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

Amin Sharifi, Martin I. De Bock, Dilshani Jayawardene, Margaret M. Loh, Jodie C. Horsburgh, Carolyn L. Berthold, Nirubasini Paramalingam, Leon A. Bach, Peter G. Colman, Elizabeth A. Davis, Benyamin Grosman, Christel Hendrieckx, Alicia J Jenkins, Kavita Kumareswaran, Natalie Kurtz, Andrew Kyoong, Richard J MacIsaac, Jane Speight, Steven L. Trawley, Glenn M. WardAnirban Roy, Timothy W Jones, David N O'Neal

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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.

Original languageEnglish
Pages (from-to)772-783
Number of pages12
JournalDiabetes Technology and Therapeutics
Volume18
Issue number12
DOIs
Publication statusPublished - 1 Dec 2016

Keywords

  • Artificial pancreas
  • Closed loop
  • Continuous subcutaneous insulin infusion
  • Insulin pumps
  • Type 1 diabetes

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