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
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 186
- 试验地点
- 1
- 主要终点
- Change in HbA1c levels from baseline
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 24 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
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.
干预措施: iBGStar (Device)
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.
干预措施: Traditional Glucometer (Device)
结局指标
主要结局
Change in HbA1c levels from baseline
时间窗: baseline to six months
Proportion of participants performing at least 30% of the recommended Self-Monitoring Blood Glucose tests after 6 months from randomization
时间窗: at 6 months
次要结局
- 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)