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 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 language | English |
|---|---|
| Pages (from-to) | 965-974 |
| Number of pages | 10 |
| Journal | Diabetes Technology and Therapeutics |
| Volume | 5 |
| Issue number | 6 |
| DOIs | |
| Publication status | Published - 2003 |
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ASJC Scopus subject areas
- Endocrinology
- Medicine (miscellaneous)
- Clinical Biochemistry
- Endocrinology, Diabetes and Metabolism
Cite this
A 2-Year Pilot Trial of Continuous Subcutaneous Insulin Infusion Versus Intensive Insulin Therapy in Patients with Newly Diagnosed Type 1 Diabetes (IMDIAB 8). / Pozzilli, Paolo; Crinó, Antonino; Schiaffini, Riccardo; Manfrini, Silvia; Fioriti, Elvira; Coppolino, Giusy; Pitocco, Dario; Visalli, Natalia; Corbi, Stefania; Spera, Sabrina; Suraci, Concetta; Cervoni, Marco; Matteoli, Maria C.; Patera, I. Patrizia; Ghirlanda, Giovanni; Valente, Luciana; Guglielmi, Chiara; Anguissola, Giuseppina Beretta; Costanza, Flavia; Montemari, Anna Lisa; Cantagallo, Anna; De Mattia, Giancarlo; Faldetta, Maria R Cassone; Bitti, Maria L Manca; Marietti, Giovanni; Bizzarri, Carla.
In: Diabetes Technology and Therapeutics, Vol. 5, No. 6, 2003, p. 965-974.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - A 2-Year Pilot Trial of Continuous Subcutaneous Insulin Infusion Versus Intensive Insulin Therapy in Patients with Newly Diagnosed Type 1 Diabetes (IMDIAB 8)
AU - Pozzilli, Paolo
AU - Crinó, Antonino
AU - Schiaffini, Riccardo
AU - Manfrini, Silvia
AU - Fioriti, Elvira
AU - Coppolino, Giusy
AU - Pitocco, Dario
AU - Visalli, Natalia
AU - Corbi, Stefania
AU - Spera, Sabrina
AU - Suraci, Concetta
AU - Cervoni, Marco
AU - Matteoli, Maria C.
AU - Patera, I. Patrizia
AU - Ghirlanda, Giovanni
AU - Valente, Luciana
AU - Guglielmi, Chiara
AU - Anguissola, Giuseppina Beretta
AU - Costanza, Flavia
AU - Montemari, Anna Lisa
AU - Cantagallo, Anna
AU - De Mattia, Giancarlo
AU - Faldetta, Maria R Cassone
AU - Bitti, Maria L Manca
AU - Marietti, Giovanni
AU - Bizzarri, Carla
PY - 2003
Y1 - 2003
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=0346993686&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=0346993686&partnerID=8YFLogxK
U2 - 10.1089/152091503322641006
DO - 10.1089/152091503322641006
M3 - Article
VL - 5
SP - 965
EP - 974
JO - Diabetes Technology and Therapeutics
JF - Diabetes Technology and Therapeutics
SN - 1520-9156
IS - 6
ER -