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Diabetes Care. 2016 Jul;39(7):1180-5. doi: 10.2337/dc15-2815. Epub 2016 May 10.

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

Author information

1
Department of Information Engineering, University of Padua, Padua, Italy.
2
Unit of Metabolic Diseases, Department of Internal Medicine, University of Padua, Padua, Italy.
3
Department of Civil Engineering and Architecture, University of Pavia, Pavia, Italy.
4
Department of Pediatrics, University of Turin, Turin, Italy.
5
Pediatric Department and Diabetes Research Institute, Scientific Institute, Hospital San Raffaele, Milan, Italy.
6
Pediatric Diabetes and Metabolic Disorders Unit, Regional Center for Pediatric Diabetes, Azienda Ospedaliera Universitaria Integrata of Verona, Verona, Italy.
7
Department of Pediatrics, Second University of Naples, Naples, Italy.
8
Unit of Endocrinology and Diabetes, Bambino Gesù Children's Hospital, Rome, Italy.
9
Department of Women's and Children's Health, University of Padua, Padua, Italy.
10
Department of Electrical, Computer and Biomedical Engineering, University of Pavia, Pavia, Italy.
11
Pediatric Diabetology Unit, Policlinico di Tor Vergata, University of Rome Tor Vergata, Rome, Italy.
12
Center for Diabetes Technology, University of Virginia, Charlottesville, VA.
13
Department of Information Engineering, University of Padua, Padua, Italy cobelli@dei.unipd.it.

Abstract

OBJECTIVE:

The Pediatric Artificial Pancreas (PedArPan) project tested a children-specific version of the modular model predictive control (MMPC) algorithm in 5- to 9-year-old children during a camp.

RESEARCH DESIGN AND METHODS:

A 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 sensor-augmented pump (SAP).

RESULTS:

Overnight 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 = 0.002), without a significant change of time-in-target, mean: 56.0% (SD 22.5) vs. 59.7% (21.2) (P = 0.430), but with increased mean glucose 173 mg/dL (36) vs. 150 mg/dL (39) (P = 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 = 0.022) and increased mean glucose 169 mg/dL (23) vs. 147 mg/dL (23) (P < 0.001).

CONCLUSIONS:

This 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.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT02620878.

PMID:
27208335
DOI:
10.2337/dc15-2815
[Indexed for MEDLINE]

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