Digital diabetes care: the certified landscape 2026
71 digital tools for diabetes and its complications, individually assessed against the FDA register, EUDAMED and the German DiGA directory. For every FDA entry we state whether the record names the exact product, its product family or only related hardware. Revision 3, after an independent editorial and regulatory review and a certificate check in EUDAMED.
Six findings
- Glucose sensing has left the insulin clinic. Four sensors are cleared in the US for over-the-counter sale to people who do not use insulin, each for a specific intended use.
- The pace is high. 17 products received their own FDA decision since January 2025: 9 first authorisations and 8 updates. Manufacturing supplements do not count.
- Decision support is moving to type 2. Basal insulin titration brings algorithmic dosing into primary care, in the US and the EU.
- Lifestyle and remission are the regulated gap. Almost no digital remission programme holds a device authorisation, except in Germany as DiGA.
- Labels mislead, in both directions. 6 tools have no matching FDA record; 5 tools are authorised only at family level and 7 only through related hardware.
- Europe is less transparent than the US. Only 10 of 51 tools with an FDA record appear in EUDAMED. Of 20 tools with a class IIa or higher record, 3 have a certificate linked to the device record and 5 a maker-level certificate whose product coverage must be confirmed; for 11 none is visible yet. Buyers must ask for the certificate.
Inside the report
- Executive summary and six findings
- Market map: six segments, one ecosystem
- What changed in 2025 and 2026: 9 first authorisations, 8 updates
- Segment tables with FDA route, first and latest decision, reference numbers and verification level for every tool, plus EU class, notified body certificate evidence from EUDAMED and DiGA status
- Lifestyle, weight and remission: the regulated gap and the white spaces
- Seven ways a diabetes label can mislead
- What it means for pharma, insurers, hospitals and pharmacists
- Method, verification levels and counting rules
What the full report adds to the free directory
Our free directory shows which tools are certified. The report shows the proof, and what it means.
- Evidence for every tool. The FDA record number, whether that record names this exact product, only its product family or only related hardware, the first and latest decision, and the notified body certificate evidence visible in EUDAMED. None of this is in the directory.
- What it means. The findings, the label traps, the white spaces in the market, and what the landscape means for pharma, payers, hospitals and clinicians.
- A document you can defend. Dated, externally reviewed and citeable in a strategy or procurement file. The organisation licence adds the Excel data file and the right to share it internally.
Order the full report
The full report (PDF, 13 pages) for one reader, personalised with your name and email on every page. For your own use, not for sharing.
Buy nowThe full report without personal marking, to share across your organisation, on your intranet and in internal presentations. Plus the Excel data file with all 71 tools, their FDA and EU references and certificate details, and an updated edition after six months.
Buy nowEverything in the organisation licence, plus a one-hour briefing with Prof. Koen Kas for your team on what the landscape means for your strategy.
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