Automated Insulin Delivery in Women with Pregnancy Complicated by Type 1 Diabetes.
Adult
Female
Humans
Pregnancy
Blood Glucose
/ analysis
Blood Glucose Self-Monitoring
Diabetes Mellitus, Type 1
/ blood
Glycated Hemoglobin
/ analysis
Hypoglycemic Agents
/ administration & dosage
Insulin
/ administration & dosage
Insulin Infusion Systems
/ adverse effects
Pregnancy in Diabetics
/ blood
Treatment Outcome
Journal
The New England journal of medicine
ISSN: 1533-4406
Titre abrégé: N Engl J Med
Pays: United States
ID NLM: 0255562
Informations de publication
Date de publication:
26 Oct 2023
26 Oct 2023
Historique:
medline:
30
10
2023
pubmed:
5
10
2023
entrez:
5
10
2023
Statut:
ppublish
Résumé
Hybrid closed-loop insulin therapy has shown promise for management of type 1 diabetes during pregnancy; however, its efficacy is unclear. In this multicenter, controlled trial, we randomly assigned pregnant women with type 1 diabetes and a glycated hemoglobin level of at least 6.5% at nine sites in the United Kingdom to receive standard insulin therapy or hybrid closed-loop therapy, with both groups using continuous glucose monitoring. The primary outcome was the percentage of time in the pregnancy-specific target glucose range (63 to 140 mg per deciliter [3.5 to 7.8 mmol per liter]) as measured by continuous glucose monitoring from 16 weeks' gestation until delivery. Analyses were performed according to the intention-to-treat principle. Key secondary outcomes were the percentage of time spent in a hyperglycemic state (glucose level >140 mg per deciliter), overnight time in the target range, the glycated hemoglobin level, and safety events. A total of 124 participants with a mean (±SD) age of 31.1±5.3 years and a mean baseline glycated hemoglobin level of 7.7±1.2% underwent randomization. The mean percentage of time that the maternal glucose level was in the target range was 68.2±10.5% in the closed-loop group and 55.6±12.5% in the standard-care group (mean adjusted difference, 10.5 percentage points; 95% confidence interval [CI], 7.0 to 14.0; P<0.001). Results for the secondary outcomes were consistent with those of the primary outcome; participants in the closed-loop group spent less time in a hyperglycemic state than those in the standard-care group (difference, -10.2 percentage points; 95% CI, -13.8 to -6.6); had more overnight time in the target range (difference, 12.3 percentage points; 95% CI, 8.3 to 16.2), and had lower glycated hemoglobin levels (difference, -0.31 percentage points; 95% CI, -0.50 to -0.12). Little time was spent in a hypoglycemic state. No unanticipated safety problems associated with the use of closed-loop therapy during pregnancy occurred (6 instances of severe hypoglycemia, vs. 5 in the standard-care group; 1 instance of diabetic ketoacidosis in each group; and 12 device-related adverse events in the closed-loop group, 7 related to closed-loop therapy). Hybrid closed-loop therapy significantly improved maternal glycemic control during pregnancy complicated by type 1 diabetes. (Funded by the Efficacy and Mechanism Evaluation Program; AiDAPT ISRCTN Registry number, ISRCTN56898625.).
Sections du résumé
BACKGROUND
BACKGROUND
Hybrid closed-loop insulin therapy has shown promise for management of type 1 diabetes during pregnancy; however, its efficacy is unclear.
METHODS
METHODS
In this multicenter, controlled trial, we randomly assigned pregnant women with type 1 diabetes and a glycated hemoglobin level of at least 6.5% at nine sites in the United Kingdom to receive standard insulin therapy or hybrid closed-loop therapy, with both groups using continuous glucose monitoring. The primary outcome was the percentage of time in the pregnancy-specific target glucose range (63 to 140 mg per deciliter [3.5 to 7.8 mmol per liter]) as measured by continuous glucose monitoring from 16 weeks' gestation until delivery. Analyses were performed according to the intention-to-treat principle. Key secondary outcomes were the percentage of time spent in a hyperglycemic state (glucose level >140 mg per deciliter), overnight time in the target range, the glycated hemoglobin level, and safety events.
RESULTS
RESULTS
A total of 124 participants with a mean (±SD) age of 31.1±5.3 years and a mean baseline glycated hemoglobin level of 7.7±1.2% underwent randomization. The mean percentage of time that the maternal glucose level was in the target range was 68.2±10.5% in the closed-loop group and 55.6±12.5% in the standard-care group (mean adjusted difference, 10.5 percentage points; 95% confidence interval [CI], 7.0 to 14.0; P<0.001). Results for the secondary outcomes were consistent with those of the primary outcome; participants in the closed-loop group spent less time in a hyperglycemic state than those in the standard-care group (difference, -10.2 percentage points; 95% CI, -13.8 to -6.6); had more overnight time in the target range (difference, 12.3 percentage points; 95% CI, 8.3 to 16.2), and had lower glycated hemoglobin levels (difference, -0.31 percentage points; 95% CI, -0.50 to -0.12). Little time was spent in a hypoglycemic state. No unanticipated safety problems associated with the use of closed-loop therapy during pregnancy occurred (6 instances of severe hypoglycemia, vs. 5 in the standard-care group; 1 instance of diabetic ketoacidosis in each group; and 12 device-related adverse events in the closed-loop group, 7 related to closed-loop therapy).
CONCLUSIONS
CONCLUSIONS
Hybrid closed-loop therapy significantly improved maternal glycemic control during pregnancy complicated by type 1 diabetes. (Funded by the Efficacy and Mechanism Evaluation Program; AiDAPT ISRCTN Registry number, ISRCTN56898625.).
Identifiants
pubmed: 37796241
doi: 10.1056/NEJMoa2303911
doi:
Substances chimiques
Blood Glucose
0
Glycated Hemoglobin
0
Hypoglycemic Agents
0
Insulin
0
Banques de données
ISRCTN
['ISRCTN56898625']
Types de publication
Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM
Pagination
1566-1578Subventions
Organisme : Efficacy and Mechanism Evaluation Programme
ID : NIHR EME reference 16/35/01
Organisme : Juvenile Diabetes Research Foundation United States of America
ID : #2-RSC-2019-828-M-N
Organisme : Juvenile Diabetes Research Foundation United States of America
ID : #22-2013-266
Organisme : Diabetes Research and Wellness Foundation
ID : Sutherland-Earl Fellowship (reference SECF/21)
Investigateurs
Katharine Hunt
(K)
Helen Rogers
(H)
Damian Morris
(D)
Duncan Fowler
(D)
Josephine Rosier
(J)
Zeenat Banu
(Z)
Sarah Barker
(S)
Gerry Rayman
(G)
Eleanor Gurnell
(E)
Caroline Byrne
(C)
Andrea Lake
(A)
Katy Davenport
(K)
Jeannie Grisoni
(J)
Shannon Savine
(S)
Helen R Murphy
(HR)
Tara T M Lee
(TTM)
Tara Wallace
(T)
Alastair McKelvey
(A)
Nina Willer
(N)
Elizabeth Turner
(E)
Corinne Collett
(C)
Mei-See Man
(MS)
Emma Flanagan
(E)
Matt Hammond
(M)
Lee Shepstone
(L)
Anna Brackenridge
(A)
Sara White
(S)
Anna Reid
(A)
Olanike Okolo
(O)
Eleanor M Scott
(EM)
Del Endersby
(D)
Anna Dover
(A)
Frances Dougherty
(F)
Susan Johnston
(S)
Rebecca M Reynolds
(RM)
Robert Lindsay
(R)
David Carty
(D)
Sharon Mackin
(S)
Isobel Crawford
(I)
Ross Buchan
(R)
David McCance
(D)
Louisa Jones
(L)
Joanne Quinn
(J)
Sarah Cains
(S)
Goher Ayman
(G)
Informations de copyright
Copyright © 2023 Massachusetts Medical Society.