Two Years with a Tubeless Automated Insulin Delivery System: A Single-Arm Multicenter Trial in Children, Adolescents, and Adults with Type 1 Diabetes
Authors' conclusion
Our study supports that long-term use of the Omnipod 5 AID System can safely maintain improvements in glycemic outcomes for up to 2 years of use in people with T1D.
Study context
- Population
- Children, adolescents and adults with T1D using the Omnipod 5 Automated Insulin Delivery (AID) System
- Participants
- 224 children
- Comparison
- Children vs Adolescents/adults
- Outcome
- HbA1c
- Follow-up
- After 15 months
Methodological details3-month pivotal trial followed by extension phase
- 3-month pivotal trial followed by extension phase
Main finding
As reported in the abstract
- HbA1c maintained vs baseline
- P < 0.0001 from baseline
Further findings
| Outcome | Children | Adolescents/adults |
|---|---|---|
| HbA1c at baseline | 7.7% ± 0.9% | 7.2% ± 0.9% |
| HbA1c at end of pivotal trial · 3 months | 7.0% ± 0.6% | 6.8% ± 0.7% |
| TIR 70-180 mg/dL at baseline | 52.4% ± 15.6% | 63.6% ± 16.5% |
| TIR 70-180 mg/dL during pivotal trial | 67.9% ± 8.0% | 73.8% ± 10.8% |
| TIR 70-180 mg/dL during extension | 65.9% ± 8.9% | 72.9% ± 11.3% |
| Time in Automated ModeMedian | 96.1% | 96.3% |
- HbA1c at end of pivotal trial — Reduction from baseline
- P < 0.0001
- TIR 70-180 mg/dL during pivotal trial — Increase from baseline
- P < 0.0001
- TIR 70-180 mg/dL during extension — Maintained vs baseline
- P < 0.0001 from baseline
Duration of AID use
- Median (IQR) months of AID completed
- 22.3 (21.7, 22.7)
Safety
Adverse events during extension
- DKA episodes
- 1
- Severe hypoglycemia episodes
- 7
Original publication
Two Years with a Tubeless Automated Insulin Delivery System: A Single-Arm Multicenter Trial in Children, Adolescents, and Adults with Type 1 Diabetes. Diabetes Technol Ther. Published 30 November 2023. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →