Closed-loop insulin delivery for adults with type 2 diabetes
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
Run by University of Cambridge · NCT06579404 · Data updated 2026-11-12
This study is testing a new closed-loop insulin delivery system to see if it helps adults with type 2 diabetes manage their blood sugar better than their usual insulin therapy.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 224 (estimated) |
| Sponsor | University of Cambridge Academic / other |
| Locations | 12 sites (Melbourne and 11 other locations) |
| Status | Recruiting |
| Started | December 6, 2024 |
| Main results expected | March 2027 |
| Study ends | July 2027 |
| Registry record updated | March 13, 2026 |
| Trial ID | NCT06579404 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older with type 2 diabetes who have been on insulin therapy for at least 6 months.
✕Probably not a fit
Patients with type 1 diabetes or those currently using an insulin pump or closed-loop system may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to evaluate the efficacy, safety, and utility of a fully closed-loop insulin delivery system in adults with type 2 diabetes over a 26-week period in a home setting. Participants will be randomly assigned to either the closed-loop system or their usual insulin therapy, with continuous glucose monitoring. The study will assess improvements in glucose control, safety regarding hypoglycemia, and the overall acceptability of the system. Additionally, cognitive and emotional responses to the closed-loop system will be evaluated through questionnaires and interviews.
Why it matters
Potential benefit: If successful, this approach could significantly improve glucose control and quality of life for patients with type 2 diabetes.
How similar studies have gone: Previous studies on closed-loop systems in diabetes management have shown promising results, indicating potential for success in this approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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Addenbrooke's Hospital, Cambridge University Hospitals NHS Foundation Trust
Cambridge, United Kingdom Recruiting -
Leicester Diabetes Centre
Leicester, United Kingdom Recruiting -
Guy's and St Thomas' NHS Foundation Trust
London, United Kingdom Recruiting -
King's College Hospital, King's College NHS Foundation Trust
London, United Kingdom Recruiting -
Norfolk and Norwich University Hospital
Norwich, United Kingdom Recruiting -
University of Melbourne
Melbourne, Australia Not yet recruiting
Show 6 more locations
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Medical University of Graz
Graz, Austria Not yet recruiting -
Diabetes Centre, Institute of Clinical and Experimental Medicine
Prague, Czechia Not yet recruiting -
CHU de Toulouse
Toulouse, France Not yet recruiting -
Bern University Hospital
Bern, Switzerland Not yet recruiting -
Royal Derby Hospital
Derby, United Kingdom Not yet recruiting -
Manchester Royal Infirmary, Central Manchester University Hospitals NHS Foundation Trust
Manchester, United Kingdom Not yet recruiting
Study contacts
- Principal investigator: Roman Hovorka — University of Cambridge
- Study coordinator: Charlotte K Boughton, PhD
- Email: cb2000@medschl.cam.ac.uk
- Phone: +44 (0)1223 769066
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Intelligent telemonitoring with decision support for insulin-treated type 2 diabetes
This trial tests whether adding decision-support algorithms to home telemonitoring helps adults with type 2 diabetes who use insulin manage their blood sugar better.
-
Nutrition guidance for managing type 2 diabetes
This study is testing if online nutrition classes and a low-fat vegan diet can help people with type 2 diabetes who have Blue Cross Blue Shield insurance improve their health over 16 weeks.
-
Using continuous glucose monitors during pregnancy for women with type 2 diabetes
This study is testing if using continuous glucose monitors during pregnancy can help women with type 2 diabetes manage their blood sugar better and have healthier babies compared to the usual fingerstick method.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.