Outcomes of hybrid closed-loop insulin delivery activated 24/7 versus evening and night in free-living prepubertal children with type 1 diabetes: A multicentre, randomized clinical trial.
children
clinical trial
closed-loop
glucose control
type 1 diabetes
Journal
Diabetes, obesity & metabolism
ISSN: 1463-1326
Titre abrégé: Diabetes Obes Metab
Pays: England
ID NLM: 100883645
Informations de publication
Date de publication:
03 2022
03 2022
Historique:
revised:
01
11
2021
received:
08
09
2021
accepted:
14
11
2021
pubmed:
25
11
2021
medline:
1
4
2022
entrez:
24
11
2021
Statut:
ppublish
Résumé
To assess the safety and efficacy of hybrid closed-loop (HCL) insulin delivery 24/7 versus only evening and night (E/N), and on extended 24/7 use, in free-living children with type 1 diabetes. Prepubertal children (n = 122; 49 females/73 males; age, 8.6 ± 1.6 years; diabetes duration, 5.2 ± 2.3 years; insulin pump use, 4.6 ± 2.5 years; HbA1c 7.7% ± 0.7%/61 ± 5 mmol/mol) from four centres were randomized for 24/7 versus E/N activation of the Tandem Control-IQ system for 18 weeks. Afterwards, all children used the activated system 24/7 for 18 more weeks. The primary outcome was the percentage of time spent in the 70-180 mg/dL glucose range (TIR). HCL was active 94.1% and 51.1% of the time in the 24/7 and E/N modes, respectively. TIR from baseline increased more in the 24/7 versus the E/N mode (52.9% ± 9.5% to 67.3% ± 5.6% [+14.4%, 95% CI 12.4%-16.7%] vs. 55.1% ± 10.8% to 64.7% ± 7.0% [+9.6%, 95% CI 7.4%-11.6%]; P = .001). Mean percentage time below range was similarly reduced, from 4.2% and 4.6% to 2.7%, and the mean percentage time above range decreased more in the 24/7 mode (41.9% to 30.0% [-11.9%, 95% CI 9.7%-14.6%] vs. 39.8% to 32.6% [-7.2%, 95% CI 5.0%-9.9%]; P = .007). TIR increased through the whole range of baseline levels and always more with 24/7 use. The results were maintained during the extension phase in those initially on 24/7 use and improved in those with initial E/N use up to those with 24/7 use. Neither ketoacidosis nor severe hypoglycaemia occurred. The current study shows the safety and efficacy of the Tandem Control-IQ system in free-living children with type 1 diabetes for both E/N and 24/7 use; 24/7 use shows better outcomes, sustained for up to 36 weeks with no safety issues.
Substances chimiques
Blood Glucose
0
Hypoglycemic Agents
0
Insulin
0
Types de publication
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
511-521Informations de copyright
© 2021 John Wiley & Sons Ltd.
Références
Foster NC, Beck RW, Miller KM, et al. State of type 1 diabetes management and outcomes from the T1D exchange in 2016-2018. Diabetes Technol Ther. 2019;21(2):66-72.
Karageorgiou V, Papaioannou TG, Bellos I, et al. Effectiveness of artificial pancreas in the non-adult population: a systematic review and network meta-analysis. Metabolism. 2019;90:20-30.
Thabit H, Hovorka R. Coming of age: the artificial pancreas for type 1 diabetes. Diabetologia. 2016;59(9):1795-1805.
Lal RA, Ekhlaspour L, Hood K, Buckingham B. Realizing a closed-loop (artificial pancreas) system for the treatment of type 1 diabetes. Endocr Rev. 2019;40(6):1521-1546.
Boughton CK, Hartnell S, Allen JM, Hovorka R. The importance of prandial insulin bolus timing with hybrid closed-loop systems. Diabet Med. 2019;36(12):1716-1717.
Tauschmann M, Thabit H, Bally L, et al. Closed-loop insulin delivery in suboptimally controlled type 1 diabetes: a multicentre, 12-week randomised trial. Lancet. 2018;392(10155):1321-1329.
Forlenza GP, Pinhas-Hamiel O, Liljenquist DR, et al. Safety evaluation of the MiniMed 670G system in children 7-13 years of age with type 1 diabetes. Diabetes Technol Ther. 2019;21(1):11-19.
Breton MD, Kanapka LG, Beck RW, et al. A randomized trial of closed-loop control in children with type 1 diabetes. N Engl J Med. 2020;383(9):836-845.
Kanapka LG, Wadwa RP, Breton MD, et al. Extended use of the control-IQ closed-loop control system in children with type 1 diabetes. Diabetes Care. 2021;44(2):473-478.
Collyns OJ, Meier RA, Betts ZL, 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. 2021;44(4):969-975.
Messer LH, Berget C, Pyle L, et al. Real-world use of a new hybrid closed loop improves glycemic control in youth with type 1 diabetes [published online ahead of print June 21, 2021]. Diabetes Technol Ther. 2021. doi:10.1089/dia.2021.0165
Breton MD, Kovatchev BP. One year real-world use of the control-IQ advanced hybrid closed-loop technology. Diabetes Technol Ther. 2021;23:601-608.
Cherubini V, Rabbone I, Berioli MG, et al. Effectiveness of a closed-loop control system and a virtual educational camp for children and adolescents with type 1 diabetes: a prospective, multicentre, real-life study. Diabetes Obes Metab. 2021;23:2484-2491.
van Bon AC, Brouwer TB, von Basum G, Hoekstra JB, DeVries JH. Future acceptance of an artificial pancreas in adults with type 1 diabetes. Diabetes Technol Ther. 2011;13(7):731-736.
Benjamini Y, Hochberg Y. On the adaptive control of the false discovery rate in multiple testing with independent statistics. J Educ Behav Stat. 2000;25(1):60-83.
Brown SA, Kovatchev BP, Raghinaru D, et al. Six-month randomized, multicenter trial of closed-loop control in type 1 diabetes. N Engl J Med. 2019;381(18):1707-1717.
Tubiana-Rufi N, Schaepelynck P, Franc S, et al. Practical implementation of automated closed-loop insulin delivery: a French position statement. Diabetes Metab. 2021;47(3):101206.
Forlenza GP, Cameron FM, Ly TT, et al. Fully closed-loop multiple model probabilistic predictive controller artificial pancreas performance in adolescents and adults in a supervised hotel setting. Diabetes Technol Ther. 2018;20(5):335-343.