Academic Journal
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).
| Τίτλος: | 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). |
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| Συγγραφείς: | Ruiz Gracia T; Department of Endocrinology and Nutrition, Hospital Universitario Ramón y Cajal, Madrid, Spain., Nattero-Chávez L; Department of Endocrinology and Nutrition, Hospital Universitario Ramón y Cajal, Madrid, Spain; Diabetes, Obesity & Human Reproduction Research Group, Instituto Ramón y Cajal de Investigación Sanitaria (IRYCIS) & Centro de Investigación Biomédica en Red de Diabetes y Enfermedades Metabólicas Asociadas (CIBERDEM), Madrid, Spain. Electronic address: marialia.nattero@salud.madrid.org., Arranz Martín A; Department of Endocrinology and Nutrition, Hospital Universitario La Princesa, Madrid, Spain., de la Calle de la Villa E; Department of Endocrinology and Nutrition, Hospital Universitario Ramón y Cajal, Madrid, Spain., Lorenzo Moñino M; Department of Endocrinology and Nutrition, Hospital Universitario Ramón y Cajal, Madrid, Spain., Bayona Cebada A; Department of Endocrinology and Nutrition, Hospital Universitario Ramón y Cajal, Madrid, Spain; Diabetes, Obesity & Human Reproduction Research Group, Instituto Ramón y Cajal de Investigación Sanitaria (IRYCIS) & Centro de Investigación Biomédica en Red de Diabetes y Enfermedades Metabólicas Asociadas (CIBERDEM), Madrid, Spain., Corral MI; Department of Endocrinology and Nutrition, Hospital Universitario Ramón y Cajal, Madrid, Spain., Quintero Tobar A; Department of Endocrinology and Nutrition, Hospital Universitario Ramón y Cajal, Madrid, Spain; Diabetes, Obesity & Human Reproduction Research Group, Instituto Ramón y Cajal de Investigación Sanitaria (IRYCIS) & Centro de Investigación Biomédica en Red de Diabetes y Enfermedades Metabólicas Asociadas (CIBERDEM), Madrid, Spain., Lahera Vargas M; Department of Endocrinology and Nutrition, Hospital Universitario La Princesa, Madrid, Spain., Jiménez Blanco S; Department of Endocrinology and Nutrition, Hospital Universitario La Princesa, Madrid, Spain., Justel Enríquez A; Department of Endocrinology and Nutrition, Hospital Universitario La Princesa, Madrid, Spain., Muriel A; Department of Clinical Biostatistics, Hospital Universitario Ramón y Cajal, Madrid, Spain; Centro de Investigación Biomédica en Red de Epidemiología y Salud Pública (CIBERESP), Madrid, Spain., de Lope S; Department of Endocrinology and Nutrition, Hospital Universitario Ramón y Cajal, Madrid, Spain; Diabetes, Obesity & Human Reproduction Research Group, Instituto Ramón y Cajal de Investigación Sanitaria (IRYCIS) & Centro de Investigación Biomédica en Red de Diabetes y Enfermedades Metabólicas Asociadas (CIBERDEM), Madrid, Spain., Luque-Ramírez M; Department of Endocrinology and Nutrition, Hospital Universitario Ramón y Cajal, Madrid, Spain; Diabetes, Obesity & Human Reproduction Research Group, Instituto Ramón y Cajal de Investigación Sanitaria (IRYCIS) & Centro de Investigación Biomédica en Red de Diabetes y Enfermedades Metabólicas Asociadas (CIBERDEM), Madrid, Spain., Escobar-Morreale HF; Department of Endocrinology and Nutrition, Hospital Universitario Ramón y Cajal, Madrid, Spain; Diabetes, Obesity & Human Reproduction Research Group, Instituto Ramón y Cajal de Investigación Sanitaria (IRYCIS) & Centro de Investigación Biomédica en Red de Diabetes y Enfermedades Metabólicas Asociadas (CIBERDEM), Madrid, Spain. |
| Πηγή: | Diabetes research and clinical practice [Diabetes Res Clin Pract] 2026 Sep; Vol. 239, pp. 113505. Date of Electronic Publication: 2026 Aug 18. |
| Τύπος έκδοσης: | Journal Article; Randomized Controlled Trial; Comparative Study |
| Γλώσσα: | English |
| Στοιχεία περιοδικού: | Publisher: Elsevier Scientific Publishers Country of Publication: Ireland NLM ID: 8508335 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1872-8227 (Electronic) Linking ISSN: 01688227 NLM ISO Abbreviation: Diabetes Res Clin Pract Subsets: MEDLINE |
| Imprint Name(s): | Publication: 1993- : Limerick : Elsevier Scientific Publishers Original Publication: Amsterdam : Elsevier Science Publishers B.V., c1985- |
| Ιατρικοί όροι (MeSH): | Diabetes Mellitus, Type 1*/drug therapy , Diabetes Mellitus, Type 1*/blood , Glycemic Control*/instrumentation , Glycemic Control*/methods , Hypoglycemic Agents*/administration & dosage , Insulin*/administration & dosage , Insulin*/therapeutic use , Insulin Infusion Systems* , Patient Reported Outcome Measures*, Blood Glucose/analysis ; Glycated Hemoglobin/analysis ; Adult ; Female ; Humans ; Male ; Middle Aged ; Blood Glucose Self-Monitoring ; Cross-Over Studies ; Treatment Outcome |
| Περίληψη: | 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 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. (Copyright © 2026 Elsevier B.V. All rights reserved.) |
| Competing Interests: | Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Teresa Ruiz Gracia reports a relationship with AstraZeneca Pharmaceuticals LP that includes: speaking and lecture fees. Teresa Ruiz Gracia reports a relationship with Medtronic that includes: speaking and lecture fees. Teresa Ruiz Gracia reports a relationship with Novo Nordisk Pharmaceuticals SA that includes: speaking and lecture fees. Teresa Ruiz Gracia reports a relationship with Sanofi-Aventis US LLC that includes: speaking and lecture fees. Lia Nattero Chavez reports a relationship with Eli Lilly and Company that includes: consulting or advisory, funding grants, and speaking and lecture fees. Lia Nattero Chavez reports a relationship with Medtronic that includes: consulting or advisory, funding grants, and speaking and lecture fees. Lia Nattero Chavez reports a relationship with Roche Diabetes Care Inc that includes: consulting or advisory, funding grants, and speaking and lecture fees. Lia Nattero Chavez reports a relationship with Sanofi Aventis SA that includes: consulting or advisory, funding grants, and speaking and lecture fees. Lia Nattero Chavez reports a relationship with Abbott Laboratories Inc that includes: consulting or advisory and speaking and lecture fees. Lia Nattero Chavez reports a relationship with Dexcom that includes: consulting or advisory and speaking and lecture fees. Lia Nattero Chavez reports a relationship with Camdiab that includes: consulting or advisory. Lia Nattero Chavez reports a relationship with Insulet Corporation that includes: consulting or advisory and speaking and lecture fees. Lia Nattero Chavez reports a relationship with Novo Nordisk Inc that includes: speaking and lecture fees. Lia Nattero Chavez reports a relationship with Air Liquide SA that includes: speaking and lecture fees. Lia Nattero Chavez reports a relationship with Diamyd Medical AB that includes: funding grants. Mar Lorenzo Monino reports a relationship with Medtronic Inc that includes: speaking and lecture fees. If there are other authors, they declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. |
| Contributed Indexing: | Keywords: Automated insulin delivery; Continuous glucose monitoring; Crossover trial; Patient-reported outcomes; Smart insulin pen; Type 1 diabetes |
| Substance Nomenclature: | 0 (Blood Glucose) 0 (Glycated Hemoglobin) 0 (hemoglobin A1c protein, human) 0 (Hypoglycemic Agents) 0 (Insulin) |
| Entry Date(s): | Date Created: 20260818 Date Completed: 20260829 Latest Revision: 20260909 |
| Update Code: | 20260909 |
| DOI: | 10.1016/j.diabres.2026.113505 |
| PMID: | 42612915 |
| Βάση Δεδομένων: | MEDLINE |
| ISSN: | 1872-8227 |
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| DOI: | 10.1016/j.diabres.2026.113505 |