COYOTE (CPMS 62516, IRAS 327889)

UPDATED - 15/10/2024

The main objective of this study is to determine the efficacy, safety and utility of fully closed-loop glucose control compared to standard insulin therapy with a glucose sensor in adults with type 2 diabetes (T2D).

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 a glucose sensor. Participants will receive appropriate training in the safe use of the devices. A total of up to 224 adults with type 2 diabetes using insulin will be recruited from outpatient diabetes clinics, primary care centres, social media advertising or other established methods at participating centres.

The primary outcome is the between group difference in glycated haemoglobin (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 the glucose sensor over the 26-week period, insulin requirements, body weight, renal and liver function will also be compared.

Safety evaluation will include reports of severe hypoglycaemia events and other adverse events and serious adverse events and adverse device effects.

Psychosocial outcomes include sensor and closed-loop usage, health-related quality of life questionnaires, and semi-structured interviews. Data will be collected for future health economic analysis.

 INCLUSION CRITERIA:

1. Aged 18 years and older.

2. Type 2 diabetes diagnosed for at least 12 months. 

3. Established on an SGLT2 inhibitor and/or GLP-1 receptor agonist for at least 3 months, or have been offered these therapies previously.

4. Treatment with insulin therapy for at least 6 months.

5. HbA1c < = 15% (140 mmol/mol) analysis from local laboratory or equivalent.

6. Willing to wear study devices and follow study instructions. 

7.Capacity to consent to participate in the study.

EXCLUSION CRITERIA:

1. Type 1 diabetes

2. Current use of insulin pump

3. Current use of any closed-loop system 

4. 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 

5. Known or suspected allergy against insulin 

6. Medically documented allergy towards the adhesive 

7. Pregnancy, planned pregnancy, or breast feeding 

8. Severe visual impairment

9. Severe hearing impairment 

10. Medically documented allergy towards the adhesive (glue) of plasters

11. Serious skin diseases located at places of the body, which potentially are possible to be used for localisation of the glucose sensor 

12. Illicit drugs abuse 

13. Prescription drugs abuse 

14. Alcohol abuse

Study Resources

Access for the SystmOne and EMIS study resources can be requested below.

For further guidance on using the resources, please refer to the guidance documents and further useful information on the PRIDES page.

The searches have been created with the study specific inclusion and exclusion criteria. 

If you require any further information or help, please contact the IT Specialists:

Jodie Button – jodie.button@nihr.ac.uk

James Baslington – james.baslington@nhs.net

Disclaimer:

Please note the resources provided are designed to assist with the identification of potentially suitable patients and to appropriately code these patients if required.

These resources have been developed based on the criteria provided by the relevant study team and whilst every effort has been made to make them universally implementable they rely on read codes and the data stored in the individual practice's clinical system. These resources are intended to assist with identification but should be used in conjunction with clinical oversight and a clear understanding of the study parameters.

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