Low-Dose Empagliflozin as Adjunct to Hybrid Closed-Loop Insulin Therapy in Adults With Suboptimally Controlled Type 1 Diabetes: A Randomized Crossover Controlled Trial
Authors' conclusion
Empagliflozin at 2.5 and 5 mg increased time in range during hybrid closed-loop therapy by 11-13 percentage points compared with placebo in those who otherwise were unable to attain glycemic targets. Future studies are required to assess long-term efficacy and safety.
Study context
- Population
- Adults with suboptimally controlled T1D (HbA1c 7.0–10.5%) not achieving TIR (3.9–10.0 mmol/L) ≥70% after 14 days of HCL24 completed
- Comparison
- Empagliflozin 2.5 mg or 5 mg vs placebo as adjunct to HCL
- Primary endpoint
- TIR (3.9-10.0 mmol/L)
Methodological detailsdouble-blind, crossover, placebo-controlled, blocked randomization
- Double-blind
- Crossover
- Placebo-controlled
- Blocked randomization
Primary result
As reported in the abstract
2.5 mg empagliflozin vs Placebo: P < 0.0001 · 5 mg empagliflozin vs Placebo: P < 0.0001
Further findings
Mean daily capillary ketone levels
- Not different between arms
Safety
- Serious adverse events
- 0
- DKA
- 0
- Severe hypoglycemia
- 0
Original publication
Low-Dose Empagliflozin as Adjunct to Hybrid Closed-Loop Insulin Therapy in Adults With Suboptimally Controlled Type 1 Diabetes: A Randomized Crossover Controlled Trial. Diabetes Care. Published 10 November 2022. doi:10.
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