Tight glycaemic control” and the risk of hypoglycaemia: Is this different between multiple injections versus insulin pump therapy? A UK multi-centre, open randomised control trial. - DUK Pump Study

niversity of Dundee (Research & Innovation Services)0 个研究点开始时间: 2008年7月16日最近更新: 2012年3月19日

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•We will recruit 10 children and adolescents (8 to 16 yrs).
•The centre will enroll subjects on the understanding that they will be allowed to continue managing their diabetes with CSII if this is the subjects choice, after completion of the study, supported by their local clinic.
•Each subject should have been diagnosed with diabetes for one year and currently be treated with MDI therapy for at least six months. Glycaemic control should be consistent with an HbA1c <10.5%.
•Each recruit should expect to comply with a rigorous programme of monitoring and insulin adjustment (see below).
•All subjects should have a mobile phone (with basic SMS facility) and be prepared to receive a daily message throughout the study.
•All patients should accept the requirement of Glycaemic excursion using continuous glocuse monitoring over 3-10 days at the begining of each treatment arm and Blind Glycaemic excursion using continuous glocuse monitoring over 3-10 days at the run-in period and at the end of each treatment arm.
•To ensure a cohesive approach to hypoglycaemiic care by parent, recruit and clinical staff, hypoglycaemia is classified and managed using the Sympotomatic Hypoglycaemia guideline.
•Are the trial subjects under 18? yes
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

发起方

niversity of Dundee (Research & Innovation Services)