The Food and Drug Administration in collaboration with the National Institutes of Health presented a public workshop to facilitate medical device innovation in the development of the artificial pancreas (or autonomous system) for the treatment of diabetes mellitus on November 10, 2010 in Gaithersburg, Maryland.
The purpose of the workshop was to discuss four aspects of artificial pancreas research and development, including: (1) the current state of device systems for autonomous systems for the treatment of diabetes mellitus; (2) challenges in developing this expert device system using existing technology; (3) clinical expectations for these systems; and (4) development plans for the transition of this device system toward an outpatient setting.
The patients discussed how clinical science, system components, and regulatory policies will all need to harmonize in order to achieve the goal of seeing an AP product brought forward to the marketplace for patients to use.
PickupJCVibertiGCBilousRWKeenHAlbertiKGHomePDBinderC. Safety of continuous subcutaneous insulin infusion: Metabolic deterioration and glycaemic autoregulation after deliberate cessation of infusion. Diabetologia.1982;22 (3): 175–9.
2.
ScheenACastilloMJandrainBKrzentowskiGHenrivauxPLuyckxASLefèbvrePJ. Metabolic alterations after a two-hour nocturnal interruption of a continuous subcutaneous insulin infusion. Diabetes Care.1984;7 (4): 338–42.
3.
CastilloMJScheenAJLefèbvrePJ. The degree/rapidity of the metabolic deterioration following interruption of a continuous subcutaneous insulin infusion is Influenced by the prevailing blood glucose level. J Clin Endocrinol Metab.1996;81 (5): 1975–8.
4.
TanenbergRJNewtonCADrakeAJ. Confirmation of hypoglycemia in the “dead-in-bed” syndrome, as captured by a retrospective continuous glucose monitoring system. Endocr Pract.2010;16 (2): 244–8.
5.
Juvenile Diabetes Research Foundation Continuous Glucose Monitoring Study Group. Prolonged nocturnal hypoglycemia is common during 12 months of continuous glucose monitoring in children and adults with type 1 diabetes. Diabetes Care.2010;33 (5): 1004–8.
6.
BuckinghamBChaseHPDassauECobryEClintonPGageVCaswellKWilkinsonJCameronFLeeHBequetteBWDoyleFJ3rd. Prevention of nocturnal hypoglycemia using predictive alarm algorithms and insulin pump suspension. Diabetes Care.2010;33 (5): 1013–7.
WilsonDXingDBeckRWBlockJBodeBFoxLAHirschIKollmanCLaffelLRuedyKJSteffesMTamborlaneWV. Hemoglobin A1c and mean glucose in patients with type 1 diabetes: Analysis of data from the juvenile diabetes research foundation continuous glucose monitoring randomized trial. Diabetes Care. Epub ahead of print.
9.
KrzentowskiGScheenACastilloMLuyckxASLefèbvrePJ. A 6-hour nocturnal interruption of a continuous subcutaneous insulin infusion: 1. Metabolic and hormonal consequences and scheme for a prompt return to adequate control. Diabetologia.1983;24 (5): 314–8.
10.
AttiaNJonesTWHolcombeJTamborlaneWV. Comparison of human regular and lispro insulins after interruption of continuous subcutaneous insulin infusion and in the treatment of acutely decompensated IDDM. Diabetes Care.1998;21 (5): 817–21.
11.
Diabetes Research in Children Network (DirecNet) Study Group, Tsalikian E, Kollman C, Tamborlane WB, Beck RW, Fiallo-Scharer R, Fox L, Janz KF, Ruedy KJ, Wilson D, Xing D, Weinzimer SA. Prevention of hypoglycemia during exercise in children with type 1 diabetes by suspending basal insulin. Diabetes Care.2006;29 (10): 2200–4.
12.
Orsini-FedericiMAkwiJACanonicoVCellenoRFerollaPPippiRTassiCTimiABenedettiMM. Early detection of insulin deprivation in continuous subcutaneous insulin infusion-treated patients with type 1 diabetes. Diabetes Technol Ther.2006;8 (1): 67–75.
13.
BuckinghamBWilsonDMLecherTHanasRKaisermanKCameronF. Duration of nocturnal hypoglycemia before seizures. Diabetes Care.2008;31 (11): 2110–2.
14.
DassauEJovanovicLDoyleFJ3rdZisserHC. Enhanced 911/global position system wizard: A telemedicine application for the prevention of severe hypoglycemia–monitor, alert, and locate. J Diabetes Sci Technol.2009;3 (6): 1501–6.
15.
WeinzimerSASteilGMSwanKLDziuraJKurtzNTamborlaneWV. Fully automated closed-loop insulin delivery versus semiautomated hybrid control in pediatric patients with type 1 diabetes using an artificial pancreas. Diabetes Care.2008;31 (5): 934–9.
16.
ChabenneJRDiMarchiMAGelfanovVMDiMarchiRD. Optimization of the native glucagon sequence for medicinal purposes. J Diabetes Sci Technol.2010;4 (6): 1322–31.
17.
WilinskaMEChassinLJAceriniCLAllenJMDungerDBHovorkaR. Simulation environment to evaluate closed-loop insulin delivery systems in type 1 diabetes. J Diabetes Sci Technol.2010;4 (1): 132–44.
