Glycemic Outcomes Persist for up to 2 Years in Very Young Children with the Omnipod ® 5 Automated Insulin Delivery System
Authors' conclusion
This evaluation of the Omnipod 5 AID System indicates that long-term use can safely maintain improvements in glycemic outcomes with up to 2 years of use in very young children with type 1 diabetes.
Study context
- Population
- Very young children with T1D, aged 2–5.9 years at enrollment
- Participants
- 80 children
- Comparison
- Omnipod 5 Automated Insulin Delivery (AID) system: long-term use vs baseline/standard therapy
- Omnipod 5 AIDn = 80
- Outcome
- HbA1c
- Follow-up
- 15 months total use
Methodological detailsmulticenter, extension phase, Total AID use 18.2 [17.4, 23.4] months (median [IQR]), incl. 3-month pivotal trial
- Multicenter
- Extension phase
- Total AID use 18.2 [17.4, 23.4] months (median [IQR]), incl. 3-month pivotal trial
Main finding
As reported in the abstract
- HbA1c during pivotal trial: from 7.4% ± 1.0% (57 ± 10.9 mmol/mol) to 6.9% ± 0.7% (52 ± 7.7 mmol/mol)
- P < 0.0001
- HbA1c maintained after 15 months total use: 7.0% ± 0.7% (53 ± 7.7 mmol/mol)
- P < 0.0001 from baseline
Further findings
TIR (70-180 mg/dL)
- TIR increased from 57.2% ± 15.3% during standard therapy to 68.1% ± 9.0% during the pivotal trial
- P < 0.0001
- TIR maintained at 67.2% ± 9.3% during the extension phase
- P < 0.0001 from standard therapy
Time in Automated Mode · extension phase
- Median time in Automated Mode during extension phase
- 97.1%
Safety
Severe hypoglycaemia and DKA · extension phase
- Severe hypoglycemia episodes
- 1
- DKA episodes
- 1
Original publication
Glycemic Outcomes Persist for up to 2 Years in Very Young Children with the Omnipod ® 5 Automated Insulin Delivery System. Diabetes Technol Ther. Published 21 February 2024. doi:10.
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