Hybrid closed-loop glucose control compared with sensor augmented pump therapy in older adults with type 1 diabetes: an open-label multicentre, multinational, randomised, crossover study.
Journal
The lancet. Healthy longevity
ISSN: 2666-7568
Titre abrégé: Lancet Healthy Longev
Pays: England
ID NLM: 101773309
Informations de publication
Date de publication:
03 2022
03 2022
Historique:
entrez:
1
4
2022
pubmed:
2
4
2022
medline:
2
4
2022
Statut:
ppublish
Résumé
Older adults with type 1 diabetes have distinct characteristics that can make optimising glycaemic control challenging. We sought to test our hypothesis that hybrid closed-loop glucose control is safe and more effective than sensor-augmented pump (SAP) therapy in older adults with type 1 diabetes. In an open-label, multicentre, multinational (UK and Austria), randomised, crossover study, adults aged 60 years and older with type 1 diabetes using insulin pump therapy underwent two 16-week periods comparing hybrid closed-loop (CamAPS FX, CamDiab, Cambridge, UK) and SAP therapy in random order. Block randomisation by means of central randomisation software to one of two treatment sequences was stratified by centre. The primary endpoint was the proportion of time sensor glucose was in target range between 3·9 and 10·0 mmol/L. Analysis for the primary endpoint and adverse events was by intention-to-treat. The study has completed and is registered at ClinicalTrials.gov NCT04025762. 38 participants were enrolled. One participant withdrew during run-in because of difficulties with the study pump infusion sets. 37 participants (median [IQR] age 68 [63-70] years, mean [SD] baseline glycated haemoglobin [HbA Hybrid closed-loop insulin delivery is safe and achieves superior glycaemic control to SAP therapy in older adults with long duration of type 1 diabetes. Importantly this was achieved without increasing the risk of hypoglycaemia in this population with risk factors for severe hypoglycaemia. This suggests that hybrid closed-loop therapy is a clinically important treatment option for older adults with type 1 diabetes.
Sections du résumé
Background
Older adults with type 1 diabetes have distinct characteristics that can make optimising glycaemic control challenging. We sought to test our hypothesis that hybrid closed-loop glucose control is safe and more effective than sensor-augmented pump (SAP) therapy in older adults with type 1 diabetes.
Methods
In an open-label, multicentre, multinational (UK and Austria), randomised, crossover study, adults aged 60 years and older with type 1 diabetes using insulin pump therapy underwent two 16-week periods comparing hybrid closed-loop (CamAPS FX, CamDiab, Cambridge, UK) and SAP therapy in random order. Block randomisation by means of central randomisation software to one of two treatment sequences was stratified by centre. The primary endpoint was the proportion of time sensor glucose was in target range between 3·9 and 10·0 mmol/L. Analysis for the primary endpoint and adverse events was by intention-to-treat. The study has completed and is registered at ClinicalTrials.gov NCT04025762.
Findings
38 participants were enrolled. One participant withdrew during run-in because of difficulties with the study pump infusion sets. 37 participants (median [IQR] age 68 [63-70] years, mean [SD] baseline glycated haemoglobin [HbA
Interpretation
Hybrid closed-loop insulin delivery is safe and achieves superior glycaemic control to SAP therapy in older adults with long duration of type 1 diabetes. Importantly this was achieved without increasing the risk of hypoglycaemia in this population with risk factors for severe hypoglycaemia. This suggests that hybrid closed-loop therapy is a clinically important treatment option for older adults with type 1 diabetes.
Identifiants
pubmed: 35359882
doi: 10.1016/S2666-7568(22)00005-8
pmc: PMC8967297
mid: NIHMS1787001
doi:
Substances chimiques
Blood Glucose
0
Hypoglycemic Agents
0
Insulin
0
Glucose
IY9XDZ35W2
Banques de données
ClinicalTrials.gov
['NCT04025762']
Types de publication
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't
Langues
eng
Pagination
e135-e142Subventions
Organisme : Wellcome Trust
Pays : United Kingdom
Organisme : NIDDK NIH HHS
ID : DP3 DK112176
Pays : United States
Organisme : Medical Research Council
ID : MR/T023899/1
Pays : United Kingdom
Commentaires et corrections
Type : CommentIn
Références
BMJ. 2018 Apr 18;361:k1310
pubmed: 29669716
Lancet. 2021 Jan 16;397(10270):208-219
pubmed: 33453783
Diabet Med. 2014 Oct;31(10):1210-7
pubmed: 24824356
Diabetes. 2012 Nov;61(11):2987-92
pubmed: 22851572
BMJ Open Diabetes Res Care. 2019 Apr 14;7(1):e000602
pubmed: 31114696
N Engl J Med. 2015 Nov 26;373(22):2129-2140
pubmed: 26379095
Diabetes Care. 2016 Jul;39(7):1168-74
pubmed: 26740634
Diabetes Care. 2019 Aug;42(8):1593-1603
pubmed: 31177185
J Clin Endocrinol Metab. 2013 Aug;98(8):3411-9
pubmed: 23760624
N Engl J Med. 2019 Oct 31;381(18):1707-1717
pubmed: 31618560
Diabetes Res Clin Pract. 2016 Dec;122:28-37
pubmed: 27764721
Diabetes Technol Ther. 2022 Feb;24(2):140-142
pubmed: 34609917
PLoS Med. 2012;9(10):e1001321
pubmed: 23055834
Diabetes Obes Metab. 2021 Sep;23(9):2048-2057
pubmed: 34010499
Diabetes Care. 2019 Dec;42(12):2220-2227
pubmed: 31548241
Diabetes Technol Ther. 2019 Feb;21(2):66-72
pubmed: 30657336
J Diabetes Sci Technol. 2021 Jan 15;:1932296820986879
pubmed: 33451264
JAMA. 2020 Jun 16;323(23):2397-2406
pubmed: 32543682