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automated closed-loop insulin delivery; automated insulin dosing controller; automated glycemic controller device; artificial pancreas

- FDA approves Medtronic's MiniMed 670G hybrid closed-loop insulin delivery system. [4] - FDA clears first automated insulin-delivery tech for type 2 diabetes [12] Also see bionic pancreas. Indications: - diabetes mellitus type-1 - better glycemic control without increases in hypoglycemia [8] - safe & feasible in patients with type 2 diabetes [5] - improves glycemic control in hospitalized patients [7] Mechanism of action: - links continuous subcutaneous glucose monitoring with subcutaneous insulin pump delivery - improves glycemic control relative to insulin pump (continuous insulin delivery system) [1,2] - associated with more time in a normal glycemic range for patients with type 1 diabetes [6] - can improve glycemic control overnight - can reduce the burden of self-management during the day - effects on long term complications of diabetes unknown [6] - insulin a+ pramlintide may improve glycemic control [10] Notes: - children age 2-6 years with an artifical pancreas achieve 3 hours more/day in their target glucose range [11]

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bionic pancreas

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insulin pump

References

  1. Hovorka R et al. Overnight closed loop insulin delivery (artificial pancreas) in adults with type 1 diabetes: Crossover randomised controlled studies. BMJ 2011 Apr 14; 342:d1855 PMID: 21493665
  2. Haidar A et al Comparison of dual-hormone artificial pancreas, single-hormone artificial pancreas, and conventional insulin pump therapy for glycaemic control in patients with type 1 diabetes: an open- label randomised controlled crossover trial. The Lancet Diabetes & Endocrinology, 27 November 2014 PMID: 25434967 http://www.thelancet.com/journals/landia/article/PIIS2213-8587%2814%2970226-8/fulltext - Russell SJ When you come to a fork in the road, take it! The Lancet Diabetes & Endocrinology, 27 November 2014 PMID: 25434966 http://www.thelancet.com/journals/landia/article/PIIS2213-8587%2814%2970195-0/fulltext
  3. Thabit H et al. Home use of an artificial beta cell in type 1 diabetes. N Engl J Med 2015 Sep 17 PMID: 26379095
  4. Tucker ME FDA Approves First 'Artificial Pancreas' for Type 1 Diabetes. Medscape. Sep 28, 2016. http://www.medscape.com/viewarticle/869400 - FDA News Release. September 28, 2016 FDA approves first automated insulin delivery device for type 1 diabetes. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm522974.htm
  5. Thabit H, Hartnell S, Allen JM et al Closed-loop insulin delivery in inpatients with type 2 diabetes: a randomised, parallel-group trial. Lancet Diabetes & Endocrinology Nov 8 2016 PMID: 27836235 Free Article http://thelancet.com/journals/landia/article/PIIS2213-8587(16)30280-7/fulltext - Rayman G Closer to closing the loop on inpatient glycaemia. Lancet Diabetes & Endocrinology Nov 8 2016 PMID: 27836233 Free Article http://thelancet.com/journals/landia/article/PIIS2213-8587(16)30327-8/fulltext
  6. Bekiari E, Kitsios K, Thabit H et al Artificial pancreas treatment for outpatients with type 1 diabetes: systematic review and meta-analysis. BMJ 2018;361:k1310 PMID: 29669716 https://www.bmj.com/content/361/bmj.k1310 - Waugh N, Adler A, Craigie I, Omer T. Closed loop systems in type 1 diabetes BMJ 2018;361:k1613 PMID: 29669729 https://www.bmj.com/content/361/bmj.k1613
  7. Bally L, Thabit H, Hartnell S et al. Closed-loop insulin delivery for glycemic control in noncritical care. N Engl J Med 2018 Jun 25; PMID: 29940126 Free Article
  8. Tauschmann M, Thabit H, Bally L et al Closed-loop insulin delivery in suboptimally controlled type 1 diabetes: a multicentre, 12-week randomised trial. Lancet. 2018 Oct 13;392(10155):1321-1329. PMID: 30292578 Free PMC Article - Galderisi A, Sherr JL. Enlarging the loop: closed-loop insulin delivery for type 1 diabetes. Lancet. 2018 Oct 13;392(10155):1282-1284. PMID: 30292579 Free full text
  9. FDA News Release. Dec 13, 2019 FDA authorizes first interoperable, automated insulin dosing controller designed to allow more choices for patients looking to customize their individual diabetes management device system. https://www.fda.gov/news-events/press-announcements/fda-authorizes-first-interoperable-automated-insulin-dosing-controller-designed-allow-more-choices
  10. Monaco K FDA OK's Trijardy XR; Dual Hormone Artificial Pancreas - News and commentary from the endocrinology world MedPage Today January 31, 2020 https://www.medpagetoday.com/endocrinology/generalendocrinology/84653
  11. Wadwa RP, Reed ZW, Buckingham BA et al Trial of Hybrid Closed-Loop Control in Young Children with Type 1 Diabetes. N Engl J Med 2023; 388:991-1001. March 16. PMID: 36920756 Clinical Trial. https://www.nejm.org/doi/full/10.1056/NEJMoa2210834
  12. Monaco K FDA Clears First Automated Insulin-Delivery Tech for Type 2 Diabetes. SmartAdjust technology is used in Insulet's Omnipod 5 Automated Insulin Delivery System. MedPage Today August 27, 2024 https://www.medpagetoday.com/endocrinology/diabetes/111676 - Tucker ME FDA Clears the Omnipod 5 System for Type 2 Diabetes. Medscape. August 26, 2024 https://www.medscape.com/viewarticle/fda-clears-omnipod-5-system-type-2-diabetes-2024a1000fld