A Patient-Designed Do-It-Yourself Mobile Technology System for Diabetes

Lee, Joyce M.; Hirschfeld, Emily; Wedding, James

doi:10.1001/jama.2016.1903

Cited by 75 publications

(68 citation statements)

References 2 publications

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“…We acknowledge the importance of the ''#we are not waiting community'' that developed Nightscout for remote sharing and monitoring of glucose levels obtained using realtime CGM 79,80 and then turned to developing an open access artificial pancreas system (OpenAPS). 81,82 These open-source, do-it-yourself (DIY) endeavors provided proof of concept that undoubtedly spurred the development of artificial pancreas systems by academia and industry, energized regulatory agencies and the general public, and raised awareness of the urgent need for these systems.…”

Section: Part Ii: Closed-loop Controlmentioning

confidence: 99%

Continuous Glucose Monitoring: A Review of Recent Studies Demonstrating Improved Glycemic Outcomes

Rodbard¹

2017

Diabetes Technology & Therapeutics

367

267

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Continuous Glucose Monitoring (CGM) has been demonstrated to be clinically valuable, reducing risks of hypoglycemia and hyperglycemia, glycemic variability (GV), and improving patient quality of life for a wide range of patient populations and clinical indications. Use of CGM can help reduce HbA1c and mean glucose. One CGM device, with accuracy (%MARD) of approximately 10%, has recently been approved for selfadjustment of insulin dosages (nonadjuvant use) and approved for reimbursement for therapeutic use in the United States. CGM had previously been used off-label for that purpose. CGM has been demonstrated to be clinically useful in both type 1 and type 2 diabetes for patients receiving a wide variety of treatment regimens. CGM is beneficial for people using either multiple daily injections (MDI) or continuous subcutaneous insulin infusion (CSII). CGM is used both in retrospective (professional, masked) and real-time (personal, unmasked) modes: both approaches can be beneficial. When CGM is used to suspend insulin infusion when hypoglycemia is detected until glucose returns to a safe level (low-glucose suspend), there are benefits beyond sensor-augmented pump (SAP), with greater reduction in the risk of hypoglycemia. Predictive low-glucose suspend provides greater benefits in this regard. Closed-loop control with insulin provides further improvement in quality of glycemic control. A hybrid closed-loop system has recently been approved by the U.S. FDA. Closed-loop control using both insulin and glucagon can reduce risk of hypoglycemia even more. CGM facilitates rigorous evaluation of new forms of therapy, characterizing pharmacodynamics, assessing frequency and severity of hypo-and hyperglycemia, and characterizing several aspects of GV.

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Section: Part Ii: Closed-loop Controlmentioning

confidence: 99%

Continuous Glucose Monitoring: A Review of Recent Studies Demonstrating Improved Glycemic Outcomes

Rodbard¹

2017

Diabetes Technology & Therapeutics

367

267

View full text Add to dashboard Cite

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“…The open source code for it is distributed for free through NightScout's web platform and its 26,000-member patient community on Facebook called CGM in the Cloud. Preliminary evidence from a survey of 1,000 NightScout users shows that the majority experience fewer hyper- and hypo-glycemic episodes and report improved quality of life since adopting the remote monitoring system (7). Therefore, lead user methods can be used in public health to identify users on the leading edge of pressing health problems.…”

Section: Next Steps For Public Health Research and Practice Using An mentioning

confidence: 99%

“…Producers' confidence in this new approach is bolstered by historical studies [e.g., (3, 6)] showing that many of the most innovative products they sell—those that have pioneered new markets and applications—were, in fact, preceded by and often based upon innovation prototypes that users designed and built to serve their own needs. For example, people living with Type 1 diabetes have developed, tested, and are diffusing designs for artificial pancreases well ahead of commercial availability of such devices from medical device producers, thereby demonstrating the feasibility of incorporating user innovations into public health interventions for self-management of chronic disease (7). …”

Section: Introductionmentioning

confidence: 99%

A Next Generation Assets-Based Public Health Intervention Development Model: The Public as Innovators

Hippel

2018

Front. Public Health

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In the public health field, the design of interventions has long been considered to be the province of public health experts. In this paper, I explore an important complement to the traditional model: the design, prototyping, and implementation of innovative public health interventions by the public (users) themselves. These user interventions can then be incorporated by public health experts, who in turn design, support, and implement improvements and diffusion strategies as appropriate for the broader community. The context and support for this proposed new public health intervention development model builds upon user innovation theory, which has only recently begun to be applied to research and practice in medicine and provides a completely novel approach in the field of public health. User innovation is an assets-based model in which end users of a product, process, or service are the locus of innovation and often more likely than producers to develop the first prototypes of new approaches to problems facing them. This occurs because users often possess essential context-specific information about their needs paired with the motivation that comes from directly benefiting from any solutions they create. Product producers in a wide range of fields have, in turn, learned to profit from the strengths of these user innovators by supporting their grass-roots, leading-edge designs and field experiments in various ways. I explore the promise of integrating user-designed and prototyped health interventions into a new assets-based public health intervention development model. In this exploration, a wide range of lead user methods and positive deviance studies provide examples for identification of user innovation in populations, community platforms, and healthcare programs. I also propose action-oriented and assets-based next steps for user-centered public health research and practice to implement this new model. This approach will enable us to call upon the strengths of the communities we serve as we develop new methods and approaches to more efficiently and effectively intervene on the varied complex health problems they face.

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“…Having realized the potential of remotely accessed CGM for monitoring their children's glucose control when away at school or university and frustrated that no commercial devices offering this facility had reached the market until recently, some parents of children with T1D developed custom-made solutions by "hacking" commercially available CGM products and releasing codes for other users (The Nightscout Foundation; www.nightscout .com; Twitter handle #WeAreNotWaiting) (53) [2g]. While the underlying motivation is completely understandable and will likely stimulate larger companies to continue to innovate, such informal solutions raise safety concerns and present a challenge for the regulatory establishment, as open-source software is not regulated by regulatory agencies like the FDA.…”

Section: Remote Usage Of Cgm Data: Opportunities and Challengesmentioning

confidence: 99%

Improving the Clinical Value and Utility of CGM Systems: Issues and Recommendations

et al. 2017

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The first systems for continuous glucose monitoring (CGM) became available over 15 years ago. Many then believed CGM would revolutionize the use of intensive insulin therapy in diabetes; however, progress toward that vision has been gradual. Although increasing, the proportion of individuals using CGM rather than conventional systems for self-monitoring of blood glucose on a daily basis is still low in most parts of the world. Barriers to uptake include cost, measurement reliability (particularly with earlier-generation systems), human factors issues, lack of a standardized format for displaying results, and uncertainty on how best to use CGM data to make therapeutic decisions. This Scientific Statement makes recommendations for systemic improvements in clinical use and regulatory (pre-and postmarketing) handling of CGM devices. The aim is to improve safety and efficacy in order to support the advancement of the technology in achieving its potential to improve quality of life and health outcomes for more people with diabetes.

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A Patient-Designed Do-It-Yourself Mobile Technology System for Diabetes

Cited by 75 publications

References 2 publications

Continuous Glucose Monitoring: A Review of Recent Studies Demonstrating Improved Glycemic Outcomes

Continuous Glucose Monitoring: A Review of Recent Studies Demonstrating Improved Glycemic Outcomes

A Next Generation Assets-Based Public Health Intervention Development Model: The Public as Innovators

Improving the Clinical Value and Utility of CGM Systems: Issues and Recommendations

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