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 (iNew Trend)

Sanofi

Status and phase: Completed; Phase 3

Conditions: Diabetes Mellitus

Treatments: Device: iBGStar; Device: Traditional Glucometer

Study type: Interventional

Funder types: Industry

Identifiers

NCT02073188

IBGST_L_05971

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 186 patients

Sex: All

Ages: 14 to 24 years old

Volunteers: No Healthy Volunteers

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

Trial design

186 participants in 2 patient groups

iBGStar (Group A)

Experimental group

Description:

Self-Monitoring Blood Glucose will be managed with iBGStar and iBGStar Diabetes Manager Application (App) uploaded on iPhone for all duration of the study (6 months of experimental phase plus 6-months of observational phase). In the first 3 months, the patients in Group A will send their glycemic test values and notes by mail to the physician through Diabetes Manager App every 2 weeks. Afterwards until the visit V2 (six months), the patients in Group A will send their glycemic test values and notes by mail monthly. 9 reports in total.

Treatment:

Device: iBGStar

Traditional Glucometer (Group B)

Active Comparator group

Description:

Self-Monitoring Blood Glucose will be managed with a traditional glucometer according to usual care for the first 6 months (experimental phase). In the 6 months post-trial follow-up (observational phase), Self-Monitoring Blood Glucose will be managed with iBGStar and iBGStar Diabetes Manager App.

Treatment:

Device: Traditional Glucometer