Insulin dose optimization using an automated artificial intelligence-based decision support system in youths with type 1 diabetes

Despite the increasing adoption of insulin pumps and continuous glucose monitoring devices, most people with type 1 diabetes do not achieve their glycemic goals(1). This could be related to a lack of expertise or inadequate time for clinicians to analyze complex sensor-augmented pump data. We tested whether frequent insulin dose adjustments guided by an automated artificial intelligence-based decision support system (AI-DSS) is as effective and safe as those guided by physicians in controlling glucose levels. ADVICE4U was a six-month, multicenter, multinational, parallel, randomized controlled, non-inferiority trial in 108 participants with type 1 diabetes, aged 10-21 years and using insulin pump therapy (ClinicalTrials.gov no. NCT03003806). Participants were randomized 1:1 to receive remote insulin dose adjustment every three weeks guided by either an AI-DSS, (AI-DSS arm, n=54) or by physicians (physician arm, n=54). The results for the primary efficacy measure-the percentage of time spent within the target glucose range (70-180mgdl(-1) (3.9-10.0mmoll(-1)))-in the AI-DSS arm were statistically non-inferior to those in the physician arm (50.211.1% versus 51.6 +/- 11.3%, respectively, P<1x10(-7)). The percentage of readings below 54mgdl(-1) (<3.0mmoll(-1)) within the AI-DSS arm was statistically non-inferior to that in the physician arm (1.3 +/- 1.4% versus 1.0 +/- 0.9%, respectively, P<0.0001). Three severe adverse events related to diabetes (two severe hypoglycemia, one diabetic ketoacidosis) were reported in the physician arm and none in the AI-DSS arm. In conclusion, use of an automated decision support tool for optimizing insulin pump settings was non-inferior to intensive insulin titration provided by physicians from specialized academic diabetes centers.The randomized-controlled trial ADVICE4U demonstrates non-inferiority of an automated AI-based decision support system compared with advice from expert physicians for optimal insulin dosing in youths with type 1 diabetes.