NCT06579404Recruiting
Closed-loop in 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
Source: ClinicalTrials.gov · Last updated 13 Mar 2026
Brief summary (registry, in English)
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 and other established methods at participating centres. Participants will receive appropriate training in the safe use of the study devices. The primary outcome is the between group difference in HbA1c at 26 weeks. Other key outcomes include the time spent with glucose levels within, above and below the target glucose range (3.9-10.0mmol/L) and mean sensor glucose as recorded by CGM over the 26 weeks. Insulin requirements, body weight, renal and liver function will also be compared. Safety evaluation comprises severe hypoglycaemic episodes, and other adverse and serious adverse events. Human factors outcomes include CGM \& closed-loop usage, questionnaires and semi-structured interviews.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 224 (estimated)
- First submitted
- 16 Aug 2024
- Start date
- 6 Dec 2024
- Primary completion date
- Mar 2027
- Lead sponsor
- University of Cambridge
- Diseases
- Type 2 diabetes
- NCT number
- NCT06579404
What you commit to
- Study type: Interventional
- Planned participants: 224
- From 6 Dec 2024 to the primary completion date, Mar 2027
- 12 sites in 6 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Illicit drugs abuse
- Prescription drugs abuse
Other illness
- Type 1 diabetes
- 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
- Severe visual impairment
- Severe hearing impairment
- Medically documented allergy towards the adhesive (glue) of plasters
Lab values
- Serious skin diseases located at places of the body, which potentially are possible to be used for localisation of the glucose sensor
Other
- Current use of insulin pump
- Current use of any closed-loop system
- Pregnancy, planned pregnancy, or breast feeding
- Alcohol abuse
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (12)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Medical University of Graz Coordinator of this site? Confirm its status | Graz | Austria | Not yet recruiting |
| University of Melbourne Coordinator of this site? Confirm its status | Melbourne | Australia | Not yet recruiting |
| Bern University Hospital Coordinator of this site? Confirm its status | Bern | Switzerland | Not yet recruiting |
| Diabetes Centre, Institute of Clinical and Experimental Medicine Coordinator of this site? Confirm its status | Prague | Czechia | Not yet recruiting |
| CHU de Toulouse Coordinator of this site? Confirm its status | Toulouse | France | Not yet recruiting |
| Addenbrooke's Hospital, Cambridge University Hospitals NHS Foundation Trust Coordinator of this site? Confirm its status | Cambridge | United Kingdom | Recruiting |
| Royal Derby Hospital Coordinator of this site? Confirm its status | Derby | United Kingdom | Not yet recruiting |
| Leicester Diabetes Centre Coordinator of this site? Confirm its status | Leicester | United Kingdom | Recruiting |
| King's College Hospital, King's College NHS Foundation Trust Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
| Guy's and St Thomas' NHS Foundation Trust Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
| Manchester Royal Infirmary, Central Manchester University Hospitals NHS Foundation Trust Coordinator of this site? Confirm its status | Manchester | United Kingdom | Not yet recruiting |
| Norfolk and Norwich University Hospital Coordinator of this site? Confirm its status | Norwich | United Kingdom | Recruiting |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.