Cited by 0Diabetes Management and ResearchDiabetes Management and EducationDiabetes and associated disorders

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)

Ruiz Gracia, Teresa, Nattero-Chávez, Lía, Arranz Martín, Alfonso, de la Calle de la Villa, Esther, Lorenzo Moñino, Mar, Bayona Cebada, Ane, Corral, María Isabel, Quintero Tobar, Alejandra +7 more·2026·Diabetes Research and Clinical Practice

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.

Integrity signals

Registry

Crossref · 10.1016/j.diabres.2026.113505

Cites

32 of 32 references verified0 citation errors · 0 not checkable

Statistics

Recomputing p-values needs the paper’s full text.

Claims the paper makes

This paper’s full text isn’t openly available, so its claims and self-check weren’t run. The registry and citation checks still apply.

Cites

Flagged first, then by citations

Cited by

Still being checked.

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)
Venue
Diabetes Research and Clinical Practice
Publisher
Elsevier BV
Published
2026-09
Volume
239
Pages
113505
ISSN
0168-8227 (ISSN-L)
OpenAlex
W7203702441
Cited by
0
References
32
FWCI
0.00
Type
journal article
Language
en
Open access
closed
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

About these checks

Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.

Statistics and arithmetic are recomputed, not judged.

Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.

What counts as a claim ›How we measure confidence ›How we check this ›

Are you an author, or do you see a problem with this page? Request a review