Short Term Closed-loop Glucose Control in Adults With Type 1 Diabetes (AP@home02)
Type 1 Diabetes
About this trial
This is an interventional treatment trial for Type 1 Diabetes focused on measuring Type 1 Diabetes, Closed Loop glucose control, Artificial Pancreas, CSII, CGM
Eligibility Criteria
Inclusion Criteria:
- The subject has type 1 diabetes as defined by WHO
- The subject is 18 years of age or older
- The subject will have been on an insulin pump for at least 3 months currently using insulin Aspart, with good knowledge of insulin self-adjustment including carbohydrate counting
- HbA1c ≤ 10 % based on analysis from local laboratory
- The subject is willing to perform regular finger-prick blood glucose monitoring, with at least 6 measurements per day during the 7 day home phase of the study
- The subject is willing to wear closed-loop system at home and at work place
- The subject is willing to follow study specific instructions
- The subject is literate in English
- Female subjects of child bearing age should be on effective contraception and must have a negative urine-HCG pregnancy test at screening. In addition in Germany, women of childbearing potential must use a highly effective method of birth control, which is defined as those which result in a low failure rate (i.e. less than 1% per year) and must use two independent methods of contraception, e.g. diaphragm and spermicide-coated condom.
Exclusion Criteria:
- Non-type 1 diabetes mellitus
- Any other physical or psychological disease or condition likely to interfere with the normal conduct of the study and interpretation of the study results
- Current treatment with drugs known to have significant interference with glucose metabolism, such as systemic corticosteroids, as judged by the investigator
- Known or suspected allergy against insulin
- Subjects with clinically significant nephropathy, neuropathy or proliferative retinopathy as judged by the investigator
- Significantly reduced hypoglycaemia awareness as judged by the investigator
- Total daily insulin dose more than 2 IU/kg/day
- Subject is pregnant or breast feeding or planning pregnancy in near future (within next 3 months)
- Severe visual impairment
- Severe hearing impairment
- Subjects using implanted internal pacemaker
- Lack of reliable telephone facility for contact
Additional exclusion criteria specific for Austria and Germany
- Positive results on urine drug screen (amphetamines/metamphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, opiates).
- Positive alcohol breath test.
Additional exclusion criteria specific for Germany only
Positive reaction to any of the following tests: hepatitis B surface (HBs) antigen, anti-hepatitis C virus (anti-HCV) antibodies, anti-human immunodeficiency virus (HIV) 1 antibodies, anti-HIV2 antibodies
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Sites / Locations
- Medical University of Graz
- Profil Institut für Stoffwechselforschung GmbH
- Cambridge University Hospitals NHS Foundation Trust
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Closed Loop Glucose control
CSII with real-time CGM
Subject's glucose level is controlled by the automated closed loop glucose control system
Subject glucose level controlled by usual insulin pump therapy in conjunction with real time continuous glucose monitoring (CGM)