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1. 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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2. 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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3. 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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4. 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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5. 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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7. The broad phenotypic spectrum of 17α-hydroxylase/17,20-lyase (CYP17A1) deficiency: a case series

Author

Sun, Min, primary, Mueller, Jonathan W, additional, Gilligan, Lorna C, additional, Taylor, Angela E, additional, Shaheen, Fozia, additional, Noczyńska, Anna, additional, T’Sjoen, Guy, additional, Denvir, Louise, additional, Shenoy, Savitha, additional, Fulton, Piers, additional, Cheetham, Timothy D, additional, Gleeson, Helena, additional, Rahman, Mushtaqur, additional, Krone, Nils P, additional, Taylor, Norman F, additional, Shackleton, Cedric H L, additional, Arlt, Wiebke, additional, and Idkowiak, Jan, additional

Published
2021
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8. 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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9. User Engagement With the CamAPS FX Hybrid Closed-Loop App According to Age and User Characteristics

Author

Chen, Natalie S, Boughton, Charlotte K, Hartnell, Sara, Fuchs, Julia, Allen, Janet M, Willinska, Malgorzata E, Thankamony, Ajay, De Beaufort, Carine, Campbell, Fiona M, Fröhlich-Reiterer, Elke, Hofer, Sabine E, Kapellen, Thomas M, Rami-Merhar, Birgit, Ghatak, Atrayee, Randell, Tabitha L, Besser, Rachel EJ, Elleri, Daniela, Trevelyan, Nicola, Denvir, Louise, Davis, Nikki, Gurnell, Eleanor, Lindsay, Robert, Morris, Damian, Scott, Eleanor M, Bally, Lia, Thabit, Hood, Leelarathna, Lalantha, Evans, Mark L, Murphy, Helen R, Mader, Julia K, Hovorka, Roman, AiDAPT, AP@Home04, Boughton, Charlotte K [0000-0003-3272-9544], Campbell, Fiona M [0000-0002-7618-6759], Lindsay, Robert [0000-0002-9868-5217], Scott, Eleanor M [0000-0001-5395-8261], Bally, Lia [0000-0003-1993-7672], Mader, Julia K [0000-0001-7854-4233], Hovorka, Roman [0000-0003-2901-461X], and Apollo - University of Cambridge Repository

Subjects
Diabetes Mellitus, Type 1, Insulin Infusion Systems, Humans, Mobile Applications
Abstract

CamAPS FX (CamDiab, Cambridge, UK) is a hybrid closed-loop app hosting the Cambridge closed-loop algorithm on an Android smartphone, and is approved in the EU for use in children ≥1 year, and adults (including during pregnancy) with type 1 diabetes (T1D). The interoperable CamAPS FX app receives glucose data from a compatible CGM system (Dexcom G6; Dexcom, San Diego, CA), connects to a compatible insulin pump (Dana Diabecare RS and DANA-i; Sooil, Seoul, South Korea) to direct glucose-responsive insulin delivery every 8-12 minutes, includes a bolus calculator allowing discrete bolusing via the app, and streams data in real-time to cloud-based diabetes data repositories (Diasend/Glooko, Gothenburg, Sweden).

Published
2021

10. User Engagement With the CamAPS FX Hybrid Closed-Loop App According to Age and User Characteristics

Author

Chen, Natalie S., primary, Boughton, Charlotte K., additional, Hartnell, Sara, additional, Fuchs, Julia, additional, Allen, Janet M., 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, Louise, additional, Davis, Nikki, additional, Gurnell, Eleanor, additional, Lindsay, Robert, additional, Morris, Damian, additional, Scott, Eleanor M., additional, Bally, Lia, additional, Thabit, Hood, additional, Leelarathna, Lalantha, additional, Evans, Mark L., additional, Murphy, Helen R., additional, Mader, Julia K., additional, and Hovorka, Roman, additional

Published
2021
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11. Genetic Characterization of Short Stature Patients With Overlapping Features of Growth Hormone Insensitivity Syndromes

Author

Andrews, Afiya, primary, Maharaj, Avinaash, additional, Cottrell, Emily, additional, Chatterjee, Sumana, additional, Shah, Pratik, additional, Denvir, Louise, additional, Dumic, Katja, additional, Bossowski, Artur, additional, Mushtaq, Talat, additional, Vukovic, Rade, additional, Didi, Mohamed, additional, Shaw, Nick, additional, Metherell, Louise A, additional, Savage, Martin O, additional, and Storr, Helen L, additional

Published
2021
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12. 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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14. Expanding the clinical and genetic spectrum of 17α-Hydroxylase/17,20-Lyase deficiency: 7 cases and 5 novel mutations in the CYP17A1 gene

Author

Sun, Min, primary, Müller, Jonathan, additional, Gilligan, Lorna, additional, Taylor, Angela, additional, Shaheen, Fozia, additional, Cheetham, Tim, additional, Denvir, Louise, additional, Gleeson, Helena, additional, Shenoy, Savitha, additional, Szarras-Czapnik, Maria, additional, Rahman, Mushtaqur, additional, Taylor, Norman, additional, T’sjoen, Guy, additional, Shackleton, Cedric, additional, Arlt, Wiebke, additional, and Idkowiak, Jan, additional

Published
2020
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17. The broad phenotypic spectrum of 17α-hydroxylase/17,20-lyase (CYP17A1) deficiency: a case series.

Author

Min Sun, Mueller, Jonathan W., Gilligan, Lorna C., Taylor, Angela E., Shaheen, Fozia, Noczyńska, Anna, T'Sjoen, Guy, Denvir, Louise, Shenoy, Savitha, Fulton, Piers, Cheetham, Timothy D., Gleeson, Helena, Rahman, Mushtaqur, Krone, Nils P., Taylor, Norman F., Shackleton, Cedric H. L., Arlt, Wiebke, and Idkowiak, Jan

Subjects
PHENOTYPES, ADRENOGENITAL syndrome, FAILURE to thrive syndrome, HYDROCORTISONE, FUNCTIONAL analysis, GENETIC mutation
Abstract

Context: 17α-Hydroxylase/17,20-lyase deficiency (17OHD) caused by mutations in the CYP17A1 gene is a rare form of congenital adrenal hyperplasia typically characterised by cortisol deficiency, mineralocorticoid excess and sex steroid deficiency. Objective: To examine the phenotypic spectrum of 17OHD by clinical and biochemical assessment and corresponding in silico and in vitro functional analysis. Design: Case series. Patients and results: We assessed eight patients with 17OHD, including four with extreme 17OHD phenotypes: two siblings presented with failure to thrive in early infancy and two with isolated sex steroid deficiency and normal cortisol reserve. Diagnosis was established by mass spectrometr y-based urinary steroid profiling and confirmed by genetic CYP17A1 analysis, revealing homozygous and compound heterozygous seque nce variants. We found novel (p.Gly111Val, p.Ala398Glu, p.Ile371Thr) and previously described sequence variants (p.Pro409Leu, p.Arg347His, p.Gly436Arg, p.Phe53/54del, p.Tyr60IlefsLys88X). In vitro functional studies employing an overexpression system in HEK293 cells showed that 17,20-lyase activity was invariably decreased while mutant 17α-hydroxylase activity retained up to 14% of WT activity in the two patients with intact cortis ol reserve. A ratio of urinary corticosterone over cortisol metabolites reflective of 17α-hydroxylase activity correlated well with clinical phenotype s everity. Conclusion: Our findings illustrate the broad phenotypic spectrum of 17OHD. Isolated sex steroid deficiency with normal stimulated cortisol has not been reported before. Attenu ation of 17α-hydroxylase activity is readily detected by urinary steroid profiling and predicts phenotype severity. [ABSTRACT FROM AUTHOR]

Published
2021
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18. Quiz

Author

DENVIR, LOUISE, POLKEY, MIKE, and KANABAR, DIPAK

Published
2001

19. Reduced brown adipose tissue‐associated skin temperature following cold stimulation in children and adolescents with type 1 diabetes.

Author

Law, James M., Morris, David E., Robinson, Lindsay, Randell, Tabitha, Denvir, Louise, Symonds, Michael E., and Budge, Helen

Subjects
ADIPOSE tissue physiology, SYMPATHETIC nervous system physiology, HYPERGLYCEMIA, GLYCEMIC control, TYPE 1 diabetes, SKIN temperature, BLOOD sugar, SENSORY stimulation, INSULIN, BODY temperature regulation, COLD (Temperature), CLAVICLE, NONIONIZING radiation, MEDICAL thermography
Abstract

Background: Brown adipose tissue (BAT) is essential to maintain body temperature. Its ability to convert chemical energy in glucose and free fatty acids to heat is conferred by a unique protein, UCP‐1. BAT activity is greatest in children and adolescents, declining through adulthood. Blood glucose concentrations outside the normal nondiabetic range are common in type 1 diabetes and hyperglycaemia leads to insulin resistance in muscle and white adipose tissue, but whether this applies to BAT, is not known. Method: To investigate the effect of type 1 diabetes on BAT activity, we measured the supraclavicular temperature of 20 children with type 1 diabetes and compared them to 20 age‐matched controls, using infrared thermography. Results: The diabetes group had lower stimulated supraclavicular temperatures (diabetes group: 35.03 (34.76–35.30)°C; control group: 35.42 (35.16–35.69)°C; p = 0.037) and a reduced response in relative temperature following cold stimulation, after adjusting for BMI (diabetes group: 0.11 (0.03–0.18)°C; control group: 0.22 (0.15–0.29)°C; p = 0.034). In the diabetes group, there was no association between glycaemic measures and supraclavicular temperatures, but the method of insulin delivery may significantly affect the change in supraclavicular temperature with stimulation (injections: 0.01 (−0.07–0.09)°C; pump: 0.15 (0.04–0.26)°C; p = 0.028). Conclusions: While further work is needed to better understand the glucose‐insulin‐BAT relationship, one possible explanation for the reduced supraclavicular temperature is that exogenous, unlike endogenous, insulin, is not suppressed by the activity of the sympathetic nervous system, preventing lipolysis‐driven activation of BAT. [ABSTRACT FROM AUTHOR]

Published
2021
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21. Assessing the efficacy, safety and utility of 6-month day-and-night automated closed-loop insulin delivery under free-living conditions compared with insulin pump therapy in children and adolescents with type 1 diabetes: an open-label, multicentre, multinational, single-period, randomised, parallel group study protocol

Author

Musolino, Gianluca, primary, Allen, Janet M, additional, Hartnell, Sara, additional, Wilinska, Malgorzata E, additional, Tauschmann, Martin, additional, Boughton, Charlotte, additional, Campbell, Fiona, additional, Denvir, Louise, additional, Trevelyan, Nicola, additional, Wadwa, Paul, additional, DiMeglio, Linda, additional, Buckingham, Bruce A, additional, Weinzimer, Stuart, additional, Acerini, Carlo L, additional, Hood, Korey, additional, Fox, Steven, additional, Kollman, Craig, additional, Sibayan, Judy, additional, Borgman, Sarah, additional, Cheng, Peiyao, additional, and Hovorka, Roman, additional

Published
2019
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37. Assessing the efficacy, safety and utility of 6-month day-and-night automated closed-loop insulin delivery under freeliving conditions compared with insulin pump therapy in children and adolescents with type 1 diabetes: an open-label, multicentre, multinational, single-period, randomised, parallel group study protocol

Author

Musolino, Gianluca, Allen, Janet M., Hartnell, Sara, Wilinska, Malgorzata E., Tauschmann, Martin, Boughton, Charlotte, Campbell, Fiona, Denvir, Louise, Trevelyan, Nicola, Wadwa, Paul, DiMeglio, Linda, Buckingham, Bruce A., Weinzimer, Stuart, Acerini, Carlo L., Hood, Korey, Fox, Steven, Kollman, Craig, Sibayan, Judy, Borgman, Sarah, and Cheng, Peiyao

Abstract

Introduction Closed-loop systems titrate insulin based on sensor glucose levels, providing novel means to reduce the risk of hypoglycaemia while improving glycaemic control. We will assess effectiveness of 6-month day-and-night closed-loop insulin delivery compared with usual care (conventional or sensor-augmented pump therapy) in children and adolescents with type 1 diabetes. Methods and analysis The trial adopts an open-label, multicentre, multinational (UK and USA), randomised, single-period, parallel design. Participants (n=130) are children and adolescents (aged ≥6 and <19 years) with type 1 diabetes for at least 1 year, and insulin pump use for at least 3 months with suboptimal glycaemic control (glycated haemoglobin ≥58 mmol/mol (7.5%) and ≤86 mmol/mol (10%)). After a 2-3 week run-in period, participants will be randomised to 6-month use of hybrid closed-loop insulin delivery, or to usual care. Analyses will be conducted on an intention-to-treat basis. The primary outcome is glycated haemoglobin at 6 months. Other key endpoints include time in the target glucose range (3.9-10 mmol/L, 70-180 mg/dL), mean sensor glucose and time spent above and below target. Secondary outcomes include SD and coefficient of variation of sensor glucose levels, time with sensor glucose levels <3.5 mmol/L (63 mg/dL) and <3.0 mmol/L (54 mg/dL), area under the curve of glucose <3.5 mmol/L (63 mg/ dL), time with glucose levels >16.7 mmol/L (300 mg/dL), area under the curve of glucose >10.0 mmol/L (180 mg/ dL), total, basal and bolus insulin dose, body mass index z-score and blood pressure. Cognitive, emotional and behavioural characteristics of participants and caregivers and their responses to the closed-loop and clinical trial will be assessed. An incremental cost-effectiveness ratio for closed-loop will be estimated. Ethics and dissemination Cambridge South Research Ethics Committee and Jaeb Center for Health Research Institutional Review Office approved the study. The findings will be disseminated by peer-review publications and conference presentations. [ABSTRACT FROM AUTHOR]

Published
2019
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41. Monogenic diabetes mellitus in cystic fibrosis.

Author

Hoong-Wei Gan, Bhatt, Jayesh Mahendra, Denvir, Louise, Randell, Tabitha, Sachdev, Pooja, and Gan, Hoong-Wei

Subjects
CYSTIC fibrosis, DIABETES, CYSTIC fibrosis transmembrane conductance regulator, INSULIN therapy, GLICLAZIDE, HYPOGLYCEMIC agents, TYPE 1 diabetes, MEMBRANE proteins, GENETIC mutation, PROTEINS, TREATMENT effectiveness, DISEASE complications
Abstract

We present a non-consanguineous family of three siblings who presented with diabetes mellitus (DM), two of whom had genetically confirmed cystic fibrosis (CF), with one pancreatic-sufficient mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene (ΔF508/R117H;IVS8-5T). A detailed history revealed family members from three successive generations diagnosed with 'type 1' or 'type 2' diabetes, leading to genetic investigations for monogenic DM. A heterozygous frameshift mutation in the hepatocyte nuclear factor 1 homeobox alpha (HNF1A) gene (c.404delA) was subsequently confirmed in all three siblings, which is known to cause monogenic diabetes and is exquisitely sensitive to sulfonylurea therapy. Following this diagnosis, both siblings with CF and HNF1A monogenic diabetes were started on gliclazide therapy, while their older brother who had been wrongly diagnosed with type 1 diabetes was switched from insulin to gliclazide, all with excellent therapeutic responses. [ABSTRACT FROM AUTHOR]

Published
2019
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45. Monogenic diabetes mellitus in cystic fibrosis

Author

Gan, Hoong-Wei, Bhatt, Jayesh Mahendra, Denvir, Louise, Randell, Tabitha, and Sachdev, Pooja

Abstract

We present a non-consanguineous family of three siblings who presented with diabetes mellitus (DM), two of whom had genetically confirmed cystic fibrosis (CF), with one pancreatic-sufficient mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene (ΔF508/R117H;IVS8-5T). A detailed history revealed family members from three successive generations diagnosed with ‘type 1’ or ‘type 2’ diabetes, leading to genetic investigations for monogenic DM. A heterozygous frameshift mutation in the hepatocyte nuclear factor 1 homeobox alpha (HNF1A) gene (c.404delA) was subsequently confirmed in all three siblings, which is known to cause monogenic diabetes and is exquisitely sensitive to sulfonylurea therapy. Following this diagnosis, both siblings with CF and HNF1Amonogenic diabetes were started on gliclazide therapy, while their older brother who had been wrongly diagnosed with type 1 diabetes was switched from insulin to gliclazide, all with excellent therapeutic responses.

Published
2019
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47. 214-OR: Cambridge Hybrid Closed-Loop in Children and Adolescents with T1D: A Multicentre Six-Month Randomised Trial.

Author

FUCHS, 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, MAURAS, NELLY, BESSER, RACHEL, GHATAK, ATRAYEE, WEINZIMER, STUART A., HOOD, KOREY K., FOX, D. STEVEN, KANAPKA, LAUREN, and KOLLMAN, CRAIG

Abstract

Aims: We assessed safety and efficacy of Cambridge hybrid closed-loop (HCL) compared with usual care over 6 months in children and young people with T1D. Methods: In an open-label multicentre multinational parallel randomised controlled trial, we randomly assigned participants on insulin pump therapy aged 6 to 18 years to receive either HCL therapy (CL) or continue usual care (control) for 6 months. We used the same Cambridge model predictive control algorithm in two consecutive hardware iterations, FlorenceM then CamAPS FX. Primary endpoint was central laboratory HbA1c at 6 months. Results: We randomised 133 participants: 65 to CL and 68 to control (baseline HbA1c 8.2±0.7% vs. 8.3±0.8%). At 6 months mean HbA1c was 0.32% lower in CL compared to control (95% CI -0.59 to -0.04; p=0.02). Closed-loop usage was low (40% [26, 53]; median [IQR]) with FlorenceM due to hardware issues, and high (93% [88, 96]) with CamAPS FX. In the CamAPS FX CL group (n=21) HbA1c was 1.05% lower (95% CI -1.43 to -0.67; p<0.0001) compared to control (n=25). CGM-based metrics favoured CamAPS FX group without increase in hypoglycaemia (Table). Treatment-related adverse event rates were low and similar between groups. Conclusion: Cambridge HCL is safe and significantly improves glycaemic control in children and young people with T1D. Efficacy relies on consistent usage of closed-loop, as demonstrated by CamAPS FX. Disclosure: J. Fuchs: None. B. A. Buckingham: Advisory Panel; Self; Medtronic, Tolerion, Inc., Research Support; Self; Beta Bionics, Inc., Insulet Corporation, Medtronic, Tandem Diabetes Care. N. Davis: None. L. Dimeglio: Advisory Panel; Self; MannKind Corporation. N. Mauras: Advisory Panel; Self; Novo Nordisk, Research Support; Self; LifeScan, Medtronic, Novo Nordisk. R. Besser: None. A. Ghatak: None. S. A. Weinzimer: Advisory Panel; Self; Dompe, Zealand Pharma A/S, Speaker's Bureau; Self; Medtronic. K. K. Hood: Consultant; Self; Cecelia Health, Cercacor, LifeScan Diabetes Institute. D. Fox: None. L. Kanapka: None. C. K. Boughton: None. C. Kollman: Consultant; Self; Diasome Pharmaceuticals, Inc., Research Support; Self; Dexcom, Inc., Tandem Diabetes Care. J. Sibayan: None. R. Beck: Consultant; Self; Bigfoot Biomedical, Inc., Diasome Pharmaceuticals, Inc., Insulet Corporation, Lilly Diabetes, vTv Therapeutics, Research Support; Self; Beta Bionics, Inc., Dexcom, Inc., Medtronic, Novo Nordisk, Tandem Diabetes Care. R. Hovorka: Research Support; Self; Abbott Laboratories, Dexcom, Inc., Medtronic, Speaker's Bureau; Self; Dexcom, Inc., Eli Lilly and Company, Stock/Shareholder; Self; CamDiab Ltd. Dan05 consortium: n/a. J. M. Allen: None. M. E. Wilinska: Consultant; Self; CamDiab Ltd. M. Tauschmann: None. L. Denvir: None. A. Thankamony: None. F. Campbell: n/a. R. Wadwa: Consultant; Self; Tandem Diabetes Care, Research Support; Self; Dexcom, Inc., Eli Lilly and Company, Tandem Diabetes Care. Funding: National Institute of Diabetes and Digestive and Kidney Diseases (UC4DK108520) [ABSTRACT FROM AUTHOR]

Published
2021
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48. Assessing the efficacy, safety and utility of 6-month day-and-night automated closed-loop insulin delivery under free-living conditions compared with insulin pump therapy in children and adolescents with type 1 diabetes: an open-label, multicentre, multinational, single-period, randomised, parallel group study protocol

Author

Musolino, Gianluca, Allen, Janet M, Hartnell, Sara, Wilinska, Malgorzata E, Tauschmann, Martin, Boughton, Charlotte, Campbell, Fiona, Denvir, Louise, Trevelyan, Nicola, Wadwa, Paul, DiMeglio, Linda, Buckingham, Bruce A, Weinzimer, Stuart, Acerini, Carlo L, Hood, Korey, Fox, Steven, Kollman, Craig, Sibayan, Judy, Borgman, Sarah, Cheng, Peiyao, and Hovorka, Roman

Subjects
2. Zero hunger, Pancreas, Artificial, closed-loop, Adolescent, type 1 diabetes, artificial pancreas, Insulins, Diabetes Mellitus, Type 1, Insulin Infusion Systems, Treatment Outcome, Humans, Hypoglycemic Agents, Multicenter Studies as Topic, Patient Safety, Child, Randomized Controlled Trials as Topic
Abstract

INTRODUCTION: Closed-loop systems titrate insulin based on sensor glucose levels, providing novel means to reduce the risk of hypoglycaemia while improving glycaemic control. We will assess effectiveness of 6-month day-and-night closed-loop insulin delivery compared with usual care (conventional or sensor-augmented pump therapy) in children and adolescents with type 1 diabetes. METHODS AND ANALYSIS: The trial adopts an open-label, multicentre, multinational (UK and USA), randomised, single-period, parallel design. Participants (n=130) are children and adolescents (aged ≥6 and 16.7 mmol/L (300 mg/dL), area under the curve of glucose >10.0 mmol/L (180 mg/dL), total, basal and bolus insulin dose, body mass index z-score and blood pressure. Cognitive, emotional and behavioural characteristics of participants and caregivers and their responses to the closed-loop and clinical trial will be assessed. An incremental cost-effectiveness ratio for closed-loop will be estimated. ETHICS AND DISSEMINATION: Cambridge South Research Ethics Committee and Jaeb Center for Health Research Institutional Review Office approved the study. The findings will be disseminated by peer-review publications and conference presentations. TRIAL REGISTRATION NUMBER: NCT02925299; Pre-results.

50. Time Spent in Hypoglycemia According to Age and Time of Day: Observations During Closed-Loop Insulin Delivery.

Author

Alwan H, Ware J, Boughton CK, Wilinska ME, Allen JM, Lakshman R, Nwokolo M, Hartnell S, Bally L, de Beaufort C, Besser REJ, Campbell FM, Davis N, Denvir L, Evans ML, Fröhlich-Reiterer E, Ghatak A, Hofer SE, Kapellen TM, Leelarathna L, Mader JK, Narendran P, Rami-Mehrar B, Tauschmann M, Thabit H, Thankamony A, and Hovorka R

Subjects
Adolescent, Aged, Child, Child, Preschool, Humans, Blood Glucose, Cross-Over Studies, Hypoglycemic Agents therapeutic use, Insulin adverse effects, Insulin Infusion Systems, Insulin, Regular, Human therapeutic use, Retrospective Studies, Treatment Outcome, Young Adult, Adult, Middle Aged, Diabetes Mellitus, Type 1 drug therapy, Hypoglycemia chemically induced, Hypoglycemia drug therapy
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 <3.9 mmol/L (<70 mg/dL). Eight weeks of data for 88 participants were analyzed. Results: Median time spent in hypoglycemia over the 24-h period was highest in children and adolescents (4.4% [interquartile range 2.4-5.0]) and very young children (4.0% [3.4-5.2]), followed by adults (2.7% [1.7-4.0]), and older adults (1.8% [1.2-2.2]); P  < 0.001 for difference between age groups. Time spent in hypoglycemia during nighttime (midnight-05:59) was lower than during daytime (06:00-23:59) across all age groups. Conclusion: Time in hypoglycemia was highest in the pediatric age group during closed-loop insulin delivery. Hypoglycemia burden was lowest overnight across all age groups.

Published
2023
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