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| Name | Class |
|---|---|
| Sanofi | INDUSTRY |
| LifeScan | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| insulin + DID | Experimental | 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. |
|
| insulin + usual care | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diabetes Interactive Diary (DID) | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Blood levels of glycosylated hemoglobin | from baseline every three months until the end of the study |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | from baseline every three months until the end of the study |
| Glucose variability |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Antonio Nicolucci, MD | Contact | +39 0872 570 | 260 | nicolucci@negrisud.it |
| Maria C Rossi | Contact | +39 0872 570 | 266 | mrossi@negrisud.it |
| Name | Affiliation | Role |
|---|---|---|
| Antonio Nicolucci, MD | Consorzio Mario Negri Sud | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ospedale G.B. Morgagni - L. Pierantoni | Not yet recruiting | Forlì | 47100 | Italy |
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| Label | URL |
|---|---|
| Related Info | View source |
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Glucose variability (MAGE, coefficient of variation of mean fasting BG and post-prandial BG)
| from baseline every three months until the end of the study |
| Change in body weight and BMI | from baseline every three months until the end of the study |
| Total daily insulin dose, total basal insulin dose, total prandial insulin dose | 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) | at baseline and at the end of the study |
| Frequency of patients with hypoglycemic episodes and frequency of hypoglycemic episodes overall | 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 | 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) | every three months until the end of the study |
| P.O. di Grosseto - Stabilimento Misericordia | Recruiting | Grosseto | 58100 | Italy |
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| Az. Osp. S. Anna - Presidio Ospedaliero Cantù - Mariano Comense | Recruiting | Mariano Comense | 22066 | Italy |
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| Istituto Scientifico San Raffaele | Recruiting | Milan | 20132 | Italy |
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| Ospedale Niguarda Cà Granda | Recruiting | Milan | 20162 | Italy |
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| II Università di Napoli Centro Regionale di Diabetologia Pediatrica "G. Stoppoloni" | Recruiting | Naples | 80138 | Italy |
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| Università degli Studi di Padova Dipartimento di Medicina Clinica e Sperimentale | Recruiting | Padua | 35128 | Italy |
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| Ospedale Cisanello | Recruiting | Pisa | 56124 | Italy |
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| U.O. di Diabetologia, Dip. di Malattie Digestive & Metaboliche | Recruiting | Ravenna | 48100 | Italy |
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| Ospedale Infermi | Not yet recruiting | Rimini | 47900 | Italy |
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| Ospedale Sandro Pertini | Recruiting | Rome | 00157 | Italy |
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| Ospedale Magati | Not yet recruiting | Scandiano | 42019 | Italy |
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| Azienda Ospedaliera-Universitaria S. Giovanni Battista | Recruiting | Turin | 10126 | Italy |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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