Proven clinical trial results and real-world data with the Omnipod® 5
Omnipod 5 clinical study summaries
Pivotal multicentre trial in paediatric and adult participants
Brown SA, et al. (2021)
Omnipod 5 significantly reduced HbA1c (–0.38% in adults/adolescents, 0.71% in children), increased TIR by up to 3.7 hours per day compared to standard therapy, and lowered hypoglycaemia without increased DKA risk.
Safety and glycaemic outcomes in very young children with type 1 diabetes
Sherr JL, et al. (2022)
Omnipod 5 improved TIR by 2.6 hours per day, lowered HbA1c by 0.55%, and reduced hypoglycaemia in children aged 2–5.9 years compared to standard therapy, with no severe hypoglycaemia or DKA reported.
Psychosocial outcomes in adults
Polonsky WH et al. (2022)
Adults reported significantly lower diabetes distress (–9.8%), greater hypoglycaemia confidence, and a 12-point increase in treatment satisfaction after 3 months of use, compared to standard therapy.
Psychosocial outcomes in children, adolescents and caregivers
Hood KK et al. (2023)
Children, adolescents, and caregivers reported significant reductions in diabetes distress and improved sleep and well-being after three months on Omnipod 5, compared to standard therapy.
Clinical implementation: key considerations for training and onboarding
Berget C et al. (2022)
Provides practical guidance for initiating, training, and optimising patients on Omnipod 5, highlighting real-world clinician insights and system features that support successful onboarding.
Recent real-world and comparative trials highlight sustained performance of Omnipod 5
Real-world evidence of Omnipod 5 automated insulin delivery system use in 69,902 people with type 1 diabetes
Forlenza G et al. (2024)
This real-world study evaluated use of the system, showing sustained improvements in TIR and low rates of severe hypoglycaemia in diverse populations.
Efficacy and safety of a tubeless AID system compared with pump therapy with CGM in the treatment of type 1 diabetes in adults with suboptimal glycemia: a randomized, parallel-group clinical trial
Renard E, et al. (2024)
This randomised controlled trial demonstrated that Omnipod 5 improves glycaemic control and user satisfaction in patients transitioning from non-AID pumps.
Practical summaries showing Omnipod 5 clinical performance and settings for optimised outcomes
Strong real-world and clinical trial evidence
Real-world and clinical data demonstrate the Omnipod 5 AID System consistently improves glycaemic control across diverse patient populations.
Optimise outcomes through smarter settings
Retrospective real-world evidence shows that users applying optimised Omnipod 5 settings achieved >80 % TIR. These settings can help clinicians fine-tune therapy and support consistent performance across patient profiles.
AID = automated insulin delivery; CGM = continuous glucose monitoring; DKA = diabetic ketoacidosis; HbA1c = haemoglobin A1c; HCP = healthcare professional; MDI = multiple daily injections; RCT = randomised controlled trial; T1D = type 1 diabetes; TIR = time in range.