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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by Consorzio Mario Negri Sud.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Sanofi
LifeScan
Information provided by:
Consorzio Mario Negri Sud
ClinicalTrials.gov Identifier:
NCT01192711
First received: August 31, 2010
Last updated: September 1, 2010
Last verified: September 2010
  Purpose

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.


Condition Intervention Phase
Type 1 Diabetes
Device: Diabetes Interactive Diary (DID)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Consorzio Mario Negri Sud:

Primary Outcome Measures:
  • Blood levels of glycosylated hemoglobin [ Time Frame: from baseline every three months until the end of the study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • blood glucose (BG) levels [ Time Frame: from baseline every three months until the end of the study ] [ Designated as safety issue: No ]
    Changes in BG levels from baseline to end of study (fasting BG, pre-/post-prandial BG, nocturnal BG, mean daily BG)

  • Glucose variability [ Time Frame: from baseline every three months until the end of the study ] [ Designated as safety issue: No ]
    Glucose variability (MAGE, coefficient of variation of mean fasting BG and post-prandial BG)

  • Change in body weight and BMI [ Time Frame: from baseline every three months until the end of the study ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Quality of life [ Time Frame: at baseline and at the end of the study ] [ Designated as safety issue: No ]
    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 [ Time Frame: every three months until the end of the study ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 130
Study Start Date: May 2009
Estimated Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: insulin + DID
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)
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.
No Intervention: insulin + usual care
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01192711

Contacts
Contact: Antonio Nicolucci, MD +39 0872 570 ext 260 nicolucci@negrisud.it
Contact: Maria C Rossi +39 0872 570 ext 266 mrossi@negrisud.it

Locations
Italy
Ospedale G.B. Morgagni - L. Pierantoni Not yet recruiting
Forlì, Italy, 47100
Contact: Silvia Acquati, MD    +39 0543 731199    s.acquati@ausl.fo.it   
Principal Investigator: Silvia Acquati, MD         
P.O. di Grosseto - Stabilimento Misericordia Recruiting
Grosseto, Italy, 58100
Contact: Mauro Rossi, MD    +39 0564 485272    m.rossi@usl9.toscana.it   
Principal Investigator: Mauro Rossi, MD         
Az. Osp. S. Anna - Presidio Ospedaliero Cantù - Mariano Comense Recruiting
Mariano Comense, Italy, 22066
Contact: Luigi Sciangula, MD    +39 031 755357    luigi.sciangula@hsacomo.org   
Principal Investigator: Luigi Sciangula, MD         
Istituto Scientifico San Raffaele Recruiting
Milan, Italy, 20132
Contact: Andrea Laurenzi, MD    +39 02 2643 ext 2894    laurenzi.andrea@hsr.it   
Principal Investigator: Gabriella Galimberti, MD         
Ospedale Niguarda Cà Granda Recruiting
Milan, Italy, 20162
Contact: Andrea M Bonomo, MD    +39 02 64443912    matteo.bonomo@ospedaleniguarda.it   
Principal Investigator: Andrea M Bonomo, MD         
II Università di Napoli Centro Regionale di Diabetologia Pediatrica "G. Stoppoloni" Recruiting
Naples, Italy, 80138
Contact: Dario Iafusco, MD    +39 081 5665434    dario.iafusco@unina2.it   
Principal Investigator: Francesco Prisco, MD         
Università degli Studi di Padova Dipartimento di Medicina Clinica e Sperimentale Recruiting
Padua, Italy, 35128
Contact: Alberto Maran, MD    +39 049 8212097    alberto.maran@unipd.it   
Principal Investigator: Alberto Maran, MD         
Ospedale Cisanello Recruiting
Pisa, Italy, 56124
Contact: Stefano Del Prato, MD    +39 050 995100    delprato@immr.med.unipi.it   
Principal Investigator: Stefano Del Prato, MD         
U.O. di Diabetologia, Dip. di Malattie Digestive & Metaboliche Recruiting
Ravenna, Italy, 48100
Contact: Paolo Di Bartolo, MD    +39 0544 286326    p.dibartolo@ausl.ra.it   
Principal Investigator: Paolo Di Bartolo, MD         
Ospedale Infermi Not yet recruiting
Rimini, Italy, 47900
Contact: Cinzia Trojani, MD    +39 0541 705370    ctrojani@auslrn.net   
Principal Investigator: Cinzia Trojani, MD         
Ospedale Sandro Pertini Recruiting
Rome, Italy, 00157
Contact: Concetta Suraci, MD    +39 06 41433513    tsuraci@tiscali.it   
Principal Investigator: Concetta Suraci, MD         
Ospedale Magati Not yet recruiting
Scandiano, Italy, 42019
Contact: Valerio Miselli, MD    +39 0522 850247    miselliv@ausl.re.it   
Principal Investigator: Valerio Miselli, MD         
Azienda Ospedaliera-Universitaria S. Giovanni Battista Recruiting
Turin, Italy, 10126
Contact: Giorgio Grassi, MD    +39 011 6335605    giorgio.grassi@gmail.com   
Principal Investigator: Giorgio Grassi, MD         
Sponsors and Collaborators
Consorzio Mario Negri Sud
Sanofi
LifeScan
Investigators
Study Chair: Antonio Nicolucci, MD Consorzio Mario Negri Sud
  More Information

Additional Information:
No publications provided

Responsible Party: Antonio Nicolucci/Chair of the Steering Committee, Consorzio Mario Negri Sud
ClinicalTrials.gov Identifier: NCT01192711     History of Changes
Other Study ID Numbers: MTD003
Study First Received: August 31, 2010
Last Updated: September 1, 2010
Health Authority: Italy: Ministry of Health

Keywords provided by Consorzio Mario Negri Sud:
diabetes
telemedicine
self monitoring blood glucose

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Glargine
Insulin glulisine
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 20, 2014