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.
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.



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.



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.



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.



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.
1 Department of Endocrinology and Diabetes, St. Vincent's Hospital Melbourne , Melbourne, Australia .
Amin
A
Sharifi
2 Department of Endocrinology and Diabetes, Princess Margaret Hospital for Children , Perth, Australia .
Martin I
MI
De Bock
1 Department of Endocrinology and Diabetes, St. Vincent's Hospital Melbourne , Melbourne, Australia .
Dilshani
D
Jayawardene
1 Department of Endocrinology and Diabetes, St. Vincent's Hospital Melbourne , Melbourne, Australia .
Margaret M
MM
Loh
1 Department of Endocrinology and Diabetes, St. Vincent's Hospital Melbourne , Melbourne, Australia .
Jodie C
JC
Horsburgh
2 Department of Endocrinology and Diabetes, Princess Margaret Hospital for Children , Perth, Australia .
Carolyn L
CL
Berthold
2 Department of Endocrinology and Diabetes, Princess Margaret Hospital for Children , Perth, Australia .
Nirubasini
N
Paramalingam
3 Department of Endocrinology and Diabetes, Alfred Hospital , Melbourne, Australia .
Leon A
LA
Bach
4 Department of Diabetes and Endocrinology, Royal Melbourne Hospital , Melbourne, Australia .
Peter G
PG
Colman
2 Department of Endocrinology and Diabetes, Princess Margaret Hospital for Children , Perth, Australia .
Elizabeth A
EA
Davis
5 Medtronic Diabetes , Northridge, California.
Benyamin
B
Grosman
6 The Australian Centre for Behavioural Research in Diabetes , Diabetes Victoria, Australia .|7 School of Psychology, Deakin University , Geelong, Australia .
Christel
C
Hendrieckx
1 Department of Endocrinology and Diabetes, St. Vincent's Hospital Melbourne , Melbourne, Australia .|8 Department of Medicine, University of Melbourne , St. Vincent's Hospital Melbourne, Melbourne, Australia .|9 University of Sydney , NHMRC Clinical Trials Centre, Australia .
Alicia J
AJ
Jenkins
3 Department of Endocrinology and Diabetes, Alfred Hospital , Melbourne, Australia .
Kavita
K
Kumareswaran
5 Medtronic Diabetes , Northridge, California.
Natalie
N
Kurtz
10 Department of Respiratory and Sleep Medicine, St. Vincent's Hospital Melbourne , Melbourne, Australia .
Andrew
A
Kyoong
1 Department of Endocrinology and Diabetes, St. Vincent's Hospital Melbourne , Melbourne, Australia .|8 Department of Medicine, University of Melbourne , St. Vincent's Hospital Melbourne, Melbourne, Australia .
Richard J
RJ
MacIsaac
6 The Australian Centre for Behavioural Research in Diabetes , Diabetes Victoria, Australia .|7 School of Psychology, Deakin University , Geelong, Australia .|11 AHP Research , Hornchurch, Essex, United Kingdom .
Jane
J
Speight
6 The Australian Centre for Behavioural Research in Diabetes , Diabetes Victoria, Australia .|7 School of Psychology, Deakin University , Geelong, Australia .
Steven
S
Trawley
1 Department of Endocrinology and Diabetes, St. Vincent's Hospital Melbourne , Melbourne, Australia .|8 Department of Medicine, University of Melbourne , St. Vincent's Hospital Melbourne, Melbourne, Australia .
Glenn M
GM
Ward
5 Medtronic Diabetes , Northridge, California.
Anirban
A
Roy
2 Department of Endocrinology and Diabetes, Princess Margaret Hospital for Children , Perth, Australia .
Timothy W
TW
Jones
1 Department of Endocrinology and Diabetes, St. Vincent's Hospital Melbourne , Melbourne, Australia .|8 Department of Medicine, University of Melbourne , St. Vincent's Hospital Melbourne, Melbourne, Australia .
David N
DN
O'Neal
D000293:Adolescent; D000328:Adult; D001786:Blood Glucose; D003071:Cognition; D018592:Cross-Over Studies; D003922:Diabetes Mellitus, Type 1 / Q000188:drug therapy*; D005260:Female; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage*; D007328:Insulin / Q000008:administration & dosage*; D007332:Insulin Infusion Systems; D008297:Male; D008838:Microcomputers; D008875:Middle Aged; D018670:Monitoring, Ambulatory; D011446:Prospective Studies; D012890:Sleep
D001786:Blood Glucose; D007004:Hypoglycemic Agents; D007328:Insulin
Artificial pancreas; Closed loop; Continuous subcutaneous insulin infusion; Insulin pumps; Type 1 diabetes