Comparative Study of a Smartphone-Linked Self-Monitoring System Versus a Traditional One for Improving Metabolic Control and Compliance to Self-Monitoring of Blood Glucose

Comparative Efficacy of iBGStar Glucose Meter vs. Traditional Glucose Monitoring in Improving Metabolic Control and Compliance Towards Self-Monitoring of Blood Glucose in Young Patients With Type 1 Diabetes

The purpose of this study is to demonstrate the superiority of iBGstar as a component of the diabetes treatment vs. traditional blood glucose self-monitoring system for improving glycemic control after 6 months in young patients with type 1 diabetes. The study is intended also to demonstrate the superiority of iBGStar as a component of the diabetes treatment vs. usual blood glucose self-monitoring system for improving the compliance to self monitoring of blood glucose after 6 months.

The planned study duration will be 20 months (5 quarters) with screening/enrollment of 7 months, followed by 2-3 weeks of a qualification phase, a 6 month experimental phase, plus a 6 month follow-up in the post-trial observational phase.

Inclusion Criteria:

• Type 1 diabetes
• Males and females
• Age between 14-24 years
• Any diabetes duration
• Cared for by the diabetes center for at least 1 year
• HbA1c ≥ 8%
• Basal bolus treatment (any insulin)
• Poor compliance with Self-Monitoring of Blood Glucose (less than 30% of the recommended Blood Glucose measurements recorded in the glucose meter in the two previous weeks, i.e. <16 Blood Glucose measurements in the last two weeks)
• Written informed consent obtained from patient or legal representative (for minor)

Exclusion Criteria:

• Treatment with other insulin regimen or Continuous Subcutaneous Insulin Infusion
• Refusal or inability to give informed consent to participate in the study
• Patients with short life expectancy
• Patients with conditions/concomitant diseases making them non evaluable for the primary efficacy endpoint according to physician's judgment
• Requirement for concomitant treatment that could bias primary evaluation
• Patients with high likelihood of being unavailable for 6 and/or 12 months visits
• Subject is the investigator, sub-investigator, research assistant, pharmacist, study coordinator, other study site staff or relative of study site staff thus considered directly involved in the conduct of the study
• Current addition/abuse of alcohol or drugs
• Severe visual or dexterity impairment
• Patients with any mental condition rendering them unable to understand the nature, scope, and possible consequences of the study
• Pregnant or breast-feeding women
• Subjects unlikely or unable to comply with the Protocol requirements