Study design
insulin pump-treated type 1, Diabetes, diabetes
DIABETES
This was an investigator-initiated, single-centre, randomised, open-label, two-period, crossover, investigational drug and device Phase II trial enrolling 24 participants with insulin pump-treated type 1 diabetes. Participants attended a screening visit and three additional study visits scheduled in between and after completing the two 2 week interventional periods (separated by a washout period of 3–7 days).The study was conducted at the Clinical Research Unit at the Steno Diabetes Center Copenhagen, Herlev, Denmark. It was approved by the Danish Medicines Agency (EudraCT: 2020-005745-16), the Regional Committee on Health Research Ethics (H-21000002) and the Danish Data Protection Agency (P-2021-185) and was monitored by the Good Clinical Practice unit at Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark. The study was registered at 