Safety and efficacy of 24-h closed-loop insulin delivery in well-controlled pregnant women with type 1 diabetes: a randomized crossover case series.
OBJECTIVE
To evaluate the safety and efficacy of closed-loop insulin delivery in well-controlled pregnant women with type 1 diabetes treated with continuous subcutaneous insulin infusion (CSII).


METHODS
A total of 12 women with type 1 diabetes (aged 32.9 years, diabetes duration 17.6 years, BMI 27.1 kg/m(2), and HbA(1c) 6.4%) were randomly allocated to closed-loop or conventional CSII. They performed normal daily activities (standardized meals, snacks, and exercise) for 24 h on two occasions at 19 and 23 weeks' gestation. Plasma glucose time in target (63-140 mg/dL) and time spent hypoglycemic were calculated.


RESULTS
Plasma glucose time in target was comparable for closed-loop and conventional CSII (median [interquartile range]: 81 [59-87] vs. 81% [54-90]; P = 0.75). Less time was spent hypoglycemic (<45 mg/dL [0.0 vs. 0.3%]; P = 0.04), with a lower low blood glucose index (2.4 [0.9-3.5] vs. 3.3 [1.9-5.1]; P = 0.03), during closed-loop insulin delivery.


CONCLUSIONS
Closed-loop insulin delivery was as effective as conventional CSII, with less time spent in extreme hypoglycemia.
Metabolic Research Laboratories and the National Institute for Health Research Cambridge Biomedical Research Center, University of Cambridge, Cambridge, UK. hm386@medschl.cam.ac.uk
Helen R
HR
Murphy
Kavita
K
Kumareswaran
Daniela
D
Elleri
Janet M
JM
Allen
Karen
K
Caldwell
Martina
M
Biagioni
David
D
Simmons
David B
DB
Dunger
Marianna
M
Nodale
Malgorzata E
ME
Wilinska
Stephanie A
SA
Amiel
Roman
R
Hovorka
D000328:Adult; D001786:Blood Glucose; D018592:Cross-Over Studies; D003922:Diabetes Mellitus, Type 1 / Q000188:drug therapy*; D005260:Female; D006801:Humans; D007003:Hypoglycemia / Q000517:prevention & control; D007328:Insulin / Q000008:administration & dosage*; D007332:Insulin Infusion Systems; D011247:Pregnancy; D011254:Pregnancy in Diabetics / Q000188:drug therapy*
D001786:Blood Glucose; D007328:Insulin