Nightscout

Last updated
Initial release2014;10 years ago (2014)
Stable release
0.12.5 / 6 October 2019;4 years ago (2019-10-06)
Repository github.com/nightscout
Operating system Linux, Unix-like
Available in JavaScript
Type Medical software
License Affero General Public License Version 3
Website www.nightscout.info

Nightscout is a free and open-source project, and associated social movement, that enables accessing and working with continuous glucose monitor (CGM) data. [1] [2] Nightscout software aims to give users access to their real time blood sugar data by putting this data in the cloud. In addition to browser-based data visualization, Nightscout can also be used to review data from a phone or smartwatch, or to remotely monitor CGM data for individuals with type 1 diabetes. Associated with Nightscout software is a broader "CGM in the Cloud" social movement, supporting individuals seeking to access and use realtime CGM data through commercial and DIY ("do it yourself") approaches. [3]

Contents

History

The Nightscout Project traces its origin to February 2013, when the parents of a 4-year-old boy newly diagnosed with type 1 diabetes began using a continuous glucose monitoring system. [1] [2] This data was inaccessible to the parents when the child was at school – there was no commercially available way to access the data in real time. The boy's father, John Costik, a software engineer, developed software to access and transfer CGM data to cloud computing infrastructure. Costik shared his accomplishment on Twitter and, after others expressed interest, privately shared the source code.[ citation needed ]

Costik's uploader was expanded by Lane Desborough and Ross Naylor, [4] to develop "Nightscout": adding a blood glucose chart display that could be viewed throughout a home. Further development to make the software accessible to the general public occurred within a private community of developers, including Ben West, [5] [6] Ross Naylor, Kevin Lee, [7] Jason Calabrese, Jason Adams, and Toby Canning. Because this software was, in effect, an unlicensed medical device, the community delayed releasing the code as open source to explore and address legal concerns. Once this was done, the combined code was released in 2014 as the Nightscout Project. [8]

A website, Facebook group, and Gitter channel were also created to support new users. [3] [9] The primary Facebook group for the movement is "CGM in the Cloud", broadly supporting individuals seeking to use realtime CGM data, via commercial and/or DIY methods. As of May 2017, this group has over 23,000 members. In addition, the related 501(c)(3) organization Nightscout Foundation was formed in 2014 to encourage and support open source technology projects for individuals with type 1 diabetes. [10]

The #WeAreNotWaiting hashtag used by the group was initially coined by Lane Desborough [11] and Howard Look, in reference to a growing call for a "diabetes data exchange" hosted by Tidepool and DiabetesMine in November 2013. [1]

A survey of the Nightscout community indicated that the software was most highly used by parents of young children with type 1 diabetes (less than 12 years of age), but is also used by adolescents and adults. [12]

Regulatory concerns

Because Nightscout software displays information relevant to medical care, there are safety concerns regarding reliability, liability, and regulation. The United States Food and Drug Administration (FDA) expressed concern that a singular entity was needed to review code, monitor safety, and respond to issues. [2] As of 2016, no such entity had arisen, beyond the unstructured approach of community communication channels (e.g. Facebook group and Gitter channel). [3] [13]

As a non-commercial open source project, Nightscout software has not been regulated by the FDA. [2] [14] The software is released with a strong disclaimer:

Highly experimental. Not intended for therapy. Use at your own risk. Intended only as an investigational and educational tool to learn about this technology.

On November 20, 2020, Medical Data Networks LLC (Ben West, CEO) met with and formally petitioned the FDA for clearance of the service product “T1Pal.” T1Pal is a hosted Nightscout platform that runs copies of the latest Nightscout software on its servers for the benefit of individual subscribers.

Nightscout, when operated as a hosted service, is expected to enable many more people to use and benefit from Nightscout. T1Pal.com charges a monthly fee to do this ($12.00/mo.), which includes technical support to set up and use the platform. Medical Data Networks LLC has asserted with the FDA that its implementation of T1Pal meets all of the stated FDA requirements for code review, safety monitoring, and responding to issues. To support this view, a complete copy of the “Quality Management System” currently used by Medical Data Networks LLC was provided to the FDA.

The FDA generally viewed each operating instance of Nightscout as a "medical device" subject to labeling, hazard management, and FDA reporting requirements. Medical Data Networks LLC asserts that its product T1Pal meets all of the FDA criteria for a "Class 2" medical device, and embraces needed FDA oversight and data reporting requirements. Medical Data Networks LLC is actively seeking to work more efficiently with firms that market CGM and other data so as to improve the quality and efficiency by which data is transferred into Nightscout. Nightscout's features for remote monitoring, data integration, and sharing are of immense value to the Nightscout community and merit continued support by the CGM device manufacturers.[ citation needed ]. T1Pal service adds to the Nightscout software patent-pending sharing features and standard email and phone support capabilities needed to enable access the largest possible community of users.

Commercial alternatives

In 2015, subsequent to the development of the Nightscout Project, Dexcom released a CGM system that included 'Share', providing software for transferring data to cell phones via Bluetooth, and sharing CGM data with others via cell phone apps.[ citation needed ]

In 2017, the Spanish company Instead Technologies launched a continuous reading system named GlucoAngel for the FreeStyle Libre flash glucose monitor. [15] [16]

In 2020, Medical Data Networks LLC commenced commercial service operations, providing T1Pal as "Nightscout in the Cloud" for $12.00/mo. The service is supported by email and phone support for paying customers. Beginning January 2022 the company added integrated support for T1Pal combined with iPhone Loop services. This positions Medical Data Networks LLC as the first commercial provider of IT services needed to implement and support closed Loop operations.

The OpenAPS project has extended Nightscout to create a do-it-yourself "artificial pancreas", by automating basal insulin delivery by an insulin pump to create a "closed loop" system. [17]

Related Research Articles

<span class="mw-page-title-main">Insulin pump</span> Medical device to administer insulin

An insulin pump is a medical device used for the administration of insulin in the treatment of diabetes mellitus, also known as continuous subcutaneous insulin therapy. The device configuration may vary depending on design. A traditional pump includes:

<span class="mw-page-title-main">Blood glucose monitoring</span> Use of a glucose monitor for testing the concentration of glucose in the blood

Blood glucose monitoring is the use of a glucose meter for testing the concentration of glucose in the blood (glycemia). Particularly important in diabetes management, a blood glucose test is typically performed by piercing the skin to draw blood, then applying the blood to a chemically active disposable 'test-strip'. The other main option is continuous glucose monitoring (CGM). Different manufacturers use different technology, but most systems measure an electrical characteristic and use this to determine the glucose level in the blood. Skin-prick methods measure capillary blood glucose, whereas CGM correlates interstitial fluid glucose level to blood glucose level. Measurements may occur after fasting or at random nonfasting intervals, each of which informs diagnosis or monitoring in different ways.

Abbott Laboratories is an American multinational medical devices and health care company with headquarters in Abbott Park, Illinois, United States. The company was founded by Chicago physician Wallace Calvin Abbott in 1888 to formulate known drugs; today, it sells medical devices, diagnostics, branded generic medicines and nutritional products. It split off its research-based pharmaceuticals business into AbbVie in 2013.

<span class="mw-page-title-main">Glucose meter</span> Medical device for determining the concentration of glucose in the blood

A glucose meter, also referred to as a "glucometer", is a medical device for determining the approximate concentration of glucose in the blood. It can also be a strip of glucose paper dipped into a substance and measured to the glucose chart. It is a key element of glucose testing, including home blood glucose monitoring (HBGM) performed by people with diabetes mellitus or hypoglycemia. A small drop of blood, obtained from slightly piercing a fingertip with a lancet, is placed on a disposable test strip that the meter reads and uses to calculate the blood glucose level. The meter then displays the level in units of mg/dL or mmol/L.

JDRF is a nonprofit 501(c)(3) organization that funds type 1 diabetes (T1D) research, provides a broad array of community and activist services to the T1D population and actively advocates for regulation favorable to medical research and approval of new and improved treatment modalities. It was initially founded as the JDF, the Juvenile Diabetes Foundation. It later changed its name to the Juvenile Diabetes Research Foundation and is now known as JDRF.

Automated insulin delivery systems are automated systems designed to assist people with insulin-requiring diabetes, by automatically adjusting insulin delivery in response to blood glucose levels. Currently available systems can only deliver a single hormone—insulin. Other systems currently in development aim to improve on current systems by adding one or more additional hormones that can be delivered as needed, providing something closer to the endocrine functionality of the pancreas.

<span class="mw-page-title-main">Diabetes management software</span>

Diabetes Management Software refers to software tools that run on personal computers and personal digital assistants to help persons with Type 1 and Type 2 diabetes manage the data associated with:

SystmOne is a centrally hosted clinical computer system developed by Horsforth-based The Phoenix Partnership (TPP). It is used by healthcare professionals in the UK predominantly in primary care. The system is being deployed as one of the accredited systems in the government's programme of modernising IT in the NHS.

<span class="mw-page-title-main">Minimed Paradigm</span> Insulin pumps

MiniMed Paradigm is a series of insulin pumps manufactured by Medtronic for patients with diabetes mellitus. The pump operates with a single AAA battery and uses a piston-plunger pump to infuse a programmed amount of insulin into the patient through a length of tubing. The Paradigm uses a one-way wireless radio frequency link to receive blood sugar measurements from select glucose meters. The Paradigm RT series adds the ability to receive data from a mated continuous blood-glucose monitor. Although the pump can use these measurements to assist in calculating a dose of insulin, no actual change in insulin delivery occurs without manual user-intervention.

DexCom, Inc. is a company that develops, manufactures, produces, and distributes continuous glucose monitoring (CGM) systems for diabetes management. It operates internationally with headquarters in San Diego, California, and has manufacturing facilities in Mesa, Arizona and Batu Kawan, Malaysia.

<span class="mw-page-title-main">OpenNebula</span> Cloud-computing platform for managing heterogeneous distributed infrastructure

OpenNebula is an open source cloud computing platform for managing heterogeneous data center, public cloud and edge computing infrastructure resources. OpenNebula manages on-premise and remote virtual infrastructure to build private, public, or hybrid implementations of Infrastructure as a Service and multi-tenant Kubernetes deployments. The two primary uses of the OpenNebula platform are data center virtualization and cloud deployments based on the KVM hypervisor, LXD/LXC system containers, and AWS Firecracker microVMs. The platform is also capable of offering the cloud infrastructure necessary to operate a cloud on top of existing VMware infrastructure. In early June 2020, OpenNebula announced the release of a new Enterprise Edition for corporate users, along with a Community Edition. OpenNebula CE is free and open-source software, released under the Apache License version 2. OpenNebula CE comes with free access to patch releases containing critical bug fixes but with no access to the regular EE maintenance releases. Upgrades to the latest minor/major version is only available for CE users with non-commercial deployments or with significant open source contributions to the OpenNebula Community. OpenNebula EE is distributed under a closed-source license and requires a commercial Subscription.

Wireless health is the integration of wireless technology into traditional medicine, such as diagnosis, monitoring and treatment of illness, as well as other tools that can help individuals improve their personal health and wellbeing. Wireless health differs from mHealth in that wireless health solutions will not always be mobile and mobile health solutions will not always be wirelessly enabled. Mobile broadband connectivity is useful in reaching new patients in remote areas while improving productivity and convenience through data transmission.

Tandem Diabetes Care is an American medical device manufacturer based in San Diego, California. The company develops medical technologies for the treatment of diabetes and specifically insulin infusion therapy.

Ambulatory glucose profile (AGP) is a single-page, standardized report for interpreting a patient's daily glucose and insulin patterns. AGP provides both graphic and quantitative characterizations of daily glucose patterns. First developed by Drs. Roger Mazze and David Rodbard, with colleagues at the Albert Einstein College of Medicine in 1987, AGP was initially used for the representation of episodic self-monitored blood glucose (SMBG). The first version included a glucose median and inter-quartile ranges graphed as a 24-hour day. Dr. Mazze brought the original AGP to the International Diabetes Center (IDC) in the late 1980s. Since then, IDC has built the AGP into the internationally recognized standard for glucose pattern reporting.

GlySens, a biomedical technology company, is a privately owned corporation developing a long term internal continuous glucose monitor in order to effectively manage and observe glucose levels in real time. The GlySens ICGM system is the world's first surgically implanted continuous glucose monitoring system to demonstrate an 18-month performance in a preclinical setting. GlySens Incorporated was founded in 1998 by David A. Gough and Joseph Lucisano, a bioengineering graduate at the University of California, San Diego. The implanted continuous glucose monitoring system uses an internal sensor equipped with electrochemical detectors to measure glucose readings via a chemical reaction between enzymes and oxygen.

Bigfoot Biomedical Inc. is a medical technology start-up headquartered in Milpitas, California, founded by a team of people with personal connections to type 1 and type 2 diabetes.

The Open Artificial Pancreas System (OpenAPS) project is a free and open-source project that aims to make basic artificial pancreas system (APS) technology available to everyone. The OpenAPS project was designed with the idea of quickly getting the APS technology to more people using a direct approach, rather than waiting for clinical trials to be completed and regulatory approval to be granted.

<span class="mw-page-title-main">Continuous glucose monitor</span> Blood glucose monitoring device

A continuous glucose monitor (CGM) is a device used for monitoring blood glucose on a continual basis instead of monitoring glucose levels periodically by drawing a drop of blood from a finger. This is known as continuous glucose monitoring. CGMs are used by people who treat their diabetes with insulin, for example people with type 1 diabetes, type 2 diabetes, or other types of diabetes, such as gestational diabetes.

Nemaura Medical Inc. is a UK based Medical Technology company developing a wireless non-invasive blood glucose monitoring system called SugarBeAT.

References

  1. 1 2 3 Sparling, Kerri (2014-07-10). "We Are Not Waiting: CGM in the Cloud (Part 1)". six until me. Archived from the original on 2014-07-13. Retrieved 2017-05-06.
  2. 1 2 3 4 Lee, Joyce M.; Hirschfield, Emily; Wedding, James (2016-04-12). "A Patient-Designed Do-It-Yourself Mobile Technology System for Diabetes: Promise and Challenges for a New Era in Medicine". JAMA. 315 (14): 1447–8. doi:10.1001/jama.2016.1903. PMID   27115262. S2CID   1858396 . Retrieved 2017-05-05.
  3. 1 2 3 www.facebook.com/groups/cgminthecloud/
  4. ↑ Nightscout Foundation. "KCGM-TV Nightscout Origins & What's Next at Bigfoot Biomedical, Ep7". YouTube.com. Retrieved 7 May 2017.
  5. ↑ Rao, Ankita. "Diabetes Hacking 101". WNYC.org. Only Human. Retrieved 7 May 2017.
  6. ↑ West, Benjamin. "6 Years Under 5 Minutes". YouTube.com. Retrieved 7 May 2017.
  7. ↑ Lee, Melissa (23 September 2014). "CGM in the Cloud: A Community Unites to Tackle Diabetes". ASweetLife.org. Retrieved 7 May 2017.
  8. ↑ github.com/Nightscout/
  9. ↑ www.nightscout.info
  10. ↑ www.nightscoutfoundation.org
  11. ↑ Desborough, Lane. "We Are Not Waiting". Tidepool.org. Retrieved 7 May 2017.
  12. ↑ Lee, Joyce M.; Newman, Mark W.; Gebremariam, Achamyeleh; Choi, Preciosa; Lewis, Dana; Nordgren, Weston; Costik, John; Wedding, James; West, Benjamin; Gilby, Nancy Benovich; Hannemann, Christopher; Pasek, Josh; Garrity, Ashley; Hirschfeld, Emily (2017-02-28). "Real-World Use and Self-Reported Health Outcomes of a Patient-Designed Do-it-Yourself Mobile Technology System for Diabetes: Lessons for Mobile Health". Diabetes Technol Ther. 19 (4): 209–219. doi:10.1089/dia.2016.0312. PMID   28245152.
  13. ↑ gitter.im/nightscout/public
  14. ↑ Torrance, Andrew W.; von Hippel, Eric A. (2013-10-12). "The Right to Innovate". Michigan State Law Review (793). doi:10.2139/ssrn.2339132. S2CID   159757936. SSRN   2339132.
  15. ↑ Plaza, Ediciones (2017-07-10). "¿Funcionan las réplicas de negocios de éxito de otros países en España?". Valencia Plaza (in Spanish). Retrieved 2020-09-09.
  16. ↑ "Un ángel de la guarda para los pacientes con diabetes". ELMUNDO (in Spanish). 2018-12-17. Retrieved 2020-09-09.
  17. ↑ "OpenAPS Offers Open Source Tools for Diabetes Management". 31 March 2017. Retrieved 2017-05-04.
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