An adaptive clinical Type 1 diabetes control protocol to optimize conventional self-monitoring blood glucose and multiple daily-injection therapy

International Journal of Adaptive Control and Signal Processing

Volumn 23, Issue 5, 2009, Pages 408-434

  Wong, Xing Wei ^a   Chase, J Geoffrey ^a   Compte, Aaron J Le ^a   Hann, Christopher E ^a   Lin, Jessica ^b   Shaw, Geoffrey M ^b  

^a UNIVERSITY OF CANTERBURY   (New Zealand)

^b UNIVERSITY OF OTAGO   (New Zealand)

Author keywords

Blood glucose; Compartmental models; Decision support; Diabetes; Hyperglycaemia; Insulin; Simulation; Subcutaneous injection

Indexed keywords

BLOOD GLUCOSE; COMPARTMENTAL MODELS; DECISION SUPPORT; DIABETES; HYPERGLYCAEMIA; SIMULATION; SUBCUTANEOUS INJECTION;

BLOOD; DECISION SUPPORT SYSTEMS; ERROR ANALYSIS; GLUCOSE; INSULIN; MONITORING; OPTIMIZATION; SEMICONDUCTOR COUNTERS; SIMULATORS; TITRATION;

ROBUSTNESS (CONTROL SYSTEMS);

EID: 67649226631     PISSN: 08906327     EISSN: 10991115     Source Type: Journal    
DOI: 10.1002/acs.l069     Document Type: Article

References (70)

1. Bequette BW. A critical assessment of algorithms and challenges in the development of a closed-loop artificial pancreas. Diabetes Technology and Therapeutics 2005; 7:28-47.
2. Klonoff DC. Continuous glucose monitoring: roadmap for 21st century diabetes therapy. Diabetes Care 2005; 28:1231-1239.
3. Guidance on the use of continuous subcutaneous insulin infusion for diabetes. Technology Appraisal Guidance No. 57, National Institute for Clinical Excellence. Available from: www.nice.org.uk, 2003.
4. Position statement on insulin pump therapy, Diabetes U. K. Available from: www.diabetes.org.uk (accessed 8 August 2007).
5. ADA. Standards of medical care in diabetes-2006. Diabetes Care 2006; 29:S4-S42.
6. Mainous AG, Diaz VA, Saxena S, Baker R, Everett CJ, Koopman RJ, Majeed A. Diabetes management in the U. S. A. and England: comparative analysis of national surveys. Journal of the Royal Society of Medicine 2006; 99:463-469.
7. Cohen M, Boyle E, Delaney C, Shaw J. A comparison of blood glucose meters in Australia. Diabetes Research and Clinical Practice 2006; 71:113-118.
8. Guerci B, Floriot M, Bohme P, Durain D, Benichou M, Jellimann S, Drouin P. Clinical performance of CGMS in Type 1 diabetic patients treated by continuous subcutaneous insulin infusion using insulin analogs. Diabetes Care 2003; 26:582-589.
9. Gerich JE. Novel insulins: expanding options in diabetes management. American Journal of Medicine 2002; 113:308-316.
10. Chase JG, Shaw GM, Lin J, Doran CV, Hann C, Robertson MB, Browne PM, Lotz T, Wake GC, Broughton B. Adaptive bolus-based targeted glucose regulation of hyperglycaemia in critical care. Medical Engineering and Physics 2005; 27:1-11.
11. Wong XW, Singh-Levett I, Hollingsworth LJ, Shaw GM, Hann CE, Lotz T, Lin J, Wong OS, Chase JG. A novel, model-based insulin and nutrition delivery controller for glycemic regulation in critically ill patients. Diabetes Technology and Therapeutics 2006; 8:174-190.
12. Wong XW, Chase JG, Hann CE, Shaw GM, Lotz T, Lin J, Le Compte AJ. A subcutaneous insulin pharmacokinetic model for computer simulation in a diabetes decision support role: validation and simulation. Part 2 of 2. Journal of Diabetes Science and Technology 2008; 2 (4) :672-680. ISSN: 1932-2968.
13. Wong XW, Chase JG, Hann CE, Shaw GM, Lotz T, Lin J, Le Compte AJ. A subcutaneous insulin pharmacokinetic model for computer simulation in a diabetes decision support role: model structure and parameter identification. Part 1 of 2. Journal of Diabetes Science and Technology 2008; 2 (4) :658-671. ISSN: 1932-2968.
14. Worthington DRL. Minimal model of food absorption in the gut. Medical Informatics 1997; 22:35-45.
15. Lehmann ED, Deutsch T, Carson ER, Sonksen PH. Aida-an interactive diabetes adviser. Computer Methods and Programs in Biomedicine 1994; 41:183-203.
16. Lehmann ED, Deutsch T. A physiological model of glucose-insulin interaction in Type 1 diabetes mellitus. Journal of Biomedical Engineering 1992; 14:235-242.
17. Dalla Man C, Caumo A, Basu R, Rizza R, Toffolo G, Cobelli C. Minimal model estimation of glucose absorption and insulin sensitivity from oral test: validation with a tracer method. American Journal of Physiology- Endocrinology and Metabolism 2004; 287:E637-E643.
18. Johansen K, Svendsen PA, Lorup B. Variations in renal threshold for glucose in Type-1 (insulin-dependent) diabetes-mellitus. Diabetologia 1984; 26:180-182.
19. Guyton AC, Hall JE. Textbook of Medical Physiology (10th edn). Saunders: Philadelphia, London, 2000.
20. Korach-Andre M, Roth H, Barnoud D, Pean M, Peronnet F, Leverve X. Glucose appearance in the peripheral circulation and liver glucose output in men after a large C-13 starch meal. American Journal of Clinical Nutrition 2004; 80:881-886.
21. Noah L, Krempf M, Lecannu G, Maugere P, Champ M. Bioavailability of starch and postprandial changes in splanchnic glucose metabolism in pigs. American Journal of Physiology-Endocrinology and Metabolism 2000; 278:E181-E188.
22. Mari A, Wahren J, Defronzo RA, Ferrannini E. Glucose-absorption and production following oral glucose- comparison of compartmental and arteriovenous-difference methods. Metabolism-Clinical and Experimental 1994; 43:1419-1425.
23. Ferrannini E, Bjorkman O, Reichard GA, Pilo A, Olsson M, Wahren J, Defronzo RA. The disposal of an oral glucose-load in healthy-subjects-a quantitative study. Diabetes 1985; 34:580-588.
24. Livesey G, Wilson PDG, Dainty JR, Brown JC, Faulks RM, Roe MA, Newman TA, Eagles J, Mellon FA, Greenwood RH. Simultaneous time-varying systemic appearance of oral and hepatic glucose in adults monitored with stable isotopes. American Journal of Physiology-Endocrinology and Metabolism 1998; 38:717-728.
25. Del Prato S, Matsuda M, Simonson DC, Groop LC, Sheehan P, Leonetti F, Bonadonna RC, DeFronzo RA. Studies on the mass action effect of glucose in NIDDM and IDDM: evidence for glucose resistance. Diabetologia 1997; 40:687-697.
26. Del Prato S, Riccio A, de Kreutzenberg SV, Dorella M, Tiengo A, DeFronzo RA. Basal plasma insulin levels exert a qualitative but not quantitative effect on glucose-mediated glucose uptake. American Journal of Physiology 1995; 268:1089-1095.
27. Scheinberg P. Observations on cerebral carbohydrate metabolism in man. Annals of Internal Medicine 1965; 62:367-371.
28. Boyle PJ, Scott JC, Krentz AJ, Nagy RJ, Comstock E, Hoffman C. Diminished brain glucose metabolism is a significant determinant for falling rates of systemic glucose utilization during sleep in normal humans. Journal of Clinical Investigation 1994; 93:529-535.
29. Baron AD, Brechtel G, Wallace P, Edelman SV. Rates and tissue sites of noninsulin- and insulin-mediated glucose uptake in humans. American Journal of Physiology 1988; 255:E769-E774.
30. Reed K, Lehmann ED. Diabetes website review: www.2aida.org. Diabetes Technology and Therapeutics 2005; 7:741-754.
31. Chase JG, Shaw GM, Lotz T, LeCompte A, Wong J, Lin J, Lonergan T, Willacy M, Hann CE. Model-based insulin and nutrition administration for tight glycaemic control in critical care. Current Drug Delivery 2007; 4:283-296.
32. Chase JG, Wong XW, Shaw GM, Hann CE, Lotz T, Lin J, Singh-Levett I, Hollingsworth L. Simulation and initial proof-of-concept validation of a glycaemic regulation algorithm in critical care. Control Engineering Practice 2008; 16 (3) :271-285. ISSN: 0967-0661.
33. Lonergan T, LeCompte A, Willacy M, Chase JG, Shaw GM, Wong XW, Lotz T, Lin J, Hann CE. A simple insulin-nutrition protocol for tight glycemic control in critical illness: development and protocol comparison. Diabetes Technology and Therapeutics 2006; 8:191-206.
34. Hann CE, Chase JG, Lin J, Lotz T, Doran CV, Shaw GM. Integral-based parameter identification for long-term dynamic verification of a glucose-insulin system model. Computer Methods and Programs in Biomedicine 2005; 77:259-270.
35. Gallen IW, Carter C. Prospective audit of the introduction of insulin glargine (Lantus) into clinical practice in Type 1 diabetic patients. Diabetes Care 2003; 26:3352-3353.
36. Distiller LA, Joffe BI. From the coalface: does glargine insulin improve hypoglycaemic episodes, glycaemic control or affect body mass in Type 1 diabetic subjects who are attending a 'routine' diabetes clinic? Diabetologia 2006; 49:2793-2794.
37. Anderson JH, Brunelle RL, Koivisto VA, Pfutzner A, Trautmann ME, Vignati L, DiMarchi R, Bowen KM, Cameron DP, Nankervis AJ, Roberts AP, Zimmet P, Borkenstein MH, Schernthaner G, Waldhausl WK, DeLeeuw IH, Fery F, Scheen A, Somers G, Fettes IM, Tildesley HD, Toth EL, Viikari J, Altman JJ, Bougneres PF, Drouin P, Fossati P, Guillausseau PJ, Marechaud E, Riou JP, Selam JL, Vialettes PB, Beyer J, Federlin K, Fussganger RD, Gries FA, Jastram HU, Koop I, Landgraf R, Rosak C, Schatz H, SchulzeSchleppinghoff B, Seif FJ, Stoeckmann F, Karasik A, Weitzman S, Andreani D, Bompiani G, Crepaldi G, Giorgino R, Greco AV, Lauro R, Maingay D, Mancini M, Menzinger G, Muggeo M, Pagano G, Sacca L, Tiengo A, Vigneri R, Erkelens DW, Janssens EN, Lekkerkerker JF, Spijker AJ, Daniels AR, Foiling I, Bonnici FB, Mollentze WF, Moore R, Omar MA, Robertson LI, Astorga R, deLeiva A, Jara A, Vazquez JA, Villardell E, Agardh CD, Alexander WD, Barnett AH, Cassar J, Hitman GA, Kesson CM, OHare JP, Shaw KM, Wales JK, Arslanian S, Bastyr EJ, Blevins TC, Boyce PA, Brink SJ, Clarke DH, DeClue T, Garber AJ, Guthrie RA, Johnson DG, Krosnick A, Linarelli LG, McCulloch DK, Mezitis NH, Raskin P, Reeves ML, Rosenblatt S, Schimel D, Skyler JS, Sonnenberg GE, Whitehouse FW, Zimmerman B. Reduction of postprandial hyperglycemia and frequency of hypoglycemia in IDDM patients on insulin-analog treatment. Diabetes 1997; 46:265-270.
38. Heinemann L, Linkeschova R, Rave K, Hompesch B, Sedlak M, Heise T. Time-action profile of the long-acting insulin analog insulin glargine (HOE901) in comparison with those of NPH insulin and placebo. Diabetes Care 2000; 23:644-649.
39. Bruttomesso D, Pianta A, Crazzolara D, Capparotto C, Dainese E, Zurlo C, Minicuci N, Briani G, Tiengo A. Teaching and training programme on carbohydrate counting in Type 1 diabetic patients. Diabetes Nutrition and Metabolism 2001; 14:259-267.
40. Warshaw HS, Kulkarni K. Complete Guide to Carb Counting: How to Take the Mystery out of Carb Counting and Unlock the Secrets to Blood Glucose Control (2nd edn). American Diabetes Association: Virginia, 2004.
41. Gregory RP, Davis DL. Use of carbohydrate counting for meal planning in type-I diabetes. Diabetes Educator 1994; 20:406-409.
42. Kildegaard J, Randlov J, Poulsen JU, Hejlesen OK. The impact of nonmodel-related variability on blood glucose prediction. Diabetes Technology and Therapeutics 2007; 9:363-371.
43. BD Diabetes Learning Centre, 'Insulin Therapies'. Managing Diabetes with Insulin, 2006. Available from: http://www.bddiabetes.com/us/main.aspx? cat=l&id=151.
44. Walsh J, Roberts R. The Pocket Pancreas: Your Diabetes Guide for Improved Blood Sugars. Diabetes Services Inc.: San Diego, CA, 1994.
45. Hanas R. Type 1 Diabetes-a Guide for Children, Adolescents, Young Adults and Their Caregivers. Marlowe and Company: New York, 2005.
46. Fritsche A, Schweitzer MA, Haring HU. Glimepiride combined with morning insulin glargine, bedtime neutral protamine hagedorn insulin, or bedtime insulin glargine in patients with type 2 diabetes. A randomized, controlled trial. Annals of Internal Medicine 2003; 138:952-959.
47. Riddle MC, Rosenstock J, Gerich J. Insulin glargine 4002 study investigators, the treat-to-target trial-randomized addition of glargine or human NPH insulin to oral therapy of type 2 diabetic patients. Diabetes Care 2003; 26:3080-3086.
48. Sanofi-Aventis, LANTUS® (insulin glargine [rDNA origin] injection). Prescribing Information, 2007. 11 October 2007. Available from: http://products.sanofi-aventis.us/lantus/lantus.html.
49. 2: a Mk. II automated insulin dosage advisor. Journal of Biomedical Engineering 1993; 15:201-211.
50. Kimberly MM, Vesper HW, Caudill SP, Ethridge SF, Archibold E, Porter KH, Myers GL. Variability among five over-the-counter blood glucose monitors. Clinica Chimica Acta 2006; 364:292-297.
51. Brunner GA, Ellmerer M, Sendlhofer G, Wutte A, Trajanoski Z, Schaupp L, Quehenberger F, Wach P, Krejs GJ, Pieber TR. Validation of home blood glucose meters with respect to clinical and analytical approaches. Diabetes Care 1998; 21:585-590.
52. Heise T, Nosek L, Ronn BB, Endahl L, Heinemann L, Kapitza C, Draeger E. Lower within-subject variability of insulin detemir in comparison to NPH insulin and insulin glargine in people with type 1 diabetes. Diabetes 2004; 53:1614-1620.
53. Guerci B, Sauvanet JP. Subcutaneous insulin: pharmacokinetic variability and glycemic variability. Diabetes and Metabolism 2005; 31:S7-S24.
54. Scholtz HE, Pretorius SG, Wessels DH, Becker RHA. Pharmacokinetic and glucodynamic variability: assessment of insulin glargine, NPH insulin and insulin ultralente in healthy volunteers using a euglycaemic clamp technique. Diabetologia 2005; 48:1988-1995.
55. Heinemann L. Variability of insulin absorption and insulin action. Diabetes Technology and Therapeutics 2002; 4:673-682.
56. Heinemann L, Weyer C, Rauhaus M, Heinrichs S, Heise T. Variability of the metabolic effect of soluble insulin and the rapid-acting insulin analog insulin aspart. Diabetes Care 1998; 21:1910-1914.
57. Lepore M, Pampanelli S, Fanelli C, Porcellati F, Bartocci L, Di Vincenzo A, Cordoni C, Costa E, Brunetti P, Bolli GB. Pharmacokinetics and pharmacodynamics of subcutaneous injection of long-acting human insulin analog glargine, NPH insulin, and ultralente human insulin and continuous subcutaneous infusion of insulin lispro. Diabetes 2000; 49:2142-2148.
58. Rohlfing CL, Wiedmeyer HM, Little RR, England JD, Tennill A, Goldstein DE. Defining the relationship between plasma glucose and HbA (1c) : analysis of glucose profiles and HbA (1c) in the diabetes control and complications trial. Diabetes Care 2002; 25:275-278.
59. 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. The New England Journal of Medicine 1993; 329:977-986.
60. Wong XW, Chase JG, Hann CE, Lotz T, Lin J, Le Compte AJ, Shaw GM. Development of a clinical type 1 diabetes metabolic system model and in silico simulation tool. Part 1 of 2. Journal of Diabetes Science and Technology 2008; 2 (3) :424-435. ISSN: 1932-2968.
61. ADA. Defining and reporting hypoglycemia in diabetes: a report from the American Diabetes Association Workgroup on Hypoglycemia. Diabetes Care 2005; 28:1245-1249.
62. AACE. Medical guidelines for the management of diabetes mellitus: the AACE system of intensive diabetes self-management-2002 update. Endocrine Practice 2002; 8 (Suppl. l) :40-64.
63. Lindholm A, McEwen J, Riis AP. Improved postprandial glycemic control with insulin aspart. A randomized double-blind cross-over trial in type 1 diabetes. Diabetes Care 1999; 22:801-805.
64. Home PD, Lindholm A, Hylleberg B, Round P. Improved glycemic control with insulin aspart: a multicenter randomized double-blind crossover trial in type 1 diabetic patients. U. K. Insulin Aspart Study Group. Diabetes Care 1998; 21:1904-1909.
65. Davidson PC, Hebblewhite HR, Bode BW, Steed RD, Steffes PG. Statistically fitted curve for A1c as a function of the SMBG tests per day. Presented at the 64th Scientific Sessions of the American Diabetes Association, Orlando, FL, 2004.
66. Samann A, Muhlhauser I, Bender R, Kloos C, Muller UA. Glycaemic control and severe hypoglycaemia following training in flexible, intensive insulin therapy to enable dietary freedom in people with type 1 diabetes: a prospective implementation study. Diabetologia 2005; 48 (10) : 1965-1970.
67. Blonde L, Karter AJ. Current evidence regarding the value of self-monitored blood glucose testing. American Journal of Medicine 2005; 118:20s-26s.
68. Monnier L, Colette C, Lapinski H, Boniface H. Self-monitoring of blood glucose in diabetic patients: from the least common denominator to the greatest common multiple. Diabetes and Metabolism 2004; 30:113-119.
69. Morris AD, Boyle DI, McMahon AD, Greene SA, MacDonald TM, Newton RW. Adherence to insulin treatment, glycaemic control, and ketoacidosis in insulin-dependent diabetes mellitus. The DARTS/MEMO Collaboration. Diabetes Audit and Research in Tayside Scotland. Medicines Monitoring Unit. Lancet 1997; 350:1505-1510.
70. Medtronic Inc, CGMS® System Gold™, Continuous Glucose Monitoring Overview, vol. 2004. Medtronic Inc., 2004.