Evidence-based Mobile Medical Applications in Diabetes

Area of Science:

• Digital health
• Medical informatics
• Health technology assessment

Background:

• Mobile medical applications are increasingly prevalent in healthcare.
• Assessing the clinical validity and regulatory status of these apps is essential.
• Existing reviews often lack a focus on regulatory approval and published clinical outcomes.

Purpose of the Study:

• To review mobile medical applications available in the US and EU.
• To identify apps with published clinical outcome data within the last five years.
• To assess apps based on their clearance by the US Food and Drug Administration (FDA) or CE marking in the EU.

Main Methods:

• Systematic literature search for studies on mobile medical applications.
• Inclusion criteria: published clinical outcomes (5 years), FDA clearance, or CE mark.
• Review of commercial availability in the United States and European Union.

Main Results:

• Numerous mobile medical applications are commercially available and meet inclusion criteria.
• Many applications demonstrate positive short-term clinical outcomes.
• A significant gap exists in long-term outcome data for most reviewed applications.

Conclusions:

• Mobile medical applications show promise for short-term health improvements.
• Further long-term studies are necessary to fully understand the impact of these technologies.
• Regulatory status (FDA/CE) can serve as an interim guide for consumers and professionals.