. Steil GM, Rebrin K, Darwin C, Hariri F, Saad MF. Feasibility of automating insulin delivery for the treatment of type 1 diabetes. Diabetes 2006; 55: 3344-3350.
38. 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: 419-424.
39. Murphy HR, Kumareswaran K, Elleri D et al. Safety and efficacy of 24-h closed-loop insulin delivery in well-controlled pregnant women with type 1 diabetes: a randomized crossover case series. Diabetes Care 2011; 34: 2527-2529.
40. Bruttomesso D, Farret A, Costa S et al. Closed-loop artificial pancreas using subcutaneous glucose sensing and insulin delivery and a model predictive control algorithm: preliminary studies in Padova and Montpellier. J Diabetes Sci Technol 2009; 3: 1014-1021.
41. Clarke WL, Anderson S, Breton M, Patek S, Kashmer L, Kovatchev B. 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: 1031-1038.
42. Chassin L, Wilinska M, Hovorka R. Evaluation of glucose controllers in virtual environment: methodology and sample application. Artif Intell Med 2004; 32: 171-181.
43. Atlas E, Nimri R, Miller S, Grunberg EA, Phillip M. MD-logic artificial pancreas system: a pilot study in adults with type 1 diabetes. Diabetes Care 2010; 33: 1072-1076.
44. Renard E. Insulin delivery route for the artificial pancreas: subcutaneous, intraperitoneal, or intravenous? Pros and cons. J Diabetes Sci Technol 2008; 2: 735-738.
45. Liebl A, Hoogma R, Renard E et al. A reduction in severe hypoglycaemia in type 1 diabetes in a randomized crossover study of continuous intraperitoneal compared with subcutaneous insulin infusion. Diabetes Obes Metab 2009; 11: 1001-1008.
46. Renard E, Place J, Cantwell M, Chevassus H, Palerm CC. Closed-loop insulin delivery using a subcutaneous glucose sensor and intraperitoneal insulin delivery: feasibility study testing a new model for the artificial pancreas. Diabetes Care 2010; 33: 121-127.
47. Juvenile Diabetes Research Foundation Continuous Glucose Monitoring Study Group. Effectiveness of continuous glucose monitoring in a clinical care environment: evidence from the Juvenile Diabetes Research Foundation continuous glucose monitoring (JDRF-CGM) trial. Diabetes Care 2010; 33: 17-22.
48. Mastrototaro J, Shin J, Marcus A, Sulur G, STAR 1 Clinical Trial Investigators. The accuracy and efficacy of real-time continuous glucose monitoring sensor in patients with type 1 diabetes. Diabetes Technol Ther 2008; 10: 385-390.
49. Hirsch IB, Abelseth J, Bode BW et al. Sensor-augmented insulin pump therapy: results of the first randomized treat-to-target study. Diabet Tech Ther 2008; 10: 377-383.
50. Slover RH, Welsh JB, Criego A et al. Effectiveness of sensor-augmented pump therapy in children and adolescents with type 1 diabetes in the STAR 3 study. Pediatr Diabetes 2012; 13: 6-11.
51. Hermanides J, Norgaard K, Bruttomesso D et al. Sensor-augmented pump therapy lowers HbA(1c) in suboptimally controlled Type 1 diabetes; a randomized controlled trial. Diabet Med 2011; 28: 1158-1167.
52. Garg S, Brazg RL, Bailey TS et al. Reduction in duration of hypoglycemia by automatic suspension of insulin delivery: the in-clinic ASPIRE study. Diabetes Technol Ther 2012; 14: 205-209.
53. Cengiz E, Swan KL, Tamborlane WV, Steil GM, Steffen AT, Weinzimer SA. Is an automatic pump suspension feature safe for children with type 1 diabetes? An exploratory analysis with a closed-loop system. Diabetes Technol Ther 2009; 11: 207-210.
54. Ly TT, Nicholas JA, Retterath A, Davis EA, Jones TW. Analysis of glucose responses to automated insulin suspension with sensor-augmented pump therapy. Diabetes Care 2012; 35: 1462-1465.
55. Choudhary P, Shin J, Wang Y et al. Insulin pump therapy with automated insulin suspension in response to hypoglycemia: reduction in nocturnal hypoglycemia in those at greatest risk. Diabetes Care 2011; 34: 2023-2025.
56. Danne T, Kordonouri O, Holder M et al. Prevention of hypoglycemia by using low glucose suspend function in sensor-augmented pump therapy. Diabetes Technol Ther 2011; 13: 1129-1134.
57. Castle JR, Engle JM, El Youssef J et al. Novel use of glucagon in a closed-loop system for prevention of hypoglycemia in type 1 diabetes. Diabetes Care 2010; 33: 1282-1287.
58. 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 2012; 35: 2148-2155.
59. Haidar A, Legault L, Dallaire M, et al. Glucose-responsive insulin and glucagon delivery (dual-hormone artificial pancreas) in adults with type 1 diabetes: a randomized crossover controlled trial. CMAJ 2013.
60. Castle JR, Engle JM, El Youssef J, Massoud RG, Ward WK. Factors influencing the effectiveness of glucagon for preventing hypoglycemia. J Diabetes Sci Technol 2010; 4: 1305-1310.
61. El Youssef J, Castle JR, Branigan DL et al. A controlled study of the effectiveness of an adaptive closed-loop algorithm to minimize corticosteroid-induced stress hyperglycemia in type 1 diabetes. J Diabetes Sci Technol 2011; 5: 1312-1326.
62. Van Bon AC, Jonker LD, Koebrugge R, Koops R, Hoekstra JB, DeVries JH. Feasibility of a bihormonal closed-loop system to control postexercise and postprandial glucose excursions. J Diabetes Sci Technol 2012; 6: 1114-1122.
63. Graf CJ, Woodworth JR, Seger ME, Holcombe JH, Bowsher RR, Lynch R. Pharmacokinetic and glucodynamic comparisons of recombinant and animal-source glucagon after IV, IM, and SC injection in healthy volunteers. J Pharm Sci 1999; 88: 991-995.
64. Ward WK, Massoud RG, Szybala CJ et al. In vitro and in vivo evaluation of native glucagon and glucagon analog (MAR-D28) during aging: lack of cytotoxicity and preservation of hyperglycemic effect. J Diabetes Sci Technol 2010; 4: 1311-1321.
65. Onoue S, Ohshima K, Debari K et al. Mishandling of the therapeutic peptide glucagon generates cytotoxic amyloidogenic fibrils. Pharm Res 2004; 21: 1274-1283.
66. Pedersen JS, Dikov D, Flink JL, Hjuler HA, Christiansen G, Otzen DE. The changing face of glucagon fibrillation: structural polymorphism and conformational imprinting. J Mol Biol 2006; 355: 501-523.
67. Maji SK, Perrin MH, Sawaya MR et al. Functional amyloids as natural storage of peptide hormones in pituitary secretory granules. Science 2009; 325: 328-332.
68. Matilainen L, Maunu SL, Pajander J et al. The stability and dissolution properties of solid glucagon/gamma-cyclodextrin powder. Eur J Pharm Sci 2009; 36: 412-420.
69. Cobelli C, Renard E, Kovatchev BP et al. Pilot studies of wearable outpatient artificial pancreas in type 1 diabetes. Diabetes Care 2012; 35: e65-e67.
70. 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: 824-833.
71. Raz I, Weiss R, Yegorchikov Y, Bitton G, Nagar R, Pesach B. Effect of a local heating device on insulin and glucose pharmacokinetic profiles in an open-label, randomized, two-period, one-way crossover study in patients with type 1 diabetes using continuous subcutaneous insulin infusion. Clin Ther 2009; 31: 980-987.
72. Vaughn DE, Yocum RC, Muchmore DB et al. Accelerated pharmacokinetics and glucodynamics of prandial insulins injected with recombinant human hyaluronidase. Diabetes Technol Ther 2009; 11: 345-352.
73. Hompesch M, Muchmore DB, Morrow L, Vaughn DE. Accelerated insulin pharmacokinetics and improved postprandial glycemic control in patients with type 1 diabetes after coadministration of prandial insulins with hyaluronidase. Diabetes Care 2011; 34: 666-668.
74. Weinzimer SA, Sherr JL, Cengiz E et al. Effect of pramlintide on prandial glycemic excursions during closed-loop control in adolescents and young adults with type 1 diabetes. Diabetes Care 2012; 35: 1994-1999.
75. Castle JR, Pitts A, Hanavan K et al. The accuracy benefit of multiple amperometric glucose sensors in people with type 1 diabetes. Diabetes Care 2012; 35: 706-710.