A Cross-Platform Mobile App for Continuous Glucose Monitoring
People managing diabetes need reliable, real-time access to their glucose data. We partnered with a global biotech company to build the mobile app that makes their CGM work.
Opportunity
A leading medical device manufacturer needed a cross-platform mobile app to connect their continuous glucose monitor (CGM) to patients’ phones and wearables.
Services
Results
- EU MDR approval and CE mark
- Apple Watch integration
- Continuous BLE connectivity
Client
A Global Leader in Biotech and Diagnostics
Founded over 125 years ago, this client has grown into one of the world’s largest biotech companies, a leading provider of in-vitro diagnostics, and a global supplier of digital health solutions. They came to SEP because of our track record with medical technology, medical mobile apps, and our ability to meet strict safety standards.
About the Client
Industry
Healthcare
Market
Global
Type
Public
Employees
10,000+
Opportunity
Putting Diabetes Care at Patients’ Fingertips
The client wanted to give patients 24/7 access to their glucose data through a wearable patch and a mobile app, replacing the need for traditional manual blood sugar tests. The app needed to collect data from the CGM sensor, work across both iOS and Android, and run continuously in the background for weeks at a time without interruption. That last requirement was the hard part. Real-time glucose monitoring depends on an unbroken Bluetooth connection between the sensor and the phone, and both iOS and Android handle background processes differently.
They needed a software partner who could handle the technical complexity and navigate the regulatory environment that comes with building medical device software. SEP’s history in both made us the right fit.
What We Did
Product Design
Mobile Development
Cross-Platform Development
User Testing
Solution
A Medical-Grade Mobile App That Runs When It Matters
The core challenge was Bluetooth reliability. For a CGM app, a dropped connection isn’t a minor inconvenience. It’s a gap in a patient’s health data. Our team developed a robust BLE connection strategy that keeps the app communicating with the sensor continuously, even while running in the background for weeks. That approach became the foundation the rest of the app was built on.
From there, we expanded the app’s reach. We integrated an Apple Watch companion app so users could check their glucose levels from their wrist.
We built alarm systems and notification logic that balance critical health alerts with user control, so patients got the information they needed without being overwhelmed.
When Apple introduced new account management requirements, we moved quickly to integrate account deletion and keep the app compliant.
“The team performed above my expectations. Anytime we needed a new configuration built, they’d jump right in and deliver earlier than I expected. Their ability to innovate, particularly in ensuring continuous Bluetooth connectivity, has set our app apart in the competitive market.”
Beyond the app itself, SEP supported the client through clinical evaluations and regulatory submissions. When clinical studies required new configurations, our team built and delivered them ahead of schedule.
We also prepared the comprehensive documentation and records needed for regulatory approval. The team proactively adopted the FHIR standard for medical data, keeping the app positioned for future interoperability requirements before the client had to ask.
The app was built with C# and .NET MAUI for cross-platform development, BLE for sensor connectivity, and Appium for automated testing.
Tech Stack
Appium
BLE
C#
MAUI
Results
MDR Approved. CE Marked. Used by Patients Daily.
The cross-platform mobile app secured both EU MDR approval and the CE mark, confirming its compliance with stringent European medical device regulations. Patients now have continuous, real-time access to their glucose data on their phones and Apple Watches, replacing the manual testing process they relied on before.
The partnership continues to grow. SEP’s role has expanded beyond the initial app development into ongoing clinical support, regulatory preparation, and proactive adoption of emerging standards like FHIR. Each phase of the work has reinforced the client’s trust in SEP as a long-term partner in their diabetes care technology.
EU MDR approval and CE mark secured
Cross-platform app running on iOS, Android, and Apple Watch
Continuous BLE connectivity that runs in the background for weeks
Clinical study configurations delivered ahead of schedule
FHIR standard adopted proactively for future interoperability
Ongoing partnership continuing to expand