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1. THE SOCIAL ACCEPTANCE OF FUTURE ARTIFICIAL PANCREAS TECHNOLOGY: PARENTS' PERCEPTIONS OF PEDARPAN (PEDIATRICS ARTIFICIAL PANCREAS) in 9th International Conference on Advanced Technologies & Treatment of Diabetes - Barcellona 2016

Author

Troncone A., Bonfanti R., Iafusco D., Rabbone I., Sabbion A., Schiaffini R., Galderisi A., Marigliano M., Rapini N., Rigamonti A., Tinti D., Vallone V., Zanfardino A., Boscari F., Del Favero S., Galasso S., Lanzola G., Messori M., Di Palma F., Visentin R., Calore R., Leal Y., Magni L., Losiouk E., Chernavvsky D., Quaglini S., Cobelli C., Bruttomesso D., Troncone, A., Bonfanti, R., Iafusco, D., Rabbone, I., Sabbion, A., Schiaffini, R., Galderisi, A., Marigliano, M., Rapini, N., Rigamonti, A., Tinti, D., Vallone, V., Zanfardino, A., Boscari, F., Del Favero, S., Galasso, S., Lanzola, G., Messori, M., Di Palma, F., Visentin, R., Calore, R., Leal, Y., Magni, L., Losiouk, E., Chernavvsky, D., Quaglini, S., Cobelli, C., and Bruttomesso, D.

Abstract

Background and Aims: To explore the experiences of parents of 5–8-year-old children with type 1 diabetes participating in a clinical trial regarding artificial pancreas (AP), semistructured interviews, based on the Technology Acceptance Model, were conducted after 3 days of children's treatment. Method: Questions focused on evaluating parents' perceived usefulness of, perceived ease of use of, trust in, and intention to use the new system. Interviews were conducted by a psychologist, and the answers, both audiorecorded and transcribed verbatim, were assessed using qualitative research methods. Results: Altogether, 27 (22 mothers) of 30 parents were interviewed (Table 1), and their overall attitude toward AP was positive (96%). Perceived advantages included stable glucose regulation (52%), better quality of life for children (22%), relief of parents' daily concerns (15%), and reduced need for continual parental monitoring of nocturnal blood glucose (11%), while perceived disadvantages included having to constantly wear a bulky, heavy device (37%) and the risk of technical error (33%). Participants were mostly confident in the positive impact of AP on diabetes control (96%) and in children's, especially older ones', capability to use the system (55%). The reactions of teachers and friends were reported to be generally positive, though some parents (28%) expected an initially fearful reaction from teachers. Nearly all participants expressed trust in AP and in the quality of glucose control (96%), as well as the intention to use the new system when available (100%). Conclusion: Results indicate that, thanks to the psychological and physical benefits of AP, parents expressed a strong likelihood of future acceptance.

Published
2016

2. THE SOCIAL ACCEPTANCE OF FUTURE ARTIFICIAL PANCREAS TECHNOLOGY: PARENTS' PERCEPTIONS OF PEDARPAN (PEDIATRICS ARTIFICIAL PANCREAS)

Author

Troncone, A., Bonfanti, R., Iafusco, D., Rabbone, I., Sabbion, A., Schiaffini, R., Galderisi, A., Marigliano, M., Rapini, N., Rigamonti, A., Tinti, D., Vallone, V., Zanfardino, A., Boscari, F., Del Favero, S., Galasso, S., Lanzola, G., Messori, M., Di Palma, F., Visentin, R., Calore, R., Leal, Y., Magni, L., Eleonora Losiouk, Chernavvsky, D., Quaglini, S., Cobelli, C., Bruttomesso, D., Troncone, Alda, Bonfanti, R, Iafusco, Dario, Rabbone, I, Sabbion, A, Schiaffini, R, Galderisi, A, Marigliano, M, Rapini, N, Rigamonti, A, Tinti, D, Vallone, V, Zanfardino, A, Boscari, F, Del Favero, S, Galasso, S, Lanzola, G, Messori, M, Di Palma, F, Visentin, R, Calore, R, Leal, Y, Magni, L, Losiouk, E, Chernavvsky, D, Quaglini, S, Cobelli, C, and Bruttomesso, D.

Published
2016

3. PERCEIVED UTILITY OF A REMOTE MONITORING SYSTEM FOR PEDIATRIC SUBJECTS AFFECTED BY TYPE 1 DIABETES IN PEDARPAN (PEDIATRICS ARTIFICIAL PANCREAS) SUMMER CAMP in 9th International Conference on Advanced Technologies & Treatment of Diabetes (ATTD) Barcellona 2016

Author

Losiouk E., Lanzola G., Bonfanti R., Iafusco D., Rabbone I., Sabbion A., Schiaffini R., Galderisi A., Marigliano M., Rapini N., Rigamonti A., Tinti D., Vallone V., Zanfardino A., Boscari F., Galasso S., Troncone A., Del Favero S., Visentin R., Calore R., Leal M. Y., Palma F. Di, Messori M., Chernavvsky D., Magni L., Bruttomesso D., Quaglini S., Cobelli C, Losiouk, E., Lanzola, G., Bonfanti, R., Iafusco, D., Rabbone, I., Sabbion, A., Schiaffini, R., Galderisi, A., Marigliano, M., Rapini, N., Rigamonti, A., Tinti, D., Vallone, V., Zanfardino, A., Boscari, F., Galasso, S., Troncone, A., Del Favero, S., Visentin, R., Calore, R., Leal, M. Y., Palma F., Di, Messori, M., Chernavvsky, D., Magni, L., Bruttomesso, D., Quaglini, S., and Cobelli, C

Published
2016

4. MULTI-CENTER RANDOMIZED CROSS-OVER ITALIAN PEDIATRIC SUMMER CAMP: AP VS SAP IN 5–9 YEAR OLD CHILDREN in 9th International Conference on Advanced Technologies & Treatment of Diabetes (ATTD) Barcellona 2016

Author

Del Favero S., Boscari F., Messori M., Rabbone I., Bonfanti R., Sabbion A., Iafusco D., Schiaffini R., Visentin R., Calore R., Leal Y., Galasso S., Galderisi A., Vallone V., Di Palma F., Losiouk E., Lanzola G., Tinti T., Rigamonti A., Marigliano M., Zanfardino A., Rapini N., Avogaro A., Chernavvsky D., Magni L., Cobelli C., Bruttomesso D., Del Favero, S., Boscari, F., Messori, M., Rabbone, I., Bonfanti, R., Sabbion, A., Iafusco, D., Schiaffini, R., Visentin, R., Calore, R., Leal, Y., Galasso, S., Galderisi, A., Vallone, V., Di Palma, F., Losiouk, E., Lanzola, G., Tinti, T., Rigamonti, A., Marigliano, M., Zanfardino, A., Rapini, N., Avogaro, A., Chernavvsky, D., Magni, L., Cobelli, C., and Bruttomesso, D.

Abstract

Background and Aims: The Artificial Pancreas (AP) system based on the Modular Model Predictive Control algorithm (MMPC) running on the wearable platform Diabetes Assistant (DiAs, University of Virginia) has been successfully used for 2 months in adults patients reducing time-in-hypo (CGM

Published
2016

5. The artificial pancreas in children: First tests in Italy

Author

Boscari F., Del Favero S., Messori M., Rabbone I., Bonfanti R., Sabbion A., Iafusco D., Schiaffini R., Visentin R., Calore R., Leal Y., 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., Boscari, F., Del Favero, S., Messori, M., Rabbone, I., Bonfanti, R., Sabbion, A., Iafusco, D., Schiaffini, R., Visentin, R., Calore, R., Leal, Y., 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., and Bruttomesso, D.

Subjects
Artificial pancreas, Hypoglycemia, Type 1 diabetes mellitus in children
Abstract

Background. The artificial pancreas (AP) system based on the Modular Model Predictive Control algorithm (MMPC) running on the wearable platform Diabetes Assistant (DiAs) has been used in adult outpatients with type 1 diabetes (T1D), reducing the time spent in hypoglycemia and increasing the time spent in the near-normal range of 70-180 mg/dl compared to Sensor Augmented Pump therapy (SAP). Objective. In the PEDiatric ARtificial PANcreas (PedArPan) project we tested a children-specific version of the MMPC on DiAs in 5-9 yearold children during a summer camp. This is the first outpatient AP trial in a population of this age. Study design and methods. Thirty 5-9 year-old children with T1D and their parents were recruited from five Italian pediatric centers and completed an open label, randomized, crossover trial in a summer camp (supervised outpatient setting). Glucose control in three days of AP use was compared with three days of parent-managed SAP. Results. Overnight (00:00-07:30). The AP significantly reduced time-in-hypo compared to SAP, 0% [0.00-2.22] vs. 2.19% [0.00- 12.30], p = 0.002, with no significant difference in time-in-target (70-180 mg/dl), 55.97% (22.53) vs. 59.69% (21.24), p = 0.430, or time-in-tight-target (80-140 mg/dl), 31.27% (20.23) vs. 33.02% (19.80), p = 0.694. Overall (00:00-24:00). There was a threefold reduction of time-in-hypo, 2.02% [1.17-4.54] vs. 6.67% [2.26-11.54], p < 0.001, with AP at the expense of some deterioration of time-in-target, 56.79% (13.47) vs. 63.09% (10.98), p = 0.022. Conclusions. This study showed the feasibility and safety of a wearable MMPC in young children. Next steps will include overnight testing at home and re-tuning the algorithm to boost efficacy during daytime.

Published
2016

6. Il pancreas artificiale in età pediatrica: Prima esperienza Italiana

Author

Federico Boscari, Simone Del Favero, Messori, M., Rabbone, I., Bonfanti, R., Sabbion, Alberto, Iafusco, D., Schiaffini, R., Roberto Visentin, Calore, R., Leal Moncada, Yenny Teresa, Galasso, S., Alfonso Galderisi, Vallone, V., Di Palma, F., Eleonora Losiouk, Lanzola, G., Tinti, D., Rigamonti, A., Marigliano, M., Zanfardino, A., Rapini, N., ANGELO AVOGARO, Chernavvsky, Daniel, Magni, L., Claudio Cobelli, Bruttomesso, Daniela, Boscari, F, Del Favero, S., Messori, M., Rabbone, I., Bonfanti, R., Sabbion, A., Iafusco, Dario, Schiaffini, R., Visentin, R., Calore, R., Leal, Y., 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., and Bruttomesso, Daniela

Subjects
Diabetes and Metabolism, Endocrinology, Endocrinology, Diabetes and Metabolism, Artificial pancreas, Hypoglycemia, Type 1 diabetes mellitus in children, Internal Medicine, Artificial pancrea
Abstract

Background. The artificial pancreas (AP) system based on the Modular Model Predictive Control algorithm (MMPC) running on the wearable platform Diabetes Assistant (DiAs) has been used in adult outpatients with type 1 diabetes (T1D), reducing the time spent in hypoglycemia and increasing the time spent in the near-normal range of 70-180 mg/dl compared to Sensor Augmented Pump therapy (SAP). Objective. In the PEDiatric ARtificial PANcreas (PedArPan) project we tested a children-specific version of the MMPC on DiAs in 5-9 yearold children during a summer camp. This is the first outpatient AP trial in a population of this age. Study design and methods. Thirty 5-9 year-old children with T1D and their parents were recruited from five Italian pediatric centers and completed an open label, randomized, crossover trial in a summer camp (supervised outpatient setting). Glucose control in three days of AP use was compared with three days of parent-managed SAP. Results. Overnight (00:00-07:30). The AP significantly reduced time-in-hypo compared to SAP, 0% [0.00-2.22] vs. 2.19% [0.00- 12.30], p = 0.002, with no significant difference in time-in-target (70-180 mg/dl), 55.97% (22.53) vs. 59.69% (21.24), p = 0.430, or time-in-tight-target (80-140 mg/dl), 31.27% (20.23) vs. 33.02% (19.80), p = 0.694. Overall (00:00-24:00). There was a threefold reduction of time-in-hypo, 2.02% [1.17-4.54] vs. 6.67% [2.26-11.54], p < 0.001, with AP at the expense of some deterioration of time-in-target, 56.79% (13.47) vs. 63.09% (10.98), p = 0.022. Conclusions. This study showed the feasibility and safety of a wearable MMPC in young children. Next steps will include overnight testing at home and re-tuning the algorithm to boost efficacy during daytime.

Published
2016

7. Closing the Loop

Author

Revital, Nimri, Nathan, Murray, Alexander, Ochs, Jordan, E Pinsker, Eyal, Dassau, Pinsker, Je, Lee, Jb, Dassau, E, Seborg, De, Bradley, Pk, Gondhalekar, R, Bevier, Wc, Huyett, L, Zisser, Hc, FJ Doyle III, DEL FAVERO, Simone, Boscari, F, Messori, M, Rabbone, I, Bonfanti, R, Sabbion, A, Iafusco, D, Schiaffini, R, Visentin, R, Calore, R, Moncada, Yl, Galasso, S, Galderisi, A, Vallone, V, DI PALMA, Federico, Losiouk, E, Lanzola, G, Tinti, D, Rigamonti, A, Marigliano, M, Zanfardino, A, Rapini, N, Avogaro, A, Chernavvsky, D, Magni, L, Cobelli, C, Bruttomesso, D, Sherr, Jl, Patel, Ns, Michaud, Ci, Palau-Collazo, Mm, MA Van Name, Tamborlane, Wv, Cengiz, E, Carria, Lr, Tichy, Em, Weinzimer, Sa, Renard, E, Farret, A, Kropff, J, Place, J, Toffanin, C, Magni, P, Keith-Hynes, P, Kovatchev, B, Devries, Jh, AP@ home Consortium, Gingras, V, Haidar, A, Messier, V, Legault, L, Ladouceur, M, Rabasa-Lhoret, R, Tt, Ly, Maahs, Dm, Roy, A, Grosman, B, Cantwell, M, Kurtz, N, Carria, L, Messer, L, R von Eyben, Buckingham, Ba, Ruan, Y, Thabit, H, Leelarathna, L, Hartnell, S, Willinska, Me, Dellweg, S, Benesch, C, Mader, Jk, Holzer, M, Kojzar, H, Evans, Ml, Pieber, Tr, Arnolds, S, Hovorka, R, Tauschmann, M, Allen, Jm, Wilinska, Me, Stewart, Z, Cheng, P, Kollman, C, Acerini, Cl, Dunger, Db, Monaro, M, Kovatchev, Bp, AP@ home consortium1, and Heinemann, L

Published
2017

11. PERCEIVED UTILITY OF A REMOTE MONITORING SYSTEM FOR PEDIATRIC SUBJECTS AFFECTED BY TYPE 1 DIABETES IN PEDARPAN (PEDIATRICS ARTIFICIAL PANCREAS) SUMMER CAMP

Author

Losiouk, E., Lanzola, G., Bonfanti, R., Iafusco, D., Rabbone, I., Sabbion, A., Schiaffini, R., Alfonso Galderisi, Marigliano, M., Rapini, N., Rigamonti, A., Tinti, D., Vallone, V., Zanfardino, A., Boscari, F., Galasso, S., Troncone, A., Simone Del Favero, Roberto Visentin, Calore, R., Leal, My, Di Palma, F., Messori, M., Chernavvsky, D., Magni, L., Bruttomesso, D., Quaglini, S., Claudio Cobelli, By:losiouk, E, Lanzola, G, Bonfanti, R, Iafusco, Dario, Rabbone, I, Sabbion, A, Schiaffini, R, Galderisi, A, Marigliano, M, Rapini, N, Rigamonti, A, Tinti, D, Vallone, V, Zanfardino, A, Boscari, F, Galasso, S, Troncone, Alda, Del Favero, S, Visentin, R, Calore, R, Leal, My, Di Palma, F, Messori, M, Chernavvsky, D, Magni, L, Bruttomesso, D, Quaglini, S, and Cobelli, C.

12. The artificial pancreas in children: First tests in Italy,Il pancreas artificiale in età pediatrica: Prima esperienza Italiana

Author

Boscari, F., Del Favero, S., Messori, M., Rabbone, I., Bonfanti, R., Sabbion, A., Iafusco, D., Schiaffini, R., Visentin, R., Calore, R., Leal, Y., Galasso, S., Alfonso Galderisi, 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., and Bruttomesso, D.

Subjects
children, type 1 diabetes, insulin pump, artificial pancreas

14. Evaluating the Experience of Children With Type 1 Diabetes and Their Parents Taking Part in an Artificial Pancreas Clinical Trial Over Multiple Days in a Diabetes Camp Setting

Author

Daniela Bruttomesso, Novella Rapini, Yenny Leal, A. Sabbion, Daniel R. Cherñavvsky, Marco Marigliano, Lalo Magni, Simone Del Favero, Federico Boscari, Ivana Rabbone, Riccardo Bonfanti, Eleonora Losiouk, Giordano Lanzola, Silvana Quaglini, Valeria Vallone, Davide Tinti, Silvia Galasso, Riccardo Schiaffini, Roberta Calore, Mirko Messori, Roberto Visentin, Angela Zanfardino, Dario Iafusco, Federico Di Palma, Alfonso Galderisi, Alda Troncone, Claudio Cobelli, Andrea Rigamonti, Troncone, A., Bonfanti, R., Iafusco, D., Rabbone, I., Sabbion, A., Schiaffini, R., Galderisi, A., Marigliano, M., Rapini, N., Rigamonti, A., Tinti, D., Vallone, V., Zanfardino, A., Boscari, F., Del, Favero, S., Galasso, S., Lanzola, G., Messori, Di, Palma, F., Visentin, R., Calore, R., Leal, Y., Magni, L., Losiouk, E., Chernavvsky, D., Quaglini, S., Cobelli, C., Bruttomesso, Del Favero, S., Galasso, S., Lanzola, G., Messori, M., Di Palma, F., Visentin, R., Calore, R., Leal, Y., Magni, L., Losiouk, E., Chernavvsky, D., Quaglini, S., Cobelli, C., and Bruttomesso, D.

Subjects
Research design, Adult, Male, Pancreas, Artificial, Parents, Endocrinology, Diabetes and Metabolism, MEDLINE, 030209 endocrinology & metabolism, Artificial pancreas, 03 medical and health sciences, Endocrinology, 0302 clinical medicine, Internal Medicine, Advanced and Specialized Nursing, Diabetes mellitus, Surveys and Questionnaires, medicine, Diabetes Mellitus, Humans, 030212 general & internal medicine, Parent-Child Relations, Child, Preschool, Pancreas, Type 1 diabetes, business.industry, Novelty, Patient Acceptance of Health Care, medicine.disease, Camping, Child, Preschool, Diabetes Mellitus, Type 1, Female, Perception, Diabetes and Metabolism, Clinical trial, Artificial, Technology acceptance model, business, Clinical psychology, Type 1
Abstract

OBJECTIVE To explore the experiences of children with type 1 diabetes and their parents taking part in an artificial pancreas (AP) clinical trial during a 7-day summer camp. RESEARCH DESIGN AND METHODS A semistructured interview, composed of 14 questions based on the Technology Acceptance Model, was conducted at the end of the clinical trial. Participants also completed the Diabetes Treatment Satisfaction Questionnaire (DTSQ, parent version) and the AP Acceptance Questionnaire. RESULTS Thirty children, aged 5–9 years, and their parents completed the study. A content analysis of the interviews showed that parents were focused on understanding the mechanisms, risks, and benefits of the new device, whereas the children were focused on the novelty of the new system. The parents’ main concerns about adopting the new system seemed related to the quality of glucose control. The mean scores of DTSQ subscales indicated general parents’ satisfaction (44.24 ± 5.99, range 32–53) and trustful views of diabetes control provided by the new system (7.8 ± 2.2, range 3–12). The AP Acceptance Questionnaire revealed that most parents considered the AP easy to use (70.5%), intended to use it long term (94.0%), and felt that it was apt to improve glucose control (67.0%). CONCLUSIONS Participants manifested a positive attitude toward the AP. Further studies are required to explore participants’ perceptions early in the AP development to individualize the new treatment as much as possible, and to tailor it to respond to their needs and values.

Published
2016

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

Author

Giordano Lanzola, Davide Tinti, Simone Del Favero, Alfonso Galderisi, Angelo Avogaro, Yenny Leal Moncada, Daniela Bruttomesso, Silvia Galasso, Andrea Rigamonti, Lalo Magni, Valeria Vallone, Daniel R. Cherñavvsky, Federico Di Palma, Federico Boscari, Dario Iafusco, Marco Marigliano, Novella Rapini, Claudio Cobelli, Eleonora Losiouk, Ivana Rabbone, Riccardo Schiaffini, Riccardo Bonfanti, Roberta Calore, Roberto Visentin, Mirko Messori, A. Sabbion, Angela Zanfardino, 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., Del Favero, Simone, Boscari, Federico, Messori, Mirko, Rabbone, Ivana, Bonfanti, Riccardo, Sabbion, Alberto, Iafusco, Dario, Schiaffini, Riccardo, Visentin, Roberto, Calore, Roberta, Moncada, Yenny Leal, Galasso, Silvia, Galderisi, Alfonso, Vallone, Valeria, Di Palma, Federico, Losiouk, Eleonora, Lanzola, Giordano, Tinti, Davide, Rigamonti, Andrea, Marigliano, Marco, Zanfardino, Angela, Rapini, Novella, Avogaro, Angelo, Chernavvsky, Daniel, Magni, Lalo, Cobelli, Claudio, and Bruttomesso, Daniela

Subjects
Blood Glucose, Male, Pediatrics, Endocrinology, Diabetes and Metabolism, law.invention, Endocrinology, 0302 clinical medicine, Randomized controlled trial, law, Insulin, 030212 general & internal medicine, Child, education.field_of_study, Cross-Over Studies, Diabetes and Metabolism, Anesthesia, Child, Preschool, Artificial, Female, Algorithms, Type 1, Pancreas, Artificial, medicine.medical_specialty, Population, 030209 endocrinology & metabolism, Hypoglycemia, Artificial pancreas, 03 medical and health sciences, Insulin Infusion Systems, Internal Medicine, Advanced and Specialized Nursing, Diabetes mellitus, medicine, Summer camp, Diabetes Mellitus, Humans, Hypoglycemic Agents, education, Preschool, Pancreas, Type 1 diabetes, business.industry, Diabetes Mellitus, Type 1, Feasibility Studies, medicine.disease, Crossover study, business
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 (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.

Published
2016

16. Feasibility of Long-Term Closed-Loop Control: A Multicenter 6-Month Trial of 24/7 Automated Insulin Delivery.

Author

Kovatchev B, Cheng P, Anderson SM, Pinsker JE, Boscari F, Buckingham BA, Doyle FJ 3rd, Hood KK, Brown SA, Breton MD, Chernavvsky D, Bevier WC, Bradley PK, Bruttomesso D, Del Favero S, Calore R, Cobelli C, Avogaro A, Ly TT, Shanmugham S, Dassau E, Kollman C, Lum JW, and Beck RW

Subjects
Adult, Diabetes Mellitus, Type 1 blood, Feasibility Studies, Female, Humans, Hypoglycemic Agents therapeutic use, Insulin therapeutic use, Male, Middle Aged, Pancreas, Artificial, Blood Glucose analysis, Diabetes Mellitus, Type 1 drug therapy, Hypoglycemic Agents administration & dosage, Insulin administration & dosage, Insulin Infusion Systems
Abstract

Background: In the past few years, the artificial pancreas-the commonly accepted term for closed-loop control (CLC) of blood glucose in diabetes-has become a hot topic in research and technology development. In the summer of 2014, we initiated a 6-month trial evaluating the safety of 24/7 CLC during free-living conditions., Research Design and Methods: Following an initial 1-month Phase 1, 14 individuals (10 males/4 females) with type 1 diabetes at three clinical centers in the United States and one in Italy continued with a 5-month Phase 2, which included 24/7 CLC using the wireless portable Diabetes Assistant (DiAs) developed at the University of Virginia Center for Diabetes Technology. Median subject characteristics were age 45 years, duration of diabetes 27 years, total daily insulin 0.53 U/kg/day, and baseline HbA1c 7.2% (55 mmol/mol)., Results: Compared with the baseline observation period, the frequency of hypoglycemia below 3.9 mmol/L during the last 3 months of CLC was lower: 4.1% versus 1.3%, P < 0.001. This was accompanied by a downward trend in HbA1c from 7.2% (55 mmol/mol) to 7.0% (53 mmol/mol) at 6 months. HbA1c improvement was correlated with system use (Spearman r = 0.55). The user experience was favorable with identified benefit particularly at night and overall trust in the system. There were no serious adverse events, severe hypoglycemia, or diabetic ketoacidosis., Conclusion: We conclude that CLC technology has matured and is safe for prolonged use in patients' natural environment. Based on these promising results, a large randomized trial is warranted to assess long-term CLC efficacy and safety.

Published
2017
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17. Evaluating the Experience of Children With Type 1 Diabetes and Their Parents Taking Part in an Artificial Pancreas Clinical Trial Over Multiple Days in a Diabetes Camp Setting.

Author

Troncone A, Bonfanti R, Iafusco D, Rabbone I, Sabbion A, Schiaffini R, Galderisi A, Marigliano M, Rapini N, Rigamonti A, Tinti D, Vallone V, Zanfardino A, Boscari F, Del Favero S, Galasso S, Lanzola G, Messori M, Di Palma F, Visentin R, Calore R, Leal Y, Magni L, Losiouk E, Chernavvsky D, Quaglini S, Cobelli C, and Bruttomesso D

Subjects
Adult, Camping, Child, Child, Preschool, Diabetes Mellitus, Type 1 drug therapy, Female, Humans, Male, Parent-Child Relations, Patient Acceptance of Health Care, Perception, Surveys and Questionnaires, Diabetes Mellitus, Type 1 psychology, Diabetes Mellitus, Type 1 therapy, Pancreas, Artificial psychology, Parents psychology
Abstract

Objective: To explore the experiences of children with type 1 diabetes and their parents taking part in an artificial pancreas (AP) clinical trial during a 7-day summer camp., Research Design and Methods: A semistructured interview, composed of 14 questions based on the Technology Acceptance Model, was conducted at the end of the clinical trial. Participants also completed the Diabetes Treatment Satisfaction Questionnaire (DTSQ, parent version) and the AP Acceptance Questionnaire., Results: Thirty children, aged 5-9 years, and their parents completed the study. A content analysis of the interviews showed that parents were focused on understanding the mechanisms, risks, and benefits of the new device, whereas the children were focused on the novelty of the new system. The parents' main concerns about adopting the new system seemed related to the quality of glucose control. The mean scores of DTSQ subscales indicated general parents' satisfaction (44.24 ± 5.99, range 32-53) and trustful views of diabetes control provided by the new system (7.8 ± 2.2, range 3-12). The AP Acceptance Questionnaire revealed that most parents considered the AP easy to use (70.5%), intended to use it long term (94.0%), and felt that it was apt to improve glucose control (67.0%)., Conclusions: Participants manifested a positive attitude toward the AP. Further studies are required to explore participants' perceptions early in the AP development to individualize the new treatment as much as possible, and to tailor it to respond to their needs and values., (© 2016 by the American Diabetes Association.)

Published
2016
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18. Randomized Summer Camp Crossover Trial in 5- to 9-Year-Old Children: Outpatient Wearable Artificial Pancreas Is Feasible and Safe.

Author

Del Favero S, Boscari F, Messori M, Rabbone I, Bonfanti R, Sabbion A, Iafusco D, Schiaffini R, Visentin R, Calore R, Moncada YL, 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, and Bruttomesso D

Subjects
Algorithms, Blood Glucose analysis, Child, Child, Preschool, Cross-Over Studies, Feasibility Studies, Female, Humans, Hypoglycemia epidemiology, Hypoglycemia prevention & control, Insulin Infusion Systems, Male, Diabetes Mellitus, Type 1 drug therapy, Hypoglycemic Agents therapeutic use, Insulin therapeutic use, Pancreas, Artificial
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., (© 2016 by the American Diabetes Association. Readers may use this article as long as the work is properly cited, the use is educational and not for profit, and the work is not altered.)

Published
2016
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19. Multinational Home Use of Closed-Loop Control Is Safe and Effective.

Author

Anderson SM, Raghinaru D, Pinsker JE, Boscari F, Renard E, Buckingham BA, Nimri R, Doyle FJ 3rd, Brown SA, Keith-Hynes P, Breton MD, Chernavvsky D, Bevier WC, Bradley PK, Bruttomesso D, Del Favero S, Calore R, Cobelli C, Avogaro A, Farret A, Place J, Ly TT, Shanmugham S, Phillip M, Dassau E, Dasanayake IS, Kollman C, Lum JW, Beck RW, and Kovatchev B

Subjects
Adolescent, Adult, Aged, Blood Glucose drug effects, Blood Glucose Self-Monitoring instrumentation, Blood Glucose Self-Monitoring methods, Female, Humans, Hypoglycemia prevention & control, Hypoglycemic Agents adverse effects, Insulin adverse effects, Internationality, Male, Middle Aged, Mobile Applications, Young Adult, Blood Glucose analysis, Diabetes Mellitus, Type 1 blood, Diabetes Mellitus, Type 1 drug therapy, Hypoglycemic Agents administration & dosage, Insulin administration & dosage, Insulin Infusion Systems, Pancreas, Artificial adverse effects, Smartphone
Abstract

Objective: To evaluate the efficacy of a portable, wearable, wireless artificial pancreas system (the Diabetes Assistant [DiAs] running the Unified Safety System) on glucose control at home in overnight-only and 24/7 closed-loop control (CLC) modes in patients with type 1 diabetes., Research Design and Methods: At six clinical centers in four countries, 30 participants 18-66 years old with type 1 diabetes (43% female, 96% non-Hispanic white, median type 1 diabetes duration 19 years, median A1C 7.3%) completed the study. The protocol included a 2-week baseline sensor-augmented pump (SAP) period followed by 2 weeks of overnight-only CLC and 2 weeks of 24/7 CLC at home. Glucose control during CLC was compared with the baseline SAP., Results: Glycemic control parameters for overnight-only CLC were improved during the nighttime period compared with baseline for hypoglycemia (time <70 mg/dL, primary end point median 1.1% vs. 3.0%; P < 0.001), time in target (70-180 mg/dL: 75% vs. 61%; P < 0.001), and glucose variability (coefficient of variation: 30% vs. 36%; P < 0.001). Similar improvements for day/night combined were observed with 24/7 CLC compared with baseline: 1.7% vs. 4.1%, P < 0.001; 73% vs. 65%, P < 0.001; and 34% vs. 38%, P < 0.001, respectively., Conclusions: CLC running on a smartphone (DiAs) in the home environment was safe and effective. Overnight-only CLC reduced hypoglycemia and increased time in range overnight and increased time in range during the day; 24/7 CLC reduced hypoglycemia and increased time in range both overnight and during the day. Compared with overnight-only CLC, 24/7 CLC provided additional hypoglycemia protection during the day., (© 2016 by the American Diabetes Association. Readers may use this article as long as the work is properly cited, the use is educational and not for profit, and the work is not altered.)

Published
2016
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20. Day-and-Night Closed-Loop Glucose Control in Patients With Type 1 Diabetes Under Free-Living Conditions: Results of a Single-Arm 1-Month Experience Compared With a Previously Reported Feasibility Study of Evening and Night at Home.

Author

Renard E, Farret A, Kropff J, Bruttomesso D, Messori M, Place J, Visentin R, Calore R, Toffanin C, Di Palma F, Lanzola G, Magni P, Boscari F, Galasso S, Avogaro A, Keith-Hynes P, Kovatchev B, Del Favero S, Cobelli C, Magni L, and DeVries JH

Subjects
Adult, Algorithms, Blood Glucose drug effects, Blood Glucose Self-Monitoring methods, Cross-Over Studies, Feasibility Studies, Female, Humans, Hypoglycemic Agents administration & dosage, Hypoglycemic Agents adverse effects, Insulin adverse effects, Male, Middle Aged, Social Conditions, Young Adult, Blood Glucose analysis, Circadian Rhythm physiology, Diabetes Mellitus, Type 1 blood, Diabetes Mellitus, Type 1 drug therapy, Insulin administration & dosage, Insulin Infusion Systems, Pancreas, Artificial
Abstract

Objective: After testing of a wearable artificial pancreas (AP) during evening and night (E/N-AP) under free-living conditions in patients with type 1 diabetes (T1D), we investigated AP during day and night (D/N-AP) for 1 month., Research Design and Methods: Twenty adult patients with T1D who completed a previous randomized crossover study comparing 2-month E/N-AP versus 2-month sensor augmented pump (SAP) volunteered for 1-month D/N-AP nonrandomized extension. AP was executed by a model predictive control algorithm run by a modified smartphone wirelessly connected to a continuous glucose monitor (CGM) and insulin pump. CGM data were analyzed by intention-to-treat with percentage time-in-target (3.9-10 mmol/L) over 24 h as the primary end point., Results: Time-in-target (mean ± SD, %) was similar over 24 h with D/N-AP versus E/N-AP: 64.7 ± 7.6 vs. 63.6 ± 9.9 (P = 0.79), and both were higher than with SAP: 59.7 ± 9.6 (P = 0.01 and P = 0.06, respectively). Time below 3.9 mmol/L was similarly and significantly reduced by D/N-AP and E/N-AP versus SAP (both P < 0.001). SD of blood glucose concentration (mmol/L) was lower with D/N-AP versus E/N-AP during whole daytime: 3.2 ± 0.6 vs. 3.4 ± 0.7 (P = 0.003), morning: 2.7 ± 0.5 vs. 3.1 ± 0.5 (P = 0.02), and afternoon: 3.3 ± 0.6 vs. 3.5 ± 0.8 (P = 0.07), and was lower with D/N-AP versus SAP over 24 h: 3.1 ± 0.5 vs. 3.3 ± 0.6 (P = 0.049). Insulin delivery (IU) over 24 h was higher with D/N-AP and SAP than with E/N-AP: 40.6 ± 15.5 and 42.3 ± 15.5 vs. 36.6 ± 11.6 (P = 0.03 and P = 0.0004, respectively)., Conclusions: D/N-AP and E/N-AP both achieved better glucose control than SAP under free-living conditions. Although time in the different glycemic ranges was similar between D/N-AP and E/N-AP, D/N-AP further reduces glucose variability., (© 2016 by the American Diabetes Association. Readers may use this article as long as the work is properly cited, the use is educational and not for profit, and the work is not altered.)

Published
2016
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