Closed-loop in Adults With Type 2 Diabetes
COYOTE
An Open-label, Multinational, Multicentre, Randomised, Single-period Parallel Study to Assess the Efficacy, Safety and Utility of Fully Closed-loop Insulin Delivery Compared to Standard Insulin Therapy With CGM in Adults With Type 2 Diabetes
1 other identifier
interventional
224
5 countries
11
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2024
Typical duration for not_applicable
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 16, 2024
CompletedFirst Posted
Study publicly available on registry
August 30, 2024
CompletedStudy Start
First participant enrolled
December 6, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2027
March 13, 2026
March 1, 2026
2.2 years
August 16, 2024
March 10, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Glycated haemoglobin (HbA1c) at 26 weeks
Centralised measurement of HbA1c
at 26 weeks
Secondary Outcomes (37)
Proportion of time spent in target glucose range (3.9 to 10.0mmol/L)
over 26 weeks
Mean glucose (mmol/L)
over 26 weeks
Proportion of time spent above target glucose (>10.0mmol/l)
over 26 weeks
Proportion of time spent below target glucose (<3.9mmol/L)
over 26 weeks
Standard deviation of sensor glucose
over 26 weeks
- +32 more secondary outcomes
Study Arms (2)
Fully closed-loop insulin delivery (CamAPS HX)
EXPERIMENTALThe automated closed loop system (CamAPS FX) will consist of: * YpsoPump insulin pump (Ypsomed, Burgdorf, Switzerland) * FreeStyle Libre 3 glucose sensor (Abbott Diabetes Care, CA, USA) * Smartphone hosting CamAPS HX app with the Cambridge model predictive control algorithm * Cloud upload system to review CGM/insulin data. Participants will use the fully closed-loop system for 26 weeks at home
Standard insulin therapy with glucose sensor
ACTIVE COMPARATORUsual insulin therapy and FreeStyle Libre 3 glucose sensor (Abbott Diabetes Care, CA, USA) for 26 weeks at home.
Interventions
The automated closed loop system (CamAPS HX) will consist of: YpsoPump insulin pump Freestyle Libre 3 glucose sensor Smartphone hosting CamAPS HX app with the Cambridge model predictive control algorithm
Participants usual insulin therapy with Freestyle Libre 3 glucose sensor
Eligibility Criteria
You may qualify if:
- Aged 18 years and older
- Type 2 diabetes diagnosed for at least 12 months
- Established on an SGLT2 inhibitor and/or GLP-1 receptor agonist for at least 3 months, or have been offered these therapies previously.
- Treatment with insulin therapy for at least 6 months
- HbA1c ≤ 15% (140 mmol/mol) analysis from local laboratory or equivalent
- Willing to wear study devices and follow study instructions
- Capacity to consent to participate in the study
You may not qualify if:
- Type 1 diabetes
- Current use of insulin pump
- Current use of any closed-loop system
- Any physical/psychological disease or medication(s) likely to interfere with the conduct of the study and interpretation of the study results, as judged by study clinician
- Known or suspected allergy against insulin
- Medically documented allergy towards the adhesive
- Pregnancy, planned pregnancy, or breast feeding
- Severe visual impairment
- Severe hearing impairment
- Medically documented allergy towards the adhesive (glue) of plasters
- Serious skin diseases located at places of the body, which potentially are possible to be used for localisation of the glucose sensor
- Illicit drugs abuse
- Prescription drugs abuse
- Alcohol abuse
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Cambridgelead
- University of Edinburghcollaborator
- Jaeb Center for Health Researchcollaborator
- Swansea Universitycollaborator
Study Sites (12)
University of Melbourne
Melbourne, Australia
Medical University of Graz
Graz, Austria
Diabetes Centre, Institute of Clinical and Experimental Medicine
Prague, Czechia
CHU de Toulouse
Toulouse, France
Bern University Hospital
Bern, Switzerland
Addenbrooke's Hospital, Cambridge University Hospitals NHS Foundation Trust
Cambridge, United Kingdom
Royal Derby Hospital
Derby, United Kingdom
Leicester Diabetes Centre
Leicester, United Kingdom
Guy's and St Thomas' NHS Foundation 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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Roman Hovorka
University of Cambridge
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Metabolic Technology
Study Record Dates
First Submitted
August 16, 2024
First Posted
August 30, 2024
Study Start
December 6, 2024
Primary Completion (Estimated)
March 1, 2027
Study Completion (Estimated)
July 1, 2027
Last Updated
March 13, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Study protocol, statistical analysis plan and fully anonymised individual participant data that underlie the results reported in the manuscript will be available 6 months following publication and ending 36 months following manuscript publication to investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose, to achieve aims in the approved proposal. Proposals should be directed to rh347@cam.ac.uk and may be submitted up to 36 months following article publication.
- Access Criteria
- Study protocol, statistical analysis plan and fully anonymised individual participant data that underlie the results reported in the manuscript will be available 6 months following publication and ending 36 months following manuscript publication to investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose, to achieve aims in the approved proposal. Proposals should be directed to rh347@cam.ac.uk and may be submitted up to 36 months following article publication.
Study protocol, statistical analysis plan and fully anonymised individual participant data that underlie the results reported in the manuscript will be available 6 months following publication and ending 36 months following manuscript publication to investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose, to achieve aims in the approved proposal. Proposals should be directed to rh347@cam.ac.uk and may be submitted up to 36 months following article publication. To gain access, data requestors will need to sign a data access agreement. Fully anonymised data may be shared with third parties (EU or non-EU based) for the purposes of advancing management and treatment of diabetes.