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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2014-02-27
Enrollment: 186
Sex: ALL
Minimum age (years): 14
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.

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

Primary outcomes:
measure: Change in HbA1c levels from baseline
timeFrame: baseline to six months
measure: Proportion of participants performing at least 30% of the recommended Self-Monitoring Blood Glucose tests after 6 months from randomization
timeFrame: at 6 months
Secondary outcomes:
measure: Percentage of participants with HbA1c ≤7.5%
timeFrame: at 6 months and 12 months
measure: Average number of recommended Self-Monitoring Blood Glucose tests daily, weekly, and monthly
timeFrame: at 6 months and 12 months
measure: Mean fasting plasma glucose (FPG) and postprandial glucose (PPG)
timeFrame: at 6 months and 12 months
measure: Mean Glycemic Variability
timeFrame: at 6 months and 12 months
measure: Average Insulin Dose
timeFrame: at 6 months and 12 months
measure: Number of Daily Injections
timeFrame: at 6 months and 12 months
measure: Number of Insulin Dose Adjustments
timeFrame: at 6 months and 12 months
measure: Quality of life: Audit of Diabetes Dependent Quality of Life (ADDQOL) (young adults 18-24 years)
timeFrame: at 6 months and 12 months
measure: Diabetes Quality of Life (DQOL-Y) (adolescents 14-17 years)
timeFrame: at 6 months and 12 months
measure: Participants satisfaction with SMBG meter assessed by Visual Analog Scale (VAS)
timeFrame: at 6 months and 12 months
measure: Number overall contacts between centers and participants
timeFrame: up to 12 months
measure: Type of overall contacts between centers and participants
timeFrame: up to 12 months
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Sanofi -Aventis Administrative Office
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References:
citation: Di Bartolo P, Nicolucci A, Cherubini V, Iafusco D, Scardapane M, Rossi MC. Young patients with type 1 diabetes poorly controlled and poorly compliant with self-monitoring of blood glucose: can technology help? Results of the i-NewTrend randomized clinical trial. Acta Diabetol. 2017 Apr;54(4):393-402. doi: 10.1007/s00592-017-0963-4. Epub 2017 Jan 30.