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

Status: Recruiting
Location: See all (11) locations...
Intervention Type: Other, Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Australia
University of Melbourne
NOT_YET_RECRUITING
Melbourne
Austria
Medical University of Graz
NOT_YET_RECRUITING
Graz
France
CHU de Toulouse
NOT_YET_RECRUITING
Toulouse
Switzerland
Bern University Hospital
NOT_YET_RECRUITING
Bern
United Kingdom
Addenbrooke's Hospital, Cambridge University Hospitals NHS Foundation Trust
RECRUITING
Cambridge
Royal Derby Hospital
NOT_YET_RECRUITING
Derby
Leicester Diabetes Centre
RECRUITING
Leicester
Guy's and St Thomas' NHS Foundation Trust
RECRUITING
London
King's College Hospital, King's College NHS Foundation Trust
RECRUITING
London
Manchester Royal Infirmary, Central Manchester University Hospitals NHS Foundation Trust
NOT_YET_RECRUITING
Manchester
Norfolk and Norwich University Hospital
RECRUITING
Norwich
Contact Information
Primary
Charlotte K Boughton, PhD
cb2000@medschl.cam.ac.uk
+44 (0)1223 769066
Backup
Angel Tseung
ftt20@cam.ac.uk
Time Frame
Start Date: 2024-12-06
Estimated Completion Date: 2027-07
Participants
Target number of participants: 224
Treatments
Experimental: Fully closed-loop insulin delivery (CamAPS HX)
The automated closed loop system (CamAPS FX) will consist of:~* YpsoPump insulin pump (Ypsomed, Burgdorf, Switzerland)~* FreeStyle Libre 3 glucose sensor (Abbott Diabetes Care, CA, USA)~* Smartphone hosting CamAPS HX app with the Cambridge model predictive control algorithm~* Cloud upload system to review CGM/insulin data.~Participants will use the fully closed-loop system for 26 weeks at home
Active_comparator: Standard insulin therapy with glucose sensor
Usual insulin therapy and FreeStyle Libre 3 glucose sensor (Abbott Diabetes Care, CA, USA) for 26 weeks at home.
Related Therapeutic Areas
Sponsors
Collaborators: Jaeb Center for Health Research, Swansea University, University of Edinburgh
Leads: University of Cambridge

This content was sourced from clinicaltrials.gov

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