A 2-Year Pilot Trial of Continuous Subcutaneous Insulin Infusion Versus Intensive Insulin Therapy in Patients with Newly Diagnosed Type 1 Diabetes (IMDIAB 8)

Diabetes Technology and Therapeutics

Volumn 5, Issue 6, 2003, Pages 965-974

  Pozzilli, Paolo ^a   Crinó, Antonino ^b   Schiaffini, Riccardo ^b   Manfrini, Silvia ^a   Fioriti, Elvira ^a   Coppolino, Giusy ^a   Pitocco, Dario ^c   Visalli, Natalia ^d   Corbi, Stefania ^a   Spera, Sabrina ^a   Suraci, Concetta ^e   Cervoni, Marco ^b   Matteoli, Maria C ^b   Patera, I Patrizia ^b   Ghirlanda, Giovanni ^c   Valente, Luciana ^f   Guglielmi, Chiara ^f   Anguissola, Giuseppina Beretta ^f   Costanza, Flavia ^f   Montemari, Anna Lisa ^f   Cantagallo, Anna ^f   De Mattia, Giancarlo ^f   Faldetta, Maria R Cassone ^f   Bitti, Maria L Manca ^f   Marietti, Giovanni ^f   Bizzarri, Carla ^f   more..

^a UNIVERSITY CAMPUS BIO MEDICO   (Italy)

^b BAMBINO GESÙ CHILDREN S HOSPITAL   (Italy)

^c CATHOLIC UNIVERSITY   (Italy)

^d SANDRO PERTINI HOSPITAL   (Italy)

^e S EUGENIO HOSPITAL   (Italy)

^f NONE

Author keywords

[No Author keywords available]

Indexed keywords

C PEPTIDE; HEMOGLOBIN A1C; INSULIN; INSULIN LISPRO; NICOTINAMIDE;

ADOLESCENT; ADULT; ARTICLE; BODY WEIGHT DISORDER; CHILD; CLINICAL ARTICLE; CLINICAL TRIAL; CONTINUOUS INFUSION; CONTINUOUS SUBCUTANEOUS INSULIN INFUSION; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIABETES CONTROL; FEMALE; FOLLOW UP; HUMAN; HYPOGLYCEMIA; INSULIN DEPENDENT DIABETES MELLITUS; INSULIN TREATMENT; INTENSIVE SUBCUTANEOUS INSULIN THERAPY; INTERMETHOD COMPARISON; MALE; PILOT STUDY; PRIORITY JOURNAL; PROTEIN SECRETION; RANDOMIZED CONTROLLED TRIAL; SUBCUTANEOUS DRUG ADMINISTRATION;

ANALYSIS OF VARIANCE; BODY MASS INDEX; C-PEPTIDE; DIABETES MELLITUS, TYPE 1; DOSE-RESPONSE RELATIONSHIP, DRUG; FOLLOW-UP STUDIES; HEMOGLOBIN A, GLYCOSYLATED; HUMANS; HYPOGLYCEMIA; HYPOGLYCEMIC AGENTS; INJECTIONS, SUBCUTANEOUS; INSULIN; INSULIN INFUSION SYSTEMS; PILOT PROJECTS; REPRODUCIBILITY OF RESULTS; TREATMENT OUTCOME;

EID: 0346993686     PISSN: 15209156     EISSN: None     Source Type: Journal    
DOI: 10.1089/152091503322641006     Document Type: Article

References (25)

1. The Diabetes Control and Complications Trial Research Group: Effect of intensive therapy on residual β-cell function patients with type 1 diabetes in the Diabetes Control and Complications Trial. A randomised, controlled trial. Ann Intern Med 1998;128:517-523.
2. Bolli GB: Physiological insulin replacement in type 1 diabetes mellitus. Exp Clin Endocrinol Diabetes 2001;109(Suppl 2):S317-S332.
3. The 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 2002;287:2563-2569.
4. Di Mario U, Dotta F: Modulation of antigen expression in relation to intervention strategies in Type 1 diabetes. Diabetes Metab Rev 1993;9:245-249.
5. Pozzilli P: Prevention of insulin-dependent diabetes mellitus. Diabetes Metab Rev 1998;14:69-84.
6. Rosenbloom AL, Schatz DA, Krischer JP, Skyler JS, Becker DJ, Laporte RE, Libman I, Pietropaolo M, Dosch HM, Finberg L, Muir A, Tamborlane WV, Grey M, Silverstein JH, Malone JI: Therapeutic controversy: prevention and treatment of diabetes in children. J Clin Endocrinol Metab 2000;85:494-522.
7. Pozzilli P, Visalli N, Boccuni ML, Baroni MG, Buzzetti R, Fioriti E, Signore A, Cavallo MG, Andreani D, Lucentini L, Crinò A, Cicconetti CA, Teodonio C, Amoretti R, Pisano L, Pennafina MG, Santopadre G, Marozzi G, Multari G, Campea L, Suppa MA, De Mattia GC, Faldetta M, Marietti G, Perrone F, Greco AV, Ghirlanda G: Randomized trial comparing nicotinamide and nicotinamide plus cyclosporin in recent onset insulin-dependent diabetes. Diabet Med 1994;11:98-104.
8. Pozzilli P, Visalli N, Signore A, Baroni MG, Buzzetti R, Cavallo MG, Boccuni ML, Valente L, Mesturino C, Andreani D, Lucentini L, Matteoli MC, Crinò A, Cicconetti CA, Teodonio C, Paci F, Amoretti R, Pisano L, Pennafina MG, Santopadre G, Marozzi G, Multari G, Suppa MA, De Mattia GC, Cassone Faldetta M, Marietti G, Perrone F, Greco AV, Ghirlanda G: Combination of nicotinamide and steroid versus nicotinamide in recent onset insulin-dependent diabetes (The IMDIAB II Study). Diabetes Care 1994;17:897-900.
9. Pozzilli P, Visalli N, Signore A, Baroni MG, Buzzetti R, Cavallo MG, Boccuni ML, Valente L, Mesturino C, Andreani D, Lucentini L, Matteoli MC, Crinò A, Cicconetti CA, Teodonio C, Paci F, Amoretti R, Pisano L, Pennafina MG, Santopadre G, Marozzi G, Multari G, Suppa MA, De Mattia GC, Cassone Faldetta M, Boscherini B, Stoduto S, Fonte MT, Batelli F, Marietti G, Perrone F, Greco AV, Ghirlanda G: Vitamin E and nicotinamide have similar effects in maintaining residual beta cell function in recent onset insulin-dependent diabetes (The IMDIAB IV Study). Eur J Endocrinol 1997;137:234-239.
10. Pozzilli P, IMDIAB Group, Rome, Italy: BCG vaccine in recent-onset IDDM: a bitter ending. Lancet 1997;349:1520-1521.
11. Pozzilli P, Visalli N, Signore A, Baroni MG, Buzzetti R, Cavallo MG, Boccuni ML, Valente L, Mesturino C, Andreani D, Lucentini L, Matteoli MC, Crinò A, Cicconetti CA, Teodonio C, Paci F, Amoretti R, Pisano L, Pennafina MG, Santopadre G, Marozzi G, Multari G, Suppa M, De Mattia GC, Cassone Faldetta M, Marietti G, Perrone F, Greco A, Ghirlanda G: Double blind trial of nicotinamide in recent onset insulin-dependent diabetes mellitus. Diabetologia 1995;38:848-852.
12. Pozzilli P, Browne PD, Kolb H, The Nicotinamide Trialists: Meta-analysis of nicotinamide treatment in patients with recent onset IDDM. Diabetes Care 1996;19:1357-1363.
13. Drash AL: Is it time to draw the curtain on immune intervention trials in newly diagnosed patients with IDDM? Diabetes Care 1995;18:1499-1501.
14. Rosenbloom AL, Schatz DA, Krischer JP, Skyler JS, Becker DJ, Laporte RE, Libman I, Pietropaolo M, Dosch HM, Finberg L, Muir A, Tamborlane WV, Grey M, Silverstein JH, Malone JI: Therapeutic controversy: prevention and treatment of diabetes in children. J Clin Endocrinol Metab 2000;85:494-522.
15. Canadian European Diabetes Study Group: Cyclosporin-induced remission of IDDM after early intervention. Association of 1 yr of cyclosporin treatment with enhanced insulin secretion. Diabetes 1998;37:1574-1582.
16. MacDonald MJ, Shahidi NT, Allen DB, Lustig RH, Mitchell TL, Cornwell ST: Pentoxifylline in the treatment of children with new-onset type 1 diabetes mellitus. JAMA 1994;271:27-28.
17. Coutant R, Landais P, Rosilio M, Johnsen C, Lahlou N, Chatelain P, Carel JC, Ludvigsson J, Boitard C, Bougneres PF: Low dose linomide in type 1 juvenile diabetes of recent onset: a randomised placebo-controlled double blind trial. Diabetologia 1998;41:1040-1046.
18. Elias D, Metzger M, Avron A, Tamir M, Yosefsberg Z, Phillip M, Raz I: C-peptide preservation and Th1 to Th2 shift in type 1 diabetes patients vaccinated with DiaPep277 [abstract]. Diabetes Metab Res Rev 2001;17(Suppl):S39.
19. Shah SC, Malone JI, Simpson RN: A randomised trial of intensive insulin therapy in newly diagnosed insulin-dependent diabetes mellitus. N Engl J Med 1989;85:494-522.
20. De Beaufort CE, Houtzagers CM, Bruining GJ, Aarsen RS, den Boer NC, Grose WF, van Strik R, de Visser JJ: Continuous subcutaneous insulin infusion (CSII) versus conventional injection therapy in newly diagnosed diabetic children: two year follow-up of a randomised, prospective trial. Diabet Med 1989;9:766-771.
21. Pozzilli P, Visalli N, Signore A, Baroni MG, Buzzetti R, Cavallo MG, Boccuni ML, Valente L, Mesturino C, Andreani D, Lucentini L, Matteoli MC, Crinò A, Cicconetti CA, Teodonio C, Paci F, Amoretti R, Pisano L, Pennafina MG, Santopadre G, Marozzi G, Multari G, Suppa MA, De Mattia GC, Cassone Faldetta M, Marietti G, Perrone F, Greco AV, Ghirlanda G: Adjuvant therapy in recent onset Type 1 diabetes at diagnosis and insulin requirement after 2 years. Diabetes Metab 1995;21:47-49.
22. Klein R, Klein BEK, Moss SC: The Wisconsin epidemiological study of diabetic retinopathy. The relationship of C-peptide to the incidence and progression of diabetic retinopathy. Diabetes 1995;44:796-801.
23. Diabetes Prevention Trial-Type 1 Diabetes Study Group: Effects of insulin in relatives of patient with type 1 diabetes mellitus. N Engl J Med 2002;346:1685-1691.
24. Tsui E, Barnie A, Ross S, Parkes R, Zinman B: Intensive insulin therapy with insulin lispro: a randomized trial of continuous subcutaneous insulin infusion versus multiple daily insulin injection. Diabetes Care 2001;24:1722-1727.
25. Schnell O, Eisfelder B, Standl E, Ziegler AG: High-dose intravenous insulin infusion versus intensive insulin treatment in newly diagnosed IDDM. Diabetes 1997;46:1607-1611.