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

Type 1 Diabetes Clinical Trial

— DID3  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01192711
• Other study ID #: MTD003
• Status: Recruiting
• Phase: Phase 3
• First received: August 31, 2010
• Last updated: September 1, 2010
• Start date: May 2009

Study information

• Verified date: September 2010
• Source: Consorzio Mario Negri Sud
• Contact: Antonio Nicolucci, MD
• Phone: +39 0872 570
• Email: nicolucci[@]negrisud.it
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 130
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Type 1 Diabetes

Intervention

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.

Locations

Country	Name	City	State
Italy	Ospedale G.B. Morgagni - L. Pierantoni	Forlì
Italy	P.O. di Grosseto - Stabilimento Misericordia	Grosseto
Italy	Az. Osp. S. Anna - Presidio Ospedaliero Cantù - Mariano Comense	Mariano Comense
Italy	Istituto Scientifico San Raffaele	Milan
Italy	Ospedale Niguarda Cà Granda	Milan
Italy	II Università di Napoli Centro Regionale di Diabetologia Pediatrica "G. Stoppoloni"	Naples
Italy	Università degli Studi di Padova Dipartimento di Medicina Clinica e Sperimentale	Padua
Italy	Ospedale Cisanello	Pisa
Italy	U.O. di Diabetologia, Dip. di Malattie Digestive & Metaboliche	Ravenna
Italy	Ospedale Infermi	Rimini
Italy	Ospedale Sandro Pertini	Rome
Italy	Ospedale Magati	Scandiano
Italy	Azienda Ospedaliera-Universitaria S. Giovanni Battista	Turin

Sponsors (3)

Lead Sponsor	Collaborator
Consorzio Mario Negri Sud	LifeScan, Sanofi

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood levels of glycosylated hemoglobin		from baseline every three months until the end of the study	No
Secondary	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	No
Secondary	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	No
Secondary	Change in body weight and BMI		from baseline every three months until the end of the study	No
Secondary	Total daily insulin dose, total basal insulin dose, total prandial insulin dose		from baseline every three months until the end of the study	No
Secondary	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	No
Secondary	Frequency of patients with hypoglycemic episodes and frequency of hypoglycemic episodes overall		every three months until the end of the study	Yes
Secondary	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	Yes
Secondary	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	Yes