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Led by University of Cambridge · Updated on 2026-03-13
224
Participants Needed
12
Research Sites
17 weeks
Total Duration
Researchers are evaluating the effectiveness, safety, and usefulness of a fully closed-loop insulin delivery system in adults with type 2 diabetes who use insulin. This study builds on previous research involving closed-loop systems for diabetes management in both hospital and home settings. The trial is open-label, multi-national, and randomized, comparing fully closed-loop insulin delivery to standard insulin therapy with continuous glucose monitoring CGM over 26 weeks. Participants will be randomly assigned to one of two groups one using the fully closed-loop system, which includes an insulin pump, glucose sensor, and a smartphone app with a control algorithm the other continuing their usual insulin therapy with a glucose sensor. Both groups will use their assigned treatments at home for 26 weeks following a 2-3 week run-in period with their usual therapy and masked CGM. Training and support will be provided for using study devices, and assessments will take place at 3 months and at the end of the study. During the study, participants will have regular evaluations including blood tests for HbA1c, lipid profiles, kidney and liver function, and measurements of weight, waist-hip ratio, and blood pressure. Glucose control will be monitored continuously by CGM, and human factors such as device use and participant experiences will be assessed through questionnaires and interviews. Safety monitoring will track adverse events, including episodes of severe low blood sugar. The total study duration for each participant is up to 30 weeks.
CONDITIONS
Closed-loop in Adults With Type 2 Diabetes
C
Charlotte K Boughton, PhD
A
Angel Tseung
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University of Cambridge
Lead Sponsor
University of Edinburgh
Collaborating Sponsor
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 2 to 3 weeks
Participants undergo baseline evaluation including medical history, physical measurements, blood and urine tests, questionnaires, and wear a masked glucose sensor while using their usual insulin therapy during the run-in period to assess baseline glucose control.
1 visit for baseline assessment and monitoring during run-in period
Duration - 26 weeks
Participants are randomised to either use the fully closed-loop insulin delivery system or continue their standard insulin therapy with a glucose sensor. Participants receive training on their assigned intervention and use it at home for 26 weeks.
1 training visit and regular use at home with scheduled study visits
Duration - 1 day
Participants return for measurements of weight, waist hip ratio, blood pressure, blood tests, review of device data, and questionnaires.
1 in-person visit at 3 months
Duration - 1 day
Final measurements including physical assessments, blood and urine tests, questionnaires, interviews for some participants, return of study devices, and resumption of usual insulin therapy and glucose monitoring.
1 in-person visit at study end
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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R Seese, C K Boughton, F T Tseung...
https://pubmed.ncbi.nlm.nih.gov/42156154/University of Cambridge
Lead Sponsor
University of Edinburgh
Collaborating Sponsor
