Background: For some with type 1 diabetes (T1D) , hybrid closed-loop insulin therapy is insufficient to achieve glycemic targets. Low doses of SGLT2i may improve glycemia in those not able to achieve their targets.
Methods: A double-blinded, cross-over, randomized controlled trial was performed in sub-optimally controlled (HbA1c 7.0-10.5%) adults with T1D who were not able to achieve a time-in-range (3.9-10.0 mmol/L) of > 70% after 14 days on closed-loop therapy. Three 14-day interventions were performed with placebo, empagliflozin 2.5 mg, or empagliflozin 5 mg, as adjunct to closed-loop therapy, with daily ketone testing.
Results: 24 participants completed the study (50% male, age 33 ± 14 yrs, HbA1c 8.1 ± 0.5%) . The time in range was 59 ± 9% for placebo, 72 ± 10% for empagliflozin 2.5 mg, and 70 ± 8 for empagliflozin 5 mg (p < 0.between placebo and empagliflozin 2.5 mg, and placebo and empagliflozin 5 mg) . Empagliflozin 2.5 mg did not increase time spent below 3.9 mmol/L though empagliflozin 5 mg did (p = 0.01) . Average ketone levels were not different between arms (p=ns) . There were no serious adverse events in any intervention.
Conclusion: Both empagliflozin 2.5 mg and 5 mg increased the time spent in target on hybrid closed-loop therapy by 11-13 % compared to placebo, in those who otherwise were unable to attain glycemic targets.
M.Pasqua: None. A.Jafar: None. A.Kobayati: None. M.Tsoukas: Speaker's Bureau; AstraZeneca, Bausch Health, Canada, Boehringer Ingelheim International GmbH, Eli Lilly and Company, Johnson & Johnson, Novo Nordisk Canada Inc. A.Haidar: Consultant; Eli Lilly and Company, Research Support; ADOCIA, Dexcom, Inc., Eli Lilly and Company, Tandem Diabetes Care, Inc.
National Institutes of Health (1DP3DK106930)
