Closed-loop in adults with T2D requiring dialysis (AP-Renal)
Research type
Research Study
Full title
An open-label, multi-centre, multi-national, randomised, 2-period crossover study to assess the efficacy, safety and utility of fully closed-loop insulin delivery in comparison with standard care, in adults with type 2 diabetes requiring maintenance dialysis.
IRAS ID
261016
Contact name
Roman Hovorka
Contact email
Sponsor organisation
Cambridge University Hospitals NHS Foundation Trust jointly with University of Cambridge
Clinicaltrials.gov Identifier
NCT0402575
Duration of Study in the UK
1 years, 8 months, 30 days
Research summary
The main objective of this study is to determine the efficacy, safety and utility of fully automated closed-loop glucose control in the home setting over a 20 day period in adults with type 2 diabetes (T2D) requiring maintenance dialysis. This study builds on previous and on-going studies of closed-loop systems that have been performed in Cambridge in adults with type 1 diabetes in the home setting, and in adults with type 2 diabetes in the inpatient setting.
This is an open-label, two-centre, randomised, cross-over study, involving two home study periods during which glucose levels will be controlled either by a fully automated closed-loop system or by participants’ usual therapy in random order. Each treatment arm is 20 days long with a 2-4 week washout period between treatments. A total of up to 20 adults with T2D requiring maintenance dialysis will be recruited through the dialysis unit, to allow for 16 completed participants available for assessment.
Participants will receive appropriate training by the research team on the safe use of the study devices (insulin pump and continuous glucose monitoring (CGM) and closed-loop insulin delivery system. Participants in the control arm will continue with standard therapy and will wear a blinded CGM system.
The primary outcome is time spent with glucose levels in the target range between 5.6 and 10.0 mmol/L as recorded by CGM. Secondary outcomes are the time spent with glucose levels above and below target, as recorded by CGM, and other CGM-based metrics in addition to insulin requirements. Safety evaluation comprises the tabulation of severe hypoglycaemic episodes.
REC name
London - Stanmore Research Ethics Committee
REC reference
19/LO/0728
Date of REC Opinion
19 Jun 2019
REC opinion
Further Information Favourable Opinion