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)
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™) and AID (MiniMed™ 780G) for 6 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 % vs 66 %; +15 %, 95 % CI 10-19; P < 0.001) and lower HbA1c (6.9 % [52 mmol/mol] vs 7.3 % [56 mmol/mol]; -0.4 %, 95 % CI - 0.6 to - 0.3; P < 0.001). Near-optimal glycemic control with SIP was achieved by 12 of 26 participants (46 %). 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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- Authors
- Ruiz Gracia, T., Nattero-Chávez, L., Arranz Martín, A., de la Calle de la Villa, E., Lorenzo Moñino, M., Bayona Cebada, A., Corral, M. I., Quintero Tobar, A., Lahera Vargas, M., Jiménez Blanco, S., Justel Enríquez, A., Muriel, A., de Lope, S., Luque-Ramírez, M., & Escobar-Morreale, H. F.
- Affiliations
- Centro de Investigación Biomédica en Red de Epidemiología y Salud Pública (ES)
- Centro de Investigación Biomédica en Red Diabetes y Enfermedades Metabólicas Asociadas (ES)
- ORCID
- Venue
- Diabetes Research and Clinical Practice
- Publisher
- Elsevier BV
- Published
- 2026-09
- Volume
- 239
- Pages
- 113505
- ISSN
- 0168-8227 (ISSN-L)
- OpenAlex
- W7203702441
- Semantic Scholar
- 92d9e6c661975e7d59859cbf000e778f1bf5afe8
- Cited by
- 0
- References
- 32
- FWCI
- 0.00
- Type
- journal article
- Language
- en
- Open access
- closed
- Licence
- Locations
- Diabetes Research and Clinical Practice (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Education
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Genetics › Diabetes and associated disorders
- Keywords
- type 1 diabetes, smart insulin pens, artificial pancreas, glycemic control, patient-reported outcome measures, HbA1c, time in range, adults with type 1 diabetes
- MeSH terms
- Patient Reported Outcome Measures, Glycemic Control, Adult, Blood Glucose, Diabetes Mellitus, Type 1, Female, Glycated Hemoglobin, Humans, Hypoglycemic Agents, Insulin, Insulin Infusion Systems, Male, Middle Aged, Blood Glucose Self-Monitoring, Treatment Outcome, Cross-Over Studies
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