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3. Cambridge hybrid closed-loop algorithm in children and adolescents with type 1 diabetes: a multicentre 6-month randomised controlled trial

Author

Hovorka, R, Acerini, C L, Thankamony, A, Allen, J M, Boughton, C K, Dovc, K, Dunger, D B, Ware, J, Musolino, G, Tauschmann, M, Wilinska, M E, Hayes, J F, Hartnell, S, Slegtenhorst, S, Ruan, Y, Haydock, M, Mangat, J, Denvir, L, Kanthagnany, SK, Law, J, Randell, T, Sachdev, P, Saxton, M, Coupe, A, Stafford, S, Ball, A, Keeton, R, Cresswell, R, Crate, L, Cripps, H, Fazackerley, H, Looby, L, Navarra, H, Saddington, C, Smith, V, Verhoeven, V, Bratt, S, Khan, N, Moyes, L, Sandhu, K, West, C, Wadwa, R P, Alonso, G, Forlenza, G, Slover, R, Towers, L, Berget, C, Coakley, A, Escobar, E, Jost, E, Lange, S, Messer, L, Thivener, K, Campbell, F M, Yong, J, Metcalfe, E, Allen, M, Ambler, S, Waheed, S, Exall, J, Tulip, J, Buckingham, B A, Ekhlaspour, L, Maahs, D, Norlander, L, Jacobson, T, Twon, M, Weir, C, Leverenz, B, Keller, J, Davis, N, Kumaran, A, Trevelyan, N, Dewar, H, Price, G, Crouch, G, Ensom, R, Haskell, L, Lueddeke, LM, Mauras, N, Benson, M, Bird, K, Englert, K, Permuy, J, Ponthieux, K, Marrero-Hernandez, J, DiMeglio, L A, Ismail, H, Jolivette, H, Sanchez, J, Woerner, S, Kirchner, M, Mullen, M, Tebbe, M, Besser, R EJ, Basu, S, London, R, Makaya, T, Ryan, F, Megson, C, Bowen-Morris, J, Haest, J, Law, R, Stamford, I, Ghatak, A, Deakin, M, Phelan, K, Thornborough, K, Shakeshaft, J, Weinzimer, S A, Cengiz, E, Sherr, J L, Van Name, M, Weyman, K, Carria, L, Steffen, A, Zgorski, M, Sibayan, J, Beck, R W, Borgman, S, Davis, J, Rusnak, J, Hellman, A, Cheng, P, Kanapka, L, Kollman, C, McCarthy, C, Chalasani, S, Hood, K K, Hanes, S, Viana, J, Lanning, M, Fox, D S, Arreaza-Rubin, G, Eggerman, T, Green, N, Janicek, R, Gabrielson, D, Belle, S H, Castle, J, Green, J, Legault, L, Willi, S M, Wysham, C, Ware, Julia, Boughton, Charlotte K, Allen, Janet M, Wilinska, Malgorzata E, Tauschmann, Martin, Denvir, Louise, Thankamony, Ajay, Campbell, Fiona M, Wadwa, R Paul, Buckingham, Bruce A, Davis, Nikki, DiMeglio, Linda A, Mauras, Nelly, Besser, Rachel E J, Ghatak, Atrayee, Weinzimer, Stuart A, Hood, Korey K, Fox, D Steven, Kanapka, Lauren, Kollman, Craig, Sibayan, Judy, Beck, Roy W, and Hovorka, Roman

Published
2022
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5. The effect of closed-loop glucose control on C-peptide secretion in youth with newly diagnosed type 1 diabetes: the CLOuD RCT

Author

Boughton, Charlotte K, primary, Allen, Janet M, additional, Ware, Julia, additional, Wilinska, Malgorzata E, additional, Hartnell, Sara, additional, Thankamony, Ajay, additional, Randell, Tabitha, additional, Ghatak, Atrayee, additional, Besser, Rachel EJ, additional, Elleri, Daniela, additional, Trevelyan, Nicola, additional, Campbell, Fiona M, additional, Rankin, David, additional, Kimbell, Barbara, additional, Lawton, Julia, additional, Sibayan, Judy, additional, Calhoun, Peter, additional, Bailey, Ryan, additional, Dunseath, Gareth, additional, and Hovorka, Roman, additional

Published
2024
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6. Hypoglycemia and Hyperglycemia According to Type of Diabetes: Observations During Fully Closed-Loop Insulin Delivery in Adults With Type 1 and Type 2 Diabetes

Author

Kadiyala, Nithya, primary, Wilinska, Malgorzata E., additional, Daly, Aideen B., additional, Nwokolo, Munachiso, additional, Lakshman, Rama, additional, Hartnell, Sara, additional, Ware, Julia, additional, Allen, Janet M., additional, Cezar, Alina, additional, Evans, Mark L., additional, Hovorka, Roman, additional, and Boughton, Charlotte K., additional

Published
2024
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8. Cost-Effectiveness of Closed-Loop Automated Insulin Delivery Using the Cambridge Hybrid Algorithm in Children and Adolescents with Type 1 Diabetes: Results from a Multicenter 6-Month Randomized Trial

Author

Fox, D. Steven, primary, Ware, Julia, additional, Boughton, Charlotte K, additional, Allen, Janet M., additional, Wilinska, Malgorzata E, additional, Tauschmann, Martin, additional, Denvir, Louise, additional, Thankamony, Ajay, additional, Campbell, Fiona, additional, Wadwa, R. Paul, additional, Buckingham, Bruce A., additional, Davis, Nikki, additional, DiMeglio, Linda A., additional, Mauras, Nelly, additional, Besser, Rachel E. J., additional, Ghatak, Atrayee, additional, Weinzimer, Stuart A., additional, Kanapka, Lauren, additional, Kollman, Craig, additional, Sibayan, Judy, additional, Beck, Roy W., additional, Hood, Korey K., additional, and Hovorka, Roman, additional

Published
2024
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9. Automatische Insulindosierung (AID)

Author

Ware, Julia

Abstract

Mit der Kommerzialisierung und klinischen Verfügbarkeit der automatischen Insulindosierung (AID) brach ein neues Zeitalter in der Behandlung des Typ-1-Diabetes an. Robuste Forschungsergebnisse randomisierter Langzeitstudien ergaben: Die AID-Therapie verbessert die Stoffwechsellage in allen pädiatrischen Altersgruppen, ohne dass höhere akute Komplikationen oder Hypoglykämieraten auftreten. Daten des realen Lebens aus prospektiven Beobachtungsstudien und retrospektive Clouddaten der Hersteller bestätigen diese Behandlungserfolge. Auch bei Manifestation sind AID-Systeme sicher einsetzbar und bringen gegenüber Standardtherapien langfristig Vorteile für Kinder und Jugendliche mit neu diagnostiziertem Typ-1-Diabetes. Langzeitstudien mit Daten des realen Lebens gibt es noch nicht. In Zukunft sollten Registerdaten diesbezüglich ausgewertet werden, um systemübergreifend die Beständigkeit der glykämischen Outcomes zu erschließen. Ein vollautomatisches AID-System, bei dem die Notwendigkeit der manuellen Abgabe von Insulinboli zu den Mahlzeiten entfällt, bleibt das ultimative Ziel der AID-Forschung, ist aber bislang nicht erhältlich und bei Kindern und Jugendlichen wenig erforscht.

Published
2024
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10. Effect of 48 Months of Closed-Loop Insulin Delivery on Residual C-Peptide Secretion and Glycemic Control in Newly Diagnosed Youth With Type 1 Diabetes: A Randomized Trial.

Author

Ware, Julia, Boughton, Charlotte K., Allen, Janet M., Wilinska, Malgorzata E., Hartnell, Sara, Thankamony, Ajay, Randell, Tabitha, Ghatak, Atrayee, Besser, Rachel E.J., Elleri, Daniela, Trevelyan, Nicola, Campbell, Fiona M., Sibayan, Judy, Bailey, Ryan, Calhoun, Peter, Dunseath, Gareth, Hovorka, Roman, Verhoeven, Vreni, Thankmonay, Ajay, and Acerini, Carlo

Subjects
*TYPE 1 diabetes, *GLYCEMIC control, *HYPERGLYCEMIA, *SECRETION, *C-peptide, *INSULIN, *CANAGLIFLOZIN, *INSULIN aspart
Abstract

OBJECTIVE: We evaluated the effect of long-term intensive metabolic control with hybrid closed-loop (CL) on residual C-peptide secretion and glucose control compared with standard insulin therapy in youth with type 1 diabetes over 48 months. RESEARCH DESIGN AND METHODS: Following the 24-month primary phase of a multicenter, randomized, parallel trial of 96 newly diagnosed youth aged 10 to 16.9 years, participants were invited to an extension phase using treatment allocated at randomization. They continued with hybrid CL using the Cambridge algorithm or standard insulin therapy (control) until 48 months after diagnosis. Analysis was by intention-to-treat. RESULTS: At 24 months after diagnosis, 81 participants (mean ± SD age 14 ± 2 years) continued in the extension phase (47 CL, 34 control). There was no difference in fasting C-peptide corrected for fasting glucose at 48 months between groups (CL: 5 ± 9 vs. control: 6 ± 14 pmol/L per mmol/L; mean adjusted difference −2 [95% CI −7, 4; P = 0.54]). Central laboratory HbA1c remained lower in the CL group by 0.9% (10 mmol/mol [95% CI 0.2, 1.5; 3, 17 mmol/mol); P = 0.009). Time in target range of 3.9 to 10.0 mmol/L was 12 percentage points (95% CI 3, 20; P = 0.008) higher in the CL group compared with control. There were 11 severe hypoglycemic events (6 CL, 5 control) and 7 diabetic ketoacidosis events (3 CL, 4 control) during the extension phase. CONCLUSIONS: Improved glycemic control was sustained over 48 months after diagnosis with CL insulin delivery compared with standard therapy in youth with type 1 diabetes. This did not appear to confer a protective effect on residual C-peptide secretion. [ABSTRACT FROM AUTHOR]

Published
2024
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12. Safety of User-Initiated Intensification of Insulin Delivery Using Cambridge Hybrid Closed-Loop Algorithm.

Author

Ware, Julia, Wilinska, Malgorzata E., Ruan, Yue, Allen, Janet M., Boughton, Charlotte K., Hartnell, Sara, Bally, Lia, de Beaufort, Carine, Besser, Rachel E. J., Campbell, Fiona M., Draxlbauer, Katharine, Elleri, Daniela, Evans, Mark L., Fröhlich-Reiterer, Elke, Ghatak, Atrayee, Hofer, Sabine E., Kapellen, Thomas M., Leelarathna, Lalantha, Mader, Julia K., and Mubita, Womba M.

Published
2024
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13. CamAPS FX Hybrid Closed-Loop with Ultra-Rapid Lispro Compared with Standard Lispro in Adults with Type 1 Diabetes: A Double-Blind, Randomized, Crossover Study

Author

Nwokolo, Munachiso, primary, Lakshman, Rama, additional, Hartnell, Sara, additional, Alwan, Heba, additional, Ware, Julia, additional, Allen, Janet M., additional, Wilinska, Malgorzata E., additional, Evans, Mark L., additional, Hovorka, Roman, additional, and Boughton, Charlotte K., additional

Published
2023
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15. Hybrid Closed-Loop with Faster Insulin Aspart Compared with Standard Insulin Aspart in Very Young Children with Type 1 Diabetes: A Double-Blind, Multicenter, Randomized, Crossover Study

Author

Ware, Julia, Allen, Janet M, Boughton, Charlotte K, Cezar, Alina, Hartnell, Sara, Wilinska, Malgorzata E, Thankamony, Ajay, Deakin, Mark, Leyland, Hannah, Phelan, Karen, Thornborough, Keith, Hovorka, Roman, Ware, Julia [0000-0002-4497-0979], Boughton, Charlotte K [0000-0003-3272-9544], and Apollo - University of Cambridge Repository

Subjects
Blood Glucose, Toddlers, Cross-Over Studies, Endocrinology, Diabetes and Metabolism, Aspart, Very young children, Artificial pancreas, Medical Laboratory Technology, Endocrinology, Type 1 diabetes, Diabetes Mellitus, Type 1, Double-Blind Method, Child, Preschool, Humans, Hypoglycemic Agents, Insulin, Closed-loop insulin delivery, Faster insulin aspart, Child, Insulin Aspart
Abstract

We evaluated the use of hybrid closed-loop (HCL) insulin delivery with faster insulin aspart (Fiasp) in very young children with type 1 diabetes (T1D). In a double-blind, multicenter, randomized, crossover study, children aged 2-6 years with T1D underwent two 8-week periods of HCL using CamAPS FX with Fiasp and standard insulin aspart (IAsp), in random order. Primary endpoint was between-treatment difference in time in target range 3.9-10.0 mmol/L. We randomized 25 participants: mean (±standard deviation) age 5.1 ± 1.3 years, baseline HbA1c 55 ± 9 mmol/mol. Time in range was not significantly different between interventions (64% ± 9% vs. 65% ± 9% for HCL with Fiasp vs. IAsp; mean difference -0.33% [95% confidence interval: -2.13 to 1.47; P = 0.71]). There was no significant difference in time with glucose

Published
2023

16. Fully closed-loop glucose control compared to insulin pump therapy with continuous glucose monitoring in adults with type 1 diabetes and sub-optimal glycemic control: a single-centre, randomized, crossover study

Author

K Boughton, Charlotte, primary, Hartnell, Sara, primary, Lakshman, Rama, primary, Nwokolo, Munachiso, primary, Wilinska, Malgorzata E, primary, Ware, Julia, primary, Allen, Janet M, primary, Evans, Mark L, primary, and Hovorka, Roman, primary

Published
2023
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17. Sleep Quality and Quantity in Caregivers of Children with Type 1 Diabetes Using Closed-Loop Insulin Delivery or a Sensor-Augmented Pump

Author

Madrid-Valero, Juan J., primary, Ware, Julia, additional, Allen, Janet M., additional, Boughton, Charlotte K., additional, Hartnell, Sara, additional, Wilinska, Malgorzata E., additional, Thankamony, Ajay, additional, de Beaufort, Carine, additional, Schierloh, Ulrike, additional, Campbell, Fiona M., additional, Sibayan, Judy, additional, Bocchino, Laura E., additional, Kollman, Craig, additional, Hovorka, Roman, additional, Gregory, Alice M., additional, and Consortium, KidsAP, additional

Published
2023
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18. Sleep Quality and Quantity in Caregivers of Children with Type 1 Diabetes Using Closed-Loop Insulin Delivery or a Sensor-Augmented Pump

Author

Madrid-Valero, Juan J., Ware, Julia, Allen, Janet M., Boughton, Charlotte K., Hartnell, Sara, Wilinska, Malgorzata E., Thankamony, Ajay, de Beaufort, Carine, Schierloh, Ulrike, Campbell, Fiona M., Sibayan, Judy, Bocchino, Laura E., Kollman, Craig, Hovorka, Roman, Gregory, Alice M., Consortium, KidsAP, Universidad de Alicante. Departamento de Psicología de la Salud, and Psicología Aplicada a la Salud y Comportamiento Humano (PSYBHE)

Subjects
Caregivers, Type 1 Diabetes, Sleep, Children
Abstract

Introduction. Parents of children living with type 1 diabetes (T1D) often report short and/or poor quality sleep. The development of closed-loop systems promises to transform the management of T1D. This study compared sleep quality and quantity in caregivers of children using a closed-loop system (CL) or sensor-augmented pump (SAP) therapy. Method. Data from sleep diaries, accelerometers, and questionnaires were provided by forty parents (classified as caregiver 1 (main analyses) or 2 (supplementary analyses) based on their contribution towards treatment management) of 21 very young children aged 1 to 7 years living with T1D (mean age: 4.7 (SD = 1.7)). Assessments were made at a single post-randomisation time point when the child was completing either the 16-week CL arm (n = 10) or the 16-week SAP arm (n = 11) of the main study. Results. Overall, there was a mixed pattern of results and group differences were not statistically significant at the p

Published
2023

19. Time spent in hypoglycemia according to age and time-of-day: Observations during closed-loop insulin delivery

Author

Alwan, Heba, Ware, Julia, Boughton, Charlotte K, Wilinska, Malgorzata E, Allen, Janet M, Lakshman, Rama, Nwokolo, Munachiso, Hartnell, Sara, Bally, Lia, De Beaufort, Carine, Besser, Rachel EJ, Campbell, Fiona M, Davis, Nikki, Denvir, Louise, Evans, Mark L, Fröhlich-Reiterer, Elke, Ghatak, Atrayee, Hofer, Sabine E, Kapellen, Thomas M, Leelarathna, Lalantha, Mader, Julia K, Narendran, Parth, Rami-Mehrar, Birgit, Tauschmann, Martin, Thabit, Hood, Thankamony, Ajay, Hovorka, Roman, Alwan, Heba [0000-0001-5516-6022], Ware, Julia [0000-0002-4497-0979], Boughton, Charlotte K [0000-0003-3272-9544], Lakshman, Rama [0000-0002-4341-1307], Bally, Lia [0000-0003-1993-7672], Besser, Rachel EJ [0000-0002-4645-6324], Mader, Julia K [0000-0001-7854-4233], and Apollo - University of Cambridge Repository

Subjects
Adult, Blood Glucose, Adolescent, Endocrinology, Diabetes and Metabolism, Artificial pancreas, 610 Medicine & health, Young Adult, Insulin pump therapy, Endocrinology, Insulin Infusion Systems, 360 Social problems & social services, Insulin, Regular, Human, Humans, Insulin, Hypoglycemic Agents, Closed-loop insulin delivery, Child, Aged, Retrospective Studies, Cross-Over Studies, Middle Aged, Hypoglycemia, Medical Laboratory Technology, Type 1 diabetes, Diabetes Mellitus, Type 1, Treatment Outcome, Child, Preschool, Randomized trial
Abstract

Objective: We aimed to assess whether percentage of time spent in hypoglycemia during closed-loop insulin delivery differs by age group and time of day. Methods: We retrospectively analyzed data from hybrid closed-loop studies involving young children (2-7 years), children and adolescents (8-18 years), adults (19-59 years), and older adults (≥60 years) with type 1 diabetes. Main outcome was time spent in hypoglycemia

Published
2023
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20. Time spent in hypoglycemia according to age and time-of-day: Observations during closed-loop insulin delivery

Author

Alwan, Heba, primary, Ware, Julia, additional, Boughton, Charlotte K, additional, Wilinska, Malgorzata, additional, Allen, Janet M, additional, Lakshman, Rama, additional, Nwokolo, Munachiso, additional, Hartnell, Sara, additional, Bally, Lia, additional, de Beaufort, Carine, additional, Besser, Rachel Elizabeth Jane, additional, Campbell, Fiona, additional, Davis, Nikki, additional, Denver, Louise, additional, Evants, Mark L, additional, Fröhlich-Reiterer, Elke, additional, Ghatak, Atrayee, additional, Hofer, Sabine E., additional, Kapellen, Thomas M, additional, Leelarathna, Lalantha, additional, Mader, Julia K, additional, Narendran, Parth, additional, Rami-Merhar, Birgit, additional, Tauschmann, Martin, additional, Thabit, Hood, additional, thankamony, Ajay, additional, and Hovorka, Roman, additional

Published
2023
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21. Hybrid closed-loop with faster insulin aspart compared with standard insulin aspart in very young children with type 1 diabetes: A double-blind, multicenter, randomized, crossover study

Author

Ware, Julia, primary, Allen, Janet M, additional, boughton, charlotte, additional, Cezar, Alina, additional, Hartnell, Sara, additional, Wilinska, Malgorzata, additional, Thankamony, Ajay, additional, Deakin, Mark, additional, Leyland, Hannah, additional, Phelan, Karen, additional, Thornborough, Keith, additional, and Hovorka, Roman, additional

Published
2023
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22. Sleep Quality and Quantity in Caregivers of Children with Type 1 Diabetes Using Closed-Loop Insulin Delivery or a Sensor-Augmented Pump

Author

Universidad de Alicante. Departamento de Psicología de la Salud, Madrid-Valero, Juan J., Ware, Julia, Allen, Janet M., Boughton, Charlotte K., Hartnell, Sara, Wilinska, Malgorzata E., Thankamony, Ajay, de Beaufort, Carine, Schierloh, Ulrike, Campbell, Fiona M., Sibayan, Judy, Bocchino, Laura E., Kollman, Craig, Hovorka, Roman, Gregory, Alice M., KidsAP Consortium, Universidad de Alicante. Departamento de Psicología de la Salud, Madrid-Valero, Juan J., Ware, Julia, Allen, Janet M., Boughton, Charlotte K., Hartnell, Sara, Wilinska, Malgorzata E., Thankamony, Ajay, de Beaufort, Carine, Schierloh, Ulrike, Campbell, Fiona M., Sibayan, Judy, Bocchino, Laura E., Kollman, Craig, Hovorka, Roman, Gregory, Alice M., and KidsAP Consortium

Abstract

Introduction. Parents of children living with type 1 diabetes (T1D) often report short and/or poor quality sleep. The development of closed-loop systems promises to transform the management of T1D. This study compared sleep quality and quantity in caregivers of children using a closed-loop system (CL) or sensor-augmented pump (SAP) therapy. Method. Data from sleep diaries, accelerometers, and questionnaires were provided by forty parents (classified as caregiver 1 (main analyses) or 2 (supplementary analyses) based on their contribution towards treatment management) of 21 very young children aged 1 to 7 years living with T1D (mean age: 4.7 (SD = 1.7)). Assessments were made at a single post-randomisation time point when the child was completing either the 16-week CL arm (n = 10) or the 16-week SAP arm (n = 11) of the main study. Results. Overall, there was a mixed pattern of results and group differences were not statistically significant at the level. However, when we consider the direction of results and results from caregiver 1, sleep diary data showed that parents of the CL (as compared to the SAP) group reported a shorter sleep duration but better sleep quality, fewer awakenings, and less wake after sleep onset (WASO). Actiwatch data showed that caregiver 1 of the CL (as compared to the SAP) group had a shorter sleep latency; greater sleep efficiency; and less wake after sleep onset. Results from the Pittsburgh Sleep Quality Index also showed better sleep quality for caregiver 1 of the CL group as compared to the SAP group. Conclusions. Results from this study suggest that sleep quality and quantity in parents of children using CL were not significantly different to those using SAP. Considering effect sizes and the direction of the non-significant results, CL treatment could be associated with better sleep quality in the primary caregiver. However, further research is needed to confirm these findings. This trial is registered with NCT05158816.

Published
2023

23. Closed-loop insulin delivery: update on the state of the field and emerging technologies

Author

Ware, Julia, Hovorka, Roman, Ware, Julia [0000-0002-4497-0979], Hovorka, Roman [0000-0003-2901-461X], and Apollo - University of Cambridge Repository

Subjects
Blood Glucose, Diabetes Mellitus, Type 1, Insulin Infusion Systems, automated insulin delivery, type 1 diabetes, insulin pump, Blood Glucose Self-Monitoring, Humans, Insulin, Artificial pancreas, continuous glucose monitoring, hybrid closed-loop
Abstract

INTRODUCTION: Over the last five years, closed-loop insulin delivery systems have transitioned from research-only to real-life use. A number of systems have been commercialized and are increasingly used in clinical practice. Given the rapidity of new developments in the field, understanding the capabilities and key similarities and differences of current systems can be challenging. This review aims to provide an update on the state of the field of closed-loop insulin delivery systems, including emerging technologies. AREAS COVERED: We summarize key clinical safety and efficacy evidence of commercial and emerging insulin-only hybrid closed-loop systems for type 1 diabetes. A literature search was conducted and clinical trials using closed-loop systems during free-living conditions were identified to report on safety and efficacy data. We comment on emerging technologies and adjuncts for closed-loop systems, as well as non-technological priorities in closed-loop insulin delivery. EXPERT OPINION: Commercial hybrid closed-loop insulin delivery systems are efficacious, consistently improving glycemic control when compared to standard therapy. Challenges remain in widespread adoption due to clinical inertia and the lack of resources to embrace technological developments by health care professionals.

Published
2022

25. Fully Closed-Loop Glucose Control Compared With Insulin Pump Therapy With Continuous Glucose Monitoring in Adults With Type 1 Diabetes and Suboptimal Glycemic Control: A Single-Center, Randomized, Crossover Study.

Author

Boughton, Charlotte K., Hartnell, Sara, Lakshman, Rama, Nwokolo, Munachiso, Wilinska, Malgorzata E., Ware, Julia, Allen, Janet M., Evans, Mark L., and Hovorka, Roman

Abstract

OBJECTIVE: We evaluated the safety and efficacy of fully closed-loop with ultrarapid insulin lispro in adults with type 1 diabetes and suboptimal glycemic control compared with insulin pump therapy with continuous glucose monitoring (CGM). RESEARCH DESIGN AND METHODS: This single-center, randomized, crossover study enrolled 26 adults with type 1 diabetes using insulin pump therapy with suboptimal glycemic control (mean ± SD, age 41 ± 12 years, HbA1c 9.2 ± 1.1% [77 ± 12 mmol/mol]). Participants underwent two 8-week periods of unrestricted living to compare fully closed-loop with ultrarapid insulin lispro (CamAPS HX system) with insulin pump therapy with CGM in random order. RESULTS: In an intention-to-treat analysis, the proportion of time glucose was in range (primary end point 3.9–10.0 mmol/L) was higher during closed-loop than during pump with CGM (mean ± SD 50.0 ± 9.6% vs. 36.2 ± 12.2%, mean difference 13.2 percentage points [95% CI 9.5, 16.9], P < 0.001). Time with glucose >10.0 mmol/L and mean glucose were lower during closed-loop than during pump with CGM (mean ± SD time >10.0 mmol/L: 49.0 ± 9.9 vs. 62.9 ± 12.6%, mean difference −13.3 percentage points [95% CI −17.2, −9.5], P < 0.001; mean ± SD glucose 10.7 ± 1.1 vs. 12.0 ± 1.6 mmol/L, mean difference −1.2 mmol/L [95% CI −1.8, −0.7], P < 0.001). The proportion of time with glucose <3.9 mmol/L was similar between periods (median [interquartile range (IQR)] closed-loop 0.88% [0.51–1.55] vs. pump with CGM 0.64% [0.28–1.10], P = 0.102). Total daily insulin requirements did not differ (median [IQR] closed-loop 51.9 units/day [35.7–91.2] vs. pump with CGM 50.7 units/day [34.0–70.0], P = 0.704). No severe hypoglycemia or ketoacidosis occurred. CONCLUSIONS: Fully closed-loop insulin delivery with CamAPS HX improved glucose control compared with insulin pump therapy with CGM in adults with type 1 diabetes and suboptimal glycemic control. [ABSTRACT FROM AUTHOR]

Published
2023
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26. Evaluating the Impact of Applying Personal Glucose Targets in a Closed-Loop System for People With Type 1 Diabetes

Author

Fattah, Mustafa, primary, Boughton, Charlotte K., additional, Ware, Julia, additional, Allen, Janet M., additional, Hartnell, Sara, additional, Willinska, Malgorzata E., additional, Thankamony, Ajay, additional, de Beaufort, Carine, additional, Campbell, Fiona M., additional, Fröhlich-Reiterer, Elke, additional, Hofer, Sabine E., additional, Kapellen, Thomas M., additional, Rami-Merhar, Birgit, additional, Ghatak, Atrayee, additional, Randell, Tabitha L., additional, Besser, Rachel E. J., additional, Elleri, Daniela, additional, Trevelyan, Nicola, additional, Denvir MD, Louise, additional, Davis, Nikki, additional, Bally, Lia, additional, Thabit, Hood, additional, Leelarathna, Lalantha, additional, Evans, Mark L., additional, Mader, Julia K., additional, and Hovorka, Roman, additional

Published
2022
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27. Safety of User-Initiated Intensification of Insulin Delivery Using Cambridge Hybrid Closed-Loop Algorithm

Author

Ware, Julia, primary, Wilinska, Malgorzata E., additional, Ruan, Yue, additional, Allen, Janet M., additional, Boughton, Charlotte K., additional, Hartnell, Sara, additional, Bally, Lia, additional, de Beaufort, Carine, additional, Besser, Rachel E. J., additional, Campbell, Fiona M., additional, Draxlbauer, Katharine, additional, Elleri, Daniela, additional, Evans, Mark L., additional, Fröhlich-Reiterer, Elke, additional, Ghatak, Atrayee, additional, Hofer, Sabine E., additional, Kapellen, Thomas M., additional, Leelarathna, Lalantha, additional, Mader, Julia K., additional, Mubita, Womba M., additional, Narendran, Parth, additional, Poettler, Tina, additional, Rami-Merhar, Birgit, additional, Tauschmann, Martin, additional, Randell, Tabitha, additional, Thabit, Hood, additional, Thankamony, Ajay, additional, Trevelyan, Nicola, additional, and Hovorka, Roman, additional

Published
2022
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28. Cambridge Hybrid Closed-Loop System in Very Young Children With Type 1 Diabetes Reduces Caregivers' Fear of Hypoglycemia and Improves Their Well-Being

Author

De Beaufort, Carine, Schierloh, Ulrike, Thankamony, Ajay, Ware, Julia, Wilinska, Malgorzata E, Fröhlich-Reiterer, Elke, Kapellen, Thomas M, Rami-Merhar, Birgit, Hofer, Sabine E, Campbell, Fiona M, Yong, James, Bocchino, Laura E, Sibayan, Judy, Lawton, Julia, Roze, Stephane, Fritsch, Maria, Thiele, Alena, Allen, Janet M, Boughton, Charlotte, Mader, Julia K, Kollman, Craig, Hovorka, Roman, Pit-Ten Cate, Ineke M, KidsAP Consortium, de Beaufort, Carine [0000-0003-4310-6799], and Apollo - University of Cambridge Repository

Subjects
KidsAP Consortium
Abstract

OBJECTIVE: To evaluate the impact of CamAPS FX hybrid closed-loop (HCL) automated insulin delivery in very young children with type 1 diabetes (T1D) on caregivers' well-being, fear of hypoglycemia, and sleepiness. RESEARCH DESIGN AND METHODS: We conducted a multinational, open-label, randomized crossover study. Children (age 1-7 years) with T1D received treatment for two 4-month periods in random order, comparing HCL with sensor augmented pump (control). At baseline and after each treatment period, caregivers were invited to complete World Health Organization-Five Well-Being Index, Hypoglycemia Fear Survey, and Epworth Sleepiness Scale questionnaires. RESULTS: Caregivers of 74 children (mean ± SD age 5 ± 2 years and baseline HbA1c 7.3 ± 0.7%; 42% female) participated. Results revealed significantly lower scores for hypoglycemia fear (P < 0.001) and higher scores for well-being (P < 0.001) after HCL treatment. A trend toward a reduction in sleepiness score was observed (P = 0.09). CONCLUSIONS: Our results suggest better well-being and less hypoglycemia fear in caregivers of very young children with T1D on CamAPS FX HCL.

Published
2022

29. Lived experience of CamAPS FX closed loop system in youth with type 1 diabetes and their parents

Author

Hood, Korey K, Garcia-Willingham, Natasha, Hanes, Sarah, Tanenbaum, Molly L, Ware, Julia, Boughton, Charlotte K, Allen, Janet M, Wilinska, Malgorzata E, Tauschmann, Martin, Denvir, Louise, Thankamony, Ajay, Campbell, Fiona, Wadwa, R Paul, Buckingham, Bruce A, Davis, Nikki, DiMeglio, Linda A, Mauras, Nelly, Besser, Rachel EJ, Ghatak, Atrayee, Weinzimer, Stuart A, Fox, D Steven, Kanapka, Lauren, Kollman, Craig, Sibayan, Judy, Beck, Roy W, Hovorka, Roman, DAN05 Consortium, Hood, Korey K [0000-0001-5730-7749], Boughton, Charlotte K [0000-0003-3272-9544], and Apollo - University of Cambridge Repository

Subjects
Blood Glucose, Parents, Diabetes Mellitus, Type 1, Treatment Outcome, Insulin Infusion Systems, Adolescent, Blood Glucose Self-Monitoring, Quality of Life, Humans, Insulin, Hypoglycemic Agents, Child
Abstract

AIM: To examine changes in the lived experience of type 1 diabetes after use of hybrid closed loop (CL), including the CamAPS FX CL system. MATERIALS AND METHODS: The primary study was conducted as an open-label, single-period, randomized, parallel design contrasting CL versus insulin pump (with or without continuous glucose monitoring). Participants were asked to complete patient-reported outcomes before starting CL and 3 and 6 months later. Surveys assessed diabetes distress, hypoglycaemia concerns and quality of life. Qualitative focus group data were collected at the completion of the study. RESULTS: In this sample of 98 youth (age range 6-18, mean age 12.7 ± 2.8 years) and their parents, CL use was not associated with psychosocial benefits overall. However, the subgroup (n = 12) using the CamAPS FX system showed modest improvements in quality of life and parent distress, reinforced by both survey (p < .05) and focus group responses. There were no negative effects of CL use reported by study participants. CONCLUSIONS: Closed loop use via the CamAPS FX system was associated with modest improvements in aspects of the lived experience of managing type 1 diabetes in youth and their families. Further refinements of the system may optimize the user experience.

Published
2022
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32. Cambridge hybrid closed-loop system in very young children with type 1 diabetes reduces caregivers’ fear of hypoglycemia and improves their well-being.

Author

de Beaufort, Carine, primary, Schierloh, Ulrike, primary, Thankamony, Ajay, primary, Ware, Julia, primary, Wilinska, Malgorzata E, primary, Fröhlich-Reiterer, Elke, primary, Kapellen, Thomas M., primary, Rami‐Merhar, Birgit, primary, Hofer, Sabine E., primary, M. Campbell, Fiona, primary, Yong, James, primary, Bocchino, Laura E., primary, Sibayan, Judy, primary, Lawton, Julia, primary, Roze, Stéphane, primary, Fritsch, Maria, primary, Thiele, Alena, primary, Allen, Janet M, primary, Boughton, Charlotte, primary, Mader, Julia K., primary, Kollman, Craig, primary, Hovorka, Roman, primary, Cate, Ineke M. Pit-ten, primary, and Consortium, KidsAP, primary

Published
2022
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34. Closed-Loop Therapy and Preservation of C-Peptide Secretion in Type 1 Diabetes

Author

Boughton, Charlotte K., primary, Allen, Janet M., additional, Ware, Julia, additional, Wilinska, Malgorzata E., additional, Hartnell, Sara, additional, Thankamony, Ajay, additional, Randell, Tabitha, additional, Ghatak, Atrayee, additional, Besser, Rachel E.J., additional, Elleri, Daniela, additional, Trevelyan, Nicola, additional, Campbell, Fiona M., additional, Sibayan, Judy, additional, Calhoun, Peter, additional, Bailey, Ryan, additional, Dunseath, Gareth, additional, and Hovorka, Roman, additional

Published
2022
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35. 288-OR: Effect of 24 Months of Optimised Glucose Control on Residual C-Peptide Secretion in Youth with New Onset Type 1 Diabetes (T1D)

Author

BOUGHTON, CHARLOTTE K., primary, WARE, JULIA, additional, ALLEN, JANET M., additional, WILINSKA, MALGORZATA E., additional, HARTNELL, SARA, additional, THANKAMONY, AJAY, additional, RANDELL, TABITHA, additional, GHATAK, ATRAYEE, additional, BESSER, RACHEL, additional, ELLERI, DANIELA, additional, TREVELYAN, NICOLA, additional, CAMPBELL, FIONA, additional, SIBAYAN, JUDY, additional, BAILEY, RYAN, additional, CALHOUN, PETER, additional, DUNSEATH, GARETH J., additional, HOVORKA, ROMAN, additional, and CONSORTIUM, CLOUD, additional

Published
2022
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36. Parents’ experiences of using remote monitoring technology to manage type 1 diabetes in very young children during a clinical trial: Qualitative study

Author

Hart, Ruth, Kimbell, Barbara, Rankin, David, Allen, Janet, Boughton, Charlotte, Campbell, Fiona, de Beaufort, Carine, Frohlich-Reiterer, Elke, Ware, Julia, Hofer, Sabine, Kapellen, Thomas, Rami-Merhar, Birgit, Thankamony, Ajay, Hovorka, Roman, and Lawton, Julia

Subjects
Blood Glucose, Parents, young children, Clinical Trials as Topic, type 1 diabetes, Blood Glucose Self-Monitoring, sensor-augmented pump therapy, Endocrinology, Diabetes and Metabolism, Infant, parents, Diabetes Mellitus, Type 1, Insulin Infusion Systems, Endocrinology, Child, Preschool, Remote Sensing Technology, Internal Medicine, Humans, Insulin, Child, closed-loop system, qualitative research, remote monitoring
Abstract

Aims: To explore parents’ experiences of using remote monitoring technology when caring for a very young child with type 1 diabetes during a clinical trial. Methods: Interviews were conducted with parents of 30 children (aged 1-7 years) participating in a trial (the KidsAP02 study) comparing hybrid closed-loop insulin delivery with sensor-augmented pump therapy. In both arms, parents had access to remote monitoring technology. Data analysis focused on identification of descriptive themes.Results: Remote monitoring technology gave parents improved access to data which helped them pre-empt and manage glucose excursions. Parents observed how, when children were in their own care, they could be more absent while present, as their attention could shift to non-diabetes-related activities. Conversely, when children were others’ care, remote monitoring enabled parents to be present while absent, by facilitating oversight and collaboration with caregivers. Parents described how remote monitoring made them feel more confident allowing others to care for their children. Parents’ confidence increased when using a hybrid closed-loop system, as less work was required to keep glucose in range. Benefits to children were also highlighted, including being able to play and sleep uninterrupted and attend parties and sleepovers without their parents. While most parents welcomed the increased sense of control remote monitoring offered, some noted downsides, such as lack of respite from caregiving responsibilities. Conclusions: Remote monitoring can offer manifold benefits to both parents and very young children with type 1 diabetes. Some parents, however, may profit from opportunities to take ‘time out’.

Published
2022
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37. Type 1 diabetes as a prototypical condition challenging what we know about sleep

Author

Universidad de Alicante. Departamento de Psicología de la Salud, Gregory, Alice M., Rutter, Martin K., Ware, Julia, Madrid-Valero, Juan J., Hovorka, Roman, Buysse, Daniel J., Universidad de Alicante. Departamento de Psicología de la Salud, Gregory, Alice M., Rutter, Martin K., Ware, Julia, Madrid-Valero, Juan J., Hovorka, Roman, and Buysse, Daniel J.

Published
2022

38. Cambridge AID bei Kleinkindern mit Typ 1 Diabetes: eine multi-nationale randomisierte Studie

Author

Kapellen, Thomas, additional, Bartelt, Heike, additional, Thiele, Alena G., additional, Ware, Julia, additional, Wilinska, Malgorzata E, additional, de Beaufort, Carine, additional, Fröhlich-Reiterer, Elke, additional, Rami-Merhar, Birgit, additional, Hofer, Sabine E., additional, Campbell, Fiona M., additional, Sibayan, Judy, additional, and Hovorka, Roman, additional

Published
2022
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39. Cambridge hybrid closed-loop algorithm in children and adolescents with type 1 diabetes: a multicentre 6-month randomised controlled trial

Author

Ware, Julia, primary, Boughton, Charlotte K, additional, Allen, Janet M, additional, Wilinska, Malgorzata E, additional, Tauschmann, Martin, additional, Denvir, Louise, additional, Thankamony, Ajay, additional, Campbell, Fiona M, additional, Wadwa, R Paul, additional, Buckingham, Bruce A, additional, Davis, Nikki, additional, DiMeglio, Linda A, additional, Mauras, Nelly, additional, Besser, Rachel E J, additional, Ghatak, Atrayee, additional, Weinzimer, Stuart A, additional, Hood, Korey K, additional, Fox, D Steven, additional, Kanapka, Lauren, additional, Kollman, Craig, additional, Sibayan, Judy, additional, Beck, Roy W, additional, Hovorka, Roman, additional, Hovorka, R, additional, Acerini, C L, additional, Thankamony, A, additional, Allen, J M, additional, Boughton, C K, additional, Dovc, K, additional, Dunger, D B, additional, Ware, J, additional, Musolino, G, additional, Tauschmann, M, additional, Wilinska, M E, additional, Hayes, J F, additional, Hartnell, S, additional, Slegtenhorst, S, additional, Ruan, Y, additional, Haydock, M, additional, Mangat, J, additional, Denvir, L, additional, Kanthagnany, SK, additional, Law, J, additional, Randell, T, additional, Sachdev, P, additional, Saxton, M, additional, Coupe, A, additional, Stafford, S, additional, Ball, A, additional, Keeton, R, additional, Cresswell, R, additional, Crate, L, additional, Cripps, H, additional, Fazackerley, H, additional, Looby, L, additional, Navarra, H, additional, Saddington, C, additional, Smith, V, additional, Verhoeven, V, additional, Bratt, S, additional, Khan, N, additional, Moyes, L, additional, Sandhu, K, additional, West, C, additional, Wadwa, R P, additional, Alonso, G, additional, Forlenza, G, additional, Slover, R, additional, Towers, L, additional, Berget, C, additional, Coakley, A, additional, Escobar, E, additional, Jost, E, additional, Lange, S, additional, Messer, L, additional, Thivener, K, additional, Campbell, F M, additional, Yong, J, additional, Metcalfe, E, additional, Allen, M, additional, Ambler, S, additional, Waheed, S, additional, Exall, J, additional, Tulip, J, additional, Buckingham, B A, additional, Ekhlaspour, L, additional, Maahs, D, additional, Norlander, L, additional, Jacobson, T, additional, Twon, M, additional, Weir, C, additional, Leverenz, B, additional, Keller, J, additional, Davis, N, additional, Kumaran, A, additional, Trevelyan, N, additional, Dewar, H, additional, Price, G, additional, Crouch, G, additional, Ensom, R, additional, Haskell, L, additional, Lueddeke, LM, additional, Mauras, N, additional, Benson, M, additional, Bird, K, additional, Englert, K, additional, Permuy, J, additional, Ponthieux, K, additional, Marrero-Hernandez, J, additional, DiMeglio, L A, additional, Ismail, H, additional, Jolivette, H, additional, Sanchez, J, additional, Woerner, S, additional, Kirchner, M, additional, Mullen, M, additional, Tebbe, M, additional, Besser, R EJ, additional, Basu, S, additional, London, R, additional, Makaya, T, additional, Ryan, F, additional, Megson, C, additional, Bowen-Morris, J, additional, Haest, J, additional, Law, R, additional, Stamford, I, additional, Ghatak, A, additional, Deakin, M, additional, Phelan, K, additional, Thornborough, K, additional, Shakeshaft, J, additional, Weinzimer, S A, additional, Cengiz, E, additional, Sherr, J L, additional, Van Name, M, additional, Weyman, K, additional, Carria, L, additional, Steffen, A, additional, Zgorski, M, additional, Sibayan, J, additional, Beck, R W, additional, Borgman, S, additional, Davis, J, additional, Rusnak, J, additional, Hellman, A, additional, Cheng, P, additional, Kanapka, L, additional, Kollman, C, additional, McCarthy, C, additional, Chalasani, S, additional, Hood, K K, additional, Hanes, S, additional, Viana, J, additional, Lanning, M, additional, Fox, D S, additional, Arreaza-Rubin, G, additional, Eggerman, T, additional, Green, N, additional, Janicek, R, additional, Gabrielson, D, additional, Belle, S H, additional, Castle, J, additional, Green, J, additional, Legault, L, additional, Willi, S M, additional, and Wysham, C, additional

Published
2022
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40. A Randomized Closed-loop Trial in Very Young Children with Type 1 Diabetes

Author

Ware, Julia, Allen, Janet M, Boughton, Charlotte K, Wilinska, Malgorzata E, Hartnell, Sara, Thankamony, Ajay, Carine de Beaufort, Carine, Schierloh, Ulrike, Froehlich- Reiterer, Elke, Mader, Julia K, Kapellen, Thomas M, Rami-Merhar, Birgit, Tauschmann, Martin, Nagl, Katrin, Hofer, Sabine E, Campbell, Fiona, Yong, James, Hood, Korey, Lawton, Julia, Roze, Stephane, Sibayan, Judy, Bocchino, Laura, Kollman, Craig, and Hovorka, Roman

Abstract

BACKGROUND The possible advantage of hybrid closed-loop therapy (i.e., artificial pancreas) over sensor-augmented pump therapy in very young children with type 1 diabetes is unclear. METHODS In this multicenter, randomized, crossover trial, we recruited children 1 to 7 years of age with type 1 diabetes who were receiving insulin-pump therapy at seven centers across Austria, Germany, Luxembourg, and the United Kingdom. Participants received treatment in two 16-week periods, in random order, in which the closed-loop system was compared with sensor-augmented pump therapy (control). The primary end point was the between-treatment difference in the percentage of time that the sensor glucose measurement was in the target range (70 to 180 mg per deciliter) during each 16-week period. The analysis was conducted according to the intention-to-treat principle. Key secondary end points included the percentage of time spent in a hyperglycemic state (glucose level, >180 mg per deciliter), the glycated hemoglobin level, the mean sensor glucose level, and the percentage of time spent in a hypoglycemic state (glucose level

Published
2022
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41. Metabolism Clinical & Experimental – Recent advances in closed-loop insulin delivery

Author

Ware, Julia and Hovorka, Roman

Subjects
Adult, Aged, 80 and over, Blood Glucose, Pancreas, Artificial, Adolescent, Middle Aged, Article, Young Adult, Diabetes Mellitus, Type 1, Insulin Infusion Systems, Pregnancy, Child, Preschool, Humans, Insulin, Female, Age of Onset, Child, Aged
Abstract

Since the discovery of insulin 100 years ago, we have seen considerable advances across diabetes therapies. The more recent advent of glucose-responsive automated insulin delivery has started to revolutionise the management of type 1 diabetes in children and adults. Evolution of closed-loop insulin delivery from research to clinical practice has been rapid, and multiple systems are now commercially available. In this review, we summarise key evidence on currently available closed-loop systems and those in development. We comment on dual-hormone and do-it-yourself systems, as well as reviewing clinical evidence in special populations such as very young children, older adults and in pregnancy. We identify future directions for research and barriers to closed-loop adoption, including how these might be addressed to ensure equitable access to this novel therapy.

Published
2021

42. Randomized Trial of Closed-Loop Control in Very Young Children with Type 1 Diabetes

Author

Ware, Julia, primary, Allen, Janet M., additional, Boughton, Charlotte K., additional, Wilinska, Malgorzata E., additional, Hartnell, Sara, additional, Thankamony, Ajay, additional, de Beaufort, Carine, additional, Schierloh, Ulrike, additional, Fröhlich-Reiterer, Elke, additional, Mader, Julia K., additional, Kapellen, Thomas M., additional, Rami-Merhar, Birgit, additional, Tauschmann, Martin, additional, Nagl, Katrin, additional, Hofer, Sabine E., additional, Campbell, Fiona M., additional, Yong, James, additional, Hood, Korey K., additional, Lawton, Julia, additional, Roze, Stephane, additional, Sibayan, Judy, additional, Bocchino, Laura E., additional, Kollman, Craig, additional, and Hovorka, Roman, additional

Published
2022
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44. Lived experience of CamAPS FX closed loop system in youth with type 1 diabetes and their parents.

Author

Hood, Korey K., Garcia‐Willingham, Natasha, Hanes, Sarah, Tanenbaum, Molly L., Ware, Julia, Boughton, Charlotte K., Allen, Janet M., Wilinska, Malgorzata E., Tauschmann, Martin, Denvir, Louise, Thankamony, Ajay, Campbell, Fiona, Wadwa, R. Paul, Buckingham, Bruce A., Davis, Nikki, DiMeglio, Linda A., Mauras, Nelly, Besser, Rachel E. J., Ghatak, Atrayee, and Weinzimer, Stuart A.

Subjects
TYPE 1 diabetes, PSYCHOLOGICAL distress, CLOSED loop systems, INSULIN pumps, QUALITY of life, HYPOGLYCEMIA
Abstract

Aim: To examine changes in the lived experience of type 1 diabetes after use of hybrid closed loop (CL), including the CamAPS FX CL system. Materials and Methods: The primary study was conducted as an open‐label, single‐period, randomized, parallel design contrasting CL versus insulin pump (with or without continuous glucose monitoring). Participants were asked to complete patient‐reported outcomes before starting CL and 3 and 6 months later. Surveys assessed diabetes distress, hypoglycaemia concerns and quality of life. Qualitative focus group data were collected at the completion of the study. Results: In this sample of 98 youth (age range 6‐18, mean age 12.7 ± 2.8 years) and their parents, CL use was not associated with psychosocial benefits overall. However, the subgroup (n = 12) using the CamAPS FX system showed modest improvements in quality of life and parent distress, reinforced by both survey (p <.05) and focus group responses. There were no negative effects of CL use reported by study participants. Conclusions: Closed loop use via the CamAPS FX system was associated with modest improvements in aspects of the lived experience of managing type 1 diabetes in youth and their families. Further refinements of the system may optimize the user experience. [ABSTRACT FROM AUTHOR]

Published
2022
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45. Parents' views about healthcare professionals having real‐time remote access to their young child's diabetes data: Qualitative study.

Author

Kimbell, Barbara, Rankin, David, Hart, Ruth I., Allen, Janet M., Boughton, Charlotte K., Campbell, Fiona, Fröhlich‐Reiterer, Elke, Hofer, Sabine E., Kapellen, Thomas M., Rami‐Merhar, Birgit, Schierloh, Ulrike, Thankamony, Ajay, Ware, Julia, Hovorka, Roman, and Lawton, Julia

Subjects
BLOOD sugar monitors, PARENT attitudes, REMOTE access networks, DATABASES, PSYCHOLOGY of parents, BLOOD sugar, PEDIATRICS, INTERVIEWING, TYPE 1 diabetes, RANDOMIZED controlled trials, COMPARATIVE studies, QUALITATIVE research, INSULIN pumps, DESCRIPTIVE statistics, MEDICAL referrals, STATISTICAL sampling, MEDICAL appointments, COVID-19 pandemic
Abstract

Objectives: We explored parents' views about healthcare professionals having remote access to their young child's insulin and glucose data during a clinical trial to inform use of data sharing in routine pediatric diabetes care. Research Design and Methods: Interviews with 33 parents of 30 children (aged 1–7 years) with type 1 diabetes participating in a randomized trial (KidsAP02) comparing hybrid closed‐loop system use with sensor‐augmented pump therapy. Data were analyzed using a qualitative descriptive approach. Results: Parents reported multiple benefits to healthcare professionals being able to remotely access their child's glucose and insulin data during the trial, despite some initial concerns regarding the insights offered into everyday family life. Key benefits included: less work uploading/sharing data; improved consultations; and, better clinical input and support from healthcare professionals between consultations. Parents noted how healthcare professionals' real‐time data access facilitated remote delivery of consultations during the COVID‐19 pandemic, and how these were more suitable for young children than face‐to‐face appointments. Parents endorsed use of real‐time data sharing in routine clinical care, subject to caveats regarding data access, security, and privacy. They also proposed that, if data sharing were used, consultations for closed‐loop system users in routine clinical care could be replaced with needs‐driven, ad‐hoc contact. Conclusions: Real‐time data sharing can offer clinical, logistical, and quality‐of‐life benefits and enhance opportunities for remote consultations, which may be more appropriate for young children. Wider rollout would require consideration of ethical and cybersecurity issues and, given the heightened intrusion on families' privacy, a non‐judgmental, collaborative approach by healthcare professionals. [ABSTRACT FROM AUTHOR]

Published
2022
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46. Cambridge Hybrid Closed-Loop Algorithm in Children and Adolescents with Type 1 Diabetes: A Multicentre 6-Month Randomised Trial

Author

Ware, Julia, primary, Boughton, Charlotte K., additional, Allen, Janet M., additional, Wilinska, Malgorzata E., additional, Tauschmann, Martin, additional, Denvir, Louise, additional, Thankamony, Ajay, additional, Campbell, Fiona M., additional, Wadwa, R. Paul, additional, Buckingham, Bruce A., additional, Davis, Nikki, additional, DiMeglio, Linda A., additional, Mauras, Nelly, additional, Besser, Rachel E.J., additional, Ghatak, Atrayee, additional, Weinzimer, Stuart A., additional, Hood, Korey K., additional, Fox, D. Steven, additional, Kanapka, Lauren, additional, Kollman, Craig, additional, Sibayan, Judy, additional, Beck, Roy W., additional, and Hovorka, Roman, additional

Published
2021
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47. Safe and effective use of a hybrid closed‐loop system from diagnosis in children under 18 months with type 1 diabetes.

Author

Tseretopoulou, Xanthippi, Viswanath, Vidya, Hartnell, Sara, Ware, Julia, Thankamony, Ajay, Webb, Emma A., Hysted, Helen, Ashford, Jennifer, Hendriks, Emile, Teoh, Yun, and Williams, Rachel M.

Subjects
BLOOD sugar monitors, INSULIN therapy, GLYCOSYLATED hemoglobin, INSULIN aspart, GLYCEMIC control, TYPE 1 diabetes
Abstract

The management of type 1 diabetes in infancy presents significant challenges. Hybrid closed loop systems have been shown to be effective in a research setting and are now available for clinical use. There are relatively little reported data regarding their safety and efficacy in a real world clinical setting. We report two cases of very young children diagnosed with type 1 diabetes at ages 18 (Case 1) and 7 months (Case 2), who were commenced on hybrid closed‐loop insulin delivery using the CamAPS FX™ system from diagnosis. At diagnosis, total daily dose (TDD) was 6 and 3.3 units for Case 1 and 2, respectively. Closed loop was started during the inpatient stay and weekly follow up was provided via video call on discharge. Seven months from diagnosis, Case 1 has an HbA1C of 49 mmol/mol, 61% time in range (TIR, 3.9–10 mmol/L) with 2% time in hypoglycemia (<3.9 mmol/L) with no incidents of very low blood glucose (BG; <3 mmol/L, 54 mg/dL) over 6 months. Given the extremely small TDD of insulin in Case 2, we elected to use diluted insulin (insulin aspart injection, NovoLog, Novo Nordisk Inc., Plainsboro, NJ, Diluting Medium for NovoLog®). Six months from diagnosis, the estimated HbA1c is 50 mmol/mol, TIR 76% with 1% hypoglycemia and no incidents of very low BG (<3 mmol/L, 54 mg/dL) over 6 months. We conclude that the use hybrid closed‐loop can be safe and effective from diagnosis in children under 2 years of age with type 1 diabetes. [ABSTRACT FROM AUTHOR]

Published
2022
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49. Safety of User-Initiated Intensification of Insulin Delivery Using Cambridge Hybrid Closed-Loop Algorithm

Author

Julia Ware, Malgorzata E. Wilinska, Yue Ruan, Janet M. Allen, Charlotte K. Boughton, Sara Hartnell, Lia Bally, Carine de Beaufort, Rachel E. J. Besser, Fiona M. Campbell, Katharine Draxlbauer, Daniela Elleri, Mark L. Evans, Elke Fröhlich-Reiterer, Atrayee Ghatak, Sabine E. Hofer, Thomas M. Kapellen, Lalantha Leelarathna, Julia K. Mader, Womba M. Mubita, Parth Narendran, Tina Poettler, Birgit Rami-Merhar, Martin Tauschmann, Tabitha Randell, Hood Thabit, Ajay Thankamony, Nicola Trevelyan, Roman Hovorka, Ware, Julia [0000-0002-4497-0979], Boughton, Charlotte K [0000-0003-3272-9544], Besser, Rachel EJ [0000-0002-4645-6324], Evans, Mark L [0000-0001-8122-8987], Leelarathna, Lalantha [0000-0001-9602-1962], Mader, Julia K [0000-0001-7854-4233], Thabit, Hood [0000-0001-6076-6997], Hovorka, Roman [0000-0003-2901-461X], and Apollo - University of Cambridge Repository

Subjects
closed-loop, hypoglycemia, automated insulin delivery, type 1 diabetes, artificial pancreas, Endocrinology, Diabetes and Metabolism, Biomedical Engineering, Internal Medicine, Bioengineering, 610 Medicine & health, personalized medicine, 610 Medizin und Gesundheit
Abstract

Objective: Many hybrid closed-loop (HCL) systems struggle to manage unusually high glucose levels as experienced with intercurrent illness or pre-menstrually. Manual correction boluses may be needed, increasing hypoglycemia risk with overcorrection. The Cambridge HCL system includes a user-initiated algorithm intensification mode (“Boost”), activation of which increases automated insulin delivery by approximately 35%, while remaining glucose-responsive. In this analysis, we assessed the safety of “Boost” mode. Methods: We retrospectively analyzed data from closed-loop studies involving young children (1-7 years, n = 24), children and adolescents (10-17 years, n = 19), adults (≥24 years, n = 13), and older adults (≥60 years, n = 20) with type 1 diabetes. Outcomes were calculated per participant for days with ≥30 minutes of “Boost” use versus days with no “Boost” use. Participants with Results: Eight weeks of data for 76 participants were analyzed. There was no difference in time spent 300 mg/dL was 1.39 percentage points (1.01 to 1.77; P < .001) higher on “Boost” days, with higher mean glucose and lower time in target range ( P < .001). Conclusions: Use of an algorithm intensification mode in HCL therapy is safe across all age groups with type 1 diabetes. The higher time in hyperglycemia observed on “Boost” days suggests that users are more likely to use algorithm intensification on days with extreme hyperglycemic excursions.

Published
2022
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50. Evaluating the Impact of Applying Personal Glucose Targets in a Closed-Loop System for People With Type 1 Diabetes

Author

Mustafa Fattah, Charlotte K. Boughton, Julia Ware, Janet M. Allen, Sara Hartnell, Malgorzata E. Willinska, Ajay Thankamony, Carine de Beaufort, Fiona M. Campbell, Elke Fröhlich-Reiterer, Sabine E. Hofer, Thomas M. Kapellen, Birgit Rami-Merhar, Atrayee Ghatak, Tabitha L. Randell, Rachel E. J. Besser, Daniela Elleri, Nicola Trevelyan, Louise Denvir MD, Nikki Davis, Lia Bally, Hood Thabit, Lalantha Leelarathna, Mark L. Evans, Julia K. Mader, Roman Hovorka, Boughton, Charlotte K [0000-0003-3272-9544], Ware, Julia [0000-0002-4497-0979], Besser, Rachel EJ [0000-0002-4645-6324], Thabit, Hood [0000-0001-6076-6997], Leelarathna, Lalantha [0000-0001-9602-1962], Evans, Mark L [0000-0001-8122-8987], Mader, Julia K [0000-0001-7854-4233], Hovorka, Roman [0000-0003-2901-461X], and Apollo - University of Cambridge Repository

Subjects
glucose control, algorithm, type 1 diabetes, Endocrinology, Diabetes and Metabolism, Biomedical Engineering, Internal Medicine, 610 Medicine & health, Bioengineering, hybrid closed-loop, personal glucose target, 610 Medizin und Gesundheit
Abstract

Background CamAPS FX is a hybrid closed-loop smartphone app used to manage type one diabetes. The closed-loop algorithm has a default target glucose of 5.8 mmol/L (104.5 mg/dL), but users can select personal glucose targets (adjustable between 4.4 mmol/L and 11.0 mmol/L [79 mg/dL and 198 mg/dL, respectively]). Method In this post-hoc analysis, we evaluated the impact of personal glucose targets on glycemic control using data from participants in five randomized controlled trials. Results Personal glucose targets were widely used, with 20.3% of all days in the data set having a target outside the default target bin (5.5-6.0 mmol/L [99-108 mg/dL]). Personal glucose targets >6.5 mmol/L (117 mg/dL) were associated with significantly less time in target range (3.9-10.0 mmol/L [70-180 mg/dL]; 6.5-7.0 mmol/L [117-126 mg/dL]: mean difference = −3.2 percentage points [95% CI: −5.3 to −1.2; P < .001]; 7.0-7.5 mmol/L [126-135 mg/dL]: −10.8 percentage points [95% CI: −14.1 to −7.6; P < .001]). Personal targets >6.5 mmol/L (117 mg/dL) were associated with significantly lower time (Conclusions Discrete study populations showed differences in glucose control when applying similar personal targets.

Published
2022
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