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

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

Research output: Contribution to journalArticle


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 A 1c (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 HbA 1c 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.

Original languageEnglish
Pages (from-to)965-974
Number of pages10
JournalDiabetes Technology and Therapeutics
Issue number6
Publication statusPublished - 2003


ASJC Scopus subject areas

  • Endocrinology
  • Medicine (miscellaneous)
  • Clinical Biochemistry
  • Endocrinology, Diabetes and Metabolism

Cite this

Pozzilli, P., Crinó, A., Schiaffini, R., Manfrini, S., Fioriti, E., Coppolino, G., Pitocco, D., Visalli, N., Corbi, S., Spera, S., Suraci, C., Cervoni, M., Matteoli, M. C., Patera, I. P., Ghirlanda, G., Valente, L., Guglielmi, C., Anguissola, G. B., Costanza, F., ... Bizzarri, C. (2003). 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, 5(6), 965-974. https://doi.org/10.1089/152091503322641006