Closed-loop insulin delivery for adults with type 2 diabetes
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
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 224 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Cambridge Academic / other |
| Locations | 12 sites (Melbourne and 11 other locations) |
| Trial ID | NCT06579404 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: Previous studies on closed-loop systems in diabetes management have shown promising results, indicating potential for success in this approach.
Eligibility criteria
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 this trial is running
Melbourne and 11 other locations
- University of Melbourne — Melbourne, Australia (Not_yet_recruiting)
- 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)
- Addenbrooke's Hospital, Cambridge University Hospitals NHS Foundation Trust — Cambridge, United Kingdom (Recruiting)
- Royal Derby Hospital — Derby, United Kingdom (Not_yet_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)
- Manchester Royal Infirmary, Central Manchester University Hospitals NHS Foundation Trust — Manchester, United Kingdom (Not_yet_recruiting)
- Norfolk and Norwich University Hospital — Norwich, United Kingdom (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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.