Diabetes and chronic disease: what the evidence shows
Software that analyzes glucose, insulin and laboratory data to recommend insulin doses, coach patients between visits or estimate the risk that chronic kidney disease will progress.
These tools analyze glucose, insulin and laboratory data to recommend insulin doses, coach patients between visits or estimate the risk of complications. FDA created the device type insulin pump therapy adjustment calculator for healthcare professionals when it granted DreaMed's De Novo request in June 2018, and granted a De Novo request for KidneyIntelX, a machine learning prognostic test for diabetic kidney disease, in June 2023. Prescription coaching apps such as BlueStar reached the market through 510(k) clearance.
Randomized evidence is thin. In the ADVICE4U trial, algorithm-guided insulin pump adjustments were noninferior to intensive titration by academic specialists in 108 youths, and a pragmatic trial of the BlueStar app found no difference in HbA1c. A European Diabetes Forum working group has noted concerns that regulatory processes may not be adequate for AI systems that adapt to new data, and an American Diabetes Association scientific statement said diabetes technologies can be integrated into primary care with standardized workflows, training and access to specialty expertise.
The tools reviewed in this category
General information, not medical advice. Every fact links to its source, and the page shows the date it was last reviewed.