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

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

Sponsors

Lead sponsor: Sanofi

Source 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.

Overall Status Completed
Start Date June 2012
Completion Date September 2014
Primary Completion Date September 2014
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
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
Measure Time Frame
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
Enrollment 186
Condition
Intervention

Intervention type: Device

Intervention name: iBGStar

Arm group label: iBGStar (Group A)

Intervention type: Device

Intervention name: Traditional Glucometer

Arm group label: Traditional Glucometer (Group B)

Eligibility

Criteria:

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

Gender: All

Minimum age: 14 Years

Maximum age: 24 Years

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Clinical Sciences & Operations Study Director Sanofi
Location
facility Sanofi -Aventis Administrative Office
Location Countries

Italy

Verification Date

April 2016

Responsible Party

Responsible party type: Sponsor

Has Expanded Access No
Number Of Arms 2
Arm Group

Arm group label: iBGStar (Group A)

Arm group type: Experimental

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.

Arm group label: Traditional Glucometer (Group B)

Arm group type: Active Comparator

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.

Acronym iNew Trend
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Masking: None (Open Label)

Source: ClinicalTrials.gov