The Experts below are selected from a list of 13446 Experts worldwide ranked by ideXlab platform
David C. Klonoff - One of the best experts on this subject based on the ideXlab platform.
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Threshold-based Insulin-Pump interruption for reduction of hypoglycemia
The New England journal of medicine, 2013Co-Authors: Richard M. Bergenstal, David C. Klonoff, Satish K. Garg, Bruce W. Bode, Melissa Meredith, Robert H. Slover, Andrew J. Ahmann, John B. Welsh, Scott W. Lee, Francine R. KaufmanAbstract:BackgroundThe threshold-suspend feature of sensor-augmented Insulin Pumps is designed to minimize the risk of hypoglycemia by interrupting Insulin delivery at a preset sensor glucose value. We evaluated sensor-augmented Insulin-Pump therapy with and without the threshold-suspend feature in patients with nocturnal hypoglycemia. MethodsWe randomly assigned patients with type 1 diabetes and documented nocturnal hypoglycemia to receive sensor-augmented Insulin-Pump therapy with or without the threshold-suspend feature for 3 months. The primary safety outcome was the change in the glycated hemoglobin level. The primary efficacy outcome was the area under the curve (AUC) for nocturnal hypoglycemic events. Two-hour threshold-suspend events were analyzed with respect to subsequent sensor glucose values. ResultsA total of 247 patients were randomly assigned to receive sensor-augmented Insulin-Pump therapy with the threshold-suspend feature (threshold-suspend group, 121 patients) or standard sensor-augmented insuli...
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Second Insulin Pump Safety Meeting: Summary Report
Journal of diabetes science and technology, 2010Co-Authors: Yi Zhang, Paul Jones, David C. KlonoffAbstract:Diabetes Technology Society facilitated a second meeting of Insulin Pump experts at Mills-Peninsula Health Services, San Mateo, California on November 4, 2009, at the request of the Food and Drug Administration, Center for Devices and Radiological Health, Office of Science and Engineering Laboratories. The first such meeting was held in Bethesda, Maryland, on November 12, 2008. The group of physicians, nurses, diabetes educators, and engineers from across the United States discussed safety issues in Insulin Pump therapy and recommended adjustments to current Insulin Pump design and use to enhance overall safety. The meeting discussed safety issues in the context of Pump operation; software; hardware; physical structure; electrical, biological, and chemical considerations; use; and environment from engineering, medical, nursing, and Pump/user perspectives. There was consensus among meeting participants that Insulin Pump designs have made great progress in improving the quality of life of people with diabetes, but much more remains to be done.
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Insulin Pump safety meeting: summary report.
Journal of diabetes science and technology, 2009Co-Authors: David C. Klonoff, Juliet S. ReyesAbstract:Diabetes Technology Society convened a panel of Insulin Pump experts in Bethesda, Maryland, on November 12, 2008, at the request of the Food and Drug Administration. The group consisted of physicians, nurses, diabetes educators, and engineers from across the United States. The panel members (1) discussed safety features of Insulin Pump therapy and (2) recommended adjustments to current Insulin Pump design and use to enhance overall safety. Software and hardware features of Insulin Pumps were analyzed from engineering, medical, nursing, and Pump-user perspectives. The meeting was divided into four sections: (1) Engineering Safety—Designing Software and Hardware for Insulin Pump Therapy; (2) Patient Safety—Selecting Patients and Clinical Settings for Insulin Pump Use; (3) Clinical Safety—Determining and Delivering Insulin Dosages Using Insulin Pump Therapy; and (4) Personal Experiences—A Panel Discussion about Insulin Pump Safety. Six aspects of Insulin Pump technology were noted to present potential safety problems: (1) software, (2) wireless communication, (3) hardware, (4) alarms, (5) human factors, and (6) bolus-dose calculation. There was consensus among meeting participants that Insulin Pump therapy is beneficial in patients of all ages and that Insulin Pump safety must be assured through careful regulation.
Yi Zhang - One of the best experts on this subject based on the ideXlab platform.
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Generic Safety Requirements for Developing Safe Insulin Pump Software
Journal of diabetes science and technology, 2011Co-Authors: Yi Zhang, Paul Jones, Raoul Jetley, Arnab RayAbstract:Background:The authors previously introduced a highly abstract generic Insulin infusion Pump (GIIP) model that identified common features and hazards shared by most Insulin Pumps on the market.The aim of this article is to extend our previous work on the GIIP model by articulating safety requirements that address the identified GIIP hazards. These safety requirements can be validated by manufacturers, and may ultimately serve as a safety reference for Insulin Pump software. Together, these two publications can serve as a basis for discussing Insulin Pump safety in the diabetes community.Method:In our previous work, we established a generic Insulin Pump architecture that abstracts functions common to many Insulin Pumps currently on the market and near-future Pump designs. We then carried out a preliminary hazard analysis based on this architecture that included consultations with many domain experts. Further consultation with domain experts resulted in the safety requirements used in the modeling work pres...
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Second Insulin Pump Safety Meeting: Summary Report
Journal of diabetes science and technology, 2010Co-Authors: Yi Zhang, Paul Jones, David C. KlonoffAbstract:Diabetes Technology Society facilitated a second meeting of Insulin Pump experts at Mills-Peninsula Health Services, San Mateo, California on November 4, 2009, at the request of the Food and Drug Administration, Center for Devices and Radiological Health, Office of Science and Engineering Laboratories. The first such meeting was held in Bethesda, Maryland, on November 12, 2008. The group of physicians, nurses, diabetes educators, and engineers from across the United States discussed safety issues in Insulin Pump therapy and recommended adjustments to current Insulin Pump design and use to enhance overall safety. The meeting discussed safety issues in the context of Pump operation; software; hardware; physical structure; electrical, biological, and chemical considerations; use; and environment from engineering, medical, nursing, and Pump/user perspectives. There was consensus among meeting participants that Insulin Pump designs have made great progress in improving the quality of life of people with diabetes, but much more remains to be done.
Mary E Boyle - One of the best experts on this subject based on the ideXlab platform.
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transitioning Insulin Pump therapy from the outpatient to the inpatient setting a review of 6 years experience with 253 cases
Journal of diabetes science and technology, 2012Co-Authors: Curtiss B Cook, Mary E Boyle, Karen M Seifert, Karen A Beer, Patricia A Mackey, Janna C CastroAbstract:Background:We reviewed the care of a large cohort of patients with diabetes mellitus on Insulin Pump therapy who required an inpatient stay.Methods:Records were reviewed of patients hospitalized between January 1, 2006, and December 31, 2011.Results:A total of 136 patients using Insulin Pumps had 253 hospitalizations. Mean (standard deviation) patient age was 55 (16) years, diabetes duration was 29 (15) years, and Pump duration was 6 (5) years. Insulin Pump therapy was continued in 164 (65%) hospitalizations. Adherence to core process measures improved over time: by 2011, 100% of cases had an endocrinology consultation, 100% had the required Insulin Pump order set completed, and 94% had documentation of the signed agreement specifying patient responsibilities for continued use of the technology while hospitalized. Documentation of the Insulin Pump flow sheet also increased but could still be located in only 64% of cases by the end of 2011. Mean glucose was not significantly different among patients who re...
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guidelines for application of continuous subcutaneous Insulin infusion Insulin Pump therapy in the perioperative period
Journal of diabetes science and technology, 2012Co-Authors: Mary E Boyle, Karen M Seifert, Karen A Beer, Heidi A Apsey, Adrienne A Nassar, Stephanie D Littman, Janice M Magallanez, Joshua D Stearns, Richard T. Schlinkert, Michael J HovanAbstract:Case reports indicate that diabetes patients receiving outpatient Insulin Pump therapy have been allowed to continue treatment during surgical procedures. Although allowed during surgery, there is actually little information in the medical literature on how to manage patients receiving Insulin Pump therapy during a planned surgical procedure. A multidisciplinary work group reviewed current information regarding the use of Insulin Pumps in the perioperative period. Although the work group identified safety issues specific to surgical scenarios, it believed that with the use of standardized guidelines and a checklist, continuation of Insulin Pump therapy during the perioperative period is feasible. A sample set of protocols have been developed and are summarized. A policy outlining clear procedures should be established at the institutional level to guide physicians and other staff if the devices are to be employed during the perioperative period. Additional clinical experience with the technology in surgical scenarios is needed, and consensus should be developed for Insulin Pump use in the perioperative phases of care.
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use of continuous subcutaneous Insulin infusion Insulin Pump therapy in the hospital setting proposed guidelines and outcome measures
The Diabetes Educator, 2005Co-Authors: Curtiss B Cook, Mary E Boyle, Nancy S Cisar, Victoria Millercage, Peggy B Bourgeois, Lori R Roust, Steven A Smith, Richard S ZimmermanAbstract:PurposeIndividuals whose diabetes is being treated in the outpatient setting via an Insulin Pump often wish to maintain this therapy during hospitalization. The authors propose guidelines for management of patients on Insulin Pumps who require a hospital admission.MethodsA collaborative interinstitutional task force reviewed current available information regarding the use of Insulin Pumps in the hospital.ResultsThere was little information in the medical literature on how to manage individuals on established Insulin Pump therapy during a hospital stay. The task force believed that a policy that promotes patient independence through continuation of Insulin Pump therapy while ensuring patient safety was possible. A set of contraindications for continued use of Pump therapy in the hospital are proposed. A sample patient consent form and order set are presented. Finally, measures that can be used to assess effectiveness of an inpatient Insulin Pump policy are outlined.ConclusionsPatients on established insuli...
Michael J Hovan - One of the best experts on this subject based on the ideXlab platform.
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guidelines for application of continuous subcutaneous Insulin infusion Insulin Pump therapy in the perioperative period
Journal of diabetes science and technology, 2012Co-Authors: Mary E Boyle, Karen M Seifert, Karen A Beer, Heidi A Apsey, Adrienne A Nassar, Stephanie D Littman, Janice M Magallanez, Joshua D Stearns, Richard T. Schlinkert, Michael J HovanAbstract:Case reports indicate that diabetes patients receiving outpatient Insulin Pump therapy have been allowed to continue treatment during surgical procedures. Although allowed during surgery, there is actually little information in the medical literature on how to manage patients receiving Insulin Pump therapy during a planned surgical procedure. A multidisciplinary work group reviewed current information regarding the use of Insulin Pumps in the perioperative period. Although the work group identified safety issues specific to surgical scenarios, it believed that with the use of standardized guidelines and a checklist, continuation of Insulin Pump therapy during the perioperative period is feasible. A sample set of protocols have been developed and are summarized. A policy outlining clear procedures should be established at the institutional level to guide physicians and other staff if the devices are to be employed during the perioperative period. Additional clinical experience with the technology in surgical scenarios is needed, and consensus should be developed for Insulin Pump use in the perioperative phases of care.
Juliet S. Reyes - One of the best experts on this subject based on the ideXlab platform.
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Insulin Pump safety meeting: summary report.
Journal of diabetes science and technology, 2009Co-Authors: David C. Klonoff, Juliet S. ReyesAbstract:Diabetes Technology Society convened a panel of Insulin Pump experts in Bethesda, Maryland, on November 12, 2008, at the request of the Food and Drug Administration. The group consisted of physicians, nurses, diabetes educators, and engineers from across the United States. The panel members (1) discussed safety features of Insulin Pump therapy and (2) recommended adjustments to current Insulin Pump design and use to enhance overall safety. Software and hardware features of Insulin Pumps were analyzed from engineering, medical, nursing, and Pump-user perspectives. The meeting was divided into four sections: (1) Engineering Safety—Designing Software and Hardware for Insulin Pump Therapy; (2) Patient Safety—Selecting Patients and Clinical Settings for Insulin Pump Use; (3) Clinical Safety—Determining and Delivering Insulin Dosages Using Insulin Pump Therapy; and (4) Personal Experiences—A Panel Discussion about Insulin Pump Safety. Six aspects of Insulin Pump technology were noted to present potential safety problems: (1) software, (2) wireless communication, (3) hardware, (4) alarms, (5) human factors, and (6) bolus-dose calculation. There was consensus among meeting participants that Insulin Pump therapy is beneficial in patients of all ages and that Insulin Pump safety must be assured through careful regulation.