Evidence map›Paper›PMID 42156154›Full record

Trial reportBMJ open2026

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.

R Seese, C K Boughton, F T Tseung, R Uy, M E Wilinska, H Thabit, Y S Cheah, S Neupane, S Hussain, P Choudhary and 11 more

Registry-linked trialAbstract readRandomized Controlled TrialMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMJ open, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06579404 (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), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT06579404 narecruitingnot on this map

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

TypeinterventionalSponsorUniversity of CambridgeRan2024 to 2027Enrolled224ConditionsType 2 Diabetes Treated With InsulinArmsCamAPS HX, Standard insulin therapy with glucose sensor
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

21 authors.

R SeeseInstitute of Metabolic Science-Metabolic Research Laboratories, University of Cambridge, Cambridge, England, UK.ORCID http://orcid.org/0009-0005-0640-0632
C K BoughtonInstitute of Metabolic Science-Metabolic Research Laboratories, University of Cambridge, Cambridge, England, UK cb2000@medschl.cam.ac.uk.
F T TseungInstitute of Metabolic Science-Metabolic Research Laboratories, University of Cambridge, Cambridge, England, UK.
R UyInstitute of Metabolic Science-Metabolic Research Laboratories, University of Cambridge, Cambridge, England, UK.
M E WilinskaInstitute of Metabolic Science-Metabolic Research Laboratories, University of Cambridge, Cambridge, England, UK.
H ThabitManchester Royal Infirmary, Central Manchester University Hospitals NHS Foundation Trust, Manchester, UK.
Y S CheahKing's College Hospital, King's College Hospital NHS Foundation Trust, London, UK.ORCID http://orcid.org/0009-0009-1948-1960
S NeupaneNorwich Medicine School, University of East Anglia, Norwich, UK.
S HussainDepartment of Diabetes, School of Cardiovascular, Metabolic Medicine and Sciences, King's College London, London, UK.
P ChoudharyLeicester Diabetes Centre, University Hospitals of Leicester NHS Trust, Leicester, UK.
E G WilmotSchool of Medicine, University of Nottingham, Nottingham, UK.
L BallyInselspital University Hospital Bern, Bern, Switzerland.ORCID http://orcid.org/0000-0003-1993-7672
H HanaireUniversity of Toulouse, Toulouse, France.
J K MaderMedical University of Graz, Graz, Austria.ORCID http://orcid.org/0000-0001-7854-4233
M HaluzíkInstitute for Clinical and Experimental Medicine, Prague, Czech Republic.
D O'NealDepartment of Medicine St. Vincent's Hospital Melbourne, The University of Melbourne, Melbourne, Victoria, Australia.ORCID http://orcid.org/0000-0002-0870-4032
J LawtonSchool of Population Health Sciences, The University of Edinburgh Usher Institute, Edinburgh, UK.
D RankinSchool of Population Health Sciences, The University of Edinburgh Usher Institute, Edinburgh, UK.
C KollmanThe Jaeb Center for Health Research, Tampa, Florida, USA.
G DunseathDiabetes Research Group, Swansea University, Swansea, UK.ORCID http://orcid.org/0000-0001-6022-862X
R HovorkaInstitute of Metabolic Science-Metabolic Research Laboratories, University of Cambridge, Cambridge, England, UK.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionType 2 diabetes (T2D) presents a global healthcare burden. Despite widespread use of non-insulin glucose lowering therapies, many individuals still require insulin to achieve recommended target glycated haemoglobin (HbA1c). Insulin injections improve HbA1c but can lead to problematic hypoglycaemia. The objective of this study is to determine whether fully closed-loop insulin delivery improves HbA1c at 26 weeks compared with standard insulin therapy with continuous glucose monitoring (CGM) in adults with T2D. METHODS AND ANALYSIS: This study adopts an open-label, multinational, randomised, single-period parallel design and aims to randomise 224 adults with T2D to either standard insulin therapy with CGM (control group) or fully closed-loop insulin delivery (intervention group) for a period of 26 weeks. Participants will complete a run-in period of 2-3 weeks wearing a masked CGM followed by randomisation to either the control or intervention group. The primary endpoint is the between-group difference in HbA1c at 26 weeks. Key endpoints include time in target glucose range (3.9-10.0 mmol/L), mean sensor glucose, time above range (>10.0 mmol/L) and non-inferiority for time below target (<3.9 mmol/L) over the 26-week study period. Secondary outcomes include standard CGM metrics, binary metrics for HbA1c, total daily insulin dose, body mass index, blood pressure, fasted lipid profile, renal function and liver function. Safety will be assessed by the frequency of severe hypoglycaemic episodes and other adverse events. Utility will be assessed by CGM and closed-loop system use. The impact of fully closed-loop will be assessed using validated questionnaires and interviews. ETHICS AND DISSEMINATION: The study has received ethical approval from the East of England Cambridgeshire and Hertfordshire Research Ethics Committee (24/EE/0149) in the UK. Ethical approval for non-UK site has been obtained by local Research Ethics Committees.Results will be disseminated by peer-reviewed publications and conference presentations, and findings will be shared with people living with diabetes, healthcare providers and relevant stakeholders. TRIAL REGISTRATION NUMBER: NCT06579404.

Indexed as

Diabetes Mellitus, Type 2Hypoglycemic AgentsInsulinInsulin Infusion SystemsAdultBlood GlucoseContinuous Glucose MonitoringFemaleGlycated HemoglobinHumansHypoglycemiaMaleMiddle AgedResearch DesignBlood GlucoseGlycated Hemoglobinhemoglobin A1c protein, humanHypoglycemic AgentsInsulinClinical ProtocolsDIABETES & ENDOCRINOLOGYDiabetes Mellitus, Type 2

Identifiers

PMID42156154
PMCPMC13202074

What Socratic holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.