Status:
RECRUITING
Closed-loop in Adults With Type 2 Diabetes
Lead Sponsor:
University of Cambridge
Collaborating Sponsors:
University of Edinburgh
Jaeb Center for Health Research
Conditions:
Type 2 Diabetes Treated With Insulin
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 pr...
Detailed Description
Purpose of clinical trial: To determine the efficacy, safety and utility of fully closed-loop insulin delivery over 26 weeks in the home setting in adults with type 2 diabetes. Study objectives: To...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 6 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2027
Estimated Enrollment :
224 Patients enrolled
Trial Details
Trial ID
NCT06579404
Start Date
December 6 2024
End Date
July 1 2027
Last Update
July 23 2025
Active Locations (12)
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1
University of Melbourne
Melbourne, Australia
2
Medical University of Graz
Graz, Austria
3
Diabetes Centre, Institute of Clinical and Experimental Medicine
Prague, Czechia
4
CHU de Toulouse
Toulouse, France