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Closed-loop in Adults With Type 2 Diabetes

RecruitingNAAges 18 Years - anyAllUniversity of Cambridge
NCT06579404 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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 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
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What it tests

  • CamAPS HX
  • Standard insulin therapy with glucose sensor
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Where

12 sites
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

…and 4 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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