NCT01588106已完成不适用
Evaluation of the Impact of the CONTOUR® USB Blood Glucose Monitoring System With Integrated Data Management on Glycaemic Control in Insulin-treated Diabetic Patients
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- GWT-TUD GmbH
- 入组人数
- 154
- 试验地点
- 16
- 主要终点
- Reduction in HbA1c
研究概览
简要总结
The purpose of this study is to evaluate if the use of the CONTOUR Next USB BGMS system with AutoLog and Trends features and integrated data management software (Glucofacts ™ DELUXE) enables behavioral changes that may lead to improvement in glycemic control, expressed as a reduction in HbA1c as primary endpoint.
Patients will be randomized either to using CONTOUR Next USB or CONTOUR. Patients will be trained in using the devices and return every 3 months until month 9 after baseline.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- •Type 2 diabetes
- •Therapy with insulin only (ICT) or ICT in combination with Metformin
- •HbA1c at baseline > 7.5% and < 11%
- •Patients at least 18 years of age
- •Patients willing to complete all study visits and study procedures including:
- •Testing their BG at least 3 times a day during the entire study.
- •Using the paper logbook provided (control group)
- •Using the Auto log meal-marker + reminder feature in CONTOUR Next USB regularly (TEST subjects only)
- •Using the Trends feature in CONTOUR Next USB regularly (TEST subjects only)
- •Uploading the CONTOUR Next USB meter to personal computer (subject must have personal computer at home or access to a computer - see system requirements in appendix for technical details).
- •Patients who are able to speak, read and understand German
- •Patients who are currently performing self-testing of blood glucose at home routinely (at least 3 times per day) for 4 weeks or more
- •Patients who are currently adjusting there insulin dosages themselves based on the self-testing of blood glucose at home
- •Written informed consent at beginning of the study
排除标准
- •Patients who have been using CONTOUR Next USB meter regularly during the previous 12 months
- •Patients treated with oral antidiabetic drugs except for Metformin; or diet alone
- •Change of diabetes therapy within the last 3 months
- •Change of HbA1c level of more than ±0.5% within the last 3 months
- •Patients who are using a continuous blood glucose measurement system regularly
- •Patients with home health aides who assist with their BG testing and /or insulin adjustment
- •Patients with macroalbuminuria
- •Steroid therapy within the last 3 months. Topic or inhalative use is no exclusion criterion when not used regularly (more than 5 times a week).
- •Uncontrolled blood pressure ≥ 170/100 at screening
- •BMI > 40 kg/m²
- •Anemia according to WHO-definition (hemoglobin < 13 g/100 ml [male] or < 12 g/100 ml [female])
- •Creatinin > 150 µmol/l and/or GFR < 50 mmol/min/ 1.73m² (measured within the last 3 months before screening)
- •Operation with inpatient stay planned during the study
- •Current pregnancy or pregnancy planned during the study; or breastfeeding women.
- •Women with childbearing potential who are not practicing an acceptable method of birth control. Acceptable methods of birth control include tubal ligation, transdermal patch, intra uterine devices/systems (IUDs/IUSs), oral, implantable or injectable contraceptives, sexual abstinence, double barrier method and vasectomized partner
- •Alcohol or drug abuse within the last 3 months
- •Patients with the following impairments which, in the opinion of the investigator, would seriously compromise the integrity of the study:
- •Significant visual impairment
- •Significant hearing impairment
- •Cognitive disorder
- •Significant unstable co-morbidity (with notable change within the past 3 months)
- •Severe renal disease, disease with a strong impact on life expectancy
- •Inability to have or use and computer
- •Inability to use a meter correctly
- •Any other condition as per investigator's discretion
- •Current participation in another clinical study. Participation in another trial within 6 weeks before screening.
- •Employees of Bayer Vital Diabetes Care, the GWT or the University of Dresden
结局指标
主要结局
Reduction in HbA1c
时间窗: Baseline, after 9 months
次要结局
未报告次要终点
研究者
研究点 (16)
Loading locations...
相似试验
已完成
不适用
Performance of Contour Next® and Contour Plus Elite® BGMS in Arterial Blood Samples From Hospitalized AdultsDiabetes MellitusNCT05449795Ascensia Diabetes Care120
已完成
不适用
Evaluation of the Performance of CONTOUR NEXT® and CONTOUR PLUS ELITE® BGMS in Neonates Using Capillary Blood SamplesDiabetes MellitusNCT05467345Ascensia Diabetes Care120
已完成
不适用
Evaluation of Blood Glucose Meter SystemsDiabetesNCT01714232Ascensia Diabetes Care106
已完成
不适用
Evaluation of Blood Glucose Monitoring SystemsDiabetesNCT01699763Ascensia Diabetes Care112
已完成
不适用
Analytical Performance Evaluation of Blood Glucose Monitoring Systems- Investigator Sponsored Contour® XT Comparator Study - Ulm GermanyDiabetesNCT01789021Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm120