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

Phase 3

• Conditions: Type 1 Diabetes
• Interventions: Device: Diabetes Interactive Diary (DID)

• Registration Number: NCT01192711
• Lead Sponsor: Consorzio Mario Negri Sud

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-05
• Study First Submitted: 2010-08-31
• Study First Submitted QC: 2010-08-31
• Status Verified: 2010-09
• Study First Posted: 2010-09-01
• Last Update Submitted: 2010-09-01
• Last Update Posted: 2010-09-02
• Primary Completion: 2011-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 130

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
insulin + DID	Diabetes Interactive Diary (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.

Primary Outcome Measures

Name	Time	Method
Blood levels of glycosylated hemoglobin	from baseline every three months until the end of the study

Secondary Outcome Measures

Name	Time	Method
blood glucose (BG) levels	from baseline every three months until the end of the study	Changes in BG levels from baseline to end of study (fasting BG, pre-/post-prandial BG, nocturnal BG, mean daily BG)
Quality of life	at baseline and at the end of the study	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	every three months until the end of the study
Glucose variability	from baseline every three months until the end of the study	Glucose variability (MAGE, coefficient of variation of mean fasting BG and post-prandial BG)
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
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
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

Trial Locations

Locations (13)

Ospedale Niguarda Cà Granda; 🇮🇹 Milan, Italy

Istituto Scientifico San Raffaele; 🇮🇹 Milan, Italy

Ospedale Sandro Pertini; 🇮🇹 Rome, Italy

Ospedale G.B. Morgagni - L. Pierantoni; 🇮🇹 Forlì, Italy

U.O. di Diabetologia, Dip. di Malattie Digestive & Metaboliche; 🇮🇹 Ravenna, Italy

Ospedale Infermi; 🇮🇹 Rimini, Italy

Ospedale Magati; 🇮🇹 Scandiano, Italy

P.O. di Grosseto - Stabilimento Misericordia; 🇮🇹 Grosseto, Italy

Az. Osp. S. Anna - Presidio Ospedaliero Cantù - Mariano Comense; 🇮🇹 Mariano Comense, Italy

Azienda Ospedaliera-Universitaria S. Giovanni Battista; 🇮🇹 Turin, 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