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Zhang Y.,U.S. Food and Drug Administration | Jones P.L.,U.S. Food and Drug Administration | Klonoff D.C.,Mills Peninsula Health Services
Journal of Diabetes Science and Technology | Year: 2010

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. © Diabetes Technology Society.

PubMed | Centers for Disease Control and Prevention, Mills Peninsula Health Services, U.S. Food and Drug Administration, American Diabetes Association and 11 more.
Type: Journal Article | Journal: Journal of diabetes science and technology | Year: 2016

Inaccurate blood glucsoe monitoring systems (BGMSs) can lead to adverse health effects. The Diabetes Technology Society (DTS) Surveillance Program for cleared BGMSs is intended to protect people with diabetes from inaccurate, unreliable BGMS products that are currently on the market in the United States. The Surveillance Program will provide an independent assessment of the analytical performance of cleared BGMSs.The DTS BGMS Surveillance Program Steering Committee included experts in glucose monitoring, surveillance testing, and regulatory science. Over one year, the committee engaged in meetings and teleconferences aiming to describe how to conduct BGMS surveillance studies in a scientifically sound manner that is in compliance with good clinical practice and all relevant regulations.A clinical surveillance protocol was created that contains performance targets and analytical accuracy-testing studies with marketed BGMS products conducted by qualified clinical and laboratory sites. This protocol entitled Protocol for the Diabetes Technology Society Blood Glucose Monitor System Surveillance Program is attached as supplementary material.This program is needed because currently once a BGMS product has been cleared for use by the FDA, no systematic postmarket Surveillance Program exists that can monitor analytical performance and detect potential problems. This protocol will allow identification of inaccurate and unreliable BGMSs currently available on the US market. The DTS Surveillance Program will provide BGMS manufacturers a benchmark to understand the postmarket analytical performance of their products. Furthermore, patients, health care professionals, payers, and regulatory agencies will be able to use the results of the study to make informed decisions to, respectively, select, prescribe, finance, and regulate BGMSs on the market.

Pfutzner A.,IKFE Institute for Clinical Research and Development | Klonoff D.C.,Mills Peninsula Health Services | Pardo S.,Bayer Diabetes Care | Parkes J.L.,Bayer Diabetes Care
Journal of Diabetes Science and Technology | Year: 2013

Background: The Parkes error grid, which was developed in 1994, presented performance zones for blood glucose (BG) monitors with borders that were not mathematically specified at the time the grid was published. Methods: In this article, we (1) review the history of the Parkes error grid, (2) present the never-before-published exact coordinates and specifications of the grid so that others may produce an exact replica of the original grid, and (3) discuss our suggestions how this metric should be applied. Results: The new ISO15197:2013 guideline for system accuracy assessment of BG meters for patient self-measurement incorporates use of this metric for defining acceptable accuracy of BG monitors. It is expected that, for regulatory purposes, this document will stipulate that the error grid version for type 1 diabetes should be applied with the caveat that only the A zone represents acceptable accuracy. Conclusions: It remains to be seen by how much the new error grid, which is currently being developed by the Food and Drug Administration/Diabetes Technology Society/American Diabetes Association/The Endocrine Society/ Association for Advancement of Medical Instrumentation, will deviate from the Parkers error grid. © Diabetes Technology Society.

Klonoff D.C.,Mills Peninsula Health Services | Reyes J.S.,Diabetes Technology Society
Journal of Diabetes Science and Technology | Year: 2013

Blood glucose monitors (BGMs) are approved by regulatory agencies based on their performance during strict testing conducted by their manufacturers. However, after approval, there is uncertainty whether BGMs maintain the accuracy levels that were achieved in the initial data. The availability of inaccurate BGM systems pose a public health problem because their readings serve as a basis for treatment decisions that can be incorrect. Several articles have concluded that BGMs in the marketplace may not consistently provide accurate results in accordance with the regulatory standards that led to approval. To address this growing concern, Diabetes Technology Society organized and conducted a 1-day public meeting on May 21, 2013, in Arlington, VA, presided by its president, David Klonof, M.D., FACP, Fellow AIMBE, to determine whether BGMs on the market meet regulatory standards. The meeting consisted of four sessions in which Food and Drug Administration diabetes experts as well as leading academic clinicians and clinical chemists participated: (1) How is BGM performance determined? (2) Do approved BGMs perform according to International Organization for Standardization standards? (3) How do approved BGMs perform when used by patients and health care professionals? (4) What could be the consequence of poor BGM performance? © Diabetes Technology Society.

Klonoff D.C.,Mills Peninsula Health Services
Journal of Diabetes Science and Technology | Year: 2012

Fluorescence represents a promising alternative technology to electrochemistry and spectroscopy for accurate analysis of glucose in diabetes; however, no implanted fluorescence glucose assay is currently commercially available. The method depends on the principle of fluorescence, which is the emission of light by a substance after absorbing light. A fluorophore is a molecule that will absorb energy of a specific wavelength and reemit energy at a different wavelength. A fluorescence glucose-sensing molecule can be constructed to increase or decrease in fluorescence from baseline according to the ambient concentration of glucose. A quantum dot is a semiconductor crystal that can serve as a sensor by fluorescing at a desired wavelength or color, depending on the crystal size and materials used. If receptor molecules for glucose can be adsorbed to single-wall carbon nanotubules, then the resulting binding of glucose to these receptors will alter the nanotubes' fluorescence. Fluorescence glucose sensors can provide a continuous glucose reading by being embedded into removable wire-shaped subcutaneous or intravenous catheters as well as other types of implanted structures, such as capsules, microcapsules, microbeads, nano-optodes, or capillary tubes. Fluorescence glucose-sensing methods, which are under development, ofer four potential advantages over commercially used continuous glucose monitoring technologies: (1) greater sensitivity to low concentrations of glucose, (2) the possibility of constructing sensors that operate most accurately in the hypoglycemic range by using binding proteins with disassociation constants in this range, (3) less need to recalibrate in response to local tissue reactions around the sensor, and (4) no need to implant either a transmitter or a power source for wireless communication of glucose data. Fluorescence glucose sensors also have four significant disadvantages compared with commercially used continuous glucose monitoring technologies: (1) a damaging foreign body response; (2) a sensitivity to local pH and/or oxygen, which can afect the dye response; (3) potential toxicity of implanted dyes, especially if the implanted fluorophore cannot be fully removed; and (4) the necessity of always carrying a dedicated light source to interrogate the implanted sensor. Fluorescence sensing is a promising method for measuring glucose continuously, especially in the hypoglycemic range. If currently vexing technical and engineering and biocompatibility problems can be overcome, then this approach could lead to a new family of continuous glucose monitors. © Diabetes Technology Society.

Klonoff D.C.,Mills Peninsula Health Services
Journal of Diabetes Science and Technology | Year: 2015

Precision medicine is a modern concept that has been used since 2011 to describe tailored accurate medical treatments selected according to individual characteristics of each patient. Each patient's disease is analyzed according to molecular data, genomics, and systems biology in this model to establish the patient's disease process at the molecular level and select appropriate treatments. The patient's response is then closely monitored with direct or surrogate measures such as biomarkers, and the treatments can then be adapted according to the patient's response. The combination of traditional gross and microscopic metrics combined with molecular profiling is precision medicine. © 2015 Diabetes Technology Society.

Klonoff D.C.,Mills Peninsula Health Services
Journal of Diabetes Science and Technology | Year: 2013

mHealth is an emerging concept in health care and uses mobile communications devices for health services and information. Mobile phones, patient monitoring devices, tablets, personal digital assistants, and other wireless devices can be part of mHealth systems. With mHealth systems, glucose data can now be automatically collected, transmitted, aggregated with other physiologic data, analyzed, stored, and presented as actionable information. mHealth systems use mobile decision support software applications (or apps) to assist or direct health care professionals to make decisions, or they can assist or direct patients to make decisions without waiting for input from a clinician. With real-time decision support for patients, appropriate actions can be taken in real time without waiting to see a clinician. Decisions can be personalized if individual treatment goals and personal preferences for treatment are inputted into an app. Few mHealth apps for diabetes have been rigorously tested. Outcome studies of the use of mHealth for diabetes from the literature have shown the potential for benefits, but higher-quality studies are needed. Regulatory approval of mHealth products will require demonstration of safety and efectiveness, especially where information and trends are not just presented to patients, but used to make treatment recommendations. Three additional hurdles must be overcome to facilitate widespread adoption of this technology, including demonstration of the following: (1) privacy to satisfy regulators, (2) clinical benefit to satisfy clinicians, and (3) economic benefit to satisfy payers. mHealth for diabetes is making rapid strides and is expected to be a transforming technology that will be the next big thing. © Diabetes Technology Society.

Garg S.,University of Colorado at Denver | Brazg R.L.,Rainier Clinical Research Center | Bailey T.S.,AMCR Institute Inc. | Buckingham B.A.,Stanford University | And 5 more authors.
Diabetes Technology and Therapeutics | Year: 2012

Background: The efficacy of automatic suspension of insulin delivery in induced hypoglycemia among subjects with type 1 diabetes was evaluated. Subjects and Methods: In this randomized crossover study, subjects used a sensor-augmented insulin pump system with a low glucose suspend (LGS) feature that automatically stops insulin delivery for 2 h following a sensor glucose (SG) value ≤70 mg/dL. Subjects fasted overnight and exercised until their plasma glucose (measured with the YSI 2300 STAT Plus™ glucose and lactate analyzer [YSI Life Sciences, Yellow Springs, OH]) value reached ≤85 mg/dL on different occasions separated by washout periods lasting 3-10 days. Exercise sessions were done with the LGS feature turned on (LGS-On) or with continued insulin delivery regardless of SG value (LGS-Off). The order of LGS-On and LGS-Off sessions was randomly assigned. YSI glucose data were used to compare the duration and severity of hypoglycemia from successful LGS-On and LGS-Off sessions and to estimate the risk of rebound hyperglycemia after pump suspension. Results: Fifty subjects attempted 134 sessions, 98 of which were successful. The mean±SD hypoglycemia duration was less during LGS-On than during LGS-Off sessions (138.5±76.68 vs. 170.7±75.91 min, P=0.006). During LGS-On compared with LGS-Off sessions, mean nadir YSI glucose was higher (59.5±5.72 vs. 57.6±5.69 mg/dL, P=0.015), as was mean end-observation YSI glucose (91.4±41.84 vs. 66.2±13.48 mg/dL, P<0.001). Most (53.2%) end-observation YSI glucose values in LGS-On sessions were in the 70-180 mg/dL range, and none was >250 mg/dL. Conclusions: Automatic suspension of insulin delivery significantly reduced the duration and severity of induced hypoglycemia without causing rebound hyperglycemia. © 2012, Mary Ann Liebert, Inc.

Klonoff D.C.,Mills Peninsula Health Services | Buckingham B.,Stanford University | Christiansen J.S.,Aarhus University Hospital | Montori V.M.,Mayo Medical School | And 3 more authors.
Journal of Clinical Endocrinology and Metabolism | Year: 2011

Objective: The aim was to formulate practice guidelines for determining settings where patients are most likely to benefit from the use of continuous glucose monitoring (CGM). Participants: The Endocrine Society appointed a Task Force of experts, a methodologist, and a medical writer. Evidence: This evidence-based guideline was developed using the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) system to describe both the strength of recommendations and the quality of evidence. Consensus Process: One group meeting, several conference calls, and e-mail communications enabled consensus. Committees and members of The Endocrine Society, the Diabetes Technology Society, and the European Society of Endocrinology reviewed and commented on preliminary drafts of these guidelines. Conclusions: The Task Force evaluated three potential uses of CGM: 1) real-time CGM in adult hospital settings; 2) real-time CGM in children and adolescent outpatients; and 3) real-time CGM in adult outpatients. The Task Force used the best available data to develop evidence-based recommendations about where CGM can be beneficial in maintaining target levels of glycemia and limiting the risk of hypoglycemia. Both strength of recommendations and quality of evidence were accounted for in the guidelines. Copyright © 2011 by The Endocrine Society.

Garg S.K.,University of Colorado at Denver | Brazg R.L.,Rainier Clinical Research Center | Bailey T.S.,AMCR Institute Inc. | Buckingham B.A.,Stanford University | And 5 more authors.
Diabetes Technology and Therapeutics | Year: 2014

Background: The ASPIRE in-clinic study established that automatic suspension of insulin with the threshold suspend (TS) feature reduces the duration of induced hypoglycemia. The study's crossover design allowed the effects of antecedent hypoglycemia to be studied. Subjects and Methods: The study enrolled 50 subjects who exercised until plasma glucose (YSI glucose and lactate analyzer; YSI, Inc., Yellow Springs, OH) reached ≤85 mg/dL. Hypoglycemia was evaluated after the YSI value reached <70 mg/dL. In TS experiments, insulin was stopped for 2 h once a sensor glucose (SG) value of ≤70 mg/dL was detected; in control experiments, basal insulin delivery continued. Subjects were randomly assigned to Group A (TS in Period 1; control in Period 2) or Group B (control in Period 1; TS in Period 2). Experiments were separated by 3-10 days. Results: Hypoglycemia was 63.7 min shorter in Period 1 TS experiments (no preceding control experiment) than in Period 2 TS experiments (one or more preceding control experiment(s)) (P<0.01). The number of experiments prior to a successful TS experiment was lower for Period 1 than for Period 2 (0.36±0.64 vs. 1.57±0.84; P<0.001), as was the cumulative duration of antecedent hypoglycemia (16.6 min vs. 204.6 min; P<0.001). The between-groups difference in hypoglycemia duration was not attributable to differences in SG rates of change, the duration of exercise, or area under the curve of <70 mg/dL×min in the 2 days before the successful experiment (all P>0.3). Conclusions: The TS feature's ability to mitigate hypoglycemia was decreased by an episode or episodes of prolonged antecedent hypoglycemia, suggesting hypoglycemia begets hypoglycemia. The effect of antecedent hypoglycemia should be taken into consideration in the design of future experiments assessing strategies to reduce hypoglycemia. © Copyright 2014, Mary Ann Liebert, Inc. 2014.

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