Dear DexCom children,
Your parents show that high IQ and a Boston education are no match for those who simply read, write and think.
1. BCG will do you more good than anything your parents have foisted upon you.
2. Dr Denise L Faustman has the ability to manufacture a peptide that will cure your autoimmune diseases.
see eg faustmanlab.org and pubmed.org faustman dl and pubmed.org ristori + BCG
while your parents may ostensibly care about you, show them no mercy, when within the Boston area there are better things than gizmos.
You are simply another mechanical apparatus for your silly money making parents, beings that put tinkering over art to your detriment and prolonging your self destroying itself, eg an autoimmune disease.
Technology
Smartwatch App Helps Track Glucose
DexCom Monitor Produces a Graph on Apple Watch
DexCom needs to make sure its smartwatch app complies with the FDA. ENLARGE
DexCom needs to make sure its smartwatch app complies with the FDA. Photo: David Paul Morris/Bloomberg News
By
Kate Linebaugh
Updated Feb. 8, 2015 8:26 p.m. ET
7 COMMENTS
Medical-device maker DexCom Inc. is designing an app that will display readings from its diabetes glucose monitor on Apple Inc. ’s smartwatch, giving the watch an early foothold in the health-care market at a time when regulatory treatment of such systems has eased.
DexCom’s glucose monitor tracks a person’s blood-sugar levels continuously. The company has shown a picture of the app, which converts that data into a simple graph that is just a glance at the wrist away. It says the app is expected to be ready when the Apple Watch is launched in April.
Apple declined to comment. The company hasn’t accepted any apps for the coming watch yet but has provided guidelines and code to developers for creating apps for it. The latest iPhone operating system increased its health and fitness offerings.
Advertisement
The Food and Drug Administration had been closely scrutinizing such applications. But the agency loosened its oversight in late January, months after a group of software engineers, many of whose children have Type 1 diabetes, developed a system for monitoring diabetes patients’ blood sugar over the Internet. The system was distributed without first getting regulatory approval.
The group’s effort challenged the slow pace of innovation and regulatory approval in the field. It also highlighted the growing role that Silicon Valley companies and software developers hope to have in monitoring and maintaining people’s health.
Advertisement
Some 29 million Americans have diabetes. Between 5% and 10% of them have Type 1, an autoimmune condition in which the body is unable to convert glucose into energy. People with Type 1 diabetes rely on taking insulin and regular monitoring to make sure their blood sugar doesn’t go dangerously high or low, both of which can cause life-threatening conditions.
The DexCom monitor uses a hair’s-width sensor under the skin to measure blood glucose levels every five minutes.
WSJ.D
WSJ.D is the Journal’s home for tech news, analysis and product reviews.
Debate Deepens About Hacking Responses
Radioshack and the Loss of Free Time
‘Crowd’ Sites Let Startups Tap Small Investors’ Cash
Smartwatch App Helps Track Glucose
Previously, the FDA considered glucose monitors and any associated software to be Class III medical devices, meaning they received the highest level of regulatory scrutiny. But the spread of NightScout, the system developed by the group of software engineers, and DexCom’s submission of a separate iPhone app for review prompted the FDA to change course last month.
DexCom’s monitors will remain Class III devices, but software that helps display the data they produce on mobile devices or smartwatches now only needs to be registered with the FDA and doesn’t require prior marketing approval.
The FDA has been reassessing its health-apps policies. “We felt that the risks that the app imposed weren’t as high,” said Alberto Gutierrez, director of the FDA’s Office of In Vitro Diagnostics and Radiological Health.
The issue came to a head last year when the group of software engineers, working on their own time, developed NightScout, which met a critical need. The software takes data from a glucose monitor made by DexCom, mainly for Type 1 diabetes patients, and uploads it to the Internet. That allows parents—and caregivers—to keep track of their children’ blood sugar from afar via their cellphones, tablets and Pebble watches.
NightScout spread quickly to thousands of users who found each other on Facebook and Twitter . By bypassing the FDA, the system’s creators skipped a process that had snarled or deterred formal development of similar products by medical-device companies.
Last fall, the group did take the invention to the FDA. The agency’s new rules give NightScout a pathway to regulatory compliance, according to FDA officials.
DexCom still needs to make sure its Apple Watch app complies with FDA rules. But thanks to the rule change, it doesn’t need to get approval before bringing the app to market.
Steve Pacelli, DexCom’s head of strategy, said the regulatory nod for the iPhone app came in January, much faster than the company expected.
Write to Kate Linebaugh at kate.linebaugh@wsj.com
Result Filters
Front Immunol. 2013 Dec 23;4:478. doi: 10.3389/fimmu.2013.00478.
TNF Receptor 2 and Disease: Autoimmunity and Regenerative Medicine.
Faustman DL1, Davis M2.
Abstract
THE
REGULATORY CYTOKINE TUMOR NECROSIS FACTOR (TNF) EXERTS ITS EFFECTS
THROUGH TWO RECEPTORS: TNFR1 and TNFR2. Defects in TNFR2 signaling are
evident in a variety of autoimmune diseases. One new treatment strategy
for autoimmune disease is selective destruction of autoreactive T cells
by administration of TNF, TNF inducers, or TNFR2 agonism. A related
strategy is to rely on TNFR2 agonism to induce T-regulatory cells
(Tregs) that suppress cytotoxic T cells. Targeting TNFR2 as a treatment
strategy is likely superior to TNFR1 because of its more limited
cellular distribution on T cells, subsets of neurons, and a few other
cell types, whereas TNFR1 is expressed throughout the body. This review
focuses on TNFR2 expression, structure, and signaling; TNFR2 signaling
in autoimmune disease; treatment strategies targeting TNFR2 in
autoimmunity; and the potential for TNFR2 to facilitate end organ
regeneration.
KEYWORDS:
TNF; TNF receptor 2; autoimmune disease; regeneration; type 1 diabetes- PMID:
- 24391650
- [PubMed]
- PMCID:
- PMC3870411
10.
3.
Faustman DL, Wang L, Okubo Y, Burger D, Ban L, Man G, Zheng H, Schoenfeld D, Pompei R, Avruch J, Nathan DM.
PLoS One. 2012;7(8):e41756. doi: 10.1371/journal.pone.0041756. Epub 2012 Aug 8.
- PMID:
- 22905105
- [PubMed - indexed for MEDLINE]
Sethi NK, Ristori G, Romano S, Coarelli G, Buscarinu MC, Salvetti M.
Neurology. 2014 Jul 15;83(3):293. doi: 10.1212/01.wnl.0000452303.37990.ff. No abstract available.
- PMID:
- 25024446
- [PubMed - indexed for MEDLINE]
Related citations
Ristori
G, Romano S, Cannoni S, Visconti A, Tinelli E, Mendozzi L, Cecconi P,
Lanzillo R, Quarantelli M, Buttinelli C, Gasperini C, Frontoni M,
Coarelli G, Caputo D, Bresciamorra V, Vanacore N, Pozzilli C, Salvetti
M.
Neurology. 2014 Jan 7;82(1):41-8. doi: 10.1212/01.wnl.0000438216.93319.ab. Epub 2013 Dec 4.
- PMID:
- 24306002
- [PubMed - indexed for MEDLINE]
No comments:
Post a Comment