NL-OMON42217已完成不适用
Randomised Controlled Study to Evaluate the Impact of Novel Glucose Sensing Technology on Hypoglycaemia in Type 1 Diabetes. - IMPACT
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 84
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •o Diagnosed with Type 1 diabetes for * 5 years
- •o On their current insulin regimen for * 3 months prior to study entry
- •o Screening HbA1c result * 7.5% (58 mmol/mol)
- •o 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
- •o In the investigator*s opinion the subject is considered technically capable of using the Abbott Sensor Based Glucose Monitoring System
- •o Aged 18 years or over.
排除标准
- •o 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)
- •o Subject is currently prescribed animal insulin
- •o Subject is currently prescribed oral steroid therapy or is likely to require oral steroid therapy for any acute or chronic condition during the study
- •o Has known allergy to medical grade adhesives
- •o Currently participating in another device or drug study that could affect glucose measurements or glucose management
- •o Currently using a Continuous Glucose Monitoring (CGM) device or has used one within the previous 4 months
- •o Currently using Sensor augmented pump therapy
- •o Is planning to use a CGM device at any time during the study
- •o A female subject who is pregnant or planning to become pregnant within the study duration
- •o A breast feeding mother
- •o Currently receiving dialysis treatment or planning to
- •receive dialysis during the study
- •o Has a pacemaker
- •o Has experienced an acute myocardial infarction within previous 6 months
- •o 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
- •o Has experienced an episode of confirmed or suspected diabetic ketoacidosis (DKA) in the previous 6 months
- •o In the investigator*s opinion, the subject is considered unsuitable for inclusion in the study for any other reason.
研究者
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