Effects of the Omnipod 5 Hybrid Closed-Loop System in People With Type 1 Diabetes With Impaired Awareness of Hypoglycemia
Authors' conclusion
Use of OP5-HCL by people with IAH reduced TBR and the number of episodes of SDH. However, the overall hypoglycemia burden remained significantly higher in those with IAH.
Study context
- Population
- People with T1D initiating Omnipod 5 HCL; 73.5% female; mean age 38.0 ± 15.6 years; diabetes duration 21.0 ± 13.5 years
- Participants
- 68 people
- Exposure
- Impaired awareness of hypoglycemia (IAH) vs normal awareness of hypoglycemia (NAH), baseline and 12 months after OP5-HCL initiation
- IAHn = 32
- NAHn = 32reference
- Outcome
- Hypoglycemia frequency, duration and awareness (28-day CGM: weekly sensor-detected hypoglycemia and glycemic metrics)
- Follow-up
- Baseline and 12 months
Methodological detailssingle-center, real-world, before–after (baseline vs 12 months), age- and sex-matched controls
- Single-center
- Real-world
- Before–after (baseline vs 12 months)
- Age- and sex-matched controls
Main finding
As reported in the abstract
Change in IAH after OP5-HCL initiation · baseline to 12 months
- Time below range (TBR) (<3.9 mmol/L) decreased in IAH from 2.8% to 1.7%; P = 0.024
- Number of SDH3.9 episodes decreased in IAH from 5.4 to 4.0; P = 0.026
Observational data: associations, not effects.
Further findings
TBR at 12 months
P = 0.007
Duration of SDH3.9 episodes at 12 months · no longer significant
P = 0.084
Median duration of SDH3.9 episodes at baseline
P = 0.007
| Outcome | IAH | NAH | P value |
|---|---|---|---|
| Number of SDH3.9 episodes at 12 months | 4.0 | 2.0 | P = 0.013 |
TBR and sensor-detected hypoglycemia (SDH) episodes at baseline
- IAH had significantly higher TBR (<3.9 mmol/L) and more SDH episodes than NAH
Original publication
Effects of the Omnipod 5 Hybrid Closed-Loop System in People With Type 1 Diabetes With Impaired Awareness of Hypoglycemia. Diabetes Care. Published 10 July 2026. doi:10.
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