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

NCT01192711 | Unknown Phase 3

• 1 other identifier: MTD003
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 13

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.

Conditions

Type 1 Diabetes

Keywords

diabetes; telemedicine; self monitoring blood glucose

Outcome Measures

Primary Outcomes (1)

• Blood levels of glycosylated hemoglobin

  from baseline every three months until the end of the study

Secondary Outcomes (8)

• blood glucose (BG) levels

  from baseline every three months until the end of the study

• Glucose variability

  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

  at baseline and at the end of the study

Study Arms (2)

insulin + DID

EXPERIMENTAL

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)

insulin + usual care

NO INTERVENTION

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.

Interventions

Diabetes Interactive Diary (DID) DEVICE

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.

insulin + DID

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Consorzio Mario Negri Sud: lead
• Sanofi: collaborator
• LifeScan: collaborator

Study Sites (13)

Ospedale G.B. Morgagni - L. Pierantoni

Forlì, 47100, Italy

NOT YET RECRUITING

P.O. di Grosseto - Stabilimento Misericordia

Grosseto, 58100, Italy

RECRUITING

Az. Osp. S. Anna - Presidio Ospedaliero Cantù - Mariano Comense

Mariano Comense, 22066, Italy

RECRUITING

Istituto Scientifico San Raffaele

Milan, 20132, Italy

RECRUITING

Ospedale Niguarda Cà Granda

Milan, 20162, Italy

RECRUITING

II Università di Napoli Centro Regionale di Diabetologia Pediatrica "G. Stoppoloni"

Naples, 80138, Italy

RECRUITING

Università degli Studi di Padova Dipartimento di Medicina Clinica e Sperimentale

Padua, 35128, Italy

RECRUITING

Ospedale Cisanello

Pisa, 56124, Italy

RECRUITING

U.O. di Diabetologia, Dip. di Malattie Digestive & Metaboliche

Ravenna, 48100, Italy

RECRUITING

Ospedale Infermi

Rimini, 47900, Italy

NOT YET RECRUITING

Ospedale Sandro Pertini

Rome, 00157, Italy

RECRUITING

Ospedale Magati

Scandiano, 42019, Italy

NOT YET RECRUITING

Azienda Ospedaliera-Universitaria S. Giovanni Battista

Turin, 10126, Italy

RECRUITING

Related Links

• Related Info

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Antonio Nicolucci, MD

  Consorzio Mario Negri Sud

  STUDY CHAIR

Central Study Contacts

Antonio Nicolucci, MD

CONTACT

+39 0872 570; nicolucci@negrisud.it

Maria C Rossi

CONTACT

+39 0872 570; mrossi@negrisud.it

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 31, 2010
• First Posted: September 1, 2010
• Study Start: May 1, 2009
• Primary Completion: October 1, 2011
• Last Updated: September 2, 2010

Record last verified: 2010-09

Locations

IT (13)