A Phase 3 interventional study of Diabetes Interactive Diary (DID) in Type 1 Diabetes, sponsored by Consorzio Mario Negri Sud. Status unknown at 13 sites in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2010-09-02.
Sponsored by Consorzio Mario Negri Sud · Phase 3, Interventional, and Treatment
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.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's planned enrollment of 130 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Consorzio Mario Negri Sud is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Three prandial (before or at the end of meal administration, based on doctor counselling and patient decision) injections per day of insulin glulisine associated with basal insulin glargine; the DID will be used to estimate the CHO content of the food intended to eat. Insulin doses in this group will be adjusted based on DID calculations and pre-meal BG values.
Device: Diabetes Interactive Diary (DID)
Three prandial (before or at the end of meal administration, based on doctor counselling and patient decision) injections of insulin glulisine associated with basal insulin glargine. Insulin doses in group B will be adjusted based on SMBG values reviewed during the doctor office visit.
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.
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
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
This study is status unknown, as verified in Sep 2010. You cannot join it, but the record below documents what was studied.
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Consorzio Mario Negri Sud