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Published Online: 1 December 2016

Glycemia, Treatment Satisfaction, Cognition, and Sleep Quality in Adults and Adolescents with Type 1 Diabetes When Using a Closed-Loop System Overnight Versus Sensor-Augmented Pump with Low-Glucose Suspend Function: A Randomized Crossover Study

Publication: Diabetes Technology & Therapeutics
Volume 18, Issue Number 12

Abstract

Background: We compared glycemia, treatment satisfaction, sleep quality, and cognition using a nighttime Android-based hybrid closed-loop system (Android-HCLS) with sensor-augmented pump with low-glucose suspend function (SAP-LGS) in people with type 1 diabetes.
Materials and Methods: An open-label, prospective, randomized crossover study of 16 adults (mean [SD] age 42.1 [9.6] years) and 12 adolescents (15.2 [1.6] years) was conducted. All participants completed four consecutive nights at home with Android-HCLS (proportional integral derivative with insulin feedback algorithm; Medtronic) and SAP-LGS. Primary outcome: percent continuous glucose monitoring (CGM) time (00:00–08:00 h) within target range (72–144 mg/dL). Secondary endpoints: percent CGM time above target (>144 mg/dL); below target (<72 mg/dL); glycemic variability (SD); symptomatic hypoglycemia; adult treatment satisfaction; sleep quality; and cognitive function.
Results: The primary outcome for all participants was not statistically different between Android-HCLS and SAP-LGS (mean [SD] 59.4 [17.9]% vs. 53.1 [18]%; p = 0.14). Adults had greater percent time within target range (57.7 [18.6]% vs. 44.5 [14.5]%; p < 0.006); less time above target (42.0 [18.7]% vs. 52.6 [16.5]%; p = 0.034); lower glycemic variability (35 [10.7] mg/dL vs. 46 [10.7] mg/dL; p = 0.003); and less (median [IQR]) time below target (0.0 [0.0–0.4]% vs. 0.80 [0.0–3.9]%; p = 0.025). In adolescents, time below target was lower with Android-HCLS vs. SAP-LGS (0.0 [0.0–0.0]% vs. 1.8 [0.1–7.9]%; p = 0.011). Nocturnal symptomatic hypoglycemia was less (1 vs. 10; p = 0.007) in adolescents, but not adults (5 vs. 13; p = 0.059). In adults, treatment satisfaction increased by 10 points (p < 0.02). Sleep quality and cognition did not differ.
Conclusions: Android-HCLS in both adults and adolescents reduced nocturnal hypoglycemia and, in adults, improved overnight time in target range and treatment satisfaction compared with SAP-LGS.

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cover image Diabetes Technology & Therapeutics
Diabetes Technology & Therapeutics
Volume 18Issue Number 12December 2016
Pages: 772 - 783
PubMed: 27835037

History

Published in print: December 2016
Published online: 1 December 2016
Published ahead of print: 11 November 2016

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Amin Sharifi
Department of Endocrinology and Diabetes, St. Vincent's Hospital Melbourne, Melbourne, Australia.
Martin I. De Bock
Department of Endocrinology and Diabetes, Princess Margaret Hospital for Children, Perth, Australia.
Dilshani Jayawardene
Department of Endocrinology and Diabetes, St. Vincent's Hospital Melbourne, Melbourne, Australia.
Margaret M. Loh
Department of Endocrinology and Diabetes, St. Vincent's Hospital Melbourne, Melbourne, Australia.
Jodie C. Horsburgh
Department of Endocrinology and Diabetes, St. Vincent's Hospital Melbourne, Melbourne, Australia.
Carolyn L. Berthold
Department of Endocrinology and Diabetes, Princess Margaret Hospital for Children, Perth, Australia.
Nirubasini Paramalingam
Department of Endocrinology and Diabetes, Princess Margaret Hospital for Children, Perth, Australia.
Leon A. Bach
Department of Endocrinology and Diabetes, Alfred Hospital, Melbourne, Australia.
Peter G. Colman
Department of Diabetes and Endocrinology, Royal Melbourne Hospital, Melbourne, Australia.
Elizabeth A. Davis
Department of Endocrinology and Diabetes, Princess Margaret Hospital for Children, Perth, Australia.
Benyamin Grosman
Medtronic Diabetes, Northridge, California.
Christel Hendrieckx
The Australian Centre for Behavioural Research in Diabetes, Diabetes Victoria, Australia.
School of Psychology, Deakin University, Geelong, Australia.
Alicia J. Jenkins
Department of Endocrinology and Diabetes, St. Vincent's Hospital Melbourne, Melbourne, Australia.
Department of Medicine, University of Melbourne, St. Vincent's Hospital Melbourne, Melbourne, Australia.
University of Sydney, NHMRC Clinical Trials Centre, Australia.
Kavita Kumareswaran
Department of Endocrinology and Diabetes, Alfred Hospital, Melbourne, Australia.
Natalie Kurtz
Medtronic Diabetes, Northridge, California.
Andrew Kyoong
Department of Respiratory and Sleep Medicine, St. Vincent's Hospital Melbourne, Melbourne, Australia.
Richard J. MacIsaac
Department of Endocrinology and Diabetes, St. Vincent's Hospital Melbourne, Melbourne, Australia.
Department of Medicine, University of Melbourne, St. Vincent's Hospital Melbourne, Melbourne, Australia.
Jane Speight
The Australian Centre for Behavioural Research in Diabetes, Diabetes Victoria, Australia.
School of Psychology, Deakin University, Geelong, Australia.
AHP Research, Hornchurch, Essex, United Kingdom.
Steven Trawley
The Australian Centre for Behavioural Research in Diabetes, Diabetes Victoria, Australia.
School of Psychology, Deakin University, Geelong, Australia.
Glenn M. Ward
Department of Endocrinology and Diabetes, St. Vincent's Hospital Melbourne, Melbourne, Australia.
Department of Medicine, University of Melbourne, St. Vincent's Hospital Melbourne, Melbourne, Australia.
Anirban Roy
Medtronic Diabetes, Northridge, California.
Timothy W. Jones
Department of Endocrinology and Diabetes, Princess Margaret Hospital for Children, Perth, Australia.
David N. O'Neal
Department of Endocrinology and Diabetes, St. Vincent's Hospital Melbourne, Melbourne, Australia.
Department of Medicine, University of Melbourne, St. Vincent's Hospital Melbourne, Melbourne, Australia.

Notes

Address correspondence to:David N. O'Neal, MD, FRACPDepartment of MedicineUniversity of MelbourneSt. Vincent's Hospital Melbourne4th Floor, Clinical Sciences Building29 Regent Street, FitzroyVictoria 3065Australia
E-mail: [email protected]

Author Disclosure Statement

A.S., M.I.D.B., D.J., M.M.L., J.C.H., C.B., N.P., L.B., C.H., A.K., K.K., G.M.W., S.T., and E.A.D. declare no competing financial interests. P.G.C. has received lecturing fees from Medtronic. N.K., B.G., and A.R. are employees and stockholders of Medtronic. A.J.J. is on an advisory board for Medtronic Diabetes and Abbott Diabetes and has received honoraria from Medtronic and Sanofi. R.J.M. reports travel support from Novo Nordisk, Sanofi, and Boehringer Ingelheim; is a member of an advisory board for Boehringer Ingelheim; and has received lecture fees from Bayer, Astra Zeneca, MSD, Novartis, Boehringer Ingelheim and Novo Nordisk. J.S. is a member of advisory boards for Roche Diagnostics and Janssen Pharmaceuticals; has received research support from Abbott and Sanofi; and educational support from Lilly, Medtronic, and Novo Nordisk. T.W.J. has received honoraria and speakers' fees from Medtronic. D.N.O. has been on an advisory board for Abbott Diabetes and has received speakers' fees and research support from Medtronic and Novo Nordisk.

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