The Diabetes Interactive Diary (DID) is both a CHO (carbohydrates )/insulin bolus calculator, an information technology and a telemedicine system based on the communication between health care professional and patient by SMS messages. Aim of the study is to compare an insulin regimen of insulin glargine + prandial insulin glulisine associated with a telemedicine system to teach CHO counting (DID) with the same insulin regimen administered according to usual practice.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
130
DID is both a CHO/insulin bolus calculator, an information technology and a telemedicine system based on the communication between health care professional (physician or dietitian) and patient by SMS messages.
Ospedale G.B. Morgagni - L. Pierantoni
Forlì, Italy
NOT_YET_RECRUITINGP.O. di Grosseto - Stabilimento Misericordia
Grosseto, Italy
Blood levels of glycosylated hemoglobin
Time frame: from baseline every three months until the end of the study
blood glucose (BG) levels
Changes in BG levels from baseline to end of study (fasting BG, pre-/post-prandial BG, nocturnal BG, mean daily BG)
Time frame: from baseline every three months until the end of the study
Glucose variability
Glucose variability (MAGE, coefficient of variation of mean fasting BG and post-prandial BG)
Time frame: from baseline every three months until the end of the study
Change in body weight and BMI
Time frame: from baseline every three months until the end of the study
Total daily insulin dose, total basal insulin dose, total prandial insulin dose
Time frame: from baseline every three months until the end of the study
Quality of life
the quality of life will be measured by Diabetes Specific Quality of Life Scale (DSQOLS) and Diabetes Treatment Satisfaction Questionnaire (DTSQ)
Time frame: at baseline and at the end of the study
Frequency of patients with hypoglycemic episodes and frequency of hypoglycemic episodes overall
Time frame: every three months until the end of the study
Frequency of patients with severe and/or symptomatic hypoglycemia and frequency of severe and/or symptomatic hypoglycemic episodes overall
Time frame: every three months until the end of the study
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Az. Osp. S. Anna - Presidio Ospedaliero Cantù - Mariano Comense
Mariano Comense, Italy
RECRUITINGIstituto Scientifico San Raffaele
Milan, Italy
RECRUITINGOspedale Niguarda Cà Granda
Milan, Italy
RECRUITINGII Università di Napoli Centro Regionale di Diabetologia Pediatrica "G. Stoppoloni"
Naples, Italy
RECRUITINGUniversità degli Studi di Padova Dipartimento di Medicina Clinica e Sperimentale
Padua, Italy
RECRUITINGOspedale Cisanello
Pisa, Italy
RECRUITINGU.O. di Diabetologia, Dip. di Malattie Digestive & Metaboliche
Ravenna, Italy
RECRUITINGOspedale Infermi
Rimini, Italy
NOT_YET_RECRUITING...and 3 more locations
Frequency and times of hypoglycemic events with regard to occurrence during the day (24 hours) and total treatment duration (24 weeks)
Time frame: every three months until the end of the study