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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

August 31, 2010
September 1, 2010
May 2009
October 2011   (final data collection date for primary outcome measure)
Blood levels of glycosylated hemoglobin [ Time Frame: from baseline every three months until the end of the study ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01192711 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Insulin Administration Plus a Telemedicine System (Diabetes Interactive Diary - DID) vs Insulin Plus Common Practice
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Type 1 Diabetes
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.
  • 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.
    Intervention: Device: Diabetes Interactive Diary (DID)
  • 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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
130
Not Provided
October 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: Antonio Nicolucci, MD +39 0872 570 ext 260 nicolucci@negrisud.it
Contact: Maria C Rossi +39 0872 570 ext 266 mrossi@negrisud.it
Italy
 
NCT01192711
MTD003
No
Antonio Nicolucci/Chair of the Steering Committee, Consorzio Mario Negri Sud
Consorzio Mario Negri Sud
  • Sanofi
  • LifeScan
Study Chair: Antonio Nicolucci, MD Consorzio Mario Negri Sud
Consorzio Mario Negri Sud
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP