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

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.

Study Overview

• Status: Unknown
• Conditions: Type 1 Diabetes
• Intervention / Treatment: Device: Diabetes Interactive Diary (DID)

• Study Type: Interventional
• Enrollment (Anticipated): 130
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Antonio Nicolucci, MD; Phone Number: 260 +39 0872 570; Email: nicolucci@negrisud.it
• Study Contact Backup: Name: Maria C Rossi; Phone Number: 266 +39 0872 570; Email: mrossi@negrisud.it

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Blood levels of glycosylated hemoglobin	from baseline every three months until the end of the study

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Consorzio Mario Negri Sud
• Collaborators: Sanofi; LifeScan

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: May 1, 2009
• Primary Completion (ANTICIPATED): October 1, 2011

Study Registration Dates

• First Submitted: August 31, 2010
• First Submitted That Met QC Criteria: August 31, 2010
• First Posted (ESTIMATE): September 1, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): September 2, 2010
• Last Update Submitted That Met QC Criteria: September 1, 2010
• Last Verified: September 1, 2010

More Information

Terms related to this study

• Keywords: diabetes; telemedicine; self monitoring blood glucose
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: MTD003