Closed-loop in Adults With Type 2 Diabetes
NCT Number: NCT06579404
Acronym: COYOTE
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Type 2 Diabetes Treated With Insulin
Interventions: DEVICE: CamAPS HX|OTHER: Standard insulin therapy with glucose sensor
Sponsor: University of Cambridge
Collaborators: University of Edinburgh|Jaeb Center for Health Research|Swansea University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 224
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2027-07
Locations: Medical University of Graz, Graz, Austria|Diabetes Centre, Institute of Clinical and Experimental Medicine, Praha, Czechia|CHU de Toulouse, Toulouse, France|Medical Center - University of Freiburg, Freiburg, Germany|Bern University Hospital, Bern, Switzerland|Addenbrooke's Hospital, Cambridge University Hospitals NHS Foundation Trust, Cambridge, United Kingdom|Leicester Diabetes Centre, Leicester, United Kingdom|Guy's and St Thomas' NHS Foundation Trust, London, United Kingdom|Imperial College Healthcare NHS Trust, London, United Kingdom|King's College Hospital, King's College NHS Foundation Trust, London, United Kingdom|Manchester Royal Infirmary, Central Manchester University Hospitals NHS Foundation Trust, Manchester, United Kingdom|Norfolk and Norwich University Hospital, Norwich, United Kingdom

Summary:
The main objective of this study is to determine the efficacy, safety and utility of fully closed-loop glucose control in the home setting in adults with type 2 diabetes (T2D). This study builds on previous and on-going studies of closed-loop systems that have been performed in Cambridge in adults with type 2 diabetes in the inpatient and in the home setting and in children and adults with type 1 diabetes.

This is an open-label, multi-national, multi-centre, randomised, single-period parallel study, involving a run-in period followed by a 26-week intervention period during which glucose levels will be controlled either by a fully closed-loop system or by participants usual insulin therapy with continuous glucose monitoring. A total of up to 224 adults with type 2 diabetes using insulin will be recruited through outpatient diabetes clinics, primary care centres, social media advertising and other established methods at participating centres. Participants will receive appropriate training in the safe use of the study devices.

The primary outcome is the between group difference in HbA1c at 26 weeks. Other key outcomes include the time spent with glucose levels within, above and below the target glucose range (3.9-10.0mmol/L) and mean sensor glucose as recorded by CGM over the 26 weeks. Insulin requirements, body weight, renal and liver function will also be compared. Safety evaluation comprises severe hypoglycaemic episodes, and other adverse and serious adverse events. Human factors outcomes include CGM \& closed-loop usage, questionnaires and semi-structured interviews.

Primary Outcome Measures: Glycated haemoglobin (HbA1c) at 26 weeks, Centralised measurement of HbA1c, at 26 weeks
Secondary Outcome Measures: Proportion of time spent in target glucose range (3.9 to 10.0mmol/L), Sensor glucose metric measured as a %, over 26 weeks|Mean glucose (mmol/L), Sensor glucose metric measured in mmol/L, over 26 weeks|Proportion of time spent above target glucose (>10.0mmol/l), Sensor glucose metric measured as a %, over 26 weeks|Proportion of time spent below target glucose (<3.9mmol/L), Sensor glucose metric measured as a %, over 26 weeks|Standard deviation of sensor glucose, Sensor glucose metric measured in mmol/L, over 26 weeks|Coefficient of variation of sensor glucose, Sensor glucose metric measured as a %, over 26 weeks|Proportion of time spent below target glucose (<3.5mmol/L), Sensor glucose metric measured as a %, over 26 weeks|Proportion of time spent below target glucose (<3.0mmol/L), Sensor glucose metric measured as a %, over 26 weeks|Proportion of time spent above target glucose (>13.9mmol/l), Sensor glucose metric measured as a %, over 26 weeks|Proportion of time spent above target glucose (>16.7mmol/l), Sensor glucose metric measured as a %, over 26 weeks|Proportion of time spent above target glucose (>20.0mmol/l), Sensor glucose metric measured as a %, over 26 weeks|Proportion of participants with HbA1c <7.0% [53mmol/mol] (%), Binary metric of HbA1c, at 26 weeks|Proportion of participants with HbA1c <7.5% [58mmol/mol] (%), Binary metric of HbA1c, at 26 weeks|Total daily insulin dose, Measured in units/day, over 26 weeks|Body weight, Measured in kilograms, at 26 weeks|Waist hip ratio, Ratio, 26 weeks|Body Mass Index (BMI), Measured in kg/m2, 26 weeks|Fasted lipid profile, Measured in mmol/L, 26 weeks|Renal function, Renal function as measured by serum creatinine, 26 weeks|Renal function, Renal function as measured by estimated Glomerular Filtration Rate, 26 weeks|Renal function, Renal function as measured by urinary albumin creatinine ratio, 26 weeks|Liver function, Liver function as measured by FIB4 index, 26 weeks|Liver function, Liver function as measured by alanine transaminase (ALT), 26 weeks|Liver function, Liver function as measured by aspartate transaminase (AST), 26 weeks|Liver function, Liver function as measured by alkaline phosphatase (ALP), 26 weeks|Liver function, Liver function as measured by gamma-glutamyl transferase (yGT), 26 weeks|Liver function, Liver function as measured by serum bilirubin, 26 weeks|Liver function, Liver function as measured by albumin and FIB4 index, 26 weeks