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 language | English |
|---|---|
| Pages (from-to) | 772-783 |
| Number of pages | 12 |
| Journal | Diabetes Technology and Therapeutics |
| Volume | 18 |
| Issue number | 12 |
| DOIs | |
| Publication status | Published - 1 Dec 2016 |
Keywords
- Artificial pancreas
- Closed loop
- Continuous subcutaneous insulin infusion
- Insulin pumps
- Type 1 diabetes
Cite this
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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 journal › Article › Research › peer-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
UR - http://www.scopus.com/inward/record.url?scp=85006983291&partnerID=8YFLogxK
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 -