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Clinical Trials/NCT02073188
NCT02073188CompletedPhase 3

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

Sanofi1 site in 1 country186 target enrollmentStarted: June 2012Last updated:
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Conditions

Trial Snapshot

Phase
Phase 3
Status
Completed
Sponsor
Sanofi
Enrollment
186
Locations
1
Primary Endpoint
Change in HbA1c levels from baseline
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Masking
None

Eligibility Criteria

Ages
14 Years to 24 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Change in HbA1c levels from baseline

Time Frame: baseline to six months

Proportion of participants performing at least 30% of the recommended Self-Monitoring Blood Glucose tests after 6 months from randomization

Time Frame: at 6 months

Secondary Outcomes

  • 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)

Investigators

Sponsor
Sanofi
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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