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

Hovorka, Roman; Acerini, Carlo L.; Thankamony, Ajay; Allen, Janet M.; Boughton, Charlotte K; Dovč, Klemen; Dunger, David; Ware, Julia; Musolino, Gianluca; Tauschmann, Martin; Wilinska, Malgorzata E.; Hayes, Josephine; Hartnell, Sara; Slegtenhorst, Sonja; Ruan, Yue; Haydock, M; Mangat, J; Denvir, Louise; Kanthagnany, SK; Law, Jennifer; Randell, Tabitha; 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, Vincent P.; Verhoeven, V; Bratt, S; Khan, N; Moyes, L; Sandhu, K; West, C; Wadwa, R. Paul; Alonso, G. Todd; Forlenza, Gregory P.; Slover, Robert; Towers, Lindsey; Berget, Cari; Coakley, Alexander; Escobar, Estella; Jost, Emily; Lange, Samantha; Messer, Laurel H.; Thivener, Katie; Campbell, Fiona; Yong, James; Metcalfe, Emily; Allen, Matt; Ambler, S; Waheed, S; Exall, Jane; Tulip, J; Buckingham, Bruce A.; Ekhlaspour, Laya; Maahs, David M.; Norlander, Lisa; Jacobson, Tali; Twon, M; Weir, C; Leverenz, Brianna; Keller, Jordan; Davis, Nikki; Kumaran, A; Trevelyan, Nicola; Dewar, Hilary; Price, G; Crouch, G; Ensom, R; Haskell, L; Lueddeke, LM; Mauras, Nelly; Benson, Matthew; Bird, Keisha; Englert, Kimberly; Permuy, Joe; Ponthieux, K; Marrero-Hernandez, J; DiMeglio, Linda A.; Ismail, Heba M.; Jolivette, Heather A.; Sanchez, Janine; Woerner, Stéphanie; Kirchner, Megan; Mullen, M; Tebbe, Megan; Besser, Rachel; Basu, S; London, R; Makaya, T; Ryan, F; Megson, C; Bowen-Morris, J; Haest, J; Law, R; Stamford, I; Ghatak, Atrayee; Deakin, M; Phelan, K; Thornborough, K; Shakeshaft, J; Weinzimer, Stuart A.; Cengiz, Eda; Sherr, Jennifer; Name, Michelle Van; Weyman, Kate; Carria, Lori; Steffen, Amy; Zgorski, Melinda; Sibayan, Judy; Beck, Roy W.; Borgman, Sarah; Davis, J; Rusnak, J; Hellman, Amanda; Cheng, Peiyao; Kanapka, Lauren; Kollman, Craig; McCarthy, Chris; Chalasani, S; Hood, Korey K.; Hanes, Sarah; Viana, J; Lanning, Monica S.; Fox, David; Arreaza-Rubín, Guillermo; Eggerman, Thomas L.; Green, N; Janicek, Robert; Gabrielson, Deanna; Belle, Steven H.; Castle, Jessica R.; Green, J; Legault, Laurent; Willi, Steven M.; Wysham, Carol

doi:10.1016/s2589-7500(22)00020-6

Cited by 57 publications

(39 citation statements)

References 20 publications

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“…Specifically, those on CamAPS FX stayed in CL for 93% of the time while those on FlorenceM stayed in CL just 57% of the time. Thus, the overall effects are influenced by differential use and overall satisfaction with the FlorenceM, which was poorer 17 . This led to the subgroup analyses with the CamAPS FX participants and their controls.…”

Section: Discussionmentioning

confidence: 99%

“…This study was conducted as an open‐label, single‐period, randomized, parallel design contrasting CL versus a control condition 17 . The control condition involved insulin pump therapy with or without glucose sensor.…”

Section: Methodsmentioning

confidence: 99%

“…Key exclusion criteria included current use of CL therapy, and more than one episode of severe hypoglycaemia or diabetic ketoacidosis during the preceding 6 months. Complete inclusion and exclusion criteria are noted elsewhere, along with full study procedures 17 …”

Section: Methodsmentioning

confidence: 99%

“…In the United States, however, participants continued using FlorenceM until study completion, as the insulin pump for CamAPS FX did not have US regulatory clearance. For more detail on the difference between these two systems, please see the primary article and associated tables 17 …”

Section: Methodsmentioning

confidence: 99%

“…17 For more detail on the difference between these two systems, please see the primary article and associated tables. 17 Control participants continued using their usual insulin pump and, if applicable, CGM. Throughout the study, participants and/or their clinical team were free to adjust diabetes therapy, but no active treatment optimization was undertaken by the research team.…”

Section: Study Participantsmentioning

confidence: 99%

See 4 more Smart Citations

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

Hood

Garcia‐Willingham

Hanes

et al. 2022

Diabetes Obesity Metabolism

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Section: Discussionmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: Study Participantsmentioning

confidence: 99%

See 3 more Smart Citations

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

Hood

Garcia‐Willingham

Hanes

et al. 2022

Diabetes Obesity Metabolism

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Use of diabetes technology in children

Schoelwer,

DeBoer,

Breton

2024

Diabetologia

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Children with type 1 diabetes and their caregivers face numerous challenges navigating the unpredictability of this complex disease. Although the burden of managing diabetes remains significant, new technology has eased some of the load and allowed children with type 1 diabetes to achieve tighter glycaemic management without fear of excess hypoglycaemia. Continuous glucose monitor use alone improves outcomes and is considered standard of care for paediatric type 1 diabetes management. Similarly, automated insulin delivery (AID) systems have proven to be safe and effective for children as young as 2 years of age. AID use improves not only blood glucose levels but also quality of life for children with type 1 diabetes and their caregivers and should be strongly considered for all youth with type 1 diabetes if available and affordable. Here, we review key data on the use of diabetes technology in the paediatric population and discuss management issues unique to children and adolescents.

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Simplified meal announcement study (SMASH) using hybrid closed-loop insulin delivery in youth and young adults with type 1 diabetes: a randomised controlled two-centre crossover trial

Laesser,

Piazza,

Schorno

et al. 2024

Diabetologia

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Aims/hypothesis The majority of hybrid closed-loop systems still require carbohydrate counting (CC) but the evidence for its justification remains limited. Here, we evaluated glucose control with simplified meal announcement (SMA) vs CC in youth and young adults with type 1 diabetes using the mylife CamAPS FX system. Methods We conducted a two-centre, randomised crossover, non-inferiority trial in two University Hospitals in Switzerland in 46 participants (aged 12–20 years) with type 1 diabetes using multiple daily injections (n=35), sensor-augmented pump (n=4) or hybrid closed-loop (n=7) therapy before enrolment. Participants underwent two 3 month periods with the mylife CamAPS FX system (YpsoPump, Dexcom G6) to compare SMA (individualised carbohydrate meal sizes) with CC, in a randomly assigned order using computer-generated sequences. The primary endpoint was the proportion of time glucose was in target range (3.9–10.0 mmol/l) with a non-inferiority margin of 5 percentage points. Secondary endpoints were other sensor glucose and insulin metrics, usability and safety endpoints. Results Forty-three participants (18 women and girls) completed the trial. In the intention-to-treat analysis, time in range (mean±SD) was 69.9±12.4% with SMA and 70.7±13.0% with CC (estimated mean difference −0.6 percentage points [95% CI −2.4, 1.1], demonstrating non-inferiority). Time <3.9 mmol/l (median [IQR] 1.8 [1.2–2.2]% vs 1.9 [1.6–2.5]%) and >10.0 mmol/l (28.2±12.6% vs 27.2±13.4%) was similar between periods. Total daily insulin dose was higher with SMA (54.0±14.7 U vs 51.7±12.1 U, p=0.037). Three participants experienced serious adverse events, none of which were intervention-related. Conclusions/interpretation Glucose control using the CamAPS FX algorithm with SMA was non-inferior to its use with CC in youth and young adults with type 1 diabetes. Trial registration ClinicalTrials.gov NCT05481034. Funding The study was supported by the Swiss Diabetes Foundation and by a YTCR grant from the Bangerter-Rhyner Foundation and the Swiss Academy of Medical Sciences. Dexcom and Ypsomed provided product support. Graphical Abstract

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

Cited by 57 publications

References 20 publications

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

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

Use of diabetes technology in children

Simplified meal announcement study (SMASH) using hybrid closed-loop insulin delivery in youth and young adults with type 1 diabetes: a randomised controlled two-centre crossover trial

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