Randomized Summer Camp Crossover Trial in 5- to 9-Year-Old Children: Outpatient Wearable Artificial Pancreas Is Feasible and Safe
Open accessAbstract
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 (25th–75th 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.
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In July 2016, Diabetes Care published a symposium featuring several outpatient AID studies using DiAs running in two different in silico designed algorithm configurations.
“In July 2016, Diabetes Care published a symposium, 129 which featured several outpatient AID studies using DiAs running in two different in silico designed algorithm configurations.[123][124][125]”
From Developing the UVA/Padova Type 1 Diabetes Simulator: Modeling, Validation, Refinements, and Utility (2023) · cites this paper as [125]
The Study Oversight section describes one outpatient artificial-pancreas trial using a children-specific MMPC algorithm running on DiAs. The paper therefore supports citing it as an example of such a study, but our copy does not establish that Diabetes Care published a July 2016 symposium or that the studies collectively used two algorithm configurations. (LLM, conf=0.86)
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Self-citation
- Authors
- Del Favero, S., Boscari, F., Messori, M., Rabbone, I., Bonfanti, R., Sabbion, A., Iafusco, D., Schiaffini, R., Visentin, R., Calore, R., Moncada, Y. L., Galasso, S., Galderisi, A., Vallone, V., Di Palma, F., Losiouk, E., Lanzola, G., Tinti, D., Rigamonti, A., Marigliano, M., Zanfardino, A., Rapini, N., Avogaro, A., Chernavvsky, D., Magni, L., Cobelli, C., & Bruttomesso, D.
- Affiliations
- Department of Information Engineering, University of Padua, Padua, Italy
- University of Padua (IT)
- University of Pavia (IT)
- University of Turin (IT)
- IRCCS Ospedale San Raffaele (IT)
- Azienda Ospedaliera Universitaria Integrata Verona (IT)
- University of Campania "Luigi Vanvitelli" (IT)
- Bambino Gesù Children's Hospital (IT)
- Department of Civil Engineering and Architecture, University of Pavia, Pavia, Italy
- University of Rome Tor Vergata (IT)
- Center for Diabetes Technology, University of Virginia, Charlottesville, VA
- Corresponding author
- Cobelli, Claudio
- ORCID
- Boscari, Federico
- Messori, Mirko
- Rabbone, Ivana
- Bonfanti, Riccardo
- Iafusco, Dario
- Schiaffini, Riccardo
- Visentin, Roberto
- Galderisi, Alfonso
- Vallone, Valeria
- Losiouk, Eleonora
- Lanzola, Giordano
- Tinti, Davide
- Rigamonti, Andrea
- Marigliano, Marco
- Zanfardino, Angela
- Rapini, Novella
- Avogaro, Angelo
- Magni, Lalo
- Cobelli, Claudio
- Bruttomesso, Daniela
- Venue
- Diabetes Care
- Publisher
- American Diabetes Association
- Published
- 2016-03-25
- Volume
- 39
- Issue
- 7
- Pages
- 1180-1185
- ISSN
- 0149-5992 (ISSN-L)
- 1935-5548
- OpenAlex
- W2367971280
- Cited by
- 94
- References
- 16
- Citations by year
- 2026: 1 · 2025: 5 · 2024: 4 · 2023: 3 · 2022: 6 · 2021: 5 · 2020: 9 · 2019: 16 · 2018: 21 · 2017: 18 · 2016: 6
- FWCI
- 20.42
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Diabetes Care (publishedVersion)
- PubMed (publishedVersion)
- Archivio Istituzionale della Ricerca - Università degli Studi della Campania "Luigi Vanvitelli" (submittedVersion, public-domain)
- Archivio Istituzionale della Ricerca - Università Vita-Salute San Raffaele (submittedVersion)
- Institutional Research Information System University of Turin (University of Turin) (submittedVersion)
- Padua Research Archive (University of Padova) (submittedVersion)
- Funders
- Generalitat de Catalunya
- Università degli Studi di Padova
- Agència de Gestió d'Ajuts Universitaris i de Recerca
- Topics
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Genetics › Diabetes and associated disorders
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Education
- Keywords
- type 1 diabetes, artificial pancreas, children, summer camps, sensor-augmented pump, hypoglycemia, glycemic control, time in target, feasibility and safety
- MeSH terms
- Algorithms, Blood Glucose, Child, Child, Preschool, Diabetes Mellitus, Type 1, Feasibility Studies, Female, Humans, Hypoglycemia, Hypoglycemic Agents, Insulin, Insulin Infusion Systems, Male, Cross-Over Studies, Pancreas, Artificial
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