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...

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Published in:Nature medicine Vol. 26; no. 9; pp. 1380 - 1384
Main Authors: Nimri, Revital, Battelino, Tadej, Laffel, Lori M., Slover, Robert H., Schatz, Desmond, Weinzimer, Stuart A., Dovc, Klemen, Danne, Thomas, Phillip, Moshe
Format: Journal Article
Language:English
Published: New York Nature Publishing Group US 01.09.2020
Nature Publishing Group
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ISSN:1078-8956, 1546-170X, 1546-170X
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Summary: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 (70–180 mg dl −1 (3.9–10.0 mmol l −1 ))—in the AI-DSS arm were statistically non-inferior to those in the physician arm (50.2 ± 11.1% versus 51.6 ± 11.3%, respectively, P  < 1 × 10 −7 ). The percentage of readings below 54 mg dl −1 (<3.0 mmol l −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.
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ISSN:1078-8956
1546-170X
1546-170X
DOI:10.1038/s41591-020-1045-7