Standardized Hybrid Closed-Loop System Reporting

Shah, Viral N.; Garg, Satish K.

doi:10.1089/dia.2020.0622

Cited by 11 publications

(9 citation statements)

References 98 publications

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“…For example, rather than or in addition to display of the glucose distribution for all data being analyzed, one might display the glucose distributions by longitudinal date, time of day, pre-and postprandial or nocturnal periods, or by day of the week in panel A of Figure 1. 39,51 We also expect that attempts will be made to facilitate automated inclusion of the dashboard report directly into electronic medical records.…”

Section: Discussionmentioning

confidence: 99%

“…24,[29][30][31][32][33][34] Patients periodically change the make and models of their devices, and periodic software updates are likely to drive further increases in the number of reports and reporting systems. Thus, there is an urgent need for standardization of the metrics and reports of these diabetes technology devices, 38,39 as in the case of previous forms of diabetes technology. [40][41][42][43][44][45] Although there will always be some variability in reports as developers seek to improve and optimize their systems, we expect that it should be possible to standardize at least a core section of the reports forming a one-page summary or ''dashboard.''…”

Section: Introductionmentioning

confidence: 99%

“…A similar proposal for a standardized reporting for automated insulin delivery systems was recently proposed. 39 In the present report, we present a prototype for a report applicable to people using CGM or BGM combined with a connected insulin pen.…”

Section: Introductionmentioning

confidence: 99%

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Standardizing Reporting of Glucose and Insulin Data for Patients on Multiple Daily Injections Using Connected Insulin Pens and Continuous Glucose Monitoring

Rodbard

Garg

2021

Diabetes Technology & Therapeutics

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Background: Recent development and availability of several connected insulin pens with digital memory are likely to expand the availability of glucose and insulin metrics that previously had been available only for the much smaller number of people using insulin pumps. It would be highly desirable to standardize data presentations to avoid the chaotic emergence of multiple formats that might reduce the clinical utility of connected pens. Methods: We reviewed the literature and analyzed data displays from multiple blood glucose monitoring, continuous glucose monitoring (CGM), insulin pump, and automated insulin delivery systems, and methods for combination of glucose and insulin data. We examined multiple forms of presentation and now propose a prototype for a standardized method for data analysis and display, focusing on the content and format of a onepage dashboard summary for patients on multiple daily injection (MDI) insulin regimens. Results: We propose the following metrics to be included in the one-page report: (A) glucose metrics: simplified glucose distribution in the form of a stacked bar chart showing percentages of time below-, above-, or within-target ranges overall and (optionally) by date, by time of day, or day of the week; (B) insulin metrics: types and doses, and timing of basal and bolus insulin; (C) an enhanced ambulatory glucose profile or ''AGP+'' showing glucose data points and/or distributions (10th to 90th percentiles), dosages and timing of basal and bolus insulins and (optionally) graphical display of risk of hypoglycemia and hyperglycemia; and (D) user experience regarding technology usage, frequency of alerts for hypo-and hyperglycemia, and information regarding lifestyle, meals, exercise, and sleep, if available; and (E) clinical insights and interpretation. Conclusion:We propose a prototype for a dashboard summary report of glucose, insulin, meals, and activity data intended for providers and patients on MDI using connected pens and CGM. Our goal is to stimulate development of a standardized approach.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Standardizing Reporting of Glucose and Insulin Data for Patients on Multiple Daily Injections Using Connected Insulin Pens and Continuous Glucose Monitoring

Rodbard

Garg

2021

Diabetes Technology & Therapeutics

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“…12 While the AGP report contains the 10 core CGM metrics for analysis, the International Diabetes Center has introduced a rapid approach to AGP assessment for the busy clinician who begins by asking two questions, both involving the use of color: suggested the use of color to enhance the value of a CGM or CGM and insulin data reports. 13,14 After, gradual but steady, lifestyle and medication adjustments guided by CGM, the goal is to achieve a glucose profile that is "flat, narrow and in-range" (FNIR-relatively flat median glucose line, narrow interquartile range or glucose variability, and most of the profile within the target glucose range). Another relevant aspect are people who are color blind or have issue to separate certain colors (color ametropia).…”

Section: Editorialmentioning

confidence: 99%

“…Other clinicians and researchers have also suggested the use of color to enhance the value of a CGM or CGM and insulin data reports. 13,14 After, gradual but steady, lifestyle and medication adjustments guided by CGM, the goal is to achieve a glucose profile that is “flat, narrow and in-range” (FNIR—relatively flat median glucose line, narrow interquartile range or glucose variability, and most of the profile within the target glucose range).…”

mentioning

confidence: 99%

More Green, Less Red: How Color Standardization May Facilitate Effective Use of CGM Data

Bergenstal

Simonson

Heinemann³

2021

J Diabetes Sci Technol

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Automated insulin delivery: benefits, challenges, and recommendations. A Consensus Report of the Joint Diabetes Technology Working Group of the European Association for the Study of Diabetes and the American Diabetes Association

Sherr

Heinemann²,

Fleming³

et al. 2022

Diabetologia

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A technological solution for the management of diabetes in people who require intensive insulin therapy has been sought for decades. The last 10 years have seen substantial growth in devices that can be integrated into clinical care. Driven by the availability of reliable systems for continuous glucose monitoring, we have entered an era in which insulin delivery through insulin pumps can be modulated based on sensor glucose data. Over the past few years, regulatory approval of the first automated insulin delivery (AID) systems has been granted, and these systems have been adopted into clinical care. Additionally, a community of people living with type 1 diabetes has created its own systems using a do-it-yourself approach by using products commercialised for independent use. With several AID systems in development, some of which are anticipated to be granted regulatory approval in the near future, the joint Diabetes Technology Working Group of the European Association for the Study of Diabetes and the American Diabetes Association has created this consensus report. We provide a review of the current landscape of AID systems, with a particular focus on their safety. We conclude with a series of recommended targeted actions. This is the fourth in a series of reports issued by this working group. The working group was jointly commissioned by the executives of both organisations to write the first statement on insulin pumps, which was published in 2015. The original authoring group was comprised by three nominated members of the American Diabetes Association and three nominated members of the European Association for the Study of Diabetes. Additional authors have been added to the group to increase diversity and range of expertise. Each organisation has provided a similar internal review process for each manuscript prior to submission for editorial review by the two journals. Harmonisation of editorial and substantial modifications has occurred at both levels. The members of the group have selected the subject of each statement and submitted the selection to both organisations for confirmation.

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Standardized Hybrid Closed-Loop System Reporting

Cited by 11 publications

References 98 publications

Standardizing Reporting of Glucose and Insulin Data for Patients on Multiple Daily Injections Using Connected Insulin Pens and Continuous Glucose Monitoring

Standardizing Reporting of Glucose and Insulin Data for Patients on Multiple Daily Injections Using Connected Insulin Pens and Continuous Glucose Monitoring

More Green, Less Red: How Color Standardization May Facilitate Effective Use of CGM Data

Automated insulin delivery: benefits, challenges, and recommendations. A Consensus Report of the Joint Diabetes Technology Working Group of the European Association for the Study of Diabetes and the American Diabetes Association

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