Glooko Achieves Reimbursement for Gestational Diabetes Monitoring in France
Glooko, Inc., a leader in integrated digital health solutions, has made significant strides in maternal healthcare by securing reimbursement for its Glooko XT platform in France. The approval, granted by the Haute Autorité de Santé (HAS) and the Commission Nationale d'Évaluation des Dispositifs Médicaux et des Technologies de Santé (CNEDiMTS), was officially published in the French Journal Officiel (JO) on December 26, 2024. This decision marks a milestone for the management of gestational diabetes, allowing healthcare providers to routinely monitor patients who are not treated with insulin.
Expanding Access to Care
The Glooko XT platform is now one of only two solutions approved in France for the remote monitoring of gestational diabetes. Previously, it was already reimbursed for insulin-treated diabetes. The recent changes aim to boost the management of gestational diabetes (GDM), which affects approximately 8.8% of pregnancies in France. GDM poses various risks, including preeclampsia, cesarean delivery, and potential long-term health issues such as type 2 diabetes in mothers. The approval of Glooko XT is particularly crucial, given the serious implications for both maternal and fetal health.
The HAS has acknowledged Glooko XT as a complementary tool that enhances conventional medical follow-up for GDM. The approval specifically covers non-insulin treated pregnant women diagnosed with GDM through a positive oral glucose tolerance test (OGTT) during the 24th to 28th week of pregnancy or those showing elevated fasting blood glucose levels as early as the first trimester. This streamlined access ensures that women have equitable resources for managing their health during pregnancy, ultimately leading to healthier outcomes for mothers and their babies.
Glooko’s Commitment to Patient-Centric Care
Mike Alvarez, the CEO of Glooko, expressed pride in this momentous achievement. He emphasized the importance of this platform in providing tailored care for pregnant women suffering from GDM. "This milestone reinforces our commitment to delivering reliable and secure platforms for managing gestational diabetes in France," he affirmed. By facilitating remote monitoring, healthcare providers can offer timely and personalized care, positively impacting maternal health.
Glooko XT is designed with the unique requirements of the French healthcare system in mind. It allows healthcare providers to access a wealth of information about their patients, including blood glucose levels, carbohydrate intake, insulin doses, and even activity levels. Additionally, the platform features secure messaging, enabling effective communication between patients and their healthcare teams for prompt interventions.
Focus on Data Privacy
In the realm of health data, Glooko XT adheres to some of the strictest regulations globally, ensuring the security and privacy of patient information. The platform is fully compliant with GDPR, thus safeguarding patient data while promoting trust among users. Moreover, it incorporates robust data protection protocols tailored to the French legal framework governing health information.
Globally, Glooko has a significant presence, reaching over 4.4 million users and partnering with more than 10,000 clinical locations. With each technological advancement, it continues to improve the health outcomes of individuals with chronic conditions through innovative, connected care solutions. The Glooko XT and Glooko platforms are certified as Class IIa medical devices under the EU Medical Device Regulation (MDR).
Glooko's mission remains clear: to enhance patient engagement and adherence through cutting-edge digital health solutions, ultimately driving healthier lives and efficient healthcare delivery across the globe. By expanding its functionalities to include remote monitoring for gestational diabetes, Glooko continues to demonstrate its dedication to transforming digital health.
For more information about Glooko and its offerings, visit
glooko.com or
glookoxt.com.