Closed-loop insulin delivery - The path to physiological glucose control

Advanced Drug Delivery Reviews

Volumn 56, Issue 2, 2004, Pages 125-144

  Steil, G M ^a   Panteleon, A E ^a   Rebrin, K ^a  

^a MEDTRONIC INC   (United States)

Author keywords

Artificial pancreas; Automated insulin delivery; Continuous glucose sensing; Control model; CSII; Diabetes mellitus; Insulin action; Insulin pump; Insulin secretion; Subcutaneous glucose sensor

Indexed keywords

ALGORITHMS; BIOSENSORS; GLUCOSE; INSULIN; PATIENT TREATMENT;

DIABETES;

CONTROLLED DRUG DELIVERY;

GLUCOSE; INSULIN;

ALGORITHM; BIOSENSOR; BIOTECHNOLOGY; CELL FUNCTION; DRUG DELIVERY SYSTEM; GLUCOSE HOMEOSTASIS; GLUCOSE TOLERANCE; HISTOLOGY; HUMAN; INSULIN METABOLISM; INSULIN PUMP; INSULIN RELEASE; MODEL; PANCREAS ISLET BETA CELL; PORTAL VEIN; PRIORITY JOURNAL; REGULATORY MECHANISM; REVIEW;

EID: 1642452596     PISSN: 0169409X     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.addr.2003.08.011     Document Type: Article

References (110)

1. Reach G. Artificial or bioartificial systems for the totally automatic treatment of diabetes mellitus: the gap between the dream and the reality. Diabet. Nutr. Metab. 2:1989;165-170.
2. Gough D.A., Armour J.C. Development of the implantable glucose sensor: what are the prospects and why is it taking so long? Diabetes. 44:1995;1005-1009.
3. Monsod T.P., Flanagan D.E., Rife F., Saenz R., Caprio S., Sherwin R.S., Tamborlane W.V. Do sensor glucose levels accurately predict plasma glucose concentrations during hypoglycemia and hyperinsulinemia? Diabetes Care. 25:2002;889-893.
4. Rebrin K., Steil G.M., Van Antwerp W.P., Mastrototaro J.J. Subcutaneous glucose predicts plasma glucose independent of insulin: implications for continuous monitoring. Am. J. Physiol. 277:1999;561-571.
5. Heinemann L., Koschinsky T. Continuous glucose monitoring: an overview of today's technologies and their clinical applications. Int. J. Clin. Pract. Suppl. 2002;75-79.
6. Jaremko J., Rorstad O. Advances toward the implantable artificial pancreas for treatment of diabetes. Diabetes Care. 21:1998;444-450.
7. Pfeiffer E.F. The glucose sensor: the missing link in diabetes therapy. Horm. Metab. Res. Suppl. 24:1990;154-164.
8. Shichiri M., Kawamori R., Yamasaki Y., Hakui N., Abe H. Wearable artificial endocrine pancreas with needle-type glucose sensor. Lancet. 20:1982;1129-1131.
9. Kadish A.H. Automation control of blood sugar: a servomechanism for glucose monitoring and control. Am. J. Med. Electron. 1964;82-86.
10. Calabrese G., Bueti A., Zega G., Giombolini A., Bellomo G., Antonella M.A., Massi-Benedetti M., Brunetti P. Improvement of artificial endocrine pancreas (biostator; GCHS) performance combining feedback controlled insulin administration with a pre-programmed insulin infusion. Horm. Metab. Res. 14:1982;505-507.
11. Clemens A.H., Chang P.H., Myers R.W. The development of BIOSTATOR, a glucose controlled insulin infusion system (GCIIS). Horm. Metab. Res. Suppl. 8:1977;23-33.
12. Fogt E., Dodd L.M., Jenning E.M., Clemens A.H. Development and evaluation of a glucose analyzer for a glucose controlled insulin infusion system (Biostator). Clin. Chem. 24:1978;1366-1372.
13. Fischer U., Jutzi E., Bombor H., Freyse E.J., Salzsieder E., Albrecht G., Besch W., Bruns W. Assessment of an algorithm for the artificial B-cell using the normal insulin-glucose relationship in diabetic dogs and men. Diabetologia. 18:1980;97-107.
14. Fischer U., Salzsieder E., Freyse E.J., Albrecht G. Experimental validationof a glucose-insulin control model to simulate patterns in glucose turnover. Comput. Methods Programs Biomed. 32:1990;249-258.
15. Shimoda S., Nishida K., Sakakida M., Konno Y., Ichinose K., Uehara M., Nowak T., Shichiri M. Closed-loop subcutaneous insulin infusion algorithm with a short-acting insulin analog for long-term clinical application of a wearable artificial endocrine pancreas. Front. Med. Biol. Eng. 8:1997;197-211.
16. Kraegen E.W., Campbell L.V., Chia Y.O., Meler H., Lazarus L. Control of blood glucose in diabetics using an artificial pancreas. Aust. N. Z. J. Med. 7:1977;280-286.
17. Broekhuyse H.M., Nelson J.D., Zinman B., Albisser A.M. Comparison of algorithms for the close-loop control of blood glucose using the artificial beta cell. IEEE Trans. Biomed. Eng. BME-28. 1981;678-686.
18. Candas B., Radziuk J. An adaptive plasma glucose controller based on a nonlinear insulin/glucose model. IEEE Trans. Biomed. Eng. 41:1994;116-124.
19. Parker R.S., Doyle F.J., Peppas N.A. A model-based algorithm for blood glucose control in type 1 diabetic patients. IEEE Trans. Biomed. Eng. 46:1999;148-157.
20. Trajanoski Z. Neural predictive controller for insulin delivery using the subcutaneous route. IEEE Trans. Biomed. Eng. 45:1998;1122-1134.
21. Kienitz K.H., Yoneyama T. A robust controller for insulin pumps based on H-infinity theory. IEEE Trans. Biomed. Eng. 40:1993;1133-1137.
22. Parker R.S., Doyle F.J. III, Peppas N.A. The intravenous route to blood glucose control. IEEE Eng. Med. Biol. Mag. 20:2001;65-73.
23. Parker R.S., Doyle F.J. III Control-relevant modeling in drug delivery. Adv. Drug Deliv. Rev. 48:2001;211-228.
24. Bergman R.N., Ider Y.Z., Bowden C.R., Cobelli C. Quantitative estimation of insulin sensitivity. Am. J. Physiol. 236:1979;E667.
25. Bergman R.N., Phillips L.S., Cobelli C. Physiologic evaluation of factors controlling glucose disposition in man. Measurement of insulin sensitivity and beta-cell sensitivity from the response to intravenous glucose. J. Clin. Invest. 68:1981;1456.
26. Bergman R.N., Steil G.M., Bradley D.C., Watanabe R.M. Modeling insulin action in vivo. Ann. Rev. Physiol. 54:1992;861-883.
27. Avogaro A., Vicini P., Valerio A., Caumo A., Cobelli C. The hot but not the cold minimal model allows precise assessment of insulin sensitivity in NIDDM subjects. Am. J. Physiol. 270:1996;E532-E570.
28. Caumo A., Cobelli C. Hepatic glucose production during the labeled IVGTT: estimation by deconvolution with a new minimal model. Am. J. Physiol. 27:1993;E829-E841.
29. Vicini P., Caumo A., Cobelli C. Hot IVGTT two-compartment minimal model: indexes of glucose effectiveness and insulin sensitivity. Am. J. Physiol. 273:1997;E000.
30. Sorensen J.T., Clark K.C., Hillman R.S., Soeldner J.S. Use of a physiologic pharmacokinetic model of glucose homeostasis for assessment of performance requirements for improved insulin therapies. Diabetes Care. 5:1982;148-157.
31. Rebrin K., Fischer U., von Woedtke T., Abel P., Brunstein E. Automated feedback control of subcutaneous glucose concentration in diabetic dogs. Diabetologia. 32:1989;573-576.
32. Stout R.W. Hyperinsulinemia and atherosclerosis. Diabetes. 45:1996;S45-S46.
33. Holl R.W., Grabert M., Sorgo W., Heinze E., Debatin K.M. Contributions of age, gender and insulin administration to weight gain in subjects with IDDM. Diabetologia. 41:1998;542-547.
34. Osei K. Insulin resistance and systemic hypertension. Am. J. Cardiol. 84:1999;33J-36J.
35. Elahi D. In praise of the hyperglycemic clamp: a method for assessment of B-cell sensitivity and insulin resistance. Diabetes Care. 19:1996;278-286.
36. King D.S., Staten M.A., Kohrt W.M., Dalsky G.P., Elahi D., Holloszy J.O. Insulin secretory capacity in endurance-trained and untrained young men. Am. J. Physiol. 259:1990;E155-E161.
37. Cherrington A.D., Sindelar D., Edgerton D., Steiner K., McGuinness O.P. Physiological consequences of phasic insulin release in the normal animal. Diabetes. 51(Suppl. 1):2002;S103-S108.
38. Luzi L., DeFronzo R.A. Effect of loss of first-phase insulin secretion on hepatic glucose production and tissue glucose disposal in humans. Am. J. Physiol. 257:1989;E241-E246.
39. Gerich J.E. Is reduced first-phase insulin release the earliest detectable abnormality in individuals destined to develop type 2 diabetes? Diabetes. 51(Suppl. 1):2002;S117-S121.
40. Pratley R.E., Foley J.E., Dunning B.E. Rapid acting insulinotropic agents: restoration of early insulin secretion as a physiologic approach to improve glucose control. Curr. Pharm. Des. 7:2001;1375-1397.
41. de Souza C.J., Gagen K., Chen W., Dragonas N. Early insulin release effectively improves glucose tolerance: studies in two rodent models of type 2 diabetes mellitus. Diabetes Obes. Metab. 3:2001;85-95.
42. Bergman R.N., Finegood D.T., Ader M. Assessment of insulin sensitivity in vivo. Endocr. Rev. 6:1985;45-86.
43. Kahn S.E., Prigeon R.L., McCulloch D.K., Boyko E.J., Bergman R.N., Schwartz M.W., Neifing J.L., Ward W.K., Beard J.C., Palmer J.P. Quantification of the relationship between insulin sensitivity and β-cell function in human subjects. Evidence for a hyperbolic function. Diabetes. 42:1993;1663-1672.
44. Martin B.C., Warram J.H., Krolewski A.S., Bergman R.N., Soeldner J.S., Kahn C.R. Role of glucose and insulin resistance in development of type 2 diabetes mellitus: results of a 25-year follow-up study. Lancet. 340:1992;925-929.
45. Steil G.M., Doria A., Soeldner J.S., Warram J.H. Heterogeneity of B-cell compensation during progression to NIDDM. (abstract) Diabetes. 46(Suppl. 1):1997;A0944.
46. Ogata K. Modern Control Engineering. 1997;Tom Robins, Prentice-Hall, NJ.
47. Borg L.A., Westberg M., Grill V. The priming effect of glucose on insulin release does not involve redistribution of secretory granules within the pancreatic B-cell. Mol. Cell. Endocrinol. 56:1988;219-225.
48. Shapiro E.T., Tillil H., Polonsky K.S., Fang V.S., Rubenstein A.H., Van Cauter E. Oscillations in insulin secretion during constant glucose infusion in normal man: relationship to changes in plasma glucose. J. Clin. Endocrinol. Metab. 67:1988;307-314.
49. Balasse E.O., Ooms H.A. Role of free fatty acids in the control of insulin secretion in man. Diabetologia. 9:1973;145-151.
50. Benthem L., Mundinger T.O., Taborsky G.J. Jr. Meal-induced insulin secretion in dogs is mediated by both branches of the autonomic nervous system. Am. J. Physiol. Endocrinol. Metab. 278:2000;E603-E610.
51. Strubbe J.H., Steffens A.B. Neural control of insulin secretion. Horm. Metab. Res. 25:1993;507-512.
52. Thorens B. Glucagon-like peptide-1 and control of insulin secretion. Diabete Metab. 21:1999;311-318.
53. Baynes C., Anyaoku V., Johnston D.G., Elkeles R.S. Feedback inhibition of insulin secretion in type 2 diabetes. Clin. Sci. (Lond.). 81:1991;685-690.
54. Sinagra D., Scarpitta A.M., Brigandi M., D'Acquisto G. Feedback inhibition of insulin secretion and insulin resistance in polycystic ovarian syndrome with and without obesity. Eur. Rev. Med. Pharmacol. Sci. 1:1997;167-171.
55. Elahi D., Nagulesparan M., Hershcopf R.J., Muller D.C., Tobin J.D., Blix P.M., Rubenstein A.H., Unger R.H., Andres R. Feedback inhibition of insulin secretion by insulin: relation to the hyperinsulinemia of obesity. N. Engl. J. Med. 306:1982;1196-1202.
56. Cavallo-Perin P., Bruno A., Nuccio P., Goria M., Pagano G., Lenti G. Feedback inhibition of insulin secretion is altered in cirrhosis. J. Clin. Endocrinol. Metab. 63:1986;1023-1027.
57. Argoud G.M., Schade D.S., Eaton R.P. Insulin suppresses its own secretion in vivo. Diabetes. 36:1987;959-962.
58. Albisser A.M., Leibel B.S., Zinman B., Murray F.T., Zingg W., Botz C.K., Denoga A., Marliss E.B. Studies with an artificial endocrine pancreas. Arch. Intern. Med. 137:1977;649.
59. Kraegen E.W., Chisholm D.J. Closure of the loop by glucose sensing. Physiological and practical considerations. Horm. Metab. Res. Suppl. 20:1988;1-4.
60. Fischer U., Detschew W., Jutzi E., Albrecht G., Abel P., Salzsieder E., Freyse E.J., Frenzel S., Lemke K. In vivo comparison of different algorithms for the artificial beta-cell. Artif. Organs. 9:1985;173-179.
61. Getty L., Hamilton-Wessler M., Ader M., Dea M.K., Bergman R.N. Biphasic insulin secretion during intravenous glucose tolerance test promotes optimal interstitial insulin profile. Diabetes. 47:1998;1941-1947.
62. Chee F., Fernando T., van Heerden P.V. Closed-loop glucose control in critically ill patients using continuous glucose monitoring system (CGMS) in real time. IEEE Trans. Inf. Technol. Biomed. 7:2003;43-53.
63. Hovorka R., Chassin L., Luzio S.D., Playle R., Owens D.R. Pancreatic beta-cell responsiveness during meal tolerance test: model assessment in normal subjects and subjects with newly diagnosed noninsulin-dependent diabetes mellitus. J. Clin. Endocrinol. Metab. 83:1998;744-750.
64. Breda E., Toffolo G., Polonsky K.S., Cobelli C. Insulin release in impaired glucose tolerance: oral minimal model predicts normal sensitivity to glucose but defective response times. Diabetes. 51(Suppl. 1):2002;S227-S233.
65. Ehrmann D.A., Breda E., Cavaghan M.K., Bajramovic S., Imperial J., Toffolo G., Cobelli C., Polonsky K.S. Insulin secretory responses to rising and falling glucose concentrations are delayed in subjects with impaired glucose tolerance. Diabetologia. 45:2002;509-517.
66. Breda E., Cavaghan M.K., Toffolo G., Polonsky K.S., Cobelli C. Oral glucose tolerance test minimal model indexes of beta-cell function and insulin sensitivity. Diabetes. 50:2001;150-158.
67. Toffolo G., Breda E., Cavaghan M.K., Ehrmann D.A., Polonsky K.S., Cobelli C. Quantitative indexes of beta-cell function during graded up and down glucose infusion from C-peptide minimal models. Am. J. Physiol. 280:2001;E2-E10.
68. Caumo A., Bergman R.N., Cobelli C. Insulin sensitivity from meal tolerance tests in normal subjects: a minimal model index. J. Clin. Endocrinol. Metab. 85:2000;4396-4402.
69. Mari A., Schmitz O., Gastaldelli A., Oestergaard T., Nyholm B., Ferrannini E. Meal and oral glucose tests for assessment of beta-cell function: modeling analysis in normal subjects. Am. J. Physiol. 283:2002;E1159-E1166.
70. Mari A., Tura A., Gastaldelli A., Ferrannini E. Assessing insulin secretion by modeling in multiple-meal tests: role of potentiation. Diabetes. 51(Suppl. 1):2002;S221-S226.
71. Mari A., Camastra S., Toschi E., Giancaterini A., Gastaldelli A., Mingrone G., Ferrannini E. A model for glucose control of insulin secretion during 24 h of free living. Diabetes. 50(Suppl. 1):2001;S164-S168.
72. Cryer P.E. Hypoglycaemia: the limiting factor in the glycaemic management of Type I and Type II diabetes. Diabetologia. 45:2002;937-948.
73. Robert J.J. Continuous monitoring of blood glucose. Horm. Res. 57(Suppl. 1):2002;81-84.
74. Schmidtke D.W., Freeland A.C., Heller A., Bonnecaze R.T. Measurement and modeling of the transient difference between blood and subcutaneous glucose concentrations in the rat after injection of insulin. Proc. Natl. Acad. Sci. U. S. A. 95:1998;294-299.
75. Beyer U., Schafer D., Thomas A., Aulich H., Haueter U., Reihl B., Ehwald R. Recording of subcutaneous glucose dynamics by a viscometric affinity sensor. Diabetologia. 44:2001;416-423.
76. Rebrin K., Steil G.M. Can interstitial glucose assessment replace blood glucose measurements? Diabetes Technol. Ther. 2:2000;461-472.
77. Steil G.M., Rebrin K., Mastrototaro J., Bernaba B., Saad M.F. Determination of plasma glucose during rapid glucose excursions with a subcutaneous glucose sensor. Diabetes Technol. Ther. 5:2003;27-31.
78. Proakis J.G., Manolakis D.G. Digital Signal Processing: Principles, Algorithms, and Applications. 1996;Prentice-Hall, NJ.
79. Jungheim K., Koschinsky T. Glucose monitoring at the thenar: evaluation of upper dermal blood glucose kinetics during rapid systemic blood glucose changes. Horm. Metab. Res. 34:2002;325-329.
80. Proakis J.G., Manolakis D.G. Digital Signal Processing: Principles, Algorhithms, and Applications. 1996;Prentice-Hall.
81. Berger M., Halban P.A., Girardier L., Seydoux J., Offord R.E., Renold A.E. Absorption kinetics of subcutaneously injected insulin. Evidence for degradation at the injection site. Diabetologia. 17:1979;97-99.
82. Heinemann L. Variability of insulin absorption and insulin action. Diabetes Technol. Ther. 4:2002;673-682.
83. Adkins B.A., Myers S.R., Hendrick G.K., Stevenson R.W., Williams P.E., Cherrington A.D. Importance of the route of intravenous glucose delivery to hepatic glucose balance in the conscious dog. J. Clin. Invest. 79:1992;557-565.
84. Cherrington A.D., Williams P.E., Abou-Mourad N., Lacy W.W., Steiner K.E., Liljenquist J.E. Insulin as a mediator of hepatic glucose uptake in the conscious dog. Am. J. Physiol. 242(5):1982;E97-E101.
85. Eaton R.P., Allen R.C., Schade D.S., Standefer J.C. "Normal" insulin secretion: the goal of artificial insulin delivery systems? Diabetes Care. 3:1980;270-273.
86. Ader M., Bergman R.N. Peripheral effects of insulin dominate suppression of fasting hepatic glucose production. Am. J. Physiol. 258:1990;E1020-E1032.
87. Bergman R.N. New concepts in extracellular signaling for insulin action: the single gateway hypothesis. Prog. Horm. Res. 52:1997;359-385.
88. Bradley D.C., Poulin R.A., Bergman R.N. Dynamics of hepatic and peripheral insulin effects suggest common rate-limiting step in vivo. Diabetes. 42:1993;296-306.
89. Rebrin K., Steil G.M., Getty L., Bergman R.N. Free fatty acid as a link in the regulation of hepatic glucose output by peripheral insulin. Diabetes. 44:1995;1038-1045.
90. Rebrin K., Steil G.M., Bergman R.N. Direct evidence that free fatty acids mediate insulin suppression of hepatic glucose output. (abstract) Diabetes. 44:1995.
91. Rebrin K., Steil G.M., Mittelman S.D., Bergman R.N. Causal linkage between insulin regulation of lipolysis and liver glucose output. J. Clin. Invest. 98:1996;741-749.
92. Lewis G.F., Zinman B., Groenewoud Y., Vranic M., Giacca A. Hepatic glucose production is regulated both by direct hepatic and extrahepatic effects of insulin in humans. Diabetes. 45:1996;454-462.
93. Lewis G.F., Vranic M., Harley P., Giacca A. Fatty acids mediate the acute extrahepatic effects of insulin on hepatic glucose production in humans. Diabetes. 46:1997;1111-1119.
94. Canavan J.P., Flecknell P.A., New J.P., Alberti K.G., Home P.D. The effect of portal and peripheral insulin delivery on carbohydrate and lipid metabolism in a miniature pig model of human IDDM. Diabetologia. 40:1997;1125-1134.
95. Chiasson J.L., el Achkar G.G., Ducros F., Bourque J., Maheux P. Glucose turnover and gluconeogenesis during pregnancy in women with and without insulin-dependent diabetes mellitus. Clin. Invest. Med. 20:1997;140-151.
96. Steil G.M., Loutseiko M., Kurtz N., Panteleon A., Long K., Leach J.S., Rebrin K. Tuning closed-loop insulin delivery based on known daily insulin requirements. (abstract) Diabetes. 51(Suppl. 2):2002.
97. Saad M.F., Riad-Gabriel M.G., Khan A., Sharma A., Michael R., Jinagouda S.D., Boyadjian R., Steil G.M. Diurnal and ultradian rhythmicity of plasma leptin: effects of gender and adiposity. J. Clin. Endocrinol. Metab. 83:1998;453-459.
98. Renard E. Implantable closed-loop glucose-sensing and insulin delivery: the future for insulin pump therapy. Curr. Opin. Pharmacol. 2:2002;708-716.
99. Renard E., Shah R., Miller M., Starkweather T., Kolopp M., Costalat G., Bringer J. Accuracy of real-time blood glucose measurement by long-term sensor system allows automated insulin delivery in diabetic patients. Diabetes. 51(Suppl. 2):2002;508-P. (A126).
100. Hogan P., Dall T., Nikolov P. Economic costs of diabetes in the US in 2002. Diabetes Care. 26:2003;917-932.
101. Tchobroutsky G. Relation of diabetic control to the development of microvascular complications. Diabetologia. 15:1987;143-152.
102. Hanssen K.F. Blood glucose control and microvascular and macrovascular complications in diabetes. Diabetes. 46:1997;S101-S103.
103. Foley J.E., Chen Y.-D.I., Lardinois C.K., Hollenbeck C.B., Liu G.C., Reaven G.M. Estimates of in vivo insulin action in humans: comparison of the insulin clamp and minimal model techniques. Horm. Metab. Res. 17:1987;406-409.
104. Reichard P., Nilsson B.Y., Rosenqvist U. The effect of long-term intensified insulin treatment on the development of microvascular complications of diabetes mellitus. N. Engl. J. Med. 329:1993;304-309.
105. Bode B.W., Steed R.D., Davidson P.C. Reduction in severe hypoglycemia with long-term continuous subcutaneous insulin infusion in type 1 diabetes. Diabetes Care. 19:1996;324-327.
106. Wang P.H., Lau J., Chalmers T.C. Meta-analysis of effects of intensive blood-glucose control on late complications of type I diabetes. Lancet. 341:1993;1306-1309.
107. Nicolucci A., Cavaliere D., Scorpiglione N., Carinci F., Tognoni G., Benedetti M.M. A comprehensive assessment of the avoidability of long-term complications of diabetes. Diabetes Care. 19:1996;927-933.
108. Steil G.M., Richey J.M., Kim J.K., Wi J.K., Rebrin K., Bergman R.N., Youn J.H. Extracellular glucose distribution is not altered by insulin: compartmental analysis of plasma and interstitial L-glc kinetics. Am. J. Physiol. 271:1996;E855-E864.
109. Mittelman S.D., You-Yin F., Steil G.M., Rebrin K., Bergman R.N. The indirect effect of insulin to suppress hepatic glucose output is dominant independent of glucagon. J. Clin. Invest. 100:1997;3121-3130.
110. Saad M.F., Steil G.M., Riad-Gabrriel M., Khan A., Sharma A., Boyadjian R., Jinagouda S.D., Bergman R.N. Method of administration has no effect on insulin sensitivity estimate from the insulin-modified minimal model protocol. Diabetes. 46:1997;2044-2048.