Closing the Loop in Adults With Sub-optimally Controlled Type 1 Diabetes Under Free Living Conditions

Exclusion Criteria

• •1. Non-type 1 diabetes mellitus
• •2. Any other physical or psychological disease or condition likely to interfere with the normal conduct of the study and interpretation of the study results
• •3. Current treatment with drugs known to have significant interference with glucose metabolism, such as systemic corticosteroids, as judged by the investigator
• •4. Known or suspected allergy against insulin
• •5. Subjects with clinically significant nephropathy, neuropathy or proliferative retinopathy as judged by the investigator
• •6. Significantly reduced hypoglycaemia awareness as judged by the investigator
• •7. More than one episode of severe hypoglycaemia as defined by American Diabetes Association (31) in preceding 6 months (Severe hypoglycaemia is defined as an event requiring assistance of another person to actively administer carbohydrates, glucagon, or take other corrective actions).
• •8. Random C-peptide \> 100pmol/l with concomitant plasma glucose \>4 mM(72 mg/dl)
• •9. Total daily insulin dose \> 2 IU/kg/day
• •10. Subject is pregnant or breast feeding or planning pregnancy in near future (within next 3 months)
• •11. Severe visual impairment
• •12. Severe hearing impairment
• •13. Subjects using implanted internal pacemaker
• •14. Lack of reliable telephone facility for contact
• •15. Subject not proficient in English (UK) or German (Germany and Austria)
• •16. Subjects who are living alone
• •1. Positive results on urine drug screen (amphetamines/metamphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, opiates).
• •2. Positive alcohol breath test.
• •1. 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.
• •2. Significantly reduced hypoglycaemia awareness withGold score ≥ 4 according to Geddes J et al, Diabetes Care 2007
• •3. Serious macro- and microangiopathy
• •4. Serious anomalies of the skin
• •5. Serious skin diseases (e.g. psoriasis vulgaris, bacterial skin diseases) located at places of the body, which potentially are possible to be used for localisation of the glucose sensor)
• •6. Renal insufficiency
• •7. Epilepsy
• •8. Eating disorders (like bulimia or anorexia nervosa)
• •9. Disorders of the lipid metabolism
• •10. Blood transfusion requiring patients
• •11. Psychiatric diseases and related conditions
• •12. Patients with frequent catheter abscesses having occurred in connection with the pump therapy
• •13. Patients with medically documented allergy towards the adhesive (glue) of plasters
• •14. Abnormal blood values for:
• •* the creatinine clearance,
• •* erythropoietin,
• •* TSH.
• •15. Patients with the following concomitant medications or misuse of substances:
• •* steroids,
• •* anticoagulant therapies.
• •16. Patients with a planned intervention under general anaesthesia.
• •17. Patients who do shift work