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

Diabetes Mellitus Clinical Trial

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Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02073188
• Other study ID #: IBGST_L_05971
• Status: Completed
• Phase: Phase 3
• First received: February 25, 2014
• Last updated: April 13, 2016
• Start date: June 2012
• Est. completion date: September 2014

Study information

• Verified date: April 2016
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 186
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 14 Years to 24 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Device:
• iBGStar

• Traditional Glucometer

Locations

Country	Name	City	State
Italy	Sanofi -Aventis Administrative Office	Milano

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in HbA1c levels from baseline		baseline to six months	No
Primary	Proportion of participants performing at least 30% of the recommended Self-Monitoring Blood Glucose tests after 6 months from randomization		at 6 months	No
Secondary	Percentage of participants with HbA1c =7.5%		at 6 months and 12 months	No
Secondary	Average number of recommended Self-Monitoring Blood Glucose tests daily, weekly, and monthly		at 6 months and 12 months	No
Secondary	Mean fasting plasma glucose (FPG) and postprandial glucose (PPG)		at 6 months and 12 months	No
Secondary	Mean Glycemic Variability		at 6 months and 12 months	No
Secondary	Average Insulin Dose		at 6 months and 12 months	No
Secondary	Number of Daily Injections		at 6 months and 12 months	No
Secondary	Number of Insulin Dose Adjustments		at 6 months and 12 months	No
Secondary	Quality of life: Audit of Diabetes Dependent Quality of Life (ADDQOL) (young adults 18-24 years)		at 6 months and 12 months	No
Secondary	Diabetes Quality of Life (DQOL-Y) (adolescents 14-17 years)		at 6 months and 12 months	No
Secondary	Participants satisfaction with SMBG meter assessed by Visual Analog Scale (VAS)		at 6 months and 12 months	No
Secondary	Number overall contacts between centers and participants		up to 12 months	No
Secondary	Type of overall contacts between centers and participants		up to 12 months	No