Poor quality sleep may hinder efforts to control glycemia of children with type 1 diabetes, according to new research from the American Academy of Sleep Medicine.

By studying the sleep patterns of 50 children with type 1 diabetes for 10 to 16 years old, they found that less time they spent within a deeper sleep was associated with poorer school performance and higher levels glucose levels.

The researchers make it clear that despite following the recommendations for controlling their diabetes, many children and youths with type 1 diabetes have difficulty with glycemic control and this could be due to abnormalities in sleep patterns, daytime sleepiness and possibly sleep apnea.

All these conditions are treatable, and young people with diabetes would benefit from treatments designed to change and improve patterns and sleep quality, therefore in a better to place to better manage their diabetes.

Informamos del restablecimiento del suministro de plumas precargadas de 3 ml de APIDRA (insulina glulisina) [procedente de rDNA] correspondiente a:

APIDRA SOLOSTAR 100 UI/ml solución inyectable con pluma precargada (CN 656073)

Tras el comunicado publicado el pasado 29 de septiembre de 2011, Sanofi-Aventis quiere poner al día sobre la situación del suministro de plumas precargadas de 3 ml de Apidra.

En esa fecha (septiembre 2011) informamos de un incidente técnico en la planta de fabricación, que ocasionó una interrupción transitoria de la producción. Se han adoptado una serie de medidas por parte de Sanofi-Aventis para resolver esta contingencia en la fabricación y así acelerar la reanudación del suministro normal, lo que se producirá de la siguiente manera:

• Las plumas precargadas de Apidra que se encuentran actualmente en el mercado se pueden usar con toda seguridad. Ninguna de las otras insulinas de Sanofi (Lantus) se han visto afectadas.
• Un nuevo suministro de Apidra SoloStar estará disponible a partir del 2 de diciembre con una reanudación del suministro de manera gradual a partir de ese momento. La disponibilidad del medicamento estará normalizada en enero del 2012 por lo que se recomienda que la dispensación y adquisición del medicamento se haga también de forma gradual para favorecer el acceso del medicamento a todos los pacientes que requieran este tratamiento (en relación a la presentación optiset, no se prevé la reanudación de su comercialización).

Esta información ha sido aprobada para su publicación y distribución por el CHMP (Comité de Medicamentos de Uso Humano) de la EMA (Agencia Europea del Medicamento), la AEMPS (Agencia Española de Medicamentos y Productos Sanitarios) y Sanofi-aventis como Titular de la Autorización de Comercialización. Puede consultar la información publicada por la AEMPS en (www.aemps.gob.es).

Los profesionales sanitarios deberían notificar las reacciones adversas y errores de medicación.  al Sistema Español de Farmacovigilancia, a través del Centro Autonómico de Farmacovigilancia, conforme al sistema nacional de comunicación espontánea. Adicionalmente pueden notificarlas al Departamento de Farmacovigilancia de Sanofi.

Para nosotros, la salud y seguridad de todos nuestros pacientes es la mayor prioridad. Nuestro compromiso es proveer insulinas de alta calidad para ayudar a los pacientes en la gestión de la diabetes.

Información adicional

Para cualquier pregunta o requierimiento de información adicional, por favor llame al servicio de Información Médica en Sanofi. Teléfono: 93 485 91 00

RESTABLECIMIENTO DEL SUMINISTRO DE APIDRA (INSULINA GLULISINA)
SOLUCIÓN INYECTABLE EN PLUMA PRECARGADA

Fecha de publicación: 30 de noviembre de 2011

Categoría: MEDICAMENTOS DE USO HUMANO, PROBLEMAS DE SUMINISTRO.
Referencia: ICM (CONT) PSUM, 6/2011

Como continuación a la nota informativa de fecha 29 de septiembre de 2011, en la que se informaba del problema de suministro de Apidra, un medicamento para el tratamiento de la diabetes, que afectaba al suministro de las siguientes presentaciones:

• Apidra 100 Unidades/ml, optiset solución inyectable en pluma precargada (CN: 651458), y
• Apidra 100 Unidades/ml, solostar solución inyectable en pluma precargada (CN: 656073).

Se informa que Sanofi-Aventis, S.A. ha comunicado a la Agencia Española de Medicamentos y Productos Sanitarios que ha adoptado una serie de medidas a fin de resolver el incidente técnico, por lo que tiene previsto iniciar el suministro de forma gradual, a partir del 2 de diciembre de 2011, de la presentación de Apidra 100 Unidades/ml, solostar solución inyectable en pluma precargada (CN: 656073). En relación a la presentación optiset, no se prevé la reanudación de su comercialización.

Toda la información sobre los medicamentos autorizados y, en su caso, sus problemas de suministro puede consultarse en la web de la Agencia Española de Medicamentos y Productos Sanitarios www.aemps.gob.es, en el Centro de Información online de Medicamentos (CIMA)  .

http://www.aemps.gob.es/informa/notasInformativas/medicamentosUsoHumano/problemasSuministro/2011/06-2011_PSUM.htm

Sanofi together with AEMPS (Agencia Española de Medicamentos y Productos Sanitarios) have announced that Sanofi will be resuming production of its rapid acting insulin drug Apidra Solostar, which is Sanofi’s pre-filled Pen device from the 2nd December.

Initially production will be slow going and Healthcare Professionals have been advised to scale the rate of prescriptions so not to overload the system and to make sure that those that need it the most do so.  By January it is hoped that production will be back up to full speed and normal service will have resumed!

For further reading, check out Sanofi’s statement and AEMPS notification.  Both in Español!

Howdy Folks!  Over the weekend Cherise, the wonderfully creative and talented founder of #DSMA Twitter Chats (Diabetes Social Media Advocacy) decided that she would like to ask me some questions!

Wooooh!  First interview!

There is also a little mention of the inaugural project #Diabetes 11.11.11 and a bit about me and having Diabetes in Spain.

Check out interview over on the DSMA site = http://diabetessocmed.com/2011/interview-with-mike-young/

Thank you ever so much Cherise.  It was a privilege, to have been interviewed!

Hey Guys

Thank you very much for your support over the last 24 hours or so.  Diabetes 11.11.11 is hoping to capture Diabetes as we know it to show the world what OUR world looks like.  I have created a new site – www.diabetes111111.com to showcase all the images and videos received which I am hoping will be lots and lots.

Once these have been submitted, I will be looking to collate them all together and to produce a video/slide show for everyone to share.

So if you are a flickr user please head over to the Flickr group and sign up as a member.  If you prefer twitter don’t forget to check my updates over the coming days. not forgetting to use the #diabetes111111 hashtag.

You will be able to upload your images/footage directly via both Diabetes in Spain site or preferably on the Diabetes111111.com site.

Well that time has come around already!  It is November!  That can only mean 1 thing!

Diabetes Month, incorporating World Diabetes Day which takes place on 14th November, the #BigBlueTest which also takes place on the 14th and coinciding with National Diabetes Awareness Month throughout the USA and starts of with JDRF’s T1 Day today 1st November 2011.

Don’t forget to Wear Blue this year to raise awareness!  Everyone is encouraged to wear blue on each Friday of November!  Check out these 2 videos!!  Enjoy!

Supporting World Diabetes Day by wearing blue on Fridays in November! Wear Blue!:
http://youtu.be/d4jha40fok8

A message from International Diabetes Federation (IDF) President Jean Claude Mbanya:
http://www.youtube.com/watch?v=06oF_xPPa20

Also for those really creative peeps out their in the DOC is the World Diabetes Day Postcard Exchange organised by the wonderfully talented Lee Ann Thill.

Please make sure you check out all the above links to see what is taking place near you and find out how you can raise awareness of Diabetes.

One thing that I would like to introduce is an event being organised for 11.11.11.

On November 11th, 11.11.11, across the planet, documentary filmmakers, students, and other inspired citizens will record the human experience over a 24-hour period and contribute their voice to the second annual global day of media creation called One Day on Earth. Together, we will create a shared archive and a film.

I would like to invite everyone from the DOC both online and offline to take part if possible by taking a Diabetes related image on 11.11.11 and submit them either via the Flickr group that has been created , via twitter with the #diabetes111111 hashtag or directly on this site.

Please join me and share! – http://www.diabetesinspain.com/diabetes-11-11-11

Cast your minds back to August this year.  The very first #insulinpumphackinggate surfaced thanks to Jay Radcliffe’s endeavors! (Hi Jay), causing outrage from within the Diabetes community and rightly so.

Initially, I was not as concerned as I’m not a pumper as yet.  The stunt proved that a pump can be told what to do by a third-party device.  I think things got blown out of proportion a little at first and I firmly believe that the Pump Manufacturers were extremely slow to react.  When they did, they were simply unable to deal with the issue it seemed.

However wind on to yesterday where a story broke from an Australian Internet Security blog about a more prominent demonstration of a Insulin Pump being guided to deliver a maximum bolus of 25 units via a third-party device and further control the pump remotely.

This is a problem!  I understand that every one is different, our diabetes does vary from each person to the next but I would assume that if anyone who has diabetes had 25 units of rapid acting insulin pump into their body without realising then that possesses a major if not fatal risk.

Just to play devils advocate and see what could go wrong?

Surely these are the questions we should all be asking the Pump Manufacturers?
No?

Personally I would like to see a big and certainly better response from the Pump Companies.  They did not do themselves any favours last time, so I’m hoping for a faster response this time and a more informed, empathetic and ultimately a more reassuring response even if to offer some piece of mind to you pumpers.

So tell me how do you feel?  Are you a concerned pumper?  Are you a soon to be pumper?  What response are you looking for this time, if any?

Created by the awesome Cherise and edited by the equally awesome Kim..

Blue Fridays is an initiative to bring attention to World Diabetes Day, and to advocate and bring awareness for diabetes and the people living with it. Diabetes is more than a national issue; it’s a world epidemic.

Quote from Cherise who also created the Diabetes Social Media Advocacy Twitter Chat:

Please, please, pleasssseeee help spread the word and remember it features me!!!  Go and enjoy!!

Informamos de un problema temporal del suministro de plumas precargadas para inyección de Apidra® 3 ml (insulina glulisina) [origen ADNr], que afecta a: Apidra® SoloStar™ 100 UI/ml, solución inyectable en pluma precargada y APIDRA OPTISET 100 UI/ml solución inyectable en pluma precargada.

Esta situación se debe a un incidente técnico en una línea de fabricación que ha llevado a una interrupción temporal de la producción. Estamos trabajando para restablecer el suministro antes de finales de 2011 y estar a plena capacidad a principios de 2012. Las plumas precargadas de Apidra actualmente en el mercado se pueden usar con toda seguridad. Ninguna de las otras insulinas de Sanofi comercializadas en España (Lantus) se han visto afectadas.

Para obtener más información acerca de Sanofi Apidra…

Problemas de suministro de Apidra 100 Unidades/ml solución inyectable en pluma precargada.

Para más información de la AEMPS en España.

Shortage of Apidra (insulin glulisine) cartridges: Este artículo en Inglés/This article in English

The European Medicines Agency is aware of a shortage of Apidra, a medicine for treating diabetes, affecting the supply of Apidra 3 ml cartridges and Apidra prefilled disposable pens (OptiSet and SoloStar) in several EU Member States.

The Agency’s Committee for Medicinal Products for Human Use (CHMP) has made several recommendations to manage the situation and ensure patients continue to receive appropriate treatment during the temporary supply shortage.

What is Apidra?
Apidra is a solution for injection that contains the active substance insulin glulisine. It is used to treat
patients aged six years or over with diabetes, when they need insulin.

What is the cause of the supply problem and how long will it last?
The company that markets Apidra, Sanofi-Aventis Deutschland GmbH, informed the Agency that an accidental spillage occurred on 11 July 2011 at the plant where the medicine is manufactured in Frankfurt, Germany. Manufacturing has been temporarily suspended while internal investigations are taking place. This will result in a continued delay in the release of batches of Apidra cartridges onto the EU market. The shortage affects Apidra cartridges and Apidra prefilled disposable pens, OptiSet and SoloStar. It does not affect Apidra vials or any other Sanofi insulin product (Lantus and Insuman).

Statement from the European Medicines Agency regarding the supply of Apidra from Sanofi.

Problemas temporales de Apidra España: Este articluo en Español/This article in Spanish