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

Phase 3

Completed

• Conditions: Diabetes Mellitus
• Interventions: Device: iBGStar; Device: Traditional Glucometer

• Registration Number: NCT02073188
• Lead Sponsor: Sanofi

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2012-06
• Study First Submitted: 2014-02-25
• Study First Submitted QC: 2014-02-26
• Study First Posted: 2014-02-27
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-13
• Last Update Posted: 2016-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 186

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
iBGStar (Group A)	iBGStar	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.
Traditional Glucometer (Group B)	Traditional Glucometer	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.

Primary Outcome Measures

Name	Time	Method
Change in HbA1c levels from baseline	baseline to six months
Proportion of participants performing at least 30% of the recommended Self-Monitoring Blood Glucose tests after 6 months from randomization	at 6 months

Secondary Outcome Measures

Name	Time	Method
Percentage of participants with HbA1c ≤7.5%	at 6 months and 12 months
Average number of recommended Self-Monitoring Blood Glucose tests daily, weekly, and monthly	at 6 months and 12 months
Mean fasting plasma glucose (FPG) and postprandial glucose (PPG)	at 6 months and 12 months
Mean Glycemic Variability	at 6 months and 12 months
Average Insulin Dose	at 6 months and 12 months
Number of Daily Injections	at 6 months and 12 months
Number of Insulin Dose Adjustments	at 6 months and 12 months
Quality of life: Audit of Diabetes Dependent Quality of Life (ADDQOL) (young adults 18-24 years)	at 6 months and 12 months
Diabetes Quality of Life (DQOL-Y) (adolescents 14-17 years)	at 6 months and 12 months
Participants satisfaction with SMBG meter assessed by Visual Analog Scale (VAS)	at 6 months and 12 months
Number overall contacts between centers and participants	up to 12 months
Type of overall contacts between centers and participants	up to 12 months

Trial Locations

Locations (1)

Sanofi -Aventis Administrative Office; 🇮🇹 Milano, Italy