Introduction & Objective: Recent advancements in glucose sensing and smart insulin pens have spurred the development of decision support systems (DSSs) to optimize insulin dosing for people with T1D on multiple daily injections (MDI). We developed the iBolus DSS, composed of a mobile app and a model-based dose titration algorithm that provides adaptive basal and bolus recommendations. We aimed to assess the effectiveness of our iBolus DSS in adults with suboptimal glucose control.
Methods: We conducted a 12-week outpatient, randomized, controlled, parallel trial in adults with T1D on insulin monotherapy and baseline HbA1c of ≥ 7.5%. Participants were randomized in a 1:1 ratio and stratified according to previous sensor usage to either use the iBolus DSS or a non-adaptive bolus calculator app (control). The iBolus DSS automatically adjusted participants’ basal and bolus doses weekly, while the control group adhered to standard care practices for dose adjustments. During the interventions, participants used flash glucose monitoring (FGM) with Freestyle Libre 1. The pre-defined primary endpoint was the change in HbA1c from baseline.
Results: The study enrolled 84 participants (44% females; HbA1c 8.6±1.1%; age 38±12 years; diabetes duration 22±12 years; 61% used carbohydrate counting). The iBolus DSS reduced mean HbA1c from 8.6% to 8.1% while the control intervention reduced HbA1c from 8.6% to 8.5%; a treatment effect in favor of the DSS of -0.40% (95% CI: -0.75 to -0.051; p=0.025). The proportion of participants with improvements in HbA1c of > 0.5%, >1.0%, > 1.5%, and > 2.0% were almost doubled in the DSS arm compared to the control arm (52%, 19%, 12%, and 5% vs. 31%, 10%, 5%, and 0%, respectively). Differences in FGM outcomes were not statistically significant. There were no cases of severe hypoglycemia or diabetic ketoacidosis in either group.
Conclusion: Our iBolus DSS significantly improves HbA1c in adults with suboptimal glucose control on MDI therapy.
A. Kobayati: None. A. El Fathi: None. N. Garfield: None. L. Legault: Advisory Panel; Abbott, Novo Nordisk. Speaker's Bureau; Novo Nordisk. Advisory Panel; Dexcom, Inc. J. Yale: Speaker's Bureau; Novo Nordisk Canada Inc., Abbott, Eli Lilly and Company. Advisory Panel; Novo Nordisk Canada Inc., Bayer Inc. Speaker's Bureau; Insulet Corporation. Advisory Panel; Eli Lilly and Company. Speaker's Bureau; Dexcom, Inc., Sanofi, Janssen Pharmaceuticals, Inc. Advisory Panel; Boehringer-Ingelheim, Mylan. Speaker's Bureau; Bayer Inc. Advisory Panel; Sanofi. Speaker's Bureau; Merck & Co., Inc. Research Support; Bayer Inc., Novartis Canada, Novo Nordisk Canada Inc. M. Tsoukas: Speaker's Bureau; Novo Nordisk, Eli Lilly and Company, Boehringer-Ingelheim, Janssen Pharmaceuticals, Inc., AstraZeneca, Sanofi, Bausch Health, Abbott. A. Haidar: Consultant; Eli Lilly and Company. Other Relationship; Bigfoot Biomedical, Inc. Research Support; ADOCIA, Tandem Diabetes Care, Inc., Dexcom, Inc., Ypsomed AG.
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