TY - JOUR
T1 - In-Clinic Evaluation of the MiniMed 670G System "suspend before Low" Feature in Children with Type 1 Diabetes
AU - Wood, Michael A.
AU - Shulman, Dorothy I.
AU - Forlenza, Gregory P.
AU - Bode, Bruce W.
AU - Pinhas-Hamiel, Orit
AU - Buckingham, Bruce A.
AU - Kaiserman, Kevin B.
AU - Liljenquist, David R.
AU - Bailey, Timothy S.
AU - Shin, John
AU - Huang, Suiying
AU - Chen, Xiaoxiao
AU - Cordero, Toni L.
AU - Lee, Scott W.
AU - Kaufman, Francine R.
N1 - Publisher Copyright:
© 2018, Mary Ann Liebert, Inc.
PY - 2018/11
Y1 - 2018/11
N2 - Background: The Medtronic predictive low-glucose management (PLGM) algorithm automatically stops insulin delivery when sensor glucose (SG) is predicted to reach or fall below a preset low-glucose value within the next 30 min, and resumes delivery after hypoglycemia recovery. The present study evaluated the PLGM algorithm performance of the MiniMed™ 670G system SmartGuard™ "suspend before low" feature in children aged 7-13 years with type 1 diabetes (T1D). Method: Participants (N = 105, mean ± standard deviation of 10.8 ± 1.8 years) underwent an overnight in-clinic evaluation of the "suspend before low" feature with a preset low limit of 65 mg/dL. After exercise, frequent sample testing (FST) was conducted every 5 min if values were <70 mg/dL; every 15 min if 70-80 mg/dL; and every 30 min if >80 mg/dL. First-day performance of the Guardian™ Sensor 3 glucose sensor and continuous glucose monitoring system was also evaluated. Results: Activation of the "suspend before low" feature occurred in 79 of the 105 participants, 79.7% (63/79) did not result in SG falling below 65 mg/dL. Mean glucose at activation was 102 ± 19 mg/dL and the initial insulin suspension duration was 87.5 ± 32.7 min. Four hours after insulin resumption, mean reference glucose was 130 ± 42 mg/dL. Mean absolute relative difference between the FST reference glucose and SG values on the first day of sensor wear was 11.4%. For the 26 participants in whom the "suspend before low" feature did not activate, none involved a reference glucose value ≤65 mg/dL, suggesting that the PLGM algorithm performed as intended. Conclusion: In children aged 7-13 years with T1D, the "suspend before low" feature of the MiniMed 670G system demonstrated a hypoglycemia prevention rate of nearly 80% after exercise and did not involve rebound hyperglycemia. There were no events of severe hypoglycemia during the evaluation.
AB - Background: The Medtronic predictive low-glucose management (PLGM) algorithm automatically stops insulin delivery when sensor glucose (SG) is predicted to reach or fall below a preset low-glucose value within the next 30 min, and resumes delivery after hypoglycemia recovery. The present study evaluated the PLGM algorithm performance of the MiniMed™ 670G system SmartGuard™ "suspend before low" feature in children aged 7-13 years with type 1 diabetes (T1D). Method: Participants (N = 105, mean ± standard deviation of 10.8 ± 1.8 years) underwent an overnight in-clinic evaluation of the "suspend before low" feature with a preset low limit of 65 mg/dL. After exercise, frequent sample testing (FST) was conducted every 5 min if values were <70 mg/dL; every 15 min if 70-80 mg/dL; and every 30 min if >80 mg/dL. First-day performance of the Guardian™ Sensor 3 glucose sensor and continuous glucose monitoring system was also evaluated. Results: Activation of the "suspend before low" feature occurred in 79 of the 105 participants, 79.7% (63/79) did not result in SG falling below 65 mg/dL. Mean glucose at activation was 102 ± 19 mg/dL and the initial insulin suspension duration was 87.5 ± 32.7 min. Four hours after insulin resumption, mean reference glucose was 130 ± 42 mg/dL. Mean absolute relative difference between the FST reference glucose and SG values on the first day of sensor wear was 11.4%. For the 26 participants in whom the "suspend before low" feature did not activate, none involved a reference glucose value ≤65 mg/dL, suggesting that the PLGM algorithm performed as intended. Conclusion: In children aged 7-13 years with T1D, the "suspend before low" feature of the MiniMed 670G system demonstrated a hypoglycemia prevention rate of nearly 80% after exercise and did not involve rebound hyperglycemia. There were no events of severe hypoglycemia during the evaluation.
KW - Automated insulin delivery
KW - Hybrid closed loop
KW - Hypoglycemia
KW - Insulin pump suspension
KW - Pediatrics
KW - Predictive low glucose management
KW - Type 1 diabetes
UR - http://www.scopus.com/inward/record.url?scp=85055782784&partnerID=8YFLogxK
U2 - 10.1089/dia.2018.0209
DO - 10.1089/dia.2018.0209
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C2 - 30299976
AN - SCOPUS:85055782784
SN - 1520-9156
VL - 20
SP - 731
EP - 737
JO - Diabetes Technology and Therapeutics
JF - Diabetes Technology and Therapeutics
IS - 11
ER -