Bienvenidos a un encuentro con la diabetes tipo 1

"El objeto de este sitio es publicar novedades cientificas, relacionadas con prevencion, diagnostico, complicaciones, tratamiento de diabetes tipo 1, como asi tambien comunicar futuros eventos (congresos, jornadas, campamentos educativos, etc) en el pais e internacionales.
Dirigido a equipo de salud de atencion diabetologica (medicos, enfermeros, educadores, nutricionistas, asistentes sociales, profesores de educacion fisica, psicologos, podologos, etc.), empresas de medicina, pacientes y sus familiares."

martes, 21 de febrero de 2017

DR:BERCOVICH: MONITOREO GLUCEMICO NO INVASIVO

MONITOREO GLUCEMICO NO INVASIVO


Una compañía Israelí esta ensayando un dispositivo para medir glucemia transdérmica en la piel del pabellón auricular, ello evitaría el constante pero necesario trauma cotidiano de tener que efectuar una punción digital para monitorear el control glucémico.



GlucoTrack® Maker Submitted Pre-­Submission Supplement to US FDA
SHDOD, Israel, June 1, 2016 /PRNewswire/ – Integrity Applications, Inc. (OTCQB: IGAP), maker of GlucoTrack®, a non­invasive device for measuring glucose levels of people with Type 2 diabetes, announced that it has set a conference call with the United States Food and Drug Administration (FDA), expected to take place in July 2016, for further discussion regarding the Company’s pre-submission supplement (including clinical trial protocol) for its GlucoTrack® Model DF­F device submitted to the FDA for review on May 10, 2016. Such protocol was modified to reflect FDA remarks and discussions with the Company during a Pre-Submission meeting which took place in October 2015. Following the July discussion and subject to FDA approval of the Company’s clinical trial protocol, the Company plans to initiate the pivotal clinical study in the third quarter of 2016.

About GlucoTrack®
GlucoTrack® is a non­invasive device for measuring glucose levels of people with Type 2 diabetes or at risk of developing diabetes that does not require pricking of the fingers to draw blood for daily glucose monitoring. GlucoTrack® features a small sensor that clips to the earlobe and measures the wearer’s glucose level by taking measurements using three technologies. The measured signals are analyzed using a proprietary algorithm and displayed on a small handheld device the size of a mobile phone. The derived glucose measurement is also announced verbally, facilitating use by elderly and vision-impaired diabetes patients.

The GlucoTrack® Model DF­F is expected to begin clinical trials for United States FDA approval in 2016, subject to approval of Integrity Applications’ clinical trial protocol by the FDA. The product is experimental in the United States and is limited to investigational use.

GlucoTrack® Model DF­F obtained a CE Mark approval in Europe (June 2013) and final CE Mark approval in March 2014 and recently received approval to market the device also to pre-diabetics.

About Integrity Applications, Inc.        
Integrity Applications, Inc. is a medical device company focused on the design, development and commercialization of non-invasive glucose monitoring devices for use by people with diabetes. Integrity Applications has developed the GlucoTrack® model DF­F noninvasive glucose monitoring device, which is designed to help people with diabetes obtain glucose level measurements without the pain, inconvenience, incremental cost and difficulty or discomfort of conventional (invasive) spot finger stick devices. Integrity Applications operates primarily through its wholly-owned Israeli subsidiary, A.D. Integrity Applications, Ltd. For more information, please visit www.integrity-app.com.

Forward-Looking Statements
This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Statements contained in this news release that are not statements of historical fact may be deemed to be forward-looking statements. Without limiting the generality of the foregoing, words such as “expect”, “plan” and “will” are intended to identify forward-looking statements. Readers are cautioned that certain important factors may affect Integrity Applications’ actual results and could cause such results to differ materially from any forward-looking statements that may be made in this news release. Factors that may affect Integrity Applications’ results include, but are not limited to, the ability of Integrity Applications to raise additional capital to finance its operations (whether through public or private equity offerings, debt financings, strategic collaborations or otherwise); risks relating to the receipt (and timing) of regulatory approvals (including FDA approval); risks relating to enrollment of patients in, and the conduct of, clinical trials; risks relating to its current and future distribution agreements; risks relating to its ability to hire and retain qualified personnel, including sales and distribution personnel; and the additional risk factors described in Integrity Applications’ filings with the U.S. Securities and Exchange Commission (SEC), including its Annual Report on Form 10-K for the year ended December 31, 2015 as filed with the SEC on March 30, 2016.

Contact:          
Eran Hertz, CFO Integrity Applications,
+972 (8) 675-7878 Ext. 400,
eranh@integrity-app.com


FEBRUARY 16 th, 2017
GlucoTrack® Maker Presents Scientific Data Demonstrating Reliable Accuracy and Precision
Ashdod, Israel, February 16, 2017 /PRNewswire/ — Integrity Applications, Inc. (OTCQB: IGAP), maker of GlucoTrack®, a noninvasive device for measuring glucose levels of people with Type 2 diabetes and pre-diabetics, announced that it is presenting this week at the 10th International Conference on Advanced Technologies & Treatments for Diabetes (ATTD 2017) in Paris, France.
The company presented findings from research that demonstrate the precision and accuracy of the GlucoTrack Model DF-F non-invasive glucose monitoring device.
Non-Invasive Glucose Monitoring Device: Reducing Impact of Postprandial Lagging Effect During Measurement (A. Gal, A. Drexler et al., E-Poster #160, available from February 15th, 2017 and E-Poster Discussion Session, Exhibition Area, February 16, 2017, 10:10am)
Key findings: · The latest generation GlucoTrack algorithm, which compensates for the tissue-lagging effect relative to blood glucose changes postmeal intake, significantly improves GlucoTrack accuracy at different post-prandial (post-meal) states, and equalizes accuracy for pre- and post-meal glucose readings. · GlucoTrack clinical accuracy as measured by Consensus Error Grid (CEG) showed 100% of the pre-prandial readings in the A+B zones, and 98.2% of the post-prandial readings in the A+B zones.
Repeatability of a Non-Invasive Glucose Monitoring Device (A. Gal, A.
Drexler et al., E-Poster #61, Exhibition Area, available from February 15th, 2017)
Key findings: · GlucoTrack Model DF-F demonstrates consistent glucose measurement repeatability between different GlucoTrack devices and on each earlobe of the same subject. · The repeatability of different GlucoTrack devices is similar at all tested glucose ranges and post-prandial time periods. · The GlucoTrack mean precision absolute relative difference (PARD) of 8.2% is equivalent or better than the independently reported PARD values of commercially available continuous glucose monitoring systems (CGMs).
The 10th annual conference on Advanced Technologies and Treatments for Diabetes (ATTD) is expected to attract over 2,500 delegates from over the globe. The conference is attended by the world’s leading researchers, clinical practitioners and industry/corporate professionals, and provides a forum for lively exchange of ideas and research relating to technologies, treatment and prevention of diabetes related illnesses.
About GlucoTrack® GlucoTrack® is a non-invasive device that measures and displays an individual’s glucose level in less than a minute without requiring a finger stick to draw blood.
GlucoTrack® features a small sensor that clips to the earlobe and measures the wearer’s glucose level by taking measurements using three technologies. The measured signals are analyzed using a proprietary algorithm and displayed on a small handheld device the size of a mobile phone. The derived glucose measurement is also announced verbally, facilitating use by vision-impaired diabetes patients.
GlucoTrack® has received CE Mark and KFDA approvals for Type 2 diabetes and pre-diabetics, and is currently being commercialized in Europe, South Korea and other geographical areas.
GlucoTrack® is expected to begin clinical trials for United States FDA approval in early 2017. The product is currently experimental in the United States and is limited to investigational use only.
About Integrity Applications, Inc. Integrity Applications was founded in 2001 and is focused on the design, development and commercialization of non-invasive glucose monitoring technologies for patients with diabetes and pre-diabetics. The company has developed GlucoTrack®, a proprietary noninvasive glucose monitoring device designed to obtain glucose level measurements in less than a minute without the pain, incremental cost, difficulty or discomfort of conventional invasive finger stick devices. Integrity Applications operates primarily through its wholly-owned Israeli subsidiary, A.D. Integrity Applications, Ltd. For more information, please visit www.integrity-app.com and www.glucotrack.com
Forward-Looking Statements This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Statements contained in this news release that are not statements of historical fact may be deemed to be forward-looking statements. Without limiting the generality of the foregoing, words such as “expect”, “plan” and “will” are intended to identify forward-looking statements. Readers are cautioned that certain important factors may affect Integrity Applications’ actual results and could cause such results to differ materially from any forward-looking statements that may be made in this news release. Factors that may affect Integrity Applications’ results include, but are not limited to, the ability of Integrity Applications to raise additional capital to finance its operations (whether through public or private equity offerings, debt financings, strategic collaborations or otherwise); risks relating to the receipt (and timing) of regulatory approvals (including FDA approval); risks relating to enrollment of patients in, and the conduct of, clinical trials; risks relating to its current and future distribution agreements; risks relating to its ability to hire and retain qualified personnel, including sales and distribution personnel; and the additional risk factors described in Integrity Applications’ filings with the U.S. Securities and Exchange Commission (SEC), including its Annual Report on Form 10-K for the year ended December 31, 2015 as filed with the SEC on March 30, 2016.
Contact:
Sami Sassoun,
CFO Integrity Applications
SamiS@integrity-app.com
+972 (8) 675-7878 Ext. 400

No hay comentarios:

Publicar un comentario