Survey on Continuos Subcutaneous Insulin Infusion in Italy
Conditions: Type 1 Diabetes
Sponsor: University of Padova

 
Title of the Study: CONTINUOS SUBCUTANEOUS INSULIN INFUSION IN ITALY (IMITA2) 
 
 
Date: 30th  March 2015 
 
 
 
NCT02620917 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Study Design 
In this multicentre cross-sectional study, data were collected using questionnaires sent by e-mail to adult 
and paediatric diabetes care centres that use CSII (continuous subcutaneous insulin infusion)for treatment. 
Centres were identified from previous surveys and through information from companies selling CSII 
devices. Incomplete data were obtained by phone or e-mail and integrated. Subjects treated with CSII for at 
least 1 year were consecutively enrolled among people who attended diabetes outpatient clinics between 
September 2015 and October 2016. Exclusion criteria were previous diagnosis of dementia or psychosis and 
pregnancy in progress. Before enrolment, informed consent was obtained from each participant. The study 
was approved by the ethical committee of each centre. Procedures complied with the ethical standards of 
the institutional and national committees on human experimentation and with the Helsinki Declaration of 
1975. 
Information on standard clinical variables (i.e. serum HbA1c, total cholesterol, high-density lipoprotein 
[HDL] cholesterol, triglycerides and creatinine), demographic data (i.e. age, gender, type of diabetes, 
duration of diabetes, duration of treatment with CSII and body mass index) and presence of hypertension 
and chronic diabetic complications (i.e. retinopathy, nephropathy and vasculopathy [cerebral, cardiac and 
peripheral]) was derived from local clinical management systems. The median HbA1c level of participants 
from the year before the study was calculated. Information on pump characteristics, use of advanced pump 
functions (i.e. different bolus types, bolus calculator and temporary basal rates), days of sensor use and 
frequency of self-monitoring of blood glucose was obtained from insulin pumps or glucometers or 
recovered from CGM receivers and was reported in the questionnaire. 
Participants were asked to record the number of severe hypoglycemia episodes (SH) experienced during 
the year preceding enrolment in the study, and the frequency of episodes was expressed as the cumulative 
number of SH episodes per participant. For adult participants, an SH episode was defined as an event 
requiring assistance and the administration of carbohydrates (CHOs) or glucagon. For paediatric 
participants, the SH episode referred to an event associated with coma, seizures or neurological symptoms 
requiring parenteral treatment. The number of diabetic ketoacidosis (DKA), defined as acidosis and 
hyperglycaemia, and the number of visits to the emergency room for acute metabolic complications of 
diabetes were collected from medical records. Information about the organisation of each centre included 
the number of people with T1DM, start of CSII treatment, team composition (physicians, nurses, dieticians 
and psychologists) and around-the-clock availability. 
Statistical analysis 
Continuous data were expressed as median and interquartile range (IQR). Categorical data were compared 

between groups using the chi-square test, whereas continuous data were compared between groups using 
the ManneWhitney or KruskaleWallis test. All tests were two sided, and a p value less than 0.05 was 
considered to be significant. A linear mixed-effect regression model was used to identify the predictors of 
HbA1c among clinically relevant variables (i.e. age, duration of diabetes, duration of CSII treatment, type of 
device, use of sensor-based treatment, CHO counting and use of advanced pump functions) that account 
for the centre’s effects. The centre was included in the model as a random effect because participant 
outcomes were expected to differ from centre to centre, possibly owing to differences among centres 
instead of differences among participants who present at different centres. Statistical analysis was 
performed using R 3.3.2 (The R Foundation for Statistical Computing, Vienna, Austria)