Why can't the Glooko (Glucose Monitoring) App UK calculate insulin doses for the Novo (Insulin Aspart) Pen?

Why the Glooko App UK Cannot Calculate Insulin Doses for Novo Pen

The Glooko App UK cannot calculate insulin doses for Novo Insulin Pens because regulatory differences between the US FDA and European Commission medical device regulations result in different app functionalities across regions, with insulin dose calculation features requiring specific regulatory approval in the UK that Glooko has not yet obtained.

Regulatory Framework Differences

• The European Commission and individual EU member states have different regulatory frameworks for medical devices compared to the FDA in the United States 1
• In the EU, each country maintains its own national pharmaceutical regulatory authorities, with the European Commission serving to complement national policies 1
• Medical device regulations in the EU follow the Medical Device Regulation (MDR), which has stricter requirements for software that calculates medication doses 1

Classification of Diabetes Apps

Diabetes apps fall into different categories with varying regulatory requirements:

• Glucose monitoring apps (like basic Glooko): Log glucose data from external devices and display glucose levels graphically 1
• Insulin titration apps: Extend glucose monitoring apps by integrating bolus calculators to help calculate basal, prandial, and correction insulin doses 1
• Insulin delivery apps: Connect to insulin pumps and smart pens to collect data, including bolus calculators and data downloaders 1

Regulatory Status of Insulin Dose Calculators

• In the US, the FDA has cleared several insulin dose calculator apps including the Glooko Mobile Insulin Dosing System 1
• Insulin dose calculators are subject to FDA approval to ensure safety and efficacy of algorithms and dosing recommendations 1
• The UK and EU have not granted similar approvals to the Glooko app for insulin dose calculation functionality 1

Safety Concerns with Insulin Dose Calculators

• A systematic assessment of insulin dose calculator apps found that 67% carried a risk of inappropriate output dose recommendations 2
• Many apps lack numeric input validation (91%), allow calculation with missing values (59%), and use ambiguous terminology (48%) 2
• These safety concerns make regulatory approval for insulin dose calculators more stringent in different regions 2

Alternative Solutions

• Connected insulin pens like the NovoPen 6 can provide insulin dosing data that integrates with continuous glucose monitoring 3
• Expert panels have recommended standardized Ambulatory Glucose Profile reports for connected insulin pens to enhance clinical utility 4
• Bolus calculators that are FDA-approved have been shown to improve dosing confidence and treatment adherence 5
• Healthcare professionals should exercise caution in recommending unregulated dose calculators to patients 2

Clinical Implications

• Proper insulin dosing is critical for glycemic control, with incorrect dosing potentially leading to hypoglycemia or hyperglycemia 3
• Studies show that connected insulin pens with proper dose calculation can increase Time in Range by 1.9 hours/day and reduce missed bolus injections by 43% 3
• Insulin pen accuracy is also important, with studies showing differences between new and used insulin pens that could affect dose precision 6

Practical Recommendations

• Patients in the UK using Novo insulin pens should consult with healthcare providers for manual insulin dose calculations 1
• Consider alternative FDA or EU-approved insulin dose calculator apps that have received proper regulatory clearance 1
• For those using Glooko in the UK, the app can still be valuable for glucose monitoring and data visualization, even without the dose calculation feature 1