Type 2 Diabetes Treated With InsulinCOYOTENCT06579404
Closed-loop in Adults With Type 2 Diabetes
A study testing CamAPS HX and Standard insulin therapy with glucose sensor in people with Type 2 Diabetes Treated With Insulin, run by University of Cambridge at 12 sites in 6 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes Treated With Insulin
- What is being tested?
- CamAPS HX and Standard insulin therapy with glucose sensor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 224 participants
- Where
- 12 sitesin 6 countries
- Study dates
- 6 Dec 2024to Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
12 sites in 6 countries. Contact the study team or a site near you to ask about taking part.
Angel Tseung contact
12 sites in 6 countries
United Kingdom7 sites, 7 recruiting
- Recruiting
Addenbrooke's Hospital, Cambridge University Hospitals NHS Foundation Trust
Cambridge
Charlotte Boughton
- Not yet recruiting
Royal Derby Hospital
Derby
Emma Wilmot
- Recruiting
Leicester Diabetes Centre
Leicester
Pratik Choudhary
- Recruiting
Guy's and St Thomas' NHS Foundation Trust
London
Sufyan Hussain
- Recruiting
King's College Hospital, King's College NHS Foundation Trust
London
Yee Cheah
- Not yet recruiting
Manchester Royal Infirmary, Central Manchester University Hospitals NHS Foundation Trust
Manchester
Hood Thabit
- Recruiting
Norfolk and Norwich University Hospital
Norwich
Sankalpa Neupane
Australia1 site, 1 recruiting
- Not yet recruiting
University of Melbourne
Melbourne
David O'Neal
Austria1 site, 1 recruiting
- Not yet recruiting
Medical University of Graz
Graz
Julia Mader
Czechia1 site, 1 recruiting
- Not yet recruiting
Diabetes Centre, Institute of Clinical and Experimental Medicine
Prague
Martin Haluzík
France1 site, 1 recruiting
- Not yet recruiting
CHU de Toulouse
Toulouse
Hélène Hanaire
Switzerland1 site, 1 recruiting
- Not yet recruiting
Bern University Hospital
Bern
Lia Bally
About this study
Official title: 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
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.
Read the detailed description
Purpose of clinical trial:
To determine the efficacy, safety and utility of fully closed-loop insulin delivery over 26 weeks in the home setting in adults with type 2 diabetes.
Study objectives:
To determine the efficacy, safety and utility of fully closed-loop insulin delivery over 26 weeks in the home setting in adults with type 2 diabetes.
- EFFICACY: The objective is to assess the ability of fully closed-loop insulin delivery to improve glucose control as measured by HbA1c (primary endpoint) and sensor glucose metrics.
- SAFETY: The objective is to evaluate the safety of fully closed-loop insulin delivery in terms of episodes and severity of hypoglycaemia, and nature and severity of other adverse events.
- UTILITY: The objective is to determine the acceptability and duration of use of the CGM and closed-loop system.
- HUMAN FACTORS: The objective is to assess cognitive, emotional, and behavioural characteristics of participants and their response to the closed-loop system using validated questionnaires and semi-structured interviews. Participating clinical centres: UK - Addenbrooke's Hospital, Cambridge University Hospitals NHS Foundation Trust. - Imperial College Healthcare NHS Trust, London
- Manchester Royal Infirmary, Manchester University NHS Foundation Trust
- King's College Hospital, King's College Hospital NHS Foundation Trust, London
- Guy's and St Thomas' NHS Foundation Trust
- Norfolk and Norwich University Hospital, Norfolk and Norwich University Hospitals NHS Foundation Trust
- University Hospitals of Leicester NHS Trust Switzerland
- Inselspital, Bern University Hospital, Bern France
- Centre Hospitalier Universitaire (CHU) de Toulouse Germany
- Medical Center - University of Freiburg Austria
- Medical University of Graz, Graz Czech Republic
- Diabetes Centre, Institute for Clinical and Experimental Medicine, Prague Sample Size:
224 participants (112 per group) will be randomised. Recruitment will target a minimum quota of 25% of participants using basal insulin and a minimum quota of 60% of participants using multiple daily insulin injections.
Maximum duration of study for a subject: 30 weeks
Recruitment:
Participants will be recruited through outpatient diabetes clinics, primary care centres, social media advertising or other established methods at participating centres
Consent:
Participants will be asked to provide written informed consent.
Baseline Assessment:
Eligible participants will undergo baseline evaluation involving talking a medical history including demographics, height/weight, waist hip ratio and blood pressure measurement and blood samples for HbA1c, fasted lipid profile, renal and liver function. A urine albumin-creatinine ratio (ACR) will be performed, along with a urine pregnancy test in females of child-bearing age. Human factors questionnaires will be completed and a masked glucose sensor will be applied.
Run-in Period:
During a 2-3 week run-in period, participants will use their usual insulin therapy and wear a masked CGM system. At the end of the run-in period, for compliance, at least 10 days of CGM data needs to be recorded. CGM data during the run-in period will be used to assess baseline glucose control before the start of the intervention phase.
Randomisation:
Eligible participants will be randomised in a 1:1 ratio using central randomisation software to fully closed-loop or standard insulin therapy with CGM for 26 weeks. Randomisation will be stratified by site and baseline HbA1c.
Fully closed loop insulin delivery (intervention arm):
Following randomisation, participants in the closed-loop group will receive training on the study CGM, study insulin pump and closed-loop App during a 1-2 hour outpatient session. Competency on the use of the closed-loop system will be evaluated. Further training may be delivered as required. Participants will be advised to use the closed-loop system for the next 26 weeks.
Standard insulin therapy with CGM (control arm):
Following randomisation, participants in the control group will use their usual insulin therapy and the study CGM. Training on the use of the CGM will be provided. Participants will use standard insulin therapy and CGM for the next 26 weeks.
3 month study visit: Weight, waist hip ratio and blood pressure will be measured and a blood sample will be taken for measurement of HbA1c, fasted lipid profile, renal and liver function. Data from the closed-loop system and CGM system will be reviewed. Human factors questionnaires will be completed.
End of study assessments:
Weight, waist hip ratio and blood pressure will be measured and a blood sample will be taken for measurement of HbA1c, fasted lipid profile, renal and liver function. Urinary ACR will be measured. Human factors questionnaires will be completed and a subset of participants will participate in interviews. Study devices will be returned and participants will resume their usual insulin therapy and standard glucose monitoring.
Procedures for safety monitoring during trial:
Standard operating procedures for monitoring and reporting of all adverse events and adverse device events will be in place, including serious adverse events (SAE), serious adverse device effects (SADE) and specific adverse events (AE) such as severe hypoglycaemia.
A data safety and monitoring board (DSMB) will be informed of all serious adverse events and any unanticipated serious adverse device effects that occur during the study and will review compiled adverse event data at periodic intervals.
Criteria for withdrawal of subjects on safety grounds:
A participant may terminate participation in the study at any time without necessarily giving a reason and without any personal disadvantage. An investigator can stop the participation of a subject after consideration of the benefit/risk ratio. Possible reasons are:
- Participant is unable to demonstrate safe use of study devices as judged by the investigator
- Serious adverse events
- Significant protocol violation or non-compliance
- Decision by the investigator, or the Sponsor, that termination is in the participant's best medical interest
- Pregnancy, planned pregnancy, or breast feeding
- Allergic reaction to insulin or severe allergic reaction to adhesive surface of infusion set or glucose sensor
- Technical grounds (e.g. participant relocates)
- Conditions
- Type 2 Diabetes Treated With Insulin
- Being tested
- CamAPS HX, Standard insulin therapy with glucose sensor
- Keywords
- Closed-loop insulin delivery, Type 2 diabetes
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CamAPS HXDevice
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
Standard insulin therapy with glucose sensorOther
Participants usual insulin therapy with Freestyle Libre 3 glucose sensor
| Study group | Role | What they receive |
|---|---|---|
| Fully closed-loop insulin delivery (CamAPS HX) | Experimental | The 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 Receives: Device: CamAPS HX |
| Standard insulin therapy with glucose sensor | Active comparator | Usual insulin therapy and FreeStyle Libre 3 glucose sensor (Abbott Diabetes Care, CA, USA) for 26 weeks at home. Receives: Other: Standard insulin therapy with glucose sensor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycated haemoglobin (HbA1c) at 26 weeks
Centralised measurement of HbA1c
Measured: at 26 weeks
Secondary outcomes (37)
Proportion of time spent in target glucose range (3.9 to 10.0mmol/L)
Sensor glucose metric measured as a %
Measured: over 26 weeks
Mean glucose (mmol/L)
Sensor glucose metric measured in mmol/L
Measured: over 26 weeks
Proportion of time spent above target glucose (>10.0mmol/l)
Sensor glucose metric measured as a %
Measured: over 26 weeks
Proportion of time spent below target glucose (<3.9mmol/L)
Sensor glucose metric measured as a %
Measured: over 26 weeks
Standard deviation of sensor glucose
Sensor glucose metric measured in mmol/L
Measured: over 26 weeks
Coefficient of variation of sensor glucose
Sensor glucose metric measured as a %
Measured: over 26 weeks
Proportion of time spent below target glucose (<3.5mmol/L)
Sensor glucose metric measured as a %
Measured: over 26 weeks
Proportion of time spent below target glucose (<3.0mmol/L)
Sensor glucose metric measured as a %
Measured: over 26 weeks
Proportion of time spent above target glucose (>13.9mmol/l)
Sensor glucose metric measured as a %
Measured: over 26 weeks
Proportion of time spent above target glucose (>16.7mmol/l)
Sensor glucose metric measured as a %
Measured: over 26 weeks
Proportion of time spent above target glucose (>20.0mmol/l)
Sensor glucose metric measured as a %
Measured: over 26 weeks
Proportion of participants with HbA1c <7.0% [53mmol/mol] (%)
Binary metric of HbA1c
Measured: at 26 weeks
Proportion of participants with HbA1c <7.5% [58mmol/mol] (%)
Binary metric of HbA1c
Measured: at 26 weeks
Total daily insulin dose
Measured in units/day
Measured: over 26 weeks
Body weight
Measured in kilograms
Measured: at 26 weeks
Waist hip ratio
Ratio
Measured: 26 weeks
Body Mass Index (BMI)
Measured in kg/m2
Measured: 26 weeks
Blood Pressure (mmHg)
Measured: 26 weeks
Fasted lipid profile
Measured in mmol/L
Measured: 26 weeks
Renal function
Renal function as measured by serum creatinine
Measured: 26 weeks
Renal function
Renal function as measured by estimated Glomerular Filtration Rate
Measured: 26 weeks
Renal function
Renal function as measured by urinary albumin creatinine ratio
Measured: 26 weeks
Liver function
Liver function as measured by FIB4 index
Measured: 26 weeks
Liver function
Liver function as measured by alanine transaminase (ALT)
Measured: 26 weeks
Liver function
Liver function as measured by aspartate transaminase (AST)
Measured: 26 weeks
Liver function
Liver function as measured by alkaline phosphatase (ALP)
Measured: 26 weeks
Liver function
Liver function as measured by gamma-glutamyl transferase (yGT)
Measured: 26 weeks
Liver function
Liver function as measured by serum bilirubin
Measured: 26 weeks
Liver function
Liver function as measured by albumin
Measured: 26 weeks
Number of severe hypoglycaemia events
Measured: 26 weeks
Number of participants with any severe hypoglycaemia event
Measured: 26 weeks
Number of diabetic ketoacidosis events
Measured: 26 weeks
Number of participants with any diabetic ketoacidosis event
Measured: 26 weeks
Number of adverse events per participant
Measured: 26 weeks
Number of serious adverse events per participant
Measured: 26 weeks
Proportion of CGM use (%)
Measured: 26 weeks
Proportion of closed-loop use (%)
Measured: 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2024
- Study start6 Dec 2024
- Primary completionMar 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes Treated With InsulinStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A multicentre, multinational, open-label, randomised single period, parallel design study contrasting fully closed-loop insulin delivery and standard insulin therapy with CGM over 26 weeks in adults with type 2 diabetes.
- Masking
- None (open label)
- Enrolment
- 224 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cambridge
- Sponsor type
- University, hospital or other
- Collaborators
- University of Edinburgh, Jaeb Center for Health Research, Swansea University
- Responsible party
- Principal investigator, Dr Roman Hovorka, University of Cambridge
- Investigators
- Roman Hovorka, Principal investigator, University of Cambridge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06579404
- Sponsor's protocol ID
- COYOTE
- Acronym
- COYOTE
- Status last verified
- Mar 2026
- First submitted
- 16 Aug 2024
- Last updated
- 13 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Seese R, Boughton CK, Tseung FT, Uy R, Wilinska ME, Thabit H, Cheah YS, Neupane S, Hussain S, Choudhary P, Wilmot EG, Bally L, Hanaire H, Mader JK, Haluzik M, O'Neal D, Lawton J, Rankin D, Kollman C, Dunseath G, Hovorka R. Assessing the efficacy, safety and utility of fully closed-loop insulin delivery compared to standard insulin therapy with a continuous glucose monitor in adults with type 2 diabetes (COYOTE study): a randomised parallel study protocol. BMJ Open. 2026 May 19;16(5):e115464. doi: 10.1136/bmjopen-2025-115464.
PubMed 42156154
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06579404
- Acronym / sponsor ID
- COYOTE / COYOTE
- Conditions
- Type 2 Diabetes Treated With Insulin
- Keywords
- Closed-loop insulin delivery, Type 2 diabetes
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 224 participants (estimated)
- Lead sponsor
- University of CambridgeUniversity, hospital or other
- Collaborators
- University of Edinburgh, Jaeb Center for Health Research, Swansea University
- Study start
- 6 Dec 2024 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 30 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Purpose of clinical trial:
To determine the efficacy, safety and utility of fully closed-loop insulin delivery over 26 weeks in the home setting in adults with type 2 diabetes.
Study objectives:
To determine the efficacy, safety and utility of fully closed-loop insulin delivery over 26 weeks in the home setting in adults with type 2 diabetes.
- EFFICACY: The objective is to assess the ability of fully closed-loop insulin delivery to improve glucose control as measured by HbA1c (primary endpoint) and sensor glucose metrics.
- SAFETY: The objective is to evaluate the safety of fully closed-loop insulin delivery in terms of episodes and severity of hypoglycaemia, and nature and severity of other adverse events.
- UTILITY: The objective is to determine the acceptability and duration of use of the CGM and closed-loop system.
- HUMAN FACTORS: The objective is to assess cognitive, emotional, and behavioural characteristics of participants and their response to the closed-loop system using validated questionnaires and semi-structured interviews. Participating clinical centres: UK - Addenbrooke's Hospital, Cambridge University Hospitals NHS Foundation Trust. - Imperial College Healthcare NHS Trust, London
- Manchester Royal Infirmary, Manchester University NHS Foundation Trust
- King's College Hospital, King's College Hospital NHS Foundation Trust, London
- Guy's and St Thomas' NHS Foundation Trust
- Norfolk and Norwich University Hospital, Norfolk and Norwich University Hospitals NHS Foundation Trust
- University Hospitals of Leicester NHS Trust Switzerland
- Inselspital, Bern University Hospital, Bern France
- Centre Hospitalier Universitaire (CHU) de Toulouse Germany
- Medical Center - University of Freiburg Austria
- Medical University of Graz, Graz Czech Republic
- Diabetes Centre, Institute for Clinical and Experimental Medicine, Prague Sample Size:
224 participants (112 per group) will be randomised. Recruitment will target a minimum quota of 25% of participants using basal insulin and a minimum quota of 60% of participants using multiple daily insulin injections.
Maximum duration of study for a subject: 30 weeks
Recruitment:
Participants will be recruited through outpatient diabetes clinics, primary care centres, social media advertising or other established methods at participating centres
Consent:
Participants will be asked to provide written informed consent.
Baseline Assessment:
Eligible participants will undergo baseline evaluation involving talking a medical history including demographics, height/weight, waist hip ratio and blood pressure measurement and blood samples for HbA1c, fasted lipid profile, renal and liver function. A urine albumin-creatinine ratio (ACR) will be performed, along with a urine pregnancy test in females of child-bearing age. Human factors questionnaires will be completed and a masked glucose sensor will be applied.
Run-in Period:
During a 2-3 week run-in period, participants will use their usual insulin therapy and wear a masked CGM system. At the end of the run-in period, for compliance, at least 10 days of CGM data needs to be recorded. CGM data during the run-in period will be used to assess baseline glucose control before the start of the intervention phase.
Randomisation:
Eligible participants will be randomised in a 1:1 ratio using central randomisation software to fully closed-loop or standard insulin therapy with CGM for 26 weeks. Randomisation will be stratified by site and baseline HbA1c.
Fully closed loop insulin delivery (intervention arm):
Following randomisation, participants in the closed-loop group will receive training on the study CGM, study insulin pump and closed-loop App during a 1-2 hour outpatient session. Competency on the use of the closed-loop system will be evaluated. Further training may be delivered as required. Participants will be advised to use the closed-loop system for the next 26 weeks.
Standard insulin therapy with CGM (control arm):
Following randomisation, participants in the control group will use their usual insulin therapy and the study CGM. Training on the use of the CGM will be provided. Participants will use standard insulin therapy and CGM for the next 26 weeks.
3 month study visit: Weight, waist hip ratio and blood pressure will be measured and a blood sample will be taken for measurement of HbA1c, fasted lipid profile, renal and liver function. Data from the closed-loop system and CGM system will be reviewed. Human factors questionnaires will be completed.
End of study assessments:
Weight, waist hip ratio and blood pressure will be measured and a blood sample will be taken for measurement of HbA1c, fasted lipid profile, renal and liver function. Urinary ACR will be measured. Human factors questionnaires will be completed and a subset of participants will participate in interviews. Study devices will be returned and participants will resume their usual insulin therapy and standard glucose monitoring.
Procedures for safety monitoring during trial:
Standard operating procedures for monitoring and reporting of all adverse events and adverse device events will be in place, including serious adverse events (SAE), serious adverse device effects (SADE) and specific adverse events (AE) such as severe hypoglycaemia.
A data safety and monitoring board (DSMB) will be informed of all serious adverse events and any unanticipated serious adverse device effects that occur during the study and will review compiled adverse event data at periodic intervals.
Criteria for withdrawal of subjects on safety grounds:
A participant may terminate participation in the study at any time without necessarily giving a reason and without any personal disadvantage. An investigator can stop the participation of a subject after consideration of the benefit/risk ratio. Possible reasons are:
- Participant is unable to demonstrate safe use of study devices as judged by the investigator
- Serious adverse events
- Significant protocol violation or non-compliance
- Decision by the investigator, or the Sponsor, that termination is in the participant's best medical interest
- Pregnancy, planned pregnancy, or breast feeding
- Allergic reaction to insulin or severe allergic reaction to adhesive surface of infusion set or glucose sensor
- Technical grounds (e.g. participant relocates)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A multicentre, multinational, open-label, randomised single period, parallel design study contrasting fully closed-loop insulin delivery and standard insulin therapy with CGM over 26 weeks in adults with type 2 diabetes.
| Arm | Type | Receives |
|---|---|---|
| Fully closed-loop insulin delivery (CamAPS HX) | Experimental | Device: CamAPS HXThe 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 comparator | Other: Standard insulin therapy with glucose sensorUsual insulin therapy and FreeStyle Libre 3 glucose sensor (Abbott Diabetes Care, CA, USA) for 26 weeks at home. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CamAPS HXThe 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 | Device | Fully closed-loop insulin delivery (CamAPS HX) |
| Standard insulin therapy with glucose sensorParticipants usual insulin therapy with Freestyle Libre 3 glucose sensor | Other | Standard insulin therapy with glucose sensor |
Primary outcome
Glycated haemoglobin (HbA1c) at 26 weeks
Time frame: at 26 weeks
Centralised measurement of HbA1c
37 secondary outcomes
Proportion of time spent in target glucose range (3.9 to 10.0mmol/L)
Time frame: over 26 weeks
Mean glucose (mmol/L)
Time frame: over 26 weeks
Proportion of time spent above target glucose (>10.0mmol/l)
Time frame: over 26 weeks
Proportion of time spent below target glucose (<3.9mmol/L)
Time frame: over 26 weeks
Standard deviation of sensor glucose
Time frame: over 26 weeks
Coefficient of variation of sensor glucose
Time frame: over 26 weeks
Proportion of time spent below target glucose (<3.5mmol/L)
Time frame: over 26 weeks
Proportion of time spent below target glucose (<3.0mmol/L)
Time frame: over 26 weeks
Proportion of time spent above target glucose (>13.9mmol/l)
Time frame: over 26 weeks
Proportion of time spent above target glucose (>16.7mmol/l)
Time frame: over 26 weeks
Proportion of time spent above target glucose (>20.0mmol/l)
Time frame: over 26 weeks
Proportion of participants with HbA1c <7.0% [53mmol/mol] (%)
Time frame: at 26 weeks
Proportion of participants with HbA1c <7.5% [58mmol/mol] (%)
Time frame: at 26 weeks
Total daily insulin dose
Time frame: over 26 weeks
Body weight
Time frame: at 26 weeks
Waist hip ratio
Time frame: 26 weeks
Body Mass Index (BMI)
Time frame: 26 weeks
Blood Pressure (mmHg)
Time frame: 26 weeks
Fasted lipid profile
Time frame: 26 weeks
Renal function
Time frame: 26 weeks
Renal function
Time frame: 26 weeks
Renal function
Time frame: 26 weeks
Liver function
Time frame: 26 weeks
Liver function
Time frame: 26 weeks
Liver function
Time frame: 26 weeks
Liver function
Time frame: 26 weeks
Liver function
Time frame: 26 weeks
Liver function
Time frame: 26 weeks
Liver function
Time frame: 26 weeks
Number of severe hypoglycaemia events
Time frame: 26 weeks
Number of participants with any severe hypoglycaemia event
Time frame: 26 weeks
Number of diabetic ketoacidosis events
Time frame: 26 weeks
Number of participants with any diabetic ketoacidosis event
Time frame: 26 weeks
Number of adverse events per participant
Time frame: 26 weeks
Number of serious adverse events per participant
Time frame: 26 weeks
Proportion of CGM use (%)
Time frame: 26 weeks
Proportion of closed-loop use (%)
Time frame: 26 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2026.
- Derived from this study: PubMed 42156154Seese R, Boughton CK, Tseung FT, Uy R, Wilinska ME, Thabit H, Cheah YS, Neupane S, Hussain S, Choudhary P, Wilmot EG, Bally L, Hanaire H, Mader JK, Haluzik M, O'Neal D, Lawton J, Rankin D, Kollman C, Dunseath G, Hovorka R. Assessing the efficacy, safety and utility of fully closed-loop insulin delivery compared to standard insulin therapy with a continuous glucose monitor in adults with type 2 diabetes (COYOTE study): a randomised parallel study protocol. BMJ Open. 2026 May 19;16(5):e115464. doi: 10.1136/bmjopen-2025-115464.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Angel Tseung contact
Roman Hovorka principal investigator
University of Cambridge
12 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CamAPS HX and Standard insulin therapy with glucose sensor in people with Type 2 Diabetes Treated With Insulin, run by University of Cambridge at 12 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United Kingdom, Australia, Austria, Czechia, France and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Charlotte K Boughton, PhD (+44 (0)1223 769066, cb2000@medschl.cam.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycated haemoglobin (HbA1c) at 26 weeks (time frame: at 26 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06579404, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2026.