Sanofi and Google Life Science Team Up

Sanofi and Google announced and agreement to work jointly on diabetes projects report Boolmberg and Wall Street Journal report and a press release. 

Sanofi's press release states the two companies will:

- Will work together on new digital technology and tools for diabetes -

- Aim to use data and miniaturized technology to provide patients with more tools to self-manage their disease, healthcare professionals with the ability to better support and treat patients -

- Strive to shift from episodic, event-driven diabetes care to continuous, value-based care

Bloomberg quote Google saying:

“Diabetes is the first disease we’re focusing on as we become an independent company,” Google said in the statement. “We’re announcing a new partnership with Sanofi to move technology out of the lab more quickly and work on better ways for patients and physicians to collect, analyze, and understand all the multiple sources of information that impact diabetes management.”

More: 

http://www.prnewswire.com/news-releases/sanofi-to-collaborate-with-google-life-sciences-to-improve-diabetes-health-outcomes-300135001.html

http://www.bloomberg.com/news/articles/2015-08-31/google-pairs-with-sanofi-to-move-diabetes-patients-to-cloud

http://www.wsj.com/articles/google-sanofi-join-forces-on-diabetes-monitoring-treatment-1441026001

FDA Approves Dexcom G5®

FDA Approves Dexcom G5® Mobile Continuous Glucose Monitoring System

From: http://investor.shareholder.com/dexcom/releaseDetail.cfm?ReleaseID=928741

First and Only Fully Mobile CGM System Allows Adults and Children as young as 2 years old to Conveniently and Discreetly Monitor and Share Glucose Levels

SAN DIEGO--(BUSINESS WIRE)-- Dexcom, Inc., (NASDAQ:DXCM), a leader in continuous glucose monitoring (CGM) for patients with diabetes, announced today that the U.S. Food and Drug Administration (FDA) has approved the Dexcom G5® Mobile Continuous Glucose Monitoring (CGM) System. With wireless Bluetooth® technology built into the device transmitter, the G5 Mobile CGM System is the first and only fully mobile CGM system approved by the FDA for both adults and children as young as 2 years of age that sends glucose data directly to a smartphone, freeing users from the need to carry a separate receiver. The new transmitter securely sends vital glucose information directly to an app on iOS-enabled devices for real-time diabetes management. Android applications will follow early next year. Like its predecessor, the G4 PLATINUM CGM with Share, users can also select up to five designated recipients, or "followers." These followers can remotely monitor a patient's glucose information and receive alert notifications from almost anywhere.

"Dexcom is rapidly advancing technology for continuous glucose monitoring devices to improve diabetes management. Since January, the company has introduced the G4 PLATINUM CGM with Share, apps to enable the first CGM on the Apple Watch^TM and now the Dexcom G5® Mobile CGM. These advances are making diabetes management more convenient and flexible than ever before," stated Kevin Sayer, President and Chief Executive Officer of Dexcom. "We are excited for the promise this new technology holds for patients and caregivers."

About the Dexcom U.S. G5 Mobile Launch

• The G5 Mobile system is anticipated to begin shipping in late September 2015.
• All purchasers of a G4 Platinum with Share system from August 1, 2015, until the G5 Mobile system is shipped, will be eligible to receive a no-cost upgrade to the G5 Mobile system.
• There will be a low cost cash upgrade to the G5 Mobile system for those patients who are still under warranty with their existing system.

Three Quick Things

... before I check out for the weekend.

All are about pregnancy and diabetes. So they don't apply to me but they are wonderful efforts, doing good things and they should get shout outs.

The Plaid Journal:

PLAID is cool. PLAID is an open access, peer-reviewed, research journal that aims to encourage dialogue among people living with and inspired by diabetes.

They're doing an issue on "Pregnancy & Diabetes." The deadline for submissions is September 15, 2015.
https://www.facebook.com/theplaidjournal

JDRF has a lovely toolkit for pregnancy and Type 1 diabetes. 

"This guide provides information for parents-to-be or future parents-to-be with T1D—explaining the disease management goals for pregnancy and reviewing how to obtain the best possible support from healthcare providers at every stage."







MyGlu has a survey about preconception, pregnancy, and childbearing at http://bit.ly/glusurvey  Help them out, take the survey. 

FDA Report on Targeted Drug Development: The Diabetes Section

Are you a policy geek? FDA has a white paper out on drug development and it has some background on diabetes (T1 and T2) and how they go about drug approval.

It isn't page turner like Game of Thrones (GoT) but hey let be honest GoT books 4 and 5 dragged on.  


Here is the preface of what they say about diabetes and a link to the section of the white paper on diabetes:

..our understanding of disease causation and progression is sufficient to permit our use of certain tools such as surrogate endpoints. But it is insufficient to develop others such as biomarkers to help target specific subset of patients who are less likely to suffer side effects from specific drugs. Even where scientific research has not yet identified the molecular and genetic bases for a disease and its treatment, FDA is using tools other than targeting and biomarkers to reduce the length and cost of clinical trials, including flexible trial designs, expedited development pathways, public-private research collaborations, and intensive engagement with drug sponsors. In addition, these tools can support the development of one of the most promising avenues for accelerating drug development: targeted, or precision, medicine—the ability to target the right drug to the right patient based on understanding of the genetic and biochemical basis of a disease in patient subgroups.

Diabetes : http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/ucm454955.htm#Diabetes

Have fun reading geeks.

The reader digest version is summed up in these quotes:

• FDA has long allowed manufacturers to show that a diabetes drug works by using a simple surrogate endpoint—lowering blood sugar. 
• There have been longstanding concerns that some drugs for type 2 diabetes that successfully lower blood sugar may nevertheless increase rather than decrease the risk of heart attack.
• To minimize the impact on innovation while ensuring acceptable cardiovascular safety, FDA asks for preliminary CV safety data before approval and for detailed additional data to characterize CV effects after the product is on the market.
• FDA has approved seven new diabetes drugs in the last two years. This includes three drugs that represent entirely new drug classes—a measure of how innovative these drugs are. In June 2014, FDA approved the only inhaled insulin product. The diabetes drug pipeline is among the strongest for any disease category and includes potentially transformative advances for type 1 diabetes.

 Yeah there is more in there. If you like wanting around in Westeros, enjoy the read.

Join DiabetesPAC calling for CGM access.

Join DPAC calling for hearing on the safety of test strip bidding.

Of Spinal Tap, One Louder and Advocacy

Diabetes advocacy can learn from the great philosopher, Nigel Tufnel, who offered this sage observation, “Well, it's one louder, isn't it?”

We need to turn up the volume and to keep it up. Why? The diabetes caucus is the largest in the US Congress, yet many pieces of diabetes legislation lack the support of those very caucus members.
Worse, in the current policy environment the squeaky wheel is going to get cut less, the other are going to get slaughtered. Diabetes needs to turn it up. We can't let them just move on after checking the diabetes box. So we to turn up the advocacy volume to help keep attention and accountability on diabetes.

But, I hear you say, “Just taking care of diabetes is a time major attention already, advocacy is just more.” 

No kidding. So advocacy needs to be easy. Click simple. OK, it will be. I am proud to partner with Christel in creating the Diabetes Patient Advocacy Coalition (DPAC.) Join us.

DPAC is a non-profit and non-partisan organization founded to provide united, simple, and effective advocacy opportunities for people impacted by diabetes for safety, quality and accessibility of care.
DPAC will keep track of issues, opportunities, and how to contact officials and make it easy to advocate.

Join the Diabetes Patient Advocacy Coalition. 

Be one louder. 

Dexcom on Android

From press release: 

Dexcom® Announces Follow App is Now Available for Android Devices

Caregivers and Loved Ones of People with Diabetes Now Have Access to Life-Saving Glucose Data on their Android Devices

June 02, 2015 08:00 AM Eastern Daylight Time

SAN DIEGO--(BUSINESS WIRE)--Dexcom, Inc., (NASDAQ:DXCM), a leader in continuous glucose monitoring (CGM) for patients with diabetes, announced today that the Dexcom Follow app is now compatible with Android devices. The app is a component of the Dexcom G4® PLATINUM Continuous Glucose Monitor System with Share™, the industry’s first mobile-connected CGM system. Already available to iOS-enabled devices, the Follow app allows family members, friends and caregivers (“Followers”) to remotely view a loved one’s glucose data and trends on their smart device, giving them peace of mind and reassurance when they are apart. CGM users (“Sharers”) can invite up to five Followers to view their glucose information via the Follow app. The Followers can view the Sharer’s glucose data and trends, as well as choose to receive alerts and notifications when the Sharer’s glucose levels are outside specified ranges.

More

This is the Follow app, not the Share tool, it is still on iOS. But it is a step in the right direction. 

Lilly Humalog U-200 KwikPen Approved.

Lilly announced FDA approval of U-200 Humalog in a release today. 

U.S. Food and Drug Administration Approves Humalog® 200 units/mL KwikPen® 

Marks approval of first concentrated mealtime insulin analog in the U.S. and expands Lilly's portfolio of medicines for people with type 1 and type 2 diabetes 

INDIANAPOLIS, May 27, 2015 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) has approved Humalog^® 200 units/mL KwikPen^® (insulin lispro 200 units/mL; U-200), a pre-filled pen containing a concentrated formulation of Lilly's rapid-acting insulin Humalog^® (insulin lispro 100 units/mL) to improve glycemic control in people with type 1 and type 2 diabetes, Eli Lilly and Company (NYSE: LLY) announced today. Humalog U-200 KwikPen marks the first FDA approval of a concentrated mealtime insulin analog 

Humalog U-200 KwikPen holds twice as many units of insulin (600 units vs. 300 units) as the U-100 formulation in the same three-milliliter cartridge. This offers patients a pen that lasts longer between pen changes, allowing for fewer changes every month.* Humalog U-200 KwikPen delivers the same dose in half the volume of Humalog U-100 KwikPen with no dose conversions required, and can be dialed in one-unit increments to a maximum of 60 units per injection.

More: https://investor.lilly.com/releaseDetail.cfm?ReleaseID=914999