Clinical trial NCT01192711: Insulin Administration Plus a Telemedicine System (Diabetes Interactive Diary - DID) vs Insulin Plus Common Practice
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Type 1 Diabetes
Keywords: diabetes
telemedicine
self monitoring blood glucose
Lead sponsor: Consorzio Mario Negri Sud
Sponsor class: OTHER
Collaborators: name: Sanofi
name: LifeScan
First posted: 2010-09-01
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Blood levels of glycosylated hemoglobin
timeFrame: from baseline every three months until the end of the study
Secondary outcomes:
measure: blood glucose (BG) levels
timeFrame: from baseline every three months until the end of the study
measure: Glucose variability
timeFrame: from baseline every three months until the end of the study
measure: Change in body weight and BMI
timeFrame: from baseline every three months until the end of the study
measure: Total daily insulin dose, total basal insulin dose, total prandial insulin dose
timeFrame: from baseline every three months until the end of the study
measure: Quality of life
timeFrame: at baseline and at the end of the study
measure: Frequency of patients with hypoglycemic episodes and frequency of hypoglycemic episodes overall
timeFrame: every three months until the end of the study
measure: Frequency of patients with severe and/or symptomatic hypoglycemia and frequency of severe and/or symptomatic hypoglycemic episodes overall
timeFrame: every three months until the end of the study
measure: Frequency and times of hypoglycemic events with regard to occurrence during the day (24 hours) and total treatment duration (24 weeks)
timeFrame: every three months until the end of the study
Other outcomes:
Locations:
city: Forlì
country: Italy
facility: Ospedale G.B. Morgagni - L. Pierantoni
city: Grosseto
country: Italy
facility: P.O. di Grosseto - Stabilimento Misericordia
city: Mariano Comense
country: Italy
facility: Az. Osp. S. Anna - Presidio Ospedaliero Cantù - Mariano Comense
city: Milan
country: Italy
facility: Istituto Scientifico San Raffaele
city: Milan
country: Italy
facility: Ospedale Niguarda Cà Granda
city: Naples
country: Italy
facility: II Università di Napoli Centro Regionale di Diabetologia Pediatrica "G. Stoppoloni"
city: Padua
country: Italy
facility: Università degli Studi di Padova Dipartimento di Medicina Clinica e Sperimentale
city: Pisa
country: Italy
facility: Ospedale Cisanello
city: Ravenna
country: Italy
facility: U.O. di Diabetologia, Dip. di Malattie Digestive & Metaboliche
city: Rimini
country: Italy
facility: Ospedale Infermi
city: Rome
country: Italy
facility: Ospedale Sandro Pertini
city: Scandiano
country: Italy
facility: Ospedale Magati
city: Turin
country: Italy
facility: Azienda Ospedaliera-Universitaria S. Giovanni Battista
Study officials:
affiliation: Consorzio Mario Negri Sud
name: Antonio Nicolucci, MD
role: STUDY_CHAIR
References: