Effects of the Omnipod 5 Hybrid Closed-Loop System in People With Type 1 Diabetes With Impaired Awareness of Hypoglycemia.

OBJECTIVE

To determine the real-world impact of initiating Omnipod 5 hybrid closed-loop (OP5-HCL) system on hypoglycemia frequency, duration, and awareness in people with type 1 diabetes and impaired awareness of hypoglycemia (IAH).

RESEARCH DESIGN AND

METHODS

A single-center study of people with type 1 diabetes and IAH (Gold score ≥4) with outcomes compared at baseline and 12 months after OP5-HCL initiation. The 28-day CGM data were analyzed to provide weekly sensor-detected hypoglycemia (SDH) data and glycemic metrics at baseline and 12 months. Outcomes of those with IAH were compared with age- and sex-matched control participants with normal awareness of hypoglycemia (NAH) (Gold score ≤2).

RESULTS

The study included 68 individuals (73.5% female; mean ± SD age 38.0 ± 15.6 years; and diabetes duration 21.0 ± 13.5 years). At baseline, people with IAH (n = 32) experienced both significantly higher time below range (TBR) (<3.9 mmol/L) and more episodes of SDH compared with those with NAH (n = 32). The IAH group also experienced a significantly longer median duration of hypoglycemia episodes below 3.9 mmol/L (SDH3.9) (33.5 vs. 24.5 min; P = 0.007). Initiation of OP5-HCL resulted in a decrease in TBR (from 2.8% to 1.7%; P = 0.024) and number of SDH3.9 episodes (from 5.4 to 4.0; P = 0.026). After 12 months of OP5-HCL use, the hypoglycemia burden experienced by those with IAH remained higher, including TBR (1.7% vs. 0.7%; P = 0.007) and number of SDH3.9 episodes (4.0 vs. 2.0; P = 0.013), but the difference in episode duration was no longer significant (29.8 vs. 28.0 min; P = 0.084).

CONCLUSIONS

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.