Comparison of two artificial pancreas systems for closed loop blood glucose control versus open loop control in patients with type 1 diabetes: a randomised, non-blinded, multi-centre, cross-over intervention trial

Academic Medical Centre (AMC) (Netherlands)0 个研究点目标入组 48 人开始时间: 2011年3月17日最近更新: 2015年1月13日

适应症

试验速览

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•1. Aged 18 years or above
•2. Diagnosed with type 1 diabetes mellitus (DM) at least 6 months according to the World Health Organisation (WHO) definition
•3. Body Mass Index (BMI) < 35 kg/m²
•4. Treated by basal-bolus insulin therapy using an external insulin pump for at least 3 months
•5. Willing to use insulin aspart and wear a continuous glucose monitoring (CGM) device for the duration of the three study days and undergo all study procedures
•6. Trained in carbohydrate counting
•7. HbA1c < 10%
•8. If patient is on antihypertensive, thyroid, anti-depressant or lipid lowering medication, patient must have stability on the medication for at least 1 month prior to enrollment in the study and for the study duration
•9. Signed informed consent form prior to study entry

•1. Patient is pregnant or breast feeding during the period of the study
•2. Haematocrit is below 36% (females) and below 38% (males)
•3. Symptomatic coronary artery disease (e.g. history of myocardial infarction, history of acute coronary syndrome, history of therapeutic coronary intervention, history of coronary bypass or stenting procedure, stable or unstable angina, positive stress test or catheterisation with coronary blockages > 50%) or congestive heart failure or a history of a cerebrovascular event
•4. Patient is using a medication that significantly impacts glucose metabolism (oral steroids) except if stable for at least the last three months and expected to remain stable for the study duration
•5. Uncontrolled hypertension with resting blood pressure over 140/90 mmHg
•6. Patient is actively enrolled in another clinical trial or took part in a study within 30 days
•7. Allergy or adverse reaction to aspart insulin
•8. Known adrenal gland problem, pancreatic tumour or insulinoma
•9. Current alcohol abuse, substance abuse or severe mental illness, as judged by the investigator
•10. Retinopathy except background retinopathy according to eye fundus examination during the last year
•11. Known bleeding diathesis or dyscrasia
•12. Renal insufficiency with serum creatinine > 150 µmol/L
•13. Patient donated blood in the last 3 months

发起方

Academic Medical Centre (AMC) (Netherlands)