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. Ward & 3 others Anirban Roy, Timothy W Jones, David N O'Neal

Research output: Contribution to journalArticleResearchpeer-review

31 Citations (Scopus)

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

Cite this

Sharifi, Amin ; De Bock, Martin I. ; Jayawardene, Dilshani ; Loh, Margaret M. ; Horsburgh, Jodie C. ; Berthold, Carolyn L. ; Paramalingam, Nirubasini ; Bach, Leon A. ; Colman, Peter G. ; Davis, Elizabeth A. ; Grosman, Benyamin ; Hendrieckx, Christel ; Jenkins, Alicia J ; Kumareswaran, Kavita ; Kurtz, Natalie ; Kyoong, Andrew ; MacIsaac, Richard J ; Speight, Jane ; Trawley, Steven L. ; Ward, Glenn M. ; Roy, Anirban ; Jones, Timothy W ; O'Neal, David N. / 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. In: Diabetes Technology and Therapeutics. 2016 ; Vol. 18, No. 12. pp. 772-783.
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title = "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",
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.",
keywords = "Artificial pancreas, Closed loop, Continuous subcutaneous insulin infusion, Insulin pumps, Type 1 diabetes",
author = "Amin Sharifi and {De Bock}, {Martin I.} and Dilshani Jayawardene and Loh, {Margaret M.} and Horsburgh, {Jodie C.} and Berthold, {Carolyn L.} and Nirubasini Paramalingam and Bach, {Leon A.} and Colman, {Peter G.} and Davis, {Elizabeth A.} and Benyamin Grosman and Christel Hendrieckx and Jenkins, {Alicia J} and Kavita Kumareswaran and Natalie Kurtz and Andrew Kyoong and MacIsaac, {Richard J} and Jane Speight and Trawley, {Steven L.} and Ward, {Glenn M.} and Anirban Roy and Jones, {Timothy W} and O'Neal, {David N}",
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doi = "10.1089/dia.2016.0288",
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journal = "Diabetes Technology and Therapeutics",
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Sharifi, A, De Bock, MI, Jayawardene, D, Loh, MM, Horsburgh, JC, Berthold, CL, Paramalingam, N, Bach, LA, Colman, PG, Davis, EA, Grosman, B, Hendrieckx, C, Jenkins, AJ, Kumareswaran, K, Kurtz, N, Kyoong, A, MacIsaac, RJ, Speight, J, Trawley, SL, Ward, GM, Roy, A, Jones, TW & O'Neal, DN 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', Diabetes Technology and Therapeutics, vol. 18, no. 12, pp. 772-783. https://doi.org/10.1089/dia.2016.0288

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

In: Diabetes Technology and Therapeutics, Vol. 18, No. 12, 01.12.2016, p. 772-783.

Research output: Contribution to journalArticleResearchpeer-review

TY - JOUR

T1 - 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

T2 - A Randomized Crossover Study

AU - Sharifi, Amin

AU - De Bock, Martin I.

AU - Jayawardene, Dilshani

AU - Loh, Margaret M.

AU - Horsburgh, Jodie C.

AU - Berthold, Carolyn L.

AU - Paramalingam, Nirubasini

AU - Bach, Leon A.

AU - Colman, Peter G.

AU - Davis, Elizabeth A.

AU - Grosman, Benyamin

AU - Hendrieckx, Christel

AU - Jenkins, Alicia J

AU - Kumareswaran, Kavita

AU - Kurtz, Natalie

AU - Kyoong, Andrew

AU - MacIsaac, Richard J

AU - Speight, Jane

AU - Trawley, Steven L.

AU - Ward, Glenn M.

AU - Roy, Anirban

AU - Jones, Timothy W

AU - O'Neal, David N

PY - 2016/12/1

Y1 - 2016/12/1

N2 - 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.

AB - 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.

KW - Artificial pancreas

KW - Closed loop

KW - Continuous subcutaneous insulin infusion

KW - Insulin pumps

KW - Type 1 diabetes

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U2 - 10.1089/dia.2016.0288

DO - 10.1089/dia.2016.0288

M3 - Article

VL - 18

SP - 772

EP - 783

JO - Diabetes Technology and Therapeutics

JF - Diabetes Technology and Therapeutics

SN - 1520-9156

IS - 12

ER -