NCT01460446已完成不适用
A Prospective, Multi-centre Study With Diabetic Patients Randomized to 24 Weeks Treatment Supported by Either Accu-Chek® Aviva Expert Blood Glucose Meter With an Integrated Bolus Advisor or MDI Standard Therapy With Accu-Chek® Aviva Nano Meter (Without Bolus Advisor)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 218
- 试验地点
- 33
- 主要终点
- Change in Glycosylated Hemoglobin A1c (HbA1c) From Baseline to Week 24
研究概览
简要总结
This clinical, prospective, randomized, multi-center study determined if the use of an insulin bolus advisor improves glycemic control as measured by a change in HbA1c in patients failing multiple daily injection/intensified conventional therapy (MDI/ICT).
详细描述
Eligible participants were randomized to 24 weeks multiple daily injection therapy using either the Accu-Chek® Aviva Expert blood glucose meter with an integrated bolus advisor or the Accu-Chek® Aviva Nano blood glucose meter and manual bolus calculation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must be 18 years of age or older.
- •Diagnosed with Type 1 or Type 2 diabetes.
- •Recent HbA1c > 7.5% (measured within the last 6 weeks at local laboratory).
- •On multiple daily injection (MDI) therapy for at least 6 months consisting of 1-2 injections per day of long-acting basal insulin (Lantus® or Detemir®) and at least 2 injections per day of regular or rapid-acting analog insulin for meal coverage.
- •Subject adjusts meal insulin doses based on carbohydrate content of meals.
- •Subject with Type 2 diabetes may be on stable metformin therapy (therapy unchanged during 3 months prior to study).
- •Subject has been in Investigator's practice for at least 3 months but may have been seen by another physician in the practice.
- •Subject has completed carbohydrate (CHO) training within the last 2 years.
排除标准
- •Subject is on a therapy regimen that conflicts with the study:
- •Neutral protamine Hagedorn (NPH) or pre-mixed insulin;
- •oral anti-diabetic agents, with the exception of metformin;
- •injectable anti-diabetic agents other than long-acting insulin and rapid-acting insulin analogs or regular insulin (eg, fixed dose therapy);
- •use of sliding scale insulin therapy that determines insulin dosages based exclusively on specific blood glucose (bG) results.
- •Subject has participated in another interventional trial within 6 weeks prior to study.
- •Subject has been diagnosed with any clinically significant infectious disease or major organ system disease, such as gastroparesis or renal disease (at Investigator's discretion).
- •Subject has used systemic oral or inhaled steroids for more than 7 days within the last 3 months.
- •Subject is on chemotherapy or radiation therapy (self-reported).
- •Subject is pregnant or lactating or is currently planning a pregnancy.
结局指标
主要结局
Change in Glycosylated Hemoglobin A1c (HbA1c) From Baseline to Week 24
时间窗: Baseline to Week 24
HbA1C was measured in blood samples at a central laboratory.
次要结局
- Percentage of Blood Glucose Measurements Within the Blood Glucose Target Range From Screening to Baseline and From Week 23 to Week 24(Screening to Week 24)
- Number of Symptomatic Hypoglycemic Episodes Per Subject Year From Screening to Baseline and From Week 23 to Week 24(Screening to Week 24)
- Change in the Mean Amplitude of Glucose Excursion (MAGE) From Baseline to Week 24(3 days prior to Baseline to Week 24)
- Percentage of Bolus Opportunities Where the Accu-Chek® Aviva Expert Blood Glucose Meter Bolus Advisor Was Used During the Study(Baseline to Week 24)
- Number of Accu-Chek® Aviva Expert Blood Glucose Meter Bolus Advices Modified Per Day by Participants During the Study(Baseline to Week 24)
- Correct and Incorrect Use of Insulin:Carbohydrate Ratio (I:CHO) and Insulin Sensitivity Factor (ISF) Advice by Participants Using the Aviva Nano Blood Glucose Meter During the Study(Baseline to Week 24)
- Change in Carbohydrate Counting Accuracy From Baseline to Week 24(Baseline to Week 24)
- Change in the Patient Health Questionnaire Depression Scale (PHQ-8) Score From Baseline to Week 24(Baseline to Week 24)
- Number of Participants With None, Mild, Moderate, Moderately Severe, and Severe Depression at Baseline and Week 24(Baseline to Week 24)
- Change in the Problem Area in Diabetes (PAID) Scale Score From Baseline to Week 24(Baseline to Week 24)
- Change in the Hypoglycemia Fear Survey (HFS-II) Score From Baseline to Week 24(Baseline to Week 24)
- The Diabetes Treatment Satisfaction Questionnaire at Baseline (DTSQs) Score and the Diabetes Treatment Satisfaction Questionnaire for Change From Baseline (DTSQc) Score(Baseline to Week 24)
研究者
研究点 (33)
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