- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02073188
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)
April 13, 2016 updated by: Sanofi
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
186
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Milano, Italy
- Sanofi -Aventis Administrative Office
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years to 24 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: iBGStar (Group A)
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.
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Active Comparator: Traditional Glucometer (Group B)
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in HbA1c levels from baseline
Time Frame: baseline to six months
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baseline to six months
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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
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at 6 months
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Percentage of participants with HbA1c ≤7.5%
Time Frame: at 6 months and 12 months
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at 6 months and 12 months
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Average number of recommended Self-Monitoring Blood Glucose tests daily, weekly, and monthly
Time Frame: at 6 months and 12 months
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at 6 months and 12 months
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Mean fasting plasma glucose (FPG) and postprandial glucose (PPG)
Time Frame: at 6 months and 12 months
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at 6 months and 12 months
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Mean Glycemic Variability
Time Frame: at 6 months and 12 months
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at 6 months and 12 months
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Average Insulin Dose
Time Frame: at 6 months and 12 months
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at 6 months and 12 months
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Number of Daily Injections
Time Frame: at 6 months and 12 months
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at 6 months and 12 months
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Number of Insulin Dose Adjustments
Time Frame: at 6 months and 12 months
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at 6 months and 12 months
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Quality of life: Audit of Diabetes Dependent Quality of Life (ADDQOL) (young adults 18-24 years)
Time Frame: at 6 months and 12 months
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at 6 months and 12 months
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Diabetes Quality of Life (DQOL-Y) (adolescents 14-17 years)
Time Frame: at 6 months and 12 months
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at 6 months and 12 months
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Participants satisfaction with SMBG meter assessed by Visual Analog Scale (VAS)
Time Frame: at 6 months and 12 months
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at 6 months and 12 months
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Number overall contacts between centers and participants
Time Frame: up to 12 months
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up to 12 months
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Type of overall contacts between centers and participants
Time Frame: up to 12 months
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up to 12 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2012
Primary Completion (Actual)
September 1, 2014
Study Completion (Actual)
September 1, 2014
Study Registration Dates
First Submitted
February 25, 2014
First Submitted That Met QC Criteria
February 26, 2014
First Posted (Estimate)
February 27, 2014
Study Record Updates
Last Update Posted (Estimate)
April 14, 2016
Last Update Submitted That Met QC Criteria
April 13, 2016
Last Verified
April 1, 2016
More Information
Terms related to this study
Other Study ID Numbers
- IBGST_L_05971
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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