Empagliflozin add-on therapy to closed-loop insulin delivery in type 1 diabetes: a 2 × 2 factorial randomized crossover trial.
Journal
Nature medicine
ISSN: 1546-170X
Titre abrégé: Nat Med
Pays: United States
ID NLM: 9502015
Informations de publication
Date de publication:
06 2022
06 2022
Historique:
received:
21
09
2021
accepted:
28
03
2022
pubmed:
14
5
2022
medline:
22
6
2022
entrez:
13
5
2022
Statut:
ppublish
Résumé
There is a need to optimize closed-loop automated insulin delivery in type 1 diabetes. We assessed the glycemic efficacy and safety of empagliflozin 25 mg d
Identifiants
pubmed: 35551290
doi: 10.1038/s41591-022-01805-3
pii: 10.1038/s41591-022-01805-3
doi:
Substances chimiques
Benzhydryl Compounds
0
Blood Glucose
0
Glucosides
0
Hypoglycemic Agents
0
Insulin
0
empagliflozin
HDC1R2M35U
Types de publication
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
1269-1276Subventions
Organisme : CIHR
ID : 4-PAR-2017-327-A-N
Pays : Canada
Informations de copyright
© 2022. The Author(s), under exclusive licence to Springer Nature America, Inc.
Références
Haidar, A. The artificial pancreas: how closed-loop control is revolutionizing diabetes. IEEE Control Syst. 36, 28–47 (2016).
doi: 10.1109/MCS.2016.2584318
Brown, S. A. et al. Six-month randomized, multicenter trial of closed-loop control in type 1 diabetes. N. Engl. J. Med. 381, 1707–1717 (2019).
doi: 10.1056/NEJMoa1907863
Thabit, H. et al. Use of an artificial beta cell in type 1 diabetes. N. Engl. J. Med. 373, 2129–2140 (2015).
doi: 10.1056/NEJMoa1509351
Collyns, O. J. et al. Improved glycemic outcomes with Medtronic MiniMed Advanced Hybrid Closed-Loop delivery: results from a randomized crossover trial comparing automated insulin delivery with predictive low glucose suspend in people with type 1 diabetes. Diabetes Care 44, 969–975 (2021).
doi: 10.2337/dc20-2250
Benhamou, P.-Y. et al. Closed-loop insulin delivery in adults with type 1 diabetes in real-life conditions: a 12-week multicentre, open-label randomised controlled crossover trial. Lancet Digit. Health 1, e17–e25 (2019).
doi: 10.1016/S2589-7500(19)30003-2
Bergenstal, R. M. et al. A comparison of two hybrid closed-loop systems in adolescents and young adults with type 1 diabetes (FLAIR): a multicentre, randomised, crossover trial. Lancet 397, 208–219 (2021).
doi: 10.1016/S0140-6736(20)32514-9
Heerspink, H. J. L., Perkins, B. A., Fitchett, D. H., Husain, M. & Cherney, D. Z. I. Sodium glucose cotransporter 2 inhibitors in the treatment of diabetes mellitus: cardiovascular and kidney effects, potential mechanisms, and clinical applications. Circulation 134, 752–772 (2016).
doi: 10.1161/CIRCULATIONAHA.116.021887
Mudaliar, S. et al. Remogliflozin etabonate, a selective inhibitor of the sodium-glucose transporter 2, improves serum glucose profiles in type 1 diabetes. Diabetes Care 35, 2198–2200 (2012).
doi: 10.2337/dc12-0508
Taylor, S. I., Blau, J. E., Rother, K. I. & Beitelshees, A. L. SGLT2 inhibitors as adjunctive therapy for type 1 diabetes: balancing benefits and risks. Lancet Diabetes Endocrinol. 7, 949–958 (2019).
doi: 10.1016/S2213-8587(19)30154-8
Lu, J., Tang, L., Meng, H., Zhao, J. & Liang, Y. Effects of sodium-glucose cotransporter (SGLT) inhibitors in addition to insulin therapy on glucose control and safety outcomes in adults with type 1 diabetes: a meta-analysis of randomized controlled trials. Diabetes Metab. Res. Rev. 35, e3169 (2019).
doi: 10.1002/dmrr.3169
Groop, P.-H. et al. Effect of dapagliflozin as an adjunct to insulin over 52 weeks in individuals with type 1 diabetes: post-hoc renal analysis of the DEPICT randomised controlled trials. Lancet Diabetes Endocrinol. 8, 845–854 (2020).
doi: 10.1016/S2213-8587(20)30280-1
Musso, G., Gambino, R., Cassader, M. & Paschetta, E. Efficacy and safety of dual SGLT 1/2 inhibitor sotagliflozin in type 1 diabetes: meta-analysis of randomised controlled trials. BMJ 365, l1328 (2019).
doi: 10.1136/bmj.l1328
Taylor, S. I., Blau, J. E. & Rother, K. I. SGLT2 inhibitors may predispose to ketoacidosis. J. Clin. Endocrinol. Metab. 100, 2849–2852 (2015).
doi: 10.1210/jc.2015-1884
Rosenstock, J. et al. Empagliflozin as adjunctive to insulin therapy in type 1 diabetes: the EASE trials. Diabetes Care 41, 2560–2569 (2018).
doi: 10.2337/dc18-1749
Mathieu, C. et al. Benefit/risk profile of dapagliflozin 5 mg in the DEPICT-1 and -2 trials in individuals with type 1 diabetes and body mass index ≥27 kg/m
doi: 10.1111/dom.14144
Kaku, K., Isaka, H., Sakatani, T. & Toyoshima, J. Efficacy and safety of ipragliflozin add-on therapy to insulin in Japanese patients with type 1 diabetes mellitus: a randomized, double-blind, phase 3 trial. Diabetes Obes. Metab. 21, 2284–2293 (2019).
doi: 10.1111/dom.13807
Pieber, T. R. et al. Empagliflozin as adjunct to insulin in patients with type 1 diabetes: a 4-week, randomized, placebo-controlled trial (EASE-1). Diabetes Obes. Metab. 17, 928–935 (2015).
doi: 10.1111/dom.12494
Battelino, T. et al. Clinical targets for continuous glucose monitoring data interpretation: recommendations from the International Consensus on Time in Range. Diabetes Care 42, 1593–1603 (2019).
doi: 10.2337/dci19-0028
Danne, T. et al. Efficacy and safety of adding sotagliflozin, a dual sodium-glucose co-transporter (SGLT)1 and SGLT2 inhibitor, to optimized insulin therapy in adults with type 1 diabetes and baseline body mass index ≥27 kg/m
doi: 10.1111/dom.14271
Singh, S., Rushakoff, R. J. & Neinstein, A. B. A case report of diabetic ketoacidosis with combined use of a sodium glucose transporter 2 inhibitor and hybrid closed-loop insulin delivery. J. Diabetes Sci. Technol. 13, 605–606 (2019).
doi: 10.1177/1932296819838875
Zhang, J. Y., Shang, T., Koliwad, S. K. & Klonoff, D. C. Continuous ketone monitoring: a new paradigm for physiologic monitoring. J. Diabetes Sci. Technol. 15, 775–780 (2021).
doi: 10.1177/19322968211009860
Goldenberg, R. M., Gilbert, J. D., Hramiak, I. M., Woo, V. C. & Zinman, B. Sodium-glucose co-transporter inhibitors, their role in type 1 diabetes treatment and a risk mitigation strategy for preventing diabetic ketoacidosis: the STOP DKA Protocol. Diabetes Obes. Metab. 21, 2192–2202 (2019).
doi: 10.1111/dom.13811
Garg, S. K., Peters, A. L., Buse, J. B. & Danne, T. Strategy for mitigating DKA risk in patients with type 1 diabetes on adjunctive treatment with SGLT inhibitors: a STICH Protocol. Diabetes Technol. Ther. 20, 571–575 (2018).
doi: 10.1089/dia.2018.0246
Alva, S., Castorino, K., Cho, H. & Ou, J. Feasibility of continuous ketone monitoring in subcutaneous tissue using a ketone sensor. J. Diabetes Sci. Technol. 15, 768–774 (2021).
doi: 10.1177/19322968211008185
Nguyen, K. T. et al. Continuous Ketone Monitoring Consensus Report 2021. J. Diabetes Sci. Technol. https://doi.org/10.1177/19322968211042656 (2021).
Cifuentes, M., Albala, C. & Rojas, C. V. Differences in lipogenesis and lipolysis in obese and non-obese adult human adipocytes. Biol. Res. 41, 197–204 (2008).
doi: 10.4067/S0716-97602008000200009
Herring, R. A. et al. Metabolic effects of an SGLT2 inhibitor (dapagliflozin) during a period of acute insulin withdrawal and development of ketoacidosis in people with type 1 diabetes. Diabetes Care 43, 2128–2136 (2020).
doi: 10.2337/dc19-2579
Schoelwer, M. J. et al. Predictors of time-in-range (70–180 mg/dL) achieved using a closed-loop control system. Diabetes Technol. Ther. 23, 475–481 (2021).
doi: 10.1089/dia.2020.0646
Pasqua, M.-R., Tsoukas, M. A. & Haidar, A. Strategically playing with fire: SGLT inhibitors as possible adjunct to closed-loop insulin therapy. J. Diabetes Sci. Technol. 15, 1232–1242 (2021).
doi: 10.1177/19322968211035411
Lind, M. et al. Glycemic control and excess mortality in type 1 diabetes. N. Engl. J. Med. 371, 1972–1982 (2014).
doi: 10.1056/NEJMoa1408214
Biester, T. et al. Add-on therapy with dapagliflozin under full closed loop control improves time in range in adolescents and young adults with type 1 diabetes: the DAPADream study. Diabetes Obes. Metab. 23, 599–608 (2021).
doi: 10.1111/dom.14258
Haidar, A. et al. Reducing the need for carbohydrate counting in type 1 diabetes using closed-loop automated insulin delivery (artificial pancreas) and empagliflozin: a randomized, controlled, non-inferiority, crossover pilot trial. Diabetes Obes. Metab. 23, 1272–1281 (2021).
doi: 10.1111/dom.14335
Ndefo, U. A., Anidiobi, N. O., Basheer, E. & Eaton, A. T. Empagliflozin (Jardiance): a novel SGLT2 inhibitor for the treatment of type-2 diabetes. P T 40, 364–368 (2015).
pubmed: 26045645
pmcid: 4450666
Haidar, A., Duval, C., Legault, L. & Rabasa-Lhoret, R. Pharmacokinetics of insulin aspart and glucagon in type 1 diabetes during closed-loop operation. J. Diabetes Sci. Technol. 7, 1507–1512 (2013).
doi: 10.1177/193229681300700610
Castle, J. R. et al. Randomized outpatient trial of single- and dual-hormone closed-loop systems that adapt to exercise using wearable sensors. Diabetes Care 41, 1471–1477 (2018).
doi: 10.2337/dc18-0228
Haidar, A., Messier, V., Legault, L., Ladouceur, M. & Rabasa-Lhoret, R. Outpatient 60-hour day-and-night glucose control with dual-hormone artificial pancreas, single-hormone artificial pancreas, or sensor-augmented pump therapy in adults with type 1 diabetes: an open-label, randomised, crossover, controlled trial. Diabetes Obes. Metab. 19, 713–720 (2017).
doi: 10.1111/dom.12880
Haidar, A. et al. Comparison of dual-hormone artificial pancreas, single-hormone artificial pancreas, and conventional insulin pump therapy for glycaemic control in patients with type 1 diabetes: an open-label randomised controlled crossover trial. Lancet Diabetes Endocrinol. 3, 17–26 (2015).
doi: 10.1016/S2213-8587(14)70226-8