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Randomized Controlled Trial
. 2023 Nov;25(11):3212-3222.
doi: 10.1111/dom.15217. Epub 2023 Aug 8.

Twelve-month results of the ADAPT randomized controlled trial: Reproducibility and sustainability of advanced hybrid closed-loop therapy outcomes versus conventional therapy in adults with type 1 diabetes

Shannon N Edd  1 , Javier Castañeda  2 , Pratik Choudhary  3   4 , Ralf Kolassa  5 , Winfried Keuthage  6 , Jens Kroeger  7 , Charles Thivolet  8 , Mark Evans  9 , Roseline Ré  1 , Jessica Cellot  1 , Simona de Portu  1 , Linda Vorrink  1 , John Shin  10 , Tim van den Heuvel  2 , Ohad Cohen  1 ; ADAPT study Group
Collaborators, Affiliations
Randomized Controlled Trial

Twelve-month results of the ADAPT randomized controlled trial: Reproducibility and sustainability of advanced hybrid closed-loop therapy outcomes versus conventional therapy in adults with type 1 diabetes

Shannon N Edd et al. Diabetes Obes Metab. 2023 Nov.

Abstract

Aims: To reassess the 6-month efficacy and to assess the 12-month sustained efficacy of the MiniMed™ 780G advanced hybrid closed-loop automated insulin delivery (AID) system compared to multiple daily injections plus intermittently scanned glucose monitoring (MDI+isCGM) in people with type 1 diabetes not meeting glucose targets.

Methods: The ADAPT study was a prospective, multicentre, open-label, randomized control trial in people with type 1 diabetes, with a glycated haemoglobin (HbA1c) concentration of at least 8.0% (64 mmol/mol), on MDI+isCGM therapy. After a 6-month study phase, participants randomized at baseline to MDI+isCGM switched to AID (SWITCH) while the others continued AID therapy (SUSTAIN) for an additional 6 months. The primary endpoint of this continuation phase was the within-group change in mean HbA1c between 6 and 12 months, with superiority in the SWITCH group and noninferiority in the SUSTAIN group (ClinicalTrials.gov: NCT04235504).

Results: A total of 39 SWITCH and 36 SUSTAIN participants entered the continuation phase. In the SWITCH group, HbA1c was significantly decreased by -1.4% (95% confidence interval [CI] -1.7% to -1.1%; P < 0.001) from a mean ± SD of 8.9% ± 0.8% (73.9 ± 8.6 mmol/mol) at 6 months to 7.5% ± 0.6% (58.5 ± 6.9 mmol/mol) at 12 months. Mean HbA1c increased by 0.1% (95% CI -0.05% to +0.25%), from 7.3% ± 0.6% (56.5 ± 6.7 mmol/mol) to 7.4% ± 0.8% (57.7 ± 9.1 mmol/mol) in the SUSTAIN group, meeting noninferiority criteria. Three severe hypoglycaemia events occurred in two SWITCH participants during the continuation phase.

Conclusion: ADAPT study phase glycaemic improvements were reproduced and sustained in the continuation phase, supporting the early adoption of AID therapy in people with type 1 diabetes not meeting glucose targets on MDI therapy.

Keywords: insulin pump therapy; patient reported outcomes; randomized trial; subcutaneous injection; type 1 diabetes.

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References

REFERENCES

    1. Boughton CK, Hovorka R. New closed-loop insulin systems. Diabetologia. 2021;64(5):1007-1015. doi:10.1007/s00125-021-05391-w
    1. Pease A, Lo C, Earnest A, Kiriakova V, Liew D, Zoungas S. The efficacy of technology in type 1 diabetes: a systematic review, network meta-analysis, and narrative synthesis. Diabetes Technol Ther. 2020;22(5):411-421. doi:10.1089/dia.2019.0417
    1. Fang Z, Liu M, Tao J, Li C, Zou F, Zhang W. Efficacy and safety of closed-loop insulin delivery versus sensor-augmented pump in the treatment of adults with type 1 diabetes: a systematic review and meta-analysis of randomized-controlled trials. J Endocrinol Invest. 2022;45(3):471-481. doi:10.1007/s40618-021-01674-6
    1. Choudhary P, Campbell F, Joule N, Kar P, Diabetes UK. A type 1 diabetes technology pathway: consensus statement for the use of technology in type 1 diabetes. Diabet Med. 2019;36(5):531-538. doi:10.1111/dme.13933
    1. Bergenstal RM, Nimri R, Beck RW, 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. 2021;397(10270):208-219. doi:10.1016/S0140-6736(20)32514-9

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