Continuous subcutaneous insulin infusion with short-acting insulin analogues or human regular insulin: efficacy, safety, quality of life, and cost-effectiveness.
Radermecker, Régis; Scheen, André
2004 • In Diabetes/Metabolism Research and Reviews, 20 (3), p. 178-88
Cost-Benefit Analysis; Diabetes Mellitus, Type 1/drug therapy; Economics; Female; Humans; Insulin/administration & dosage/analogs & derivatives; Insulin Infusion Systems/adverse effects; Pregnancy; Pregnancy in Diabetics/drug therapy; Quality of Life; Randomized Controlled Trials as Topic
Abstract :
[en] Portable insulin infusion devices are effective and safe insulin delivery systems for managing diabetes mellitus, especially type 1 diabetes. Rapidly absorbed insulin analogues, such as insulin lispro or insulin aspart, may offer an advantage over regular human insulin for insulin pumps. Several open-label randomised crossover trials demonstrated that continuous subcutaneous insulin infusion (CSII) with insulin lispro provided a better control of postprandial hyperglycaemia and a slightly but significantly lower glycated haemoglobin level, with lower daily insulin requirement and similar or even less hypoglycaemic episodes. A CSII study comparing insulin lispro and insulin aspart demonstrated similar results with the two analogues, and better results than those with regular insulin. Because these analogues have a quicker onset and a shorter duration of action than regular insulin, one might expect an earlier and greater metabolic deterioration in case of CSII interruption, but a more rapid correction of metabolic abnormalities after insulin boluses when reactivating the pump. These expectations were confirmed in randomised protocols comparing the metabolic changes occurring during and after CSII interruption of various durations when the pump infused either insulin lispro or regular insulin. The extra cost resulting from the use of CSII and insulin analogues in diabetes management should be compensated for by better metabolic control and quality of life. In conclusion, CSII delivering fast-acting insulin analogues may be considered as one of the best methods to replace insulin in a physiological manner by mimicking meal and basal insulin requirements, without higher risk of hypoglycaemia or ketoacidosis in well-educated diabetic patients.
Disciplines :
Endocrinology, metabolism & nutrition
Author, co-author :
Radermecker, Régis ; Centre Hospitalier Universitaire de Liège - CHU > Diabétologie,nutrition, maladies métaboliques
Scheen, André ; Université de Liège - ULiège > Département des sciences cliniques > Diabétologie, nutrition et maladie métaboliques - Médecine interne générale
Language :
English
Title :
Continuous subcutaneous insulin infusion with short-acting insulin analogues or human regular insulin: efficacy, safety, quality of life, and cost-effectiveness.
Publication date :
2004
Journal title :
Diabetes/Metabolism Research and Reviews
ISSN :
1520-7552
eISSN :
1520-7560
Publisher :
John Wiley & Sons, Inc, Chichester, United Kingdom
Pickup JC, Keen H, Pavsons JA, Alberti KGMM. Continuous subcutaneous insulin infusion: an approach to achieving normoglycaemia. Br Med J 1978; i: 204-207.
Van Cauter E, Polonsky KS, Scheen AJ. Roles of circadian rhythmicity and sleep in human glucose regulation. Endocr Rev 1997; 18: 716-738.
Diabetes Control and Complications Trial Research Group. Implementation of treatment protocols in the diabetes control and complications trial. Diabetes Care 1995; 18: 361-376.
Haardt MJ, Berne C, Dorange C, et al. Efficacy and indications of CSII revisited: the Hotel Dieu cohort. Diabetic Med 1997; 14: 407-408.
Hanaire-Broutin H, Melki V, Bessieres-Lacombe S, Tauber JP. The Study Group for the Development of Pump Therapy in Diabetes. Comparison of continuous subcutaneous insulin infusion and multiple daily injection regimens using insulin lispro in type 1 diabetic patients on intensified treatment: a randomized study. Diabetes Care 2000; 23: 1232-1235.
Pickup J, Martin 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. Br Med J 2002; 324: 705-708.
Lenhard MJ, Reeves GD. Continuous subcutaneous insulin infusion. A comprehensive review of insulin pump therapy. Arch Intern Med 2001; 161: 2293-2300.
Selam JL. External and implantable insulin pumps: current place in the treatment of diabetes. Exp Clin Endocrinol Diabetes 2001; 109(Suppl. 2): S333-S340.
Pickup JC. Is insulin pump treatment justifiable? In Difficult diabetes, Gill GV, Pickup JC, Williams G (eds). Oxford: Blackwell Science, 2001; 205-223.
Pickup J, Keen H. Continuous subcutaneous insulin infusion at 25 years: evidence base for the expanding use of insulin pump therapy in type 1 diabetes. Diabetes Care 2002; 25: 593-598.
Weissberg-Benchell J, Antisdel-Lomaglio J, Seshadri R. Insulin pump therapy. A meta-analysis. Diabetes Care 2003; 26: 1079-1087.
Lee WL, Zinman B. From insulin to insulin analogs: progress in the treatment of type 1 diabetes. Diabetes Rev 1998; 6: 73-88.
Bolli GB, Di Marchi RD, Park GD, Pramming S, Koivisto VA. Insulin analogues and their potential in the management of diabetes mellitus. Diabetologia 1999; 42: 1151-1167.
Madsbad S. Insulin analogues: have they changed insulin treatment and improved glycaemic control? Diabetes/Metab Res Rev 2002; 18(Suppl. 1): S21-S28.
Wilde MI, McTavish D. Insulin lispro. A review of its pharmacological properties and therapeutic use in the management of diabetes melitus. Drugs 1997; 54: 597-614.
Anderson JH, Bunelle RL, Koivisto VA, et al. Reduction of postprandial hyperglycemia and frequency of hypoglycemia in IDDM patients on insulin-analog treatment. Diabetes 1997; 46: 265-270.
Holleman F, Hoekstra JBL. Insulin lispro. N Engl, J Med 1997; 337: 176-183.
Heller S. Insulin lispro: a useful advance in insulin therapy. Expert Opin Pharmacother 2003; 4: 1407-1416.
Home PhD, Lindholm A, Hylleberg B, Round P for the U.K. Insulin Aspart Study Group. Improved glycemic control with insulin aspart. A multicenter randomized double-blind crossover trial in type 1 diabetic patients. Diabetes Care 1998; 21: 1904-1909.
Raskin P, Guthrie RA, Leiter L, Riis A, Jovanovic L. Use of insulin aspart, a fast-acting insulin analog, as the mealtime insulin in the management of patients with type 1 diabetes. Diabetes Care 2000; 23: 583-588.
Home PD, Lindholm A, Riis A for the European Insulin Aspart Study Group. Insulin aspart vs. human insulin in the management of long-term blood glucose control in type 1 diabetes mellitus: a randomised controlled trial. Diabetic Med 2000; 17: 762-770.
Lindholm A, Jacobsen LV. Clinical pharmacokinetics and pharmacodynamics of insulin aspart. Clin Pharmacokin 2001; 40: 641-659.
Chapman TM, Noble S, Goa KL. Insulin aspart: a review of its use in the management of type 1 and type 2 diabetes mellitus. Drugs 2002; 62: 1945-1981.
Holleman F, Schmitt H, Rottiers R, Rees A, Symanowski S, Anderson JH. Reduced frequency of severe hypoglycemia and coma in well-controlled IDDM patients treated with insulin lispro. Diabetes Care 1997; 20: 1827-1832.
Heller SR, Amiel SA, Mansell P. Effect of the fast-acting insulin analog lispro on the risk of nocturnal hypoglycemia during intensified insulin therapy. Diabetes Care 1999; 22: 1607-1611.
Brunelle RL, Llewelyn J, Anderson JH Jr, Gale EAM, Koivisto VA. Meta-analysis of the effect of insulin lispro on severe hypoglycemia in patients with type 1 diabetes. Diabetes Care 1998; 21: 1726-1731.
Lalli C, Ciofetta M, Del Sindaco P, et al. Long-term intensive treatment of type 1 diabetes with the short-acting insulin analog lispro in variable combination with NPH insulin at mealtime. Diabetes Care 1999; 22: 468-477.
Rönnemaa T, Viikari J. Reducing snacks when switching from conventional soluble to lispro insulin treatment: effects on glycaemic control and hypoglycaemia. Diabetic Med 1998; 15: 601-607.
Ebeling P, Jansson P-A, Smith U, Lalli C, Bolli GB, Koivisto VA. Strategies toward improved control during insulin lispro therapy in IDDM. Diabetes Care 1997; 20: 1287-1289.
Kraegen EW, Chisholm DJ. Pharmacokinetics of insulin. Implications for continuous subcutaneous insulin infusion therapy. Clin Pharmacokin 1985; 10: 303-314.
Scheen AJ. Pharmacocinétique de l'insuline administrée par voie sous-cutanée. Application au traitement par pompe portable. Diabete Metab 1989; 15: 128-138.
Lougheed WD, Zinman B, Strack TR, et al. Stability of insulin lispro in insulin infusion systems. Diabetes Care 1997; 20: 1061-1065.
Zinman B. Insulin pump therapy and rapid acting insulin: what have we learned? Int J Clin Pract 2001; 123(Suppl.): 47-50.
Bode B, Weinstein R, Bell D, et al. Comparison of insulin aspart with buffered regular insulin and insulin lispro in continuous subcutaneous insulin infusion. Diabetes Care 2002; 25: 439-444.
Mecklenburg RS, Benson EA, Benson JW, et al. Acute complications associated with insulin infusion pump therapy: report of experience with 161 patients. JAMA 1984; 252: 3265-3269.
Bending JJ, Pickup JC, Keen H. Frequency of diabetic ketoacidosis and hypoglycaemic coma during treatment with continuous subcutaneous insulin infusion. Audit of medical care. Am J Med 1985; 79: 685-691.
Castillo MJ, Scheen A, Lefèbvre PJ. Treatment with insulin infusion pumps and ketoacidotic episodes: from physiology to troubleshooting. Diabetes/Metab Rev 1995; 11: 161-177.
Zinman B, Tildesley H, Chiasson J-L, Tsui E, Strack T. Insulin lispro in CSII. Results of a double-blind crossover study. Diabetes 1997; 46: 440-443.
Schmauss S, König A, Landgraf R. Human insulin analogue [Lys(B28),PRO(B29)]: the ideal pump insulin? Diabetic Med 1998; 15: 247-249.
Melki V, Renard E, Lassmann-Vague V, et al. Improvement of HbA1c and blood glucose stability in IDDM patients treated with lispro insulin analog in external pumps. Diabetes Care 1998; 21: 977-982.
Renner R, Pfützner A, Trautmann M, et al. Use of insulin lispro in continuous subcutaneous insulin infusion treatment. Results of a multicenter trial. Diabetes Care 1999; 22: 784-788.
Johansson UB, Adamson UCK, Lins PES, Wredling RAM. The Swedish Multicenter Lispro Insulin Study. Improved blood glucose variability, HbA1c Insuman Infusat and less insulin requirement in IDDM patients using insulin lispro in CSII. Diabetes Metab 2000; 26: 192-196.
Raskin P, Holcombe JH, Tamborlane WV, et al. A comparison of insulin lispro and buffered regular human insulin administered via continuous subcutaneous insulin infusion pump. J Diabetes Complications 2001; 15: 295-300.
Campbell RK, Sclar DA, Robison LM, et al. Impact on clinical status and quality of life of switching from regular human insulin to insulin lispro among patients using insulin pumps. Diabetes Educator 1998; 24: 95-99.
Garg SK, Anderson JH, Gerard LA, et al. Impact of insulin lispro on HbA1c values in insulin pump users. Diab Obesity Metab 2000; 2: 307-311.
Catargi B, Breihl D, Roger P, Tabarin A. Glucose profiles in a type 1 diabetic patient successively treated with CSII using regular insulin, lispro and an implantable insulin pump. Diabetes Metab 2000; 26: 210-214.
Catargi B, Meyer L, Melki V, Renard E, Jeandidier N for the EVADIAC Study Group. Comparison of blood glucose stability and HbA1c between implantable insulin pumps using U400 HOE 21PH insulin and external pumps using lispro in type 1 diabetic patients: a pilot study. Diabetes Metab 2002; 28: 133-137.
Tsui EY, Chiasson JL, Tildesley H, Barnie A, Simkins S, Strack T. Counterregulatory hormone responses after long-term continuous subcutaneous insulin infusion with lispro insulin. Diabetes Care 1998; 21: 93-96.
Homko C, Deluzio A, Jimenez C, Kolaczynski JW, Boden G. Comparison of insulin aspart and lispro. Pharmacokinetic and metabolic effects. Diabetes Care 2003; 26: 2027-2031.
Bode BW, Strange P. Efficacy, safety, and pump compatibility of insulin aspart used in continuous subcutaneous insulin infusion therapy in patients with type 1 diabetes. Diabetes Care 2001; 24: 69-72.
Guerci B, Jeandidier N, Lassmann-Vague V, Renard E, Hanaire-Broutin H. Comment utiliser l'analogue de l'insuline Lys-Pro en perfusion sous-cutanée continue par pompe portable? Diabetes Metab 2000; 26: 513-519.
Krzentowski G, Scheen A, Castillo M, Luyckx AS, Lefèbvre PJ. A 6-hour nocturnal interruption of a continuous subcutaneous insulin infusion: 1. Metabolic and hormonal consequences and scheme for a prompt return to adequate control. Diabetologia 1983; 24: 314-318.
Scheen A, Henrivaux P, Jandrain B, Paolisso G, Lefèbvre P. Prevention of metabolic alterations by insulin supplements administered either before or after 2-h nocturnal interruption of CSII. Diabetes Care 1987; 10: 567-572.
Attia N, Jones TW, Holcombe J, Tamborlane WV. Comparison of human regular and lispro insulins after interruption of continuous subcutaneous insulin infusion and in the treatment of acutely decompensated IDDM. Diabetes Care 1998; 21: 817-821.
Reichel A, Rietzsch H, Kohler HJ, et al. Cessation of insulin infusion at night-time during CSII-therapy: comparison of regular human insulin and insulin lispro. Exp Clin Endocrinol Diabetes 1998; 106: 168-172.
Guerci B, Meyer L, Sallé A, et al. Comparison of metabolic deterioration between insulin analog and regular insulin after a 5-hour interruption of a continuous subcutaneous insulin infusion in type 1 diabetic patients. J Clin Endocrinol Metab 1999; 84: 2673-2678.
Dahl JS, Toriesen P, Hanssen K, Sandvik L, Aagenes O. Increase in insulin antibodies during continuous subcutaneous insulin infusion and multiple-injection therapy in contrast to conventional treatment. Diabetes 1987; 36: 1-5.
Olsen CL, Chan E, Turner DS, et al. Insulin antibody responses after long-term intraperitoneal insulin administration via implantable programmable insulin delivery systems. Diabetes Care 1994; 17: 169-176.
Walford S, Allison SP, Reeves WG. The effect of insulin antibodies on insulin dose and diabetic control. Diabetologia 1982; 22: 106-110.
Roach P, Varshavsky JA, Gantner K, Anderson JH. Insulin antibody-formation during treatment with human insulin or insulin lispro does not affect insulin dose requirements (Abstract). Diabetes 1996; 45(Suppl. 2): 958.
Scheen A, Henrivaux P, Jandrain B, Lefèbvre P. Anti-insulin antibodies and metabolic deterioration after interruption of continuous subcutaneous insulin infusion. Diabetes Care 1986; 9: 673-674.
Montana E, Fernandez-Castaner M, Rosel P, Gomez JM, Vinzia C, Soler J. The influence of insulin antibodies on metabolic deterioration after interruption of continuous subcutaneous insulin infusion. Diab Metab 1990; 16: 220-225.
Fineberg NS, Fineberg SG, Anderson JH, Birkett MA, Gibson RG, Hufferd S. Immunologic effects of insulin lispro [(Lys (B28), Pro (B29) human insulin)] in IDDM and NIDDM patients previously treated with insulin. Diabetes 1996; 45: 1750-1754.
Fineberg SE, Huang J, Brunelle R, Gulliya KS, Anderson JH Jr. Effect of long-term exposure to insulin lispro on the induction of antibody response in patients with type 1 or type 2 diabetes. Diabetes Care 2003; 26: 89-96.
Lahtela JT, Knip M, Paul R, Antonen J, Salmi J. Severe antibody-mediated human insulin resistance: successful treatment with the insulin analog lispro: a case report. Diabetes Care 1997; 20: 71-73.
Kumar D. Lispro analog for treatment of generalized allergy to human insulin. Diabetes Care 1997; 20: 1357-1359.
Eapen SS, Connor EL, Gern JE. Insulin desensitisation with insulin lispro and an insulin pump in a 5-year-old child. Ann Allergy Asthma Immunol 2000; 85: 395-397.
Näf S, Esmatjes E, Recasens M, et al. Continuous subcutaneous insulin infusion to resolve an allergy to human insulin. Diabetes Care 2002; 25: 634-635.
Sola-Gazagnes A, Pecquet C, Radermecker R, et al. Successful treatment of insulin allergy in a type 1 diabetic patient by means of constant subcutaneous pump infusion of insulin (Letter). Diabetes Care 2003; 26: 2961-2962.
Griffin ME, Feder A, Tamborlane WV. Lipoatrophy associated with lispro in insulin pump therapy (Letter). Diabetes Care 2001; 24: 174.
Ampudia-Blasco FJ, Hasbum B, Carmena R. A new case of lipoatrophy with lispro insulin in insulin pump therapy. Diabetes Care 2003; 26: 953-954.
Gabbe SG. New concepts and applications in the use of the insulin pump during pregnancy. J Matern Fetal Med 2000; 9: 42-45.
Gabbe SG, Holing E, Temple P, Brown ZA. Benefits, risks, costs, and patient satisfaction associated with insulin pump therapy for the pregnancy complicated by type 1 diabetes mellitus. Am J Obstet Gynecol 2000; 182: 1283-1291.
El-Sayed YY, Lyell DJ. New therapies for the pregnant patient with diabetes. Diabetes Technol Ther 2001; 3: 635-640.
Jovanovic L, Ilic S, Pettit DJ, et al. Metabolic and immunologic effects of insulin lispro in gestational diabetes. Diabetes Care 1999; 22: 1422-1427.
Bhattacharyya A, Brown S, Hughes S, Vice PA. Insulin lispro and regular insulin in pregnancy. Q J Med 2001; 94: 255-260.
Calle-Pascual AL, Bagazgoitia J, Calle JR, Charro A, Maranes JP. Use of insulin lispro in pregnancy. Diabetes Nutr Metab 2000; 13: 173-177.
Buchbinder A, Miodovnik M, Khoury J, Sibai BM. Is the use of insulin lispro safe in pregnancy? J Matern Fetal Neonatal Med 2002; 11: 232-237.
Masson EA, Patmore JE, Brash PD, et al. Pregnancy outcome in type 1 diabetes mellitus treated with insulin lispro (Humalog). Diabetic Med 2003; 20: 46-50.
Boskovic R, Feig DS, Derewlany L, Knie B, Portnoi G, Koren G. Transfer of insulin lispro across the human placenta: in vitro perfusion studies. Diabetes Care 2003; 26: 1390-1394.
Pettitt DJ, Ospina P, Kolaczynski JW, Jovanovic L. Comparison of an insulin analog, insulin aspart, and regular human insulin with no insulin in gestational diabetes mellitus. Diabetes Care 2003; 26: 183-186.
American Diabetes Association. Continuous subcutaneous insulin infusion. Diabetes Care 2003; 26(Suppl. 1): S125.
Kitzmiller JL, Main E, Ward B, Theiss T, Peterson DL. Insulin lispro and the development of proliferative diabetic retinopathy during pregnancy. Diabetes Care 1999; 22: 874-875.
Buchbinder A, Miodovnik M, McElvy S, et al. Is insulin lispro associated with the development or progression of diabetic retinopathy during pregnancy? Am J Obstet Gynecol 2000; 183: 1162-1165.
Loukovaara S, Immonen I, Teramo KA, Kaaja R. Progression of retinopathy during pregnancy in type 1 diabetic women treated with insulin lispro. Diabetes Care 2003; 23: 1193-1198.
Bruttomesso D, Pianta A, Crazzolara D, et al. Continuous subcutaneous insulin infusion (CSII) in the Veneto region: efficacy, acceptability and quality of life. Diabet Med 2002; 19: 628-634.
Wolf FM, Jacober SJ, Wolf L, Cornell RG, Floyd JC. Quality of life activities associated with adherence to insulin infusion pump therapy in the treatment of insulin dependent diabetes mellitus. J Clin Epidemiol 1989; 42: 1129-1136.
Dunn CJ, Plosker GL. Insulin lispro: a pharmacoeconomic review of its use in diabetes mellitus. PharmacoEconomics 2002; 20: 989-1025.
Kotsanos JG, Vignati L, Huster W, et al. Health-related quality-of-life results from multinational clinical trials of insulin lispro: assessing benefits of a new diabetes therapy. Diabetes Care 1997; 20: 948-958.
Bott U, Ebrahim S, Hirschberger S, Skovlund SE. Effect of the rapid-acting insulin analogue insulin aspart on quality of life and treatment satisfaction in patients with type 1 diabetes. Diabet Med 2003; 20: 626-634.
De Witt DE, Hirsch IB. Outpatient insulin therapy in type 1 and type 2 diabetes mellitus. JAMA 2003; 289: 2254-2264.
Scuffham P, Carr L. The cost-effectiveness of continuous subcutaneous insulin infusion compared with multiple daily injections for the management of diabetes. Diabet Med 2003; 20: 586-593.
Colquitt J, Royle P, Waugh N. Are analogue insulins better than soluble in continuous subcutaneous insulin infusion? Results of a meta-analysis. Diabet Med 2003; 20: 863-866.