Diabetes Mellitus
Conditions
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.
Interventions
DEVICEiBGStar
DEVICETraditional Glucometer
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
14 Years to 24 Years
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
Design outcomes
Primary
| 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
| Measure | Time frame |
|---|---|
| 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 |
| Percentage of participants with HbA1c ≤7.5% | 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 |
| Quality of life: Audit of Diabetes Dependent Quality of Life (ADDQOL) (young adults 18-24 years) | 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 |
Countries
Italy
Outcome results
None listed