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PubMed · 42612915

Technology choice, glycemic control and patient-reported outcome measures in adults with type 1 diabetes: A randomized crossover trial comparing a smart insulin pen with an automated insulin delivery system (EBIACE-1).

Teresa Ruiz Gracia·Lía Nattero-Chávez·Alfonso Arranz Martín·Esther de la Calle de la Villa·Mar Lorenzo Moñino·Ane Bayona Cebada·María Isabel Corral·Alejandra Quintero Tobar·Marcos Lahera Vargas·Sara Jiménez Blanco·Alicia Justel Enríquez·Alfonso Muriel·Sara de Lope·Manuel Luque-Ramírez·Héctor F Escobar-Morreale
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Abstract

AIMS: To compare glycemic outcomes and patient-reported outcome measures (PROMs) between smart insulin pens (SIP) and an automated insulin delivery (AID) system in adults with type 1 diabetes (T1D), and to identify individuals able to maintain near-optimal glycemic control using SIP. METHODS: EBIACE-1 was a randomized, open-label, crossover trial including 31 adults with T1D. Participants received SIP (InPen&#x2122;) and AID (MiniMed&#x2122; 780G) for 6&#xa0;months each. Co-primary outcomes were time in range (TIR 70-180 mg/dL) and HbA1c. Treatment effects were assessed using longitudinal models in intention-to-treat (ITT) and per-protocol (PP) analyses. Predictors of near-optimal glycemic control with SIP were evaluated using multivariable logistic regression. RESULTS: AID improved glycemic control versus SIP, with higher TIR (81&#xa0;% vs 66&#xa0;%; +15&#xa0;%, 95&#xa0;% CI 10-19; P&#xa0;<&#xa0;0.001) and lower HbA1c (6.9&#xa0;% [52&#xa0;mmol/mol] vs 7.3&#xa0;% [56&#xa0;mmol/mol]; -0.4&#xa0;%, 95&#xa0;% CI&#xa0;-&#xa0;0.6 to&#xa0;-&#xa0;0.3; P&#xa0;<&#xa0;0.001). Near-optimal glycemic control with SIP was achieved by 12 of 26 participants (46&#xa0;%). In exploratory analyses, higher baseline diabetes-related life interference was associated with a lower probability of achieving this outcome. CONCLUSIONS: AID provides superior glycemic control, although nearly half of participants achieved near-optimal control with SIP, supporting a personalized approach to technology selection.

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AdultFemaleHumansMaleMiddle AgedBlood GlucoseBlood Glucose Self-MonitoringCross-Over StudiesDiabetes Mellitus, Type 1Glycated HemoglobinGlycemic ControlHypoglycemic AgentsInsulinInsulin Infusion SystemsPatient Reported Outcome MeasuresTreatment OutcomeAutomated insulin deliveryContinuous glucose monitoringCrossover trialPatient-reported outcomesSmart insulin penType 1 diabetesJournal ArticleRandomized Controlled TrialComparative Study

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Teresa Ruiz Gracia, L&#xed;a Nattero-Ch&#xe1;vez, Alfonso Arranz Mart&#xed;n, Esther de la Calle de la Villa, Mar Lorenzo Mo&#xf1;ino, Ane Bayona Cebada, Mar&#xed;a Isabel Corral, Alejandra Quintero Tobar, Marcos Lahera Vargas, Sara Jim&#xe9;nez Blanco, Alicia Justel Enr&#xed;quez, Alfonso Muriel, Sara de Lope, Manuel Luque-Ram&#xed;rez, H&#xe9;ctor F Escobar-Morreale. 2026-08-18. Technology choice, glycemic control and patient-reported outcome measures in adults with type 1 diabetes: A randomized crossover trial comparing a smart insulin pen with an automated insulin delivery system (EBIACE-1).. https://doi.org/10.1016/j.diabres.2026.113505

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Journal Article; Randomized Controlled Trial; Comparative Study resourceAdult subjectBlood Glucose subjectComparative Study subjectContinuous Glucose Monitoring subjectCross-Over Studies subjectFemale subjectHumans subjectJournal Article subjectMale subjectMiddle Aged subjectRandomized controlled trials study

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