Manual Closed-Loop Insulin Delivery Using a Saddle Point Model Predictive Control Algorithm: Results of a Crossover Randomized Overnight Study

Abstract : Background: The purpose was to assess the efficacy of a new closed-loop algorithm (Saddle Point Model Predictive Control, SP-MPC) in achieving nocturnal normoglycemia while reducing the risk of hypoglycemia in patients with type 1 diabetes. Method: In this randomized crossover study, 10 adult patients (mean hemoglobin A1c 7.35 ± 1.04%) were assigned to be treated overnight by open loop using sensor-augmented pump therapy (open-loop SAP) or manual closed-loop delivery. During closed loop, insulin doses were calculated using the SP-MPC algorithm and administered as manual boluses every 15 minutes from 9:00 pm to 8:00 am. Patients consumed a self-selected meal (65-125 g of carbohydrates) at 7:00 pm accompanied by their usual prandial bolus. Blood glucose was measured every 30 minutes. The primary endpoints were the time spent in target (70-145 mg/dl) and time spent below 70 mg/dl from 11:00 pm to 8:00 am. Results: Time spent in target did not differ between closed-loop and open-loop SAP. The number of hypoglycemic events (more than 70 mg/dl) was reduced 2.8-fold in closed loop (n = 5, median = 0/patient/hour; interquartile range: 0-0.11) as compared to open-loop SAP (n = 14, median = 0.22/patient/hour, 0.02-0.22) (P =.02). The area under the curve for sensor glucose values >145 mg/dl was significantly lower during closed-loop than during open-loop SAP (P =.03) as well as HBGI (P =.02). Conclusions: This pilot study suggests that the use of the SP-MPC algorithm may improve mean overnight glucose control and reduce the number of hypoglycemic events as compared to SAP therapy. © 2016 Diabetes Technology Society.
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Journal of Diabetes Science and Technology, 2017, 11 (5), pp.1007-1014. 〈10.1177/1932296817717503〉
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Soumis le : mercredi 11 octobre 2017 - 11:59:29
Dernière modification le : mercredi 16 mai 2018 - 11:23:51

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I. Guilhem, M. Penet, A. Paillard, M. Carpentier, A. Esvant, et al.. Manual Closed-Loop Insulin Delivery Using a Saddle Point Model Predictive Control Algorithm: Results of a Crossover Randomized Overnight Study. Journal of Diabetes Science and Technology, 2017, 11 (5), pp.1007-1014. 〈10.1177/1932296817717503〉. 〈hal-01614703〉

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