Glucose Level Awareness (using self-monitoring of blood glucose [SMBG] and continuous glucose monitoring [CGM]) in Diabetes Study: a multicentre randomised controlled three-arm study

Abbott Diabetes Care Ltd (UK)0 个研究点目标入组 150 人开始时间: 2011年2月18日最近更新: 2016年10月17日

适应症

试验速览

暂无简介。

•Inclusion criteria as of 13/03/2012:
•1. Subject with type 1 or type 2 diabetes on multiple daily injections (MDI) (3 or more insulin injections per day) or continuous subcutaneous insulin infusion (CSII) for greater than 6 months prior to study enrolment
•2. Aged 18 - 65 years, either sex and, in the Investigator's opinion, thought technically capable of using CGM
•3. HbA1c between 7% and 11% (inclusive) for previous HbA1c test obtained within 3 months prior to enrolment
•4. Subject reporting testing of blood glucose an average of 2 - 7 times per day
•Previous inclusion criteria
•1. Subject with type 1 or type 2 diabetes on multiple daily injections (MDI) (3 or more insulin injections per day) or continuous subcutaneous insulin infusion (CSII) for greater than 1 year prior to study enrolment
•2. Aged 18 - 65 years, either sex and, in the Investigator's opinion, thought technically capable of using CGM
•3. HbA1c between 7.5% and 10% (inclusive) for previous HbA1c test obtained within 3 months prior to enrolment
•4. Subject reporting testing of blood glucose an average of 2 - 7 times per day

•1. Subject has known allergy to medical grade adhesives
•2. Subject has concomitant disease or condition that influences metabolic control or, in the investigator?s opinion, may compromise patient safety
•3. Subject is participating in another study of a glucose monitoring device or drug that could affect glucose measurements or glucose management
•4. Subject is currently using another continuous glucose monitoring device or has used real-time continuous glucose monitoring in the last 6 months
•5. Subject is pregnant/planning to become pregnant within the planned study duration

发起方

Abbott Diabetes Care Ltd (UK)