NCT02232698已完成不适用
Randomised Controlled Study to Evaluate the Impact of Novel Glucose Sensing Technology on Hypoglycaemia in Type 1 Diabetes
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 328
- 试验地点
- 23
- 主要终点
- Time Spent <70 mg/dL
研究概览
简要总结
The purpose of this study is to evaluate the impact of the Abbott Sensor Based Glucose Monitoring System on hypoglycaemia compared to Self Monitoring Blood Glucose (SMBG) testing using a randomised controlled study design in adults with Type 1 diabetes using insulin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •Diagnosed with Type 1 diabetes for ≥ 5 years
- •On their current insulin regimen for ≥ 3 months prior to study entry
- •Screening HbA1c result ≤ 7.5% (58 mmol/mol)
- •Reports self testing of blood glucose levels on a regular basis equivalent to a minimum of 3 times daily for at least 2 months prior to study entry
- •In the investigator's opinion the subject is considered technically capable of using the Abbott Sensor Based Glucose Monitoring System
- •Aged 18 years or over.
排除标准
- •Subject has been diagnosed with hypoglycaemic unawareness (i.e. subject has a diagnosis of impaired awareness of hypoglycaemia recorded in their medical notes OR in the investigator's opinion the subject currently experiences less than minimal warning symptoms for impending hypoglycaemia)
- •Subject is currently prescribed animal insulin
- •Subject is currently prescribed oral steroid therapy or is likely to require oral steroid therapy for any acute or chronic condition during the study
- •Has known allergy to medical grade adhesives
- •Currently participating in another device or drug study that could affect glucose measurements or glucose management
- •Currently using a Continuous Glucose Monitoring (CGM) device or has used one within the previous 4 months
- •Currently using Sensor augmented pump therapy
- •Is planning to use a CGM device at any time during the study
- •A female subject who is pregnant or planning to become pregnant within the study duration
- •A breast feeding mother
- •Currently receiving dialysis treatment or planning to receive dialysis during the study
- •Has a pacemaker
- •Has experienced an acute myocardial infarction within previous 6 months
- •Has a concomitant disease or condition that may compromise subject safety including; unstable coronary heart disease, cystic fibrosis, serious psychiatric disorder, or any other uncontrolled medical condition
- •Has experienced an episode of confirmed or suspected diabetic ketoacidosis (DKA) in the previous 6 months
- •In the investigator's opinion, the subject is considered unsuitable for inclusion in the study for any other reason.
研究组 & 干预措施
Sensor Based Glucose Monitoring System
Experimental
Standard sensing system use for 6 months.
干预措施: Sensor Based Glucose Monitoring System (Device)
Standard Blood Glucose Monitoring
Active Comparator
Subjects randomised to the control group will be given blood glucose meters for monitoring for the 6 months study duration.
干预措施: Standard Blood Glucose Monitoring (Device)
结局指标
主要结局
Time Spent <70 mg/dL
时间窗: Baseline and Days 194 to 208
Difference in time \<70 mg/dL between intervention and control group assessed in days 194 to 208 adjusting for baseline (days 1 to 15).
次要结局
- HbA1c at 6 Months(Baseline and Day 208)
- Time in Range(Baseline and Days 194 to 208)
- Number of Glucose Measurements Performed(Days 1 to 208)
- Time Spent <55 mg/dL and <40 mg/dL(Baseline and Days 194 to 208)
- Change in Diabetes Treatment Satisfaction Questionnaire (DTSQc) Scores From Day 1 to Day 208(Baseline and Day 208)
- Frequency of Episodes <70 mg/dL, <55 mg/dL and <40 mg/dL(Baseline and Days 194-208)
- Time Spent >180 mg/dL and >240 mg/dL(Baseline and Days 194 to 208)
- System Utilisation(Days 15 to 208)
研究者
研究点 (23)
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