2 month evening and night closed-loop glucose control in patients with type 1 diabetes under free-living conditions: a randomised crossover trial

Kropff, Jort; Favero, Simone Del; Place, Jérôme; Toffanin, Chiara; Visentin, Roberto; Monaro, Marco; Messori, Mirko; Palma, Federico Di; Lanzola, Giordano; Farret, Anne; Boscari, Federico; Galasso, Silvia; Magni, Paolo; Avogaro, Angelo; Keith-Hynes, Patrick; Kovatchev, Boris; Bruttomesso, Daniela; Cobelli, Claudio; DeVries, J. Hans; Renard, Éric; Magni, Lalo

doi:10.1016/s2213-8587(15)00335-6

Cited by 194 publications

(142 citation statements)

References 30 publications

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“…Another reason for worse mean glucose and time-in-target during the AP is the prudent-by-design tuning of the algorithm, because this trial was the first with the children-specific version of our MMPC algorithm, previously tested only in adults (10,14,15).The data collected in this camp trial will allow a more effective tuning of the algorithm, thus likely improving its efficacy.…”

Section: Discussionmentioning

confidence: 99%

“…Thus, 30 patients (19 boys and 11 girls) completed the study: age, 7.6 years (SD 1.2); body weight, 26.0 kg (6.1); height, 123 cm (8); BMI, 16.9 kg/m 2 (2.1), BMI z-score, 20.09 (0.91); HbA 1c , 7.3% (0.9) (57 mmol/mol [10]); duration of diabetes, 4.7 years (1.6); pump users for 3.3 years (1.9), and total daily insulin, 20.3 units (6.2) (0.78 units/kg per day [0.16]).…”

Section: Participantsmentioning

confidence: 99%

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Randomized Summer Camp Crossover Trial in 5- to 9-Year-Old Children: Outpatient Wearable Artificial Pancreas Is Feasible and Safe

et al. 2016

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OBJECTIVEThe Pediatric Artificial Pancreas (PedArPan) project tested a children-specific version of the modular model predictive control (MMPC) algorithm in 5-to 9-yearold children during a camp. RESEARCH DESIGN AND METHODSA total of 30 children, 5-to 9-years old, with type 1 diabetes completed an outpatient, open-label, randomized, crossover trial. Three days with an artificial pancreas (AP) were compared with three days of parent-managed sensoraugmented pump (SAP). RESULTSOvernight time-in-hypoglycemia was reduced with the AP versus SAP, median (25 th -75 th percentiles): 0.0% (0.0-2.2) vs. 2.2% (0.0-12.3) (P 5 0.002), without a significant change of time-in-target, mean: 56.0% (SD 22.5) vs. 59.7% (21.2) (P 5 0.430), but with increased mean glucose 173 mg/dL (36) vs. 150 mg/dL (39) (P 5 0.002). Overall, the AP granted a threefold reduction of time-in-hypoglycemia (P < 0.001) at the cost of decreased time-in-target, 56.8% (13.5) vs. 63.1% (11.0) (P 5 0.022) and increased mean glucose 169 mg/dL (23) vs. 147 mg/dL (23) (P < 0.001). CONCLUSIONSThis trial, the first outpatient single-hormone AP trial in a population of this age, shows feasibility and safety of MMPC in young children. Algorithm retuning will be performed to improve efficacy.Only three artificial pancreas (AP) trials have focused on the prepubertal population so far: two single-hormone AP studies, performed inpatient for less than 1 day (1,2) and a recent dual-hormone AP study, performed in a camp for 5 days (3). Here we report the first outpatient single-hormone AP trial focusing on 5-to 9-year-old children.Data were collected in the Pediatric Artificial Pancreas (PedArPan) camp, where sensor-augmented pump (SAP) therapy was compared with the modular model predictive control algorithm (MMPC) (4,5), running on the wearable platform Diabetes Assistant (DiAs) (6).

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Section: Discussionmentioning

confidence: 99%

Section: Participantsmentioning

confidence: 99%

Randomized Summer Camp Crossover Trial in 5- to 9-Year-Old Children: Outpatient Wearable Artificial Pancreas Is Feasible and Safe

et al. 2016

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“…To this end, a smartphone-based AP platform (currently, for the development phase of the Diabetes Assistant (DiAS) platform, the smartphone is employed as a dedicated controller, and no other phone-related functions are permitted) (DiAS; University of Virginia, Charlottesville, VA, USA) has been developed [22] and evaluated in outpatient studies [10,[23][24][25][26]. Extended studies involving a two-month evening and night closed-loop control study have also been performed [27]. Results from these studies indicate that the developed platform is reliable in terms of computational efficiency and safety.…”

Section: Hardware Configurations Of the Ap Systemmentioning

confidence: 99%

Embedded Control in Wearable Medical Devices: Application to the Artificial Pancreas

et al. 2016

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Significant increases in processing power, coupled with the miniaturization of processing units operating at low power levels, has motivated the embedding of modern control systems into medical devices. The design of such embedded decision-making strategies for medical applications is driven by multiple crucial factors, such as: (i) guaranteed safety in the presence of exogenous disturbances and unexpected system failures; (ii) constraints on computing resources; (iii) portability and longevity in terms of size and power consumption; and (iv) constraints on manufacturing and maintenance costs. Embedded control systems are especially compelling in the context of modern artificial pancreas systems (AP) used in glucose regulation for patients with type 1 diabetes mellitus (T1DM). Herein, a review of potential embedded control strategies that can be leveraged in a fully-automated and portable AP is presented. Amongst competing controllers, emphasis is provided on model predictive control (MPC), since it has been established as a very promising control strategy for glucose regulation using the AP. Challenges involved in the design, implementation and validation of safety-critical embedded model predictive controllers for the AP application are discussed in detail. Additionally, the computational expenditure inherent to MPC strategies is investigated, and a comparative study of runtime performances and storage requirements among modern quadratic programming solvers is reported for a desktop environment and a prototype hardware platform.

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“…Closed-loop insulin delivery systems have recently been demonstrated to be safe and efficient in summer camps [11] and free-living conditions [12][13][14][15][16]. Data on closed-loop insulin delivery during physical activity is scarce [17,18], particularly in children and adolescents.…”

Section: Introductionmentioning

confidence: 99%

Closed-loop glucose control in young people with type 1 diabetes during and after unannounced physical activity: a randomised controlled crossover trial

et al. 2017

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Aims/hypothesis Hypoglycaemia during and after exercise remains a challenge. The present study evaluated the safety and efficacy of closed-loop insulin delivery during unannounced (to the closed-loop algorithm) afternoon physical activity and during the following night in young people with type 1 diabetes. Methods A randomised, two-arm, open-label, in-hospital, crossover clinical trial was performed at a single site in Slovenia. The order was randomly determined using an automated web-based programme with randomly permuted blocks of four. Allocation assignment was not masked. Children and adolescents with type 1 diabetes who were experienced insulin pump users were eligible for the trial. During four separate in-hospital visits, the participants performed two unannounced exercise protocols: moderate intensity (55% of V Á O 2max ) and moderate intensity with integrated highintensity sprints (55/80% of V Á O 2max ), using the same study device either for closed-loop or open-loop insulin delivery. We investigated glycaemic control during the exercise period and the following night. The closed-loop insulin delivery was applied from 15:00 h on the day of the exercise to 13:00 h on the following day.Results Between 20 January and 16 June 2016, 20 eligible participants (9 female, mean age 14.2 ± 2.0 years, HbA 1c 7.7 ± 0.6% [60.0 ± 6.6 mmol/mol]) were included in the trial and performed all trial-mandated activities. The median proportion of time spent in hypoglycaemia below 3.3 mmol/l was 0.00% for both treatment modalities (p = 0.7910). Use of the closed-loop insulin delivery system increased the proportion of time spent within the target glucose range of 3.9-10 mmol/l when compared with open-loop delivery: 84.1% (interquartile range 70.0-85.5) vs 68.7% (59.0-77.7), respectively (p = 0.0057), over the entire study period. This was achieved with significantly less insulin delivered via the closed-loop (p = 0.0123). Conclusions/interpretation Closed-loop insulin delivery was safe both during and after unannounced exercise protocols in the in-hospital environment, maintaining glucose values mostly within the target range without an increased risk of hypoglycaemia.Trial registration Clinicaltrials.gov NCT02657083 Funding

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2 month evening and night closed-loop glucose control in patients with type 1 diabetes under free-living conditions: a randomised crossover trial

Cited by 194 publications

References 30 publications

Randomized Summer Camp Crossover Trial in 5- to 9-Year-Old Children: Outpatient Wearable Artificial Pancreas Is Feasible and Safe

Randomized Summer Camp Crossover Trial in 5- to 9-Year-Old Children: Outpatient Wearable Artificial Pancreas Is Feasible and Safe

Embedded Control in Wearable Medical Devices: Application to the Artificial Pancreas

Closed-loop glucose control in young people with type 1 diabetes during and after unannounced physical activity: a randomised controlled crossover trial

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