title: A 2-year pilot trial of continuous subcutaneous insulin infusion versus intensive insulin therapy in patients with newly diagnosed type 1 diabetes (IMDIAB 8).
abstract: In a pilot study, the metabolic effects of continuous subcutaneous insulin infusion (CSII) versus intensive subcutaneous insulin therapy (ISIT) started at diagnosis in patients with Type 1 diabetes and continued for a 2-year period were evaluated and compared. Twenty-three patients (between 12 and 35 years old, mean +/- SD 18.4 +/- 9 years) were randomized into two treatment groups (CSII vs. ISIT), and both received supplemental nicotinamide (NA), 25 mg/kg of body weight. CSII was started immediately after admission to the hospital. Parameters of metabolic control [insulin dose, hemoglobin A1c (HbA1c), and C-peptide] were evaluated for a 2-year follow-up period. Data are presented for a total of 19 patients who remained in the study for its duration. Two years after diagnosis, mean +/- SD HbA1c was 6.3 +/- 0.5% and 6.2 +/- 0.3% for the CSII and ISIT groups, respectively (p=not significant). Compared with baseline values, an increase of baseline C-peptide of 38% for the CSII group and 27% for the ISIT group was observed; however, the difference between the groups was not significant. The insulin requirement for the entire duration of the study, but not at entry and 3 months, was significantly higher in CSII compared with ISIT patients (0.62 +/- 0.4 IU/kg/day vs. 0.3 +/- 0.4 IU/kg/day, respectively; p<0.01). After trial completion patients on CSII continued with this mode of therapy. Implementation of CSII as well as ISIT at diagnosis of Type 1 diabetes and continuation for 2 years thereafter achieved similar and optimal metabolic control, but more insulin was required with the CSII group. Both types of intensive insulin therapy combined with NA are able to preserve C-peptide secretion or even increase baseline levels for up to 2 years after diagnosis.
authors.affiliation: Department of Endocrinology and Diabetes, Università Campus Bio-Medico, Rome, Italy. p.pozzilli@unicampus.it
authors.forename: Paolo
authors.initials: P
authors.lastname: Pozzilli
authors.forename: Antonino
authors.initials: A
authors.lastname: Crinò
authors.forename: Riccardo
authors.initials: R
authors.lastname: Schiaffini
authors.forename: Silvia
authors.initials: S
authors.lastname: Manfrini
authors.forename: Elvira
authors.initials: E
authors.lastname: Fioriti
authors.forename: Giusy
authors.initials: G
authors.lastname: Coppolino
authors.forename: Dario
authors.initials: D
authors.lastname: Pitocco
authors.forename: Natalia
authors.initials: N
authors.lastname: Visalli
authors.forename: Stefania
authors.initials: S
authors.lastname: Corbi
authors.forename: Sabrina
authors.initials: S
authors.lastname: Spera
authors.forename: Concetta
authors.initials: C
authors.lastname: Suraci
authors.forename: Marco
authors.initials: M
authors.lastname: Cervoni
authors.forename: Maria C
authors.initials: MC
authors.lastname: Matteoli
authors.forename: I Patrizia
authors.initials: IP
authors.lastname: Patera
authors.forename: Giovanni
authors.initials: G
authors.lastname: Ghirlanda
mesh_terms: D000704:Analysis of Variance; D015992:Body Mass Index; D002096:C-Peptide / Q000097:blood; D003922:Diabetes Mellitus, Type 1 / Q000188:drug therapy*; D004305:Dose-Response Relationship, Drug; D005500:Follow-Up Studies; D006442:Glycated Hemoglobin / Q000187:drug effects / Q000378:metabolism; D006801:Humans; D007003:Hypoglycemia / Q000453:epidemiology; D007004:Hypoglycemic Agents / Q000008:administration & dosage / Q000627:therapeutic use; D007279:Injections, Subcutaneous; D007328:Insulin / Q000008:administration & dosage / Q000627:therapeutic use*; D007332:Insulin Infusion Systems; D010865:Pilot Projects; D015203:Reproducibility of Results; D016896:Treatment Outcome
chemical_list: D002096:C-Peptide; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D007328:Insulin