France Approves Reimbursement for Glooko XT in Gestational Diabetes Care

January 22, 2025

A groundbreaking development in digital health technology has been achieved as Glooko, Inc., a global digital health company, recently received approval for reimbursement of its Glooko XT solution from France’s Haute Autorité de Santé (HAS) and Commission Nationale d’Évaluation des Dispositifs Médicaux et des Technologies de Santé (CNEDiMTS). This approval marks a pivotal milestone for the company and expands the existing reimbursement policies to include remote monitoring for gestational diabetes mellitus (GDM) in patients not treated with insulin. With the decision from the French authorities, healthcare providers can access reimbursement for the remote monitoring of GDM, enhancing the care for pregnant women who need it most.

Glooko, Inc. integrates key stakeholders in the health sector, namely patients, healthcare providers, biopharma companies, and medical device partners. Facilitating smoother interactions and improving health outcomes, the company’s innovative solutions bridge the gaps usually present in traditional healthcare settings. The Glooko XT solution offers critical support for gestational diabetes management, benefiting both mothers and their babies by providing personalized and timely care. The expanded reimbursement policy signifies a robust acknowledgment of Glooko XT’s efficacy in gestational diabetes care.

The Impact of Gestational Diabetes

Gestational diabetes mellitus affects approximately 8.8% of pregnancies in France, carrying significant health risks for both mothers and their newborns. For pregnant women, this condition can increase the chances of preeclampsia, necessitate cesarean deliveries, and heighten the likelihood of developing type 2 diabetes later in life. Newborns, on the other hand, face risks such as macrosomia (excessive birth weight), preterm birth, and respiratory distress. By enabling remote monitoring through the Glooko XT solution, pregnant women with GDM can expect to achieve healthier pregnancies with enhanced outcomes for both themselves and their babies.

The approval for reimbursement is largely attributed to Glooko XT’s ability to offer valuable monitoring, complementing traditional medical follow-ups for gestational diabetes. Now, the solution can be reimbursed specifically for non-insulin-treated pregnant women who test positive for GDM through an oral glucose tolerance test (OGTT) between the 24th and 28th week of amenorrhea. Additionally, those with fasting blood glucose levels of at least 0.92g/L during the first trimester of pregnancy, provided they are at risk, can also benefit. This substantial step ensures affected women receive necessary care and monitoring to manage their condition effectively.

Expanding Access to Remote Monitoring

The expansion of coverage to include remote monitoring for GDM in non-insulin-treated women ensures more patients have equitable access to this crucial technology. This development enables healthcare providers to deliver high-quality, personalized, and timely care, potentially leading to better health outcomes for both mothers and infants. With the widespread implementation of remote monitoring technology, pregnant women can receive consistent support throughout their pregnancy journey, making this policy a vital part of enhancing maternal and neonatal healthcare.

Mike Alvarez, Chief Executive Officer of Glooko, praised the French health authorities’ decision and underscored the significance of the Glooko XT solution in managing gestational diabetes. He highlighted that the remote monitoring capability allows healthcare providers to deliver timely interventions, which can translate into better health outcomes. This decision supports Glooko’s broader mission to expand access to innovative digital health solutions globally, ultimately advancing the quality of care for people dealing with chronic conditions.

Features and Benefits of Glooko XT

Glooko XT offers a streamlined system for remote patient monitoring by consolidating key data such as blood glucose readings, insulin dosages, carbohydrate intake, and activity levels into one comprehensive platform. This system enables secure communication between patients and healthcare providers, allowing for timely interventions and continuous support. Such a platform is crucial in ensuring that healthcare providers can promptly respond to any health changes, offering a seamless patient experience that caters to specific health needs during pregnancy.

Moreover, Glooko XT adheres to stringent French regulations concerning health data management, ensuring robust patient privacy and data security. The platform is designed to guarantee data sovereignty and incorporates extensive security measures, aligning with the General Data Protection Regulation (GDPR). These features make the Glooko XT platform a reliable and secure option for both patients and healthcare professionals in France. The adherence to stringent guidelines presents a strong case for broader applications of digital technologies in healthcare.

Glooko’s Global Reach and Commitment

Glooko, Inc. remains steadfast in its mission to improve health outcomes for people with chronic conditions by leveraging personalized, connected care and life sciences platforms. Their technology enhances the connection between patients and providers, driving patient engagement and adherence through digital therapeutics, and accelerating clinical trials. With its solutions deployed in more than 30 countries and over 10,000 clinical locations globally, Glooko continues to expand its reach, impacting millions of people living with diabetes. The Glooko XT and Glooko platforms, both certified under the EU Medical Device Regulation (MDR) as Class IIa medical devices, bolster the company’s reputation for delivering high-quality health solutions.

As Glooko’s services are utilized by more than 4.4 million people living with diabetes worldwide, the company holds the largest installed base in the sector. This widespread adoption demonstrates the trust and efficacy of Glooko’s offerings, paving the way for continued innovation and improved health outcomes. Their consistent commitment to maintaining global standards and certifications underscores their dedication to delivering reliable, effective health solutions across diverse healthcare landscapes.

National Recognition and Future Implications

Glooko, Inc., a leading company in digital health, recently achieved a significant milestone by receiving approval for the reimbursement of its Glooko XT solution from France’s Haute Autorité de Santé (HAS) and the Commission Nationale d’Évaluation des Dispositifs Médicaux et des Technologies de Santé (CNEDiMTS). This approval expands reimbursement policies to cover remote monitoring for gestational diabetes mellitus (GDM) in patients not treated with insulin. With the French authorities’ decision, healthcare providers can now be reimbursed for the remote monitoring of GDM, improving care for pregnant women who need it.

Glooko, Inc. connects essential stakeholders in the health sector, including patients, healthcare providers, biopharma companies, and medical device partners. The company’s innovative solutions enhance interactions and improve health outcomes, bridging gaps often seen in traditional healthcare. The Glooko XT solution offers crucial support for managing gestational diabetes, benefiting mothers and babies by providing personalized, timely care. This expanded reimbursement policy is a strong acknowledgment of Glooko XT’s effectiveness in gestational diabetes management.

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