Closing the Loop in Adults With Type 1 Diabetes and HbA1C<7.5% Under Free Living Conditions
Closing the Loop in Adults With Type 1 Diabetes and HbA1C<7.5% Under Free Living Conditions
The main objective of this study is to determine whether day and night closed-loop insulin
 delivery for 4 weeks under free living conditions is superior to usual insulin pump therapy
 in adults with type 1 diabetes and HbA1C<7.5%.

 This is an open-label, multi center, randomized, crossover design study, involving a 2-4 week
 run-in period, followed by two 4 weeks study periods during which glucose levels will be
 controlled either by an automated day- and night closed-loop system or by subjects usual
 insulin pump therapy in random order. A total of up to 34 adults (aiming for 24 completed
 subjects) aged 18 years and older with T1D on insulin pump therapy and HbA1C<7.5% will be
 recruited through diabetes clinics and other established methods in participating centers.

 Subjects will receive appropriate training in the safe use of closed-loop insulin delivery
 system. Subjects will have regular contact with the study team during the home study phase
 including 24/7 telephone support.

 The primary outcome is time spent in target range between 3.9 and 10.0 mmol/L as recorded by
 CGM during home stay. Secondary outcomes are time spent with glucose levels above and below
 target, as recorded by CGM, and other CGM-based metrics.
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 6 months with good
 knowledge of insulin self-adjustment including carbohydrate counting

 -  The subject is treated with one of the rapid acting insulin analogues (Insulin Aspart,
 Insulin Lispro or Insulin Glulisine)

 -  HbA1c <7.5% (58mmol/mmol) based on analysis from central laboratory or equivalent

 -  The subject is willing to perform regular finger-prick blood glucose monitoring, with
 at least 6 measurements per day

 -  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 willing to upload pump and CGM data at regular intervals

 -  Female subjects of child bearing age should be on effective contraception and must
 have a negative urine-HCG pregnancy test at screening.

 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

 -  More than one episode of severe hypoglycaemia as defined by American Diabetes
 Association 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).

 -  Random C-peptide > 100pmol/l with concomitant plasma glucose >4 mM(72 mg/dl) Total
 daily insulin dose > 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

 -  Subject not proficient in English (UK) or German (Austria)

 -  Subjects who are living alone

 -  Additional exclusion criteria specific for Austria: Positive results on urine drug
 screen (amphetamines/metamphetamines, barbiturates, benzodiazepines, cannabinoids,
 cocaine, opiates).

 -  Additional exclusion criteria specific for Austria:Positive alcohol breath test.