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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06579404




Registration number
NCT06579404
Ethics application status
Date submitted
16/08/2024
Date registered
30/08/2024
Date last updated
23/07/2025

Titles & IDs
Public title
Closed-loop in Adults With Type 2 Diabetes
Scientific 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
Secondary ID [1] 0 0
COYOTE
Universal Trial Number (UTN)
Trial acronym
COYOTE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes Treated With Insulin 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - CamAPS HX
Other interventions - Standard insulin therapy with glucose sensor

Experimental: Fully closed-loop insulin delivery (CamAPS HX) - 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

Active comparator: Standard insulin therapy with glucose sensor - Usual insulin therapy and FreeStyle Libre 3 glucose sensor (Abbott Diabetes Care, CA, USA) for 26 weeks at home.


Treatment: Devices: CamAPS HX
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

Other interventions: Standard insulin therapy with glucose sensor
Participants usual insulin therapy with Freestyle Libre 3 glucose sensor
Intervention code [1] 0 0
Treatment: Devices
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Glycated haemoglobin (HbA1c) at 26 weeks
Timepoint [1] 0 0
at 26 weeks
Secondary outcome [1] 0 0
Proportion of time spent in target glucose range (3.9 to 10.0mmol/L)
Timepoint [1] 0 0
over 26 weeks
Secondary outcome [2] 0 0
Mean glucose (mmol/L)
Timepoint [2] 0 0
over 26 weeks
Secondary outcome [3] 0 0
Proportion of time spent above target glucose (>10.0mmol/l)
Timepoint [3] 0 0
over 26 weeks
Secondary outcome [4] 0 0
Proportion of time spent below target glucose (<3.9mmol/L)
Timepoint [4] 0 0
over 26 weeks
Secondary outcome [5] 0 0
Standard deviation of sensor glucose
Timepoint [5] 0 0
over 26 weeks
Secondary outcome [6] 0 0
Coefficient of variation of sensor glucose
Timepoint [6] 0 0
over 26 weeks
Secondary outcome [7] 0 0
Proportion of time spent below target glucose (<3.5mmol/L)
Timepoint [7] 0 0
over 26 weeks
Secondary outcome [8] 0 0
Proportion of time spent below target glucose (<3.0mmol/L)
Timepoint [8] 0 0
over 26 weeks
Secondary outcome [9] 0 0
Proportion of time spent above target glucose (>13.9mmol/l)
Timepoint [9] 0 0
over 26 weeks
Secondary outcome [10] 0 0
Proportion of time spent above target glucose (>16.7mmol/l)
Timepoint [10] 0 0
over 26 weeks
Secondary outcome [11] 0 0
Proportion of time spent above target glucose (>20.0mmol/l)
Timepoint [11] 0 0
over 26 weeks
Secondary outcome [12] 0 0
Proportion of participants with HbA1c <7.0% [53mmol/mol] (%)
Timepoint [12] 0 0
at 26 weeks
Secondary outcome [13] 0 0
Proportion of participants with HbA1c <7.5% [58mmol/mol] (%)
Timepoint [13] 0 0
at 26 weeks
Secondary outcome [14] 0 0
Total daily insulin dose
Timepoint [14] 0 0
over 26 weeks
Secondary outcome [15] 0 0
Body weight
Timepoint [15] 0 0
at 26 weeks
Secondary outcome [16] 0 0
Waist hip ratio
Timepoint [16] 0 0
26 weeks
Secondary outcome [17] 0 0
Body Mass Index (BMI)
Timepoint [17] 0 0
26 weeks
Secondary outcome [18] 0 0
Fasted lipid profile
Timepoint [18] 0 0
26 weeks
Secondary outcome [19] 0 0
Renal function
Timepoint [19] 0 0
26 weeks
Secondary outcome [20] 0 0
Renal function
Timepoint [20] 0 0
26 weeks
Secondary outcome [21] 0 0
Renal function
Timepoint [21] 0 0
26 weeks
Secondary outcome [22] 0 0
Liver function
Timepoint [22] 0 0
26 weeks
Secondary outcome [23] 0 0
Liver function
Timepoint [23] 0 0
26 weeks
Secondary outcome [24] 0 0
Liver function
Timepoint [24] 0 0
26 weeks
Secondary outcome [25] 0 0
Liver function
Timepoint [25] 0 0
26 weeks
Secondary outcome [26] 0 0
Liver function
Timepoint [26] 0 0
26 weeks
Secondary outcome [27] 0 0
Liver function
Timepoint [27] 0 0
26 weeks
Secondary outcome [28] 0 0
Liver function
Timepoint [28] 0 0
26 weeks

Eligibility
Key inclusion criteria
* 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
6/12/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/07/2027
Actual
Sample size
Target
224
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
University of Melbourne - Melbourne
Recruitment postcode(s) [1] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Graz
Country [2] 0 0
Czechia
State/province [2] 0 0
Prague
Country [3] 0 0
France
State/province [3] 0 0
Toulouse
Country [4] 0 0
Switzerland
State/province [4] 0 0
Bern
Country [5] 0 0
United Kingdom
State/province [5] 0 0
Cambridge
Country [6] 0 0
United Kingdom
State/province [6] 0 0
Derby
Country [7] 0 0
United Kingdom
State/province [7] 0 0
Leicester
Country [8] 0 0
United Kingdom
State/province [8] 0 0
London
Country [9] 0 0
United Kingdom
State/province [9] 0 0
Manchester
Country [10] 0 0
United Kingdom
State/province [10] 0 0
Norwich

Funding & Sponsors
Primary sponsor type
Other
Name
University of Cambridge
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
University of Edinburgh
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Jaeb Center for Health Research
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Swansea University
Address [3] 0 0
Country [3] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Roman Hovorka
Address 0 0
University of Cambridge
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Charlotte K Boughton, PhD
Address 0 0
Country 0 0
Phone 0 0
+44 (0)1223 769066
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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 [email protected] 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.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP)
When will data be available (start and end dates)?
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 [email protected] and may be submitted up to 36 months following article publication.
Available to whom?
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 [email protected] and may be submitted up to 36 months following article publication.
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT06579404