One-year real-world performance of the DBLG1 closed-loop system: Data from 3706 adult users with type 1 diabetes in Germany.
Humans
Adult
Female
Middle Aged
Male
Diabetes Mellitus, Type 1
/ drug therapy
Hypoglycemic Agents
/ therapeutic use
Glycated Hemoglobin
Hypoglycemia
Blood Glucose
Blood Glucose Self-Monitoring
Retrospective Studies
Insulin Infusion Systems
Insulin
/ therapeutic use
Glucose
/ therapeutic use
Germany
/ epidemiology
artificial pancreas
automated insulin delivery
closed-loop
hyperglycaemia
hypoglycaemia
time in range
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:
06 2023
06 2023
Historique:
revised:
27
01
2023
received:
06
12
2022
accepted:
04
02
2023
medline:
4
5
2023
pubmed:
9
2
2023
entrez:
8
2
2023
Statut:
ppublish
Résumé
The Diabeloop Generation 1 (DBLG1) system is an interoperable hybrid closed-loop solution that was commercialized in Germany in March 2021. We report the longitudinal glycaemic outcomes among the first 3706 users in a real-world setting. We performed a retrospective data collection of all consenting adult patients with type 1 diabetes who were equipped in Germany with the DBLG1 system before 30 April 2022, and with a minimum 14 days of closed-loop usage. In total, 3706 users (41% women, age 45.1 ± 14.5 years) met the inclusion criteria, reaching a mean follow-up of 131.0 ± 85.1 days, an overall 485 600 days of continuous glucose monitoring data, and a median time spent in closed-loop of 95.0% (IQR 89.1-97.4). The median percentage time in range (70-180 mg/dl) was 72.1% (IQR 65.0-78.9); the time below 70 mg/dl was 0.9% (0.5-1.7), the time below 54 mg/dl was 0.1% (0.1-0.3), and the median Glucose Management Index was 7.0% (6.8-7.3). Exploratory analysis of a subset of 2460 patients in whom baseline glycated haemoglobin (HbA1c) was available [7.4% (IQR 6.9-8.0)] showed that the achieved mean time in range was influenced by baseline HbA1c, ranging from 65.8 ± 9.9% (A1c ≥8.5%) to 81.3 ± 6.8% (A1c <6.5%). This large real-world analysis confirms the relevance of the DBLG1 automated insulin delivery solution for the achievement of standards of care in adult patients with type 1 diabetes.
Substances chimiques
Hypoglycemic Agents
0
Glycated Hemoglobin
0
Blood Glucose
0
Insulin
0
Glucose
IY9XDZ35W2
Types de publication
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
1607-1613Informations de copyright
© 2023 The Authors. Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd.
Références
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;392:1321-1329.
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;381:1707-1717.
Benhamou PY, Franc S, Reznik 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. 2019;1:e17-e25.
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;397:208-219.
Brown SA, Forlenza GP, Bode BW, et al. Multicenter trial of a tubeless, on-body automated insulin delivery system with customizable glycemic targets in pediatric and adult participants with type 1 diabetes. Diabetes Care. 2021;44:1630-1640.
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.
Da Silva J, Lepore G, Battelino T, et al. Real-world performance of the MiniMed™ 780G system: first report of outcomes from 4120 users. Diabetes Technol Ther. 2022;24:113-119.
Amadou C, Franc S, Benhamou PY, et al. Diabeloop DBLG1 closed-loop system enables patients with type 1 diabetes to significantly improve their glycemic control in real-life situations without serious adverse events: 6-month follow-up. Diabetes Care. 2021;44:844-846.
Danne T, Nimri R, Battelino T, et al. International consensus on use of continuous glucose monitoring. Diabetes Care. 2017;40:1631-1640.
Battelino T, Danne T, Bergenstal RM, et al. Clinical targets for continuous glucose monitoring data interpretation: recommendations from the international consensus on time in range. Diabetes Care. 2019;42:1593-1603.
Beck RW, Bergenstal RM, Cheng P, et al. The relationships between time in range, hyperglycemia metrics, and HbA1c. J Diabetes Sci Technol. 2019;13:614-626.
American Diabetes Association. 6. Glycemic targets: standards of medical care in diabetes-2021. Diabetes Care. 2021;44(Suppl 1):S73-S84.
Holt RIG, DeVries JH, Hess-Fischl A, et al. The Management of Type 1 diabetes in adults. A consensus report by the American Diabetes Association (ADA) and the European Association for the Study of diabetes (EASD). Diabetes Care. 2021;44:2589-2625.
Renard E, Ikegami H, Daher Vianna AG, et al. The SAGE study: global observational analysis of glycaemic control, hypoglycaemia and diabetes management in T1DM. Diabetes Metab Res Rev. 2021;37(7):e3430.
Lind M, Svensson AM, Kosiborod M, et al. Glycemic control and excess mortality in type 1 diabetes. N Engl J Med. 2014;371:1972-1982.
Diabetes Control and Complications Trial (DCCT)/Epidemiology of Diabetes Interventions and Complications (EDIC) Study Research Group. Mortality in type 1 diabetes in the DCCT/EDIC versus the general population. Diabetes Care. 2016;39:1378-1383.
Beato-Víbora PI, Gallego-Gamero F, Ambrojo-López A, Gil-Poch E, Martín-Romo I, Arroyo-Díez FJ. Rapid improvement in time in range after the implementation of an advanced hybrid closed-loop system in adolescents and adults with type 1 diabetes. Diabetes Technol Ther. 2021;23:609-615.
Boughton CK, Hartnell S, Allen JM, Fuchs J, Hovorka R. Training and support for hybrid closed-loop therapy. J Diabetes Sci Technol. 2022;16:218-223.
Ekhlaspour L, Town M, Raghinaru D, Lum JW, Brown SA, Buckingham BA. Glycemic outcomes in baseline hemoglobin A1C subgroups in the international diabetes closed-loop trial. Diabetes Technol Ther. 2022;24:588-591.
Noor N, Kamboj MK, Triolo T, et al. Hybrid closed-loop systems and glycemic outcomes in children and adults with type 1 diabetes: real-world evidence from a U.S.-based multicenter collaborative. Diabetes Care. 2022;45:e118-e119.
Arrieta A, Battelino T, Scaramuzza AE, et al. Comparison of MiniMed 780G system performance in users aged younger and older than 15 years: evidence from 12 870 real-world users. Diabetes Obes Metab. 2022;24:1370-1379.