search
Back to results

Insulin Administration Plus a Telemedicine System (Diabetes Interactive Diary - DID) vs Insulin Plus Common Practice (DID3)

Primary Purpose

Type 1 Diabetes

Status
Unknown status
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
Diabetes Interactive Diary (DID)
Sponsored by
Consorzio Mario Negri Sud
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 1 Diabetes focused on measuring diabetes, telemedicine, self monitoring blood glucose

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Individuals with type 1 diabetes as defined by the criteria of the Expert Committee on the Diagnosis and Classification of Diabetes Mellitus (29)
  • Males and females
  • Age equal or more than 18 years
  • Patients not habitually using CHO (carbohydrates) counting
  • Self monitoring blood glucose (SMBG) at least 3 times a day
  • Four basal-bolus daily injections of short-acting and long-acting insulin analogues
  • HbA1c equal or more than 7.5%
  • Female patients have to be postmenopausal, hysterectomised or surgically sterilized or using reliable and adequate contraceptive methods (oral contraception or IUD);
  • A full study-specific informed consent must be obtained in writing for all subjects

Exclusion Criteria:

  • Multiple daily injections of NPH insulin or soluble rapid insulin or Continuous Subcutaneous Insulin Infusion (CSII) therapy
  • Mental conditions, depression, or high anxiety rendering the subject unable to understand the nature, scope, and possible consequences of the study
  • Eating disorders
  • Pregnancy / lactation.
  • Any clinically significant major organ system disease such as relevant cardiovascular, gastrointestinal, hepatic, neurological, endocrine, haematological or other major systemic diseases or infective diseases making implementation of the protocol or interpretation of the study results difficult
  • Any disease or condition including abuse of illicit drugs, prescription medicines or alcohol that in the opinion of the investigator may interfere with the completion of the study
  • Subjects unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study procedures.

Sites / Locations

  • Ospedale G.B. Morgagni - L. Pierantoni
  • P.O. di Grosseto - Stabilimento MisericordiaRecruiting
  • Az. Osp. S. Anna - Presidio Ospedaliero Cantù - Mariano ComenseRecruiting
  • Istituto Scientifico San RaffaeleRecruiting
  • Ospedale Niguarda Cà GrandaRecruiting
  • II Università di Napoli Centro Regionale di Diabetologia Pediatrica "G. Stoppoloni"Recruiting
  • Università degli Studi di Padova Dipartimento di Medicina Clinica e SperimentaleRecruiting
  • Ospedale CisanelloRecruiting
  • U.O. di Diabetologia, Dip. di Malattie Digestive & MetabolicheRecruiting
  • Ospedale Infermi
  • Ospedale Sandro PertiniRecruiting
  • Ospedale Magati
  • Azienda Ospedaliera-Universitaria S. Giovanni BattistaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

insulin + DID

insulin + usual care

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Blood levels of glycosylated hemoglobin

Secondary Outcome Measures

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)
Glucose variability
Glucose variability (MAGE, coefficient of variation of mean fasting BG and post-prandial BG)
Change in body weight and BMI
Total daily insulin dose, total basal insulin dose, total prandial insulin dose
Quality of life
the quality of life will be measured by Diabetes Specific Quality of Life Scale (DSQOLS) and Diabetes Treatment Satisfaction Questionnaire (DTSQ)
Frequency of patients with hypoglycemic episodes and frequency of hypoglycemic episodes overall
Frequency of patients with severe and/or symptomatic hypoglycemia and frequency of severe and/or symptomatic hypoglycemic episodes overall
Frequency and times of hypoglycemic events with regard to occurrence during the day (24 hours) and total treatment duration (24 weeks)

Full Information

First Posted
August 31, 2010
Last Updated
September 1, 2010
Sponsor
Consorzio Mario Negri Sud
Collaborators
Sanofi, LifeScan
search

1. Study Identification

Unique Protocol Identification Number
NCT01192711
Brief Title
Insulin Administration Plus a Telemedicine System (Diabetes Interactive Diary - DID) vs Insulin Plus Common Practice
Acronym
DID3
Official Title
An Open Label, Multicentre, Randomized Study of Insulin Glargine + Prandial Insulin Glulisine Associated With a Telemedicine System for Carbohydrates Counting vs. Insulin Glargine + Prandial Insulin Glulisine Associated With Common Practice
Study Type
Interventional

2. Study Status

Record Verification Date
September 2010
Overall Recruitment Status
Unknown status
Study Start Date
May 2009 (undefined)
Primary Completion Date
October 2011 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Consorzio Mario Negri Sud
Collaborators
Sanofi, LifeScan

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes
Keywords
diabetes, telemedicine, self monitoring blood glucose

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
130 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
insulin + DID
Arm Type
Experimental
Arm Description
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.
Arm Title
insulin + usual care
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Diabetes Interactive Diary (DID)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Blood levels of glycosylated hemoglobin
Time Frame
from baseline every three months until the end of the study
Secondary Outcome Measure Information:
Title
blood glucose (BG) levels
Description
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
Title
Glucose variability
Description
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
Title
Change in body weight and BMI
Time Frame
from baseline every three months until the end of the study
Title
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
Title
Quality of life
Description
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
Title
Frequency of patients with hypoglycemic episodes and frequency of hypoglycemic episodes overall
Time Frame
every three months until the end of the study
Title
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
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Individuals with type 1 diabetes as defined by the criteria of the Expert Committee on the Diagnosis and Classification of Diabetes Mellitus (29) Males and females Age equal or more than 18 years Patients not habitually using CHO (carbohydrates) counting Self monitoring blood glucose (SMBG) at least 3 times a day Four basal-bolus daily injections of short-acting and long-acting insulin analogues HbA1c equal or more than 7.5% Female patients have to be postmenopausal, hysterectomised or surgically sterilized or using reliable and adequate contraceptive methods (oral contraception or IUD); A full study-specific informed consent must be obtained in writing for all subjects Exclusion Criteria: Multiple daily injections of NPH insulin or soluble rapid insulin or Continuous Subcutaneous Insulin Infusion (CSII) therapy Mental conditions, depression, or high anxiety rendering the subject unable to understand the nature, scope, and possible consequences of the study Eating disorders Pregnancy / lactation. Any clinically significant major organ system disease such as relevant cardiovascular, gastrointestinal, hepatic, neurological, endocrine, haematological or other major systemic diseases or infective diseases making implementation of the protocol or interpretation of the study results difficult Any disease or condition including abuse of illicit drugs, prescription medicines or alcohol that in the opinion of the investigator may interfere with the completion of the study Subjects unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study procedures.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Antonio Nicolucci, MD
Phone
+39 0872 570
Ext
260
Email
nicolucci@negrisud.it
First Name & Middle Initial & Last Name or Official Title & Degree
Maria C Rossi
Phone
+39 0872 570
Ext
266
Email
mrossi@negrisud.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antonio Nicolucci, MD
Organizational Affiliation
Consorzio Mario Negri Sud
Official's Role
Study Chair
Facility Information:
Facility Name
Ospedale G.B. Morgagni - L. Pierantoni
City
Forlì
ZIP/Postal Code
47100
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Silvia Acquati, MD
Phone
+39 0543 731199
Email
s.acquati@ausl.fo.it
First Name & Middle Initial & Last Name & Degree
Silvia Acquati, MD
Facility Name
P.O. di Grosseto - Stabilimento Misericordia
City
Grosseto
ZIP/Postal Code
58100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mauro Rossi, MD
Phone
+39 0564 485272
Email
m.rossi@usl9.toscana.it
First Name & Middle Initial & Last Name & Degree
Mauro Rossi, MD
Facility Name
Az. Osp. S. Anna - Presidio Ospedaliero Cantù - Mariano Comense
City
Mariano Comense
ZIP/Postal Code
22066
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luigi Sciangula, MD
Phone
+39 031 755357
Email
luigi.sciangula@hsacomo.org
First Name & Middle Initial & Last Name & Degree
Luigi Sciangula, MD
Facility Name
Istituto Scientifico San Raffaele
City
Milan
ZIP/Postal Code
20132
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrea Laurenzi, MD
Phone
+39 02 2643
Ext
2894
Email
laurenzi.andrea@hsr.it
First Name & Middle Initial & Last Name & Degree
Gabriella Galimberti, MD
Facility Name
Ospedale Niguarda Cà Granda
City
Milan
ZIP/Postal Code
20162
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrea M Bonomo, MD
Phone
+39 02 64443912
Email
matteo.bonomo@ospedaleniguarda.it
First Name & Middle Initial & Last Name & Degree
Andrea M Bonomo, MD
Facility Name
II Università di Napoli Centro Regionale di Diabetologia Pediatrica "G. Stoppoloni"
City
Naples
ZIP/Postal Code
80138
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dario Iafusco, MD
Phone
+39 081 5665434
Email
dario.iafusco@unina2.it
First Name & Middle Initial & Last Name & Degree
Francesco Prisco, MD
Facility Name
Università degli Studi di Padova Dipartimento di Medicina Clinica e Sperimentale
City
Padua
ZIP/Postal Code
35128
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alberto Maran, MD
Phone
+39 049 8212097
Email
alberto.maran@unipd.it
First Name & Middle Initial & Last Name & Degree
Alberto Maran, MD
Facility Name
Ospedale Cisanello
City
Pisa
ZIP/Postal Code
56124
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stefano Del Prato, MD
Phone
+39 050 995100
Email
delprato@immr.med.unipi.it
First Name & Middle Initial & Last Name & Degree
Stefano Del Prato, MD
Facility Name
U.O. di Diabetologia, Dip. di Malattie Digestive & Metaboliche
City
Ravenna
ZIP/Postal Code
48100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paolo Di Bartolo, MD
Phone
+39 0544 286326
Email
p.dibartolo@ausl.ra.it
First Name & Middle Initial & Last Name & Degree
Paolo Di Bartolo, MD
Facility Name
Ospedale Infermi
City
Rimini
ZIP/Postal Code
47900
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cinzia Trojani, MD
Phone
+39 0541 705370
Email
ctrojani@auslrn.net
First Name & Middle Initial & Last Name & Degree
Cinzia Trojani, MD
Facility Name
Ospedale Sandro Pertini
City
Rome
ZIP/Postal Code
00157
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Concetta Suraci, MD
Phone
+39 06 41433513
Email
tsuraci@tiscali.it
First Name & Middle Initial & Last Name & Degree
Concetta Suraci, MD
Facility Name
Ospedale Magati
City
Scandiano
ZIP/Postal Code
42019
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Valerio Miselli, MD
Phone
+39 0522 850247
Email
miselliv@ausl.re.it
First Name & Middle Initial & Last Name & Degree
Valerio Miselli, MD
Facility Name
Azienda Ospedaliera-Universitaria S. Giovanni Battista
City
Turin
ZIP/Postal Code
10126
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Giorgio Grassi, MD
Phone
+39 011 6335605
Email
giorgio.grassi@gmail.com
First Name & Middle Initial & Last Name & Degree
Giorgio Grassi, MD

12. IPD Sharing Statement

Links:
URL
http://www.negrisud.it/did/
Description
Related Info

Learn more about this trial

Insulin Administration Plus a Telemedicine System (Diabetes Interactive Diary - DID) vs Insulin Plus Common Practice

We'll reach out to this number within 24 hrs