Closing the Loop in Adults With Type 1 Diabetes and HbA1C<7.5% Under Free Living Conditions

University of Cambridge

Status

Completed

Conditions

Type 1 Diabetes

Treatments

Device: CSII with CGM

Device: Florence D2A or similar closed loop glucose control system

Study type

Interventional

Funder types

Other

Identifiers

NCT02727231

AP@home04 phase2

Details and patient eligibility

About

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.

Enrollment

29 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.