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Latest Developments in Artificial Pancreas Research and Adoption

Explore the newest advancements in artificial pancreas research and its clinical implementation, including closed-loop outpatient studies, randomized clinical trials, and the future outlook. Learn about the benefits of closed-loop systems in improving time in target glucose range and reducing hypoglycemic episodes.

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Latest Developments in Artificial Pancreas Research and Adoption

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  1. What is new in the artificial pancreas research and its clinical practice adoption? Roman Hovorka University of Cambridge, UK

  2. Duality of interest declaration Advisory Panel: Merck, Novo Nordisk, Artsana Research Support: Minimed Medtronic, Abbott Diabetes Care Speaker’s Bureau: Novo Nordisk, Eli Lilly License fees: BBraun, Medtronic Other: Patents and patent applications

  3. Content • (Not so) hot news • Closed loop outpatient studies: • Randomised clinical trials • Outlook

  4. US Launch spring 2017 Outside US launch spring 2018 (or later)

  5. The artificial pancreas sensor insulin pump control algorithm

  6. Outpatient Randomised Clinical Trials

  7. Adolescents overnight camp study 1 night RCT • Closed loop vs SAP • Adolescents (n=56) • Three-centre • Baseline A1C 8.0% 23:00 to 07:00 data • Fewer episodes below 3.5mmol/l Reduced number of hypos Phillip et al NEJM 2013; 368:824-833

  8. Adolescent and adult overnight home study 6 week RCT • Closed loop vs SAP • Adults (n=24) • One-centre • Baseline A1C 7.5% Overnight data • Time in target ↑13% • Hypo 3.9mmol/l↓1.9% Improved time in target and time in hypo MD-logic algorithm working with Medtronic on 690G pump (adding correction bolus to 670G) Nimri et al Diabetes Care 2014 Nov; 37(11): 3025-3032

  9. Cambridge closed-loop prototypes 2014 2007 2012 2013 2010 2016

  10. Cambridge free-living studies since 2012 • N = 190 • 7 centres, adults pregnancy, adolescents, children • 4 RCTs night only over 3 to 12 weeks • 6 RCT 24/7 over 1 to 12 weeks • total closed loop operation • 125,949 hours • 4,248 days • 14.4 years

  11. Adult 24/7 home study 12 week RCT • Closed loop vs SAP • Adults (n=33) • Three-centre • Baseline A1C 7.6% 24 hour data • Time in target ↑11% • Mean glucose ↓0.6mmol/l • Hypo AUC ↓2/5 • HbA1c ↓0.3% Improved time in target and time below target Thabit, Tauschmann et al NEJM 2015 26;373(22):2129-40

  12. Children and adolescents overnight home study 12 week RCT • Closed loop vs SAP • 6 – 18 years (n=25) • Three-centre • Baseline A1C 8.1% Midnight to 08:00 data • Time in target ↑25% • Mean glucose ↓1.6mmol/l Improved time in target no change in hypo burden Thabit, Tauschmann et al NEJM 2015 26;373(22):2129-40

  13. Teens 24/7 home study 3 week RCT • Closed loop vs SAP • Teens (n=12) • Single-centre • Baseline A1C 8.5% 24hour data • Time in target ↑19% • Mean glucose ↓1.8mmol/l Improved time in target Tauschmann et al Diabetes Care. 2016 Nov;39(11):2019-2025

  14. Well controlled adults home study 3 week RCT • Closed loop vs conventional pump therapy • Adults (n=29) • Two-centre • Baseline A1C 6.9% 24hour data • Time in target ↑11% • Mean glucose ↓0.4mmol/l • Hypo AUC ↓2/3 Improved time in target and time below target Conventional pump therapy Bally et al Lancet Diabetes Endocrinol. 2017 pii: S2213-8587(17)30001-3

  15. Free living home use: No remote monitoring or supervision

  16. Pregnant women overnight home study 4 week RCT • Closed loop vs SAP • Adult (n=16) • Single-centre • Baseline A1C 6.8% Overnight data • Time in target ↑15% • Mean glucose ↓0.8mmol/l Improved time in target no change in hypo burden Stewart et al NEJM 2016 26;375:644-54

  17. Overnight closed-loop at home in pregnant women Courtesy of Dr Helen Murphy and Dr Zoe Stewart

  18. Cambridge home use: summary of results • Time in target 3.9 to 10mmol/l • Increase by 11-19 percentage points • Time in hypoglycaemia < 3.9 mmol/l • No change to halved • Largest reduction when comparator conventional pump therapy • Greatest benefits overnight • Closed-loop well tolerated by users and guardians

  19. Adolescents overnight camp study 6 day RCT • Closed loop vs SAP • Adolescents (n=20) • One-centre • Baseline A1C 8.1% 23:00 to 07:00 data • Time in target ↑20% • Hypo 3.9mmol/l ↓14% Increased time in target and reduced time in hypoglycaemia Ly et al Diabetes Technol & Therap. 2016, 18(6): 377-384

  20. Adolescents and adults 24/7 camp study 6 day RCT (670G) • Closed loop vs SAP • Adolescents and adults (n=21) • One-centre • Baseline A1C 8.6% 24 hour data • No change No change (Improvements over time) Ly et al Diabetes Care 2015 Jul; 38(7): 1205-1211

  21. 670G Hybrid closed-loop • PID controller • N=124 • 3 months • 14-75 years • HbA1c 7.4%(0.9) Bergenstal et al JAMA 2016

  22. Adult 24/7 hotel vs home study 5 nights RCT • Closed loop (hotel) vs SAP (home) • Adults (n=10) • Two-centre • Baseline A1C 7.0% 23:00 to 07:00 data • Time in target ↑22% • Mean glucose ↓1.7mmol/l Improved time in target and no change in hypo burden Brown et al Diabetes Technol Ther. 2015 Mar;17(3):203-9

  23. Adult evening/night home study 8 week RCT • Closed loop vs SAP • Adults (n=32) • Three-centre • Baseline A1C 8.2% Data 20:00 to 08:00 • Time in target ↑7% • Mean glucose ↓0.3 mmol/l • Hypo 3.9mmol/l↓1.6% • HbA1c ↓0.2% Improved time in target and time below target Kropff et al Lancet Diabetes Endocrinol 2015;3:939–947

  24. 5-9 year old 24/7 camp study 3 days RCT • Closed loop vs SAP • Preadolescents (n=30) • One-centre • Baseline A1C 7.3% Overnight data • Mean glucose ↑1.3mmol/l • Hypo 3.9mmol/l ↓2.2% Increased mean glucose reduced time below target Del Favero et al Diabetes Care 2016 Jul; 39(7): 1180-1185

  25. Bi-hormonal closed-loop system at camp 5 days diabetes camp RCT (usual therapy) • Young children 6-11 years (n=19) • Baseline A1C 7.8% 24 hour data • Time in target ↑23% • Mean glucose ↓1.7 mmol/l • Hypo 3.3mmol/l↓1.6% Overnight data • Time in target ↑32% • Mean glucose ↓2.6 mmol/l • Hypo 3.3mmol/l↓2.2% Russell et al, Lancet Diabetes Endocrinol. 2016;4(3):233-43

  26. Bi-hormonal adult home monitored study 11 day RCT • Closed loop vs conventional • Adults (n=39) • Three-centre • Baseline A1C 7.7% 24 hour data • Time in target ↑17% • Mean glucose ↓1.1mmol/l • Time below tgt↓1.3% Improved time in target and time below target El-Khatib et al Lancet 2017 ;389:369-380

  27. Single vs dual hormone overnight closed loop at camp • Adolescents and adults • N=28 • 2 nights per treatment Haidar et al, JCEM 2016

  28. Dual hormone closed-loop • Benefits • Increased hypoglycaemia protection • More aggressive insulin delivery • Challenges • Room-temperature stable glucagon • Dual-chamber pumps (and two catheters) • Insulin “trumps” glucagon • Meal bolus required • Chronic sc delivery – biological risks • Cost Russell et al, Diabetes Care, 2012 Castle et al, Diabetes Care, 33, 2010 El Khatib et al, Sci Transl Med, 2, 2010

  29. Summary: RCT outpatient studies Study outcomes Reduced mean glucose and reduced hypoglycaemia Reduced mean glucose Reduced hypoglycaemia No change Increased mean glucose and reduced hypoglycaemia Algorithm matters and/or Baseline characteristics/population/settings matter

  30. Variability in insulin requirements (adults) Ruan Y et al, Diabetes Care. 2016;39:830-2

  31. Commercialisation of artificial pancreas single single dual single single dual single single Kropff et al, Diabetes Technol Ther. 2016;18 Suppl 2:S253-63

  32. Large outcome studies • Large outcomes studies planned/underway • 80 – 1,500 subjects • Lasting 3 months to 2 years • Children, adolescents, adults, newly diagnosed • US, Australia, Europe • Prototype systems & prototype systems

  33. CLOuD study: newly diagnosed youth

  34. Clinical practice adoption • Adoption challenges • Approved system • Target populations • Training • Reimbursement • Performance barriers • Speed of insulin absorption/reliability of insulin delivery • Sensor reliability

  35. Acknowledgement Helen Murphy David Dunger Mark Evans Cambridge AP Group, February 2017 Carlo Acerini

  36. King’s College University of Sheffield University College London Leeds Teaching Hospital Norfolk and Norwich University Hospital University of Manchester University of Southampton University of Edinburgh University of Swansea University of Oxford Southampton NHS Trust Nottingham NHS Trust Alder Hey Liverpool Edinburgh NHS Trust JaebCentre University of Graz ProfilInstitute PediatricHospital of Luxembourg Stanford University Yale University University of Denver Park Nicollet, Minnesota UCLA University of Innsbruck University of Vienna University of Leipzig HevaHeor University of Bern Stefanie Amiel, Pratik Choudhary Simon Heller Peter Hindmarsh Fiona Campbell NanduThalange Lalantha Leelarathna Kath Barnard Julia Lawton Steve Luzio Julie Edge. Rachel Besser Nicola Trevelyan Tabitha Randell AtrayeeGhatak Daniela Elleri Judy Sibayan, John Lum, Craig Kollman Thomas Pieber, Elke Froehlich-Reiterer, Julia Mader Lutz Heinemann, Carsten Benesch, Sabine Arnolds Carine de Beaufort Bruce Buckingham Stuart Weinzimer Viral Shah Richard Bergenstal, Amy Criego Steven Fox Sabine Hofer Birgit Rami-Berhar Thomas Kapellen Stephane Roze Christoph Settler, Lia Bally UK and further afield

  37. Participants and families

  38. Funders and Support

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