Study design and participants
diabetes
TYPE 2 DIABETES, DIABETES
The study used an open-label, single-center, randomized, two-period crossover design, contrasting fully closed-loop glucose control using faster-acting insulin aspart (Fiasp, Novo Nordisk) (closed-loop) and standard multiple daily insulin injection therapy (control) during two 8-week periods of unrestricted living. The intervention periods were separated by a 2-week to 4-week washout period during which participants used their pre-study treatment. Assignment of participants to the two groups (with a different order of interventions) was random.Ethical and regulatory approvals were obtained from the London-Stanmore Ethics Committee and the Medicines and Healthcare Products Regulatory Agency. The study protocol is provided in the Supplementary Information. The safety aspects of the trial were overseen by an independent data and safety monitoring board. The study is registered with ClinicalTrials.gov (NCT04701424).Recruitment for the study took place through diabetes outpatient clinics at Addenbrooke’s Hospital (Cambridge, UK) and a primary care participant identification center (Granta Medical Practices, Cambridge, UK). Planned population size was 30, to ensure 24 participants completed the study, allowing for a 20% dropout rate.Inclusion criteria were age 18 years and older with type 2 diabetes requiring subcutaneous insulin therapy and screening HbA1c ≤ 12% (108 mmol molWritten informed consent was obtained from all study participants before any study-related activities. Participants received £30 for each 8-week study period completed, and all reasonable traveling expenses were reimbursed.