PALO ALTO, Calif., Jan. 21, 2025 /PRNewswire/ -- Glooko, Inc., a global integrated digital health company connecting patients, providers, biopharma, and medical device partners, today announced that its Glooko XT solution has been approved for reimbursement by the Haute Autorité de Santé (HAS) and the Commission Nationale d'Évaluation des Dispositifs Médicaux et des Technologies de Santé (CNEDiMTS) in France. This decision, published in the French Journal Officiel (JO) on December 26, 20241, 2, allows healthcare providers to receive reimbursement for remote monitoring of gestational diabetes (GDM) in patients not treated with insulin.
This expands upon the existing reimbursement for Glooko XT for remote monitoring of people with insulin-treated diabetes, making it one of only two solutions in France with this GDM indication and further demonstrating the value of this technology in diabetes management.
GDM has a significant impact on maternal and fetal health in France:
- Prevalence: GDM affects an estimated 8.8% of pregnancies in France.3
- Health Risks: GDM increases risks of preeclampsia, cesarean delivery, and type 2 diabetes in mothers. For newborns, it can lead to macrosomia, preterm birth, and respiratory distress.4
The HAS approval is based on the recognition that Glooko XT provides a valuable complementary monitoring option for conventional medical follow-up of GDM. The specific indications for reimbursement include:
- Non insulin treated pregnant women diagnosed with GDM through a positive oral glucose tolerance test (OGTT) performed between the 24th and 28th week of amenorrhea, or with a fasting blood glucose level greater than or equal to 0.92g/L during the first trimester of pregnancy in the presence of at least one risk factor.
Expanding reimbursement for GDM ensures equitable access to this vital technology, supporting healthier pregnancies and improved outcomes for mothers and babies.
"This is a significant milestone for Glooko and for the management of gestational diabetes in France. We are proud that the French health authorities recognize the benefits of Glooko XT for the health of patients, and we are committed to providing a reliable and secure platform for the management of gestational diabetes in France," said Mike Alvarez, Chief Executive Officer of Glooko. "By enabling remote monitoring, we can empower healthcare providers to deliver more personalized and timely care to pregnant women with GDM, potentially contributing to better outcomes for mothers and babies. This approval also reinforces Glooko's commitment to expanding access to innovative digital health solutions globally."
Glooko XT: Tailored for the French Healthcare Landscape
Glooko XT simplifies remote patient monitoring by providing healthcare professionals with a comprehensive view of their patients' diabetes data, including blood glucose readings, insulin doses, carbohydrate intake, and activity levels. The platform also allows for secure messaging and communication between patients and providers, facilitating timely interventions and support.
Glooko XT in France complies specifically with French regulations on health data management. These regulations, some of the most stringent in the world, prioritize patient privacy and data security. Glooko XT has been meticulously designed to meet these requirements, including features that ensure data sovereignty, robust security measures, and full compliance with the General Data Protection Regulation (GDPR) and guidelines established by l'Agence du Numérique en santé, as outlined in the relevant legal texts governing health data in France. This commitment to data privacy allows Glooko to provide a trusted and secure platform for both patients and healthcare professionals in France.
About Glooko
Glooko improves health outcomes of people with chronic conditions through personalized, intelligent, connected care and life sciences platforms. Our proven technologies make lives better by revolutionizing the connection between patients and providers, driving patient engagement and adherence via digital therapeutics, and accelerating the speed of clinical trials. Glooko solutions are globally deployed in more than 30 countries, 10,000+ clinical locations* and partner to connect with over 200 devices. With more than 4.4 million people worldwide who have used Glooko platforms, Glooko boasts the largest installed base of patients living with diabetes. Glooko XT and Glooko are Class IIa medical devices certified under the EU Medical Device Regulation (MDR). For more information, please visit glooko.com or glookoxt.com.
1. Arrêté du 26 décembre 2024 portant inscription d'activités de télésurveillance médicale sur la liste prévue à l'article L. 162-52 du code de la sécurité sociale https://www.legifrance.gouv.fr/jorf/id/JORFTEXT000050872057
2. Arrêté du 26 décembre 2024 fixant le montant d'un forfait technique applicable à une activité de télésurveillance inscrite sur la liste des activités de télésurveillance médicale prévue à l'article L. 162-52 du code de la sécurité sociale https://www.legifrance.gouv.fr/jorf/id/JORFTEXT000050872088
3. International Diabetes Federation, 2021
4. Chiefari et al., 2017
*This count indicates the number of health clinics that have registered and uploaded health data over the 14 year period with one of the Glooko solutions, which are the Glooko® System, Glooko XT®, and diasend® System.
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