Peri-operative closed loop control (POP-LOOP)
Research type
Research Study
Full title
Peri-operative closed-loop insulin delivery versus standard insulin therapy - a randomised controlled parallel clinical trial in adults with type 2 diabetes (POP-LOOP)
IRAS ID
291935
Contact name
Roman Hovorka
Contact email
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 9 months, 1 days
Research summary
The objective of this study is to compare the efficacy, safety and utility of fully automated closed loop insulin delivery to standard insulin therapy in adults with type 2 diabetes (T2D) undergoing elective abdominal, thoracic, orthopaedic or vascular surgery at Addenbrooke's Hospital in a single-centre, randomised, controlled, parallel clinical trial during which glucose levels will be controlled by either a fully automated closed loop system or by participants usual insulin therapy until discharge from hospital or a maximum of twenty days.
A total of 20 adults with type 2 diabetes will be recruited through pre-operative assessment clinics to allow for 16 completed participants at the end of the study.
This study builds on previous and ongoing studies of the closed loop system in Cambridge in adults with type 1 and type 2 diabetes both in inpatient and outpatient settings.
The primary endpoint is the time spent in target glucose range from 5.6 to 10 mmol/L from hospital admission to discharge, or a maximum of twenty days based on continuous glucose monitoring (CGM). Secondary endpoints will include proportion of time spent above and below target glucose levels and other glucose metrics, time spent on diabetes management and total daily insulin dose. Safety evaluation comprises assessment of frequency and severity of hypoglycaemia, hyperglycaemia and other serious adverse events related to the study procedures.
REC name
North West - Preston Research Ethics Committee
REC reference
21/NW/0058
Date of REC Opinion
6 Apr 2021
REC opinion
Further Information Favourable Opinion