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
Recruitment status was Recruiting
Sponsor:
Consorzio Mario Negri Sud
Collaborators:
Sanofi-Aventis
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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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
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-Aventis
LifeScan
Investigators
Study Chair: | Antonio Nicolucci, MD | Consorzio Mario Negri Sud |
More Information
Additional Information:
No publications provided
Keywords provided by Consorzio Mario Negri Sud:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on October 17, 2012
Additional Information:
Related Info 
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 October 17, 2012