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We aimed to assess whether a connected insulin pen cap improves glycaemic management compared with an otherwise identical non-connected cap.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>\n                      We conducted an investigator-initiated, randomised, open-label, parallel-group trial in a European public hospital over 8 weeks. Adults with type 1 diabetes treated with multiple daily injections and who had suboptimal glycaemic management (baseline time above range [&gt;10.0 mmol\/l, &gt;180 mg\/dl] &gt;25%) were randomly assigned (1:1) to a connected pen cap (Insulclock\u00a02.0; Insulcloud, Madrid, Spain) or an identical cap for which the Bluetooth connectivity had been disabled (disconnected). Allocation was performed using opaque sealed envelopes, and no masking was applied. The primary outcome was time above range, with two thresholds (&gt;10.0 mmol\/l, &gt;180 mg\/dl and &gt;13.9 mmol\/l, &gt;250 mg\/dl) based on intermittently scanned CGM downloads. Analyses followed the intention-to-treat principle, using longitudinal mixed models and multiple imputation. Secondary outcomes included time in range, glycaemic variability (standard deviation and coefficient of variation), HbA\n                      <jats:sub>1c<\/jats:sub>\n                      and patient-reported outcomes (fear of hypoglycaemia).\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      Forty-two participants were randomised for inclusion in the study (21 per group: 25 women, 17 men). One withdrew before baseline, leaving 41 in the intention-to-treat analysis. Compared with the control group, the connected-cap group had lower time above range &gt;13.9 mmol\/l (mean difference \u22124.8 percentage points; 95% CI \u22129.5, \u22120.1;\n                      <jats:italic>p<\/jats:italic>\n                      =0.045) and reduced glucose standard deviation (\u22120.35 mmol\/l; 95% CI \u22120.64, \u22120.06;\n                      <jats:italic>p<\/jats:italic>\n                      =0.018). HbA\n                      <jats:sub>1c<\/jats:sub>\n                      showed a borderline reduction of \u22123.5 mmol\/mol (\u22120.32%) (95% CI \u22127.1, 0.0 mmol\/mol; \u22120.65, 0.00%;\n                      <jats:italic>p<\/jats:italic>\n                      =0.050). Per-protocol analyses suggested an 8% absolute increase in time in range among adherent users. No adverse events or device-related serious adverse events occurred. No between-group differences were observed in avoidance behaviours based on the hypoglycaemia fear survey significantly decreased in the treatment group (\u03b2=\u22122.44; 95% CI \u22124.45, \u22120.43;\n                      <jats:italic>p<\/jats:italic>\n                      =0.019).\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions\/interpretation<\/jats:title>\n                    <jats:p>In routine clinical care, use of a connected pen cap reduced severe hyperglycaemia, glycaemic variability and hypoglycaemia avoidance behaviours in adults with type 1 diabetes and suboptimal glycaemic management. These findings support the integration of low-burden, data-driven tools into public diabetes care. Larger and longer trials should evaluate the durability and cost-effectiveness of these interventions.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration<\/jats:title>\n                    <jats:p>ClinicalTrials.gov NCT06845891<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Funding<\/jats:title>\n                    <jats:p>Investigator-initiated study without industry funding; devices were procured by the hospital. Funders had no role in study design, conduct, analysis or reporting<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1007\/s00125-026-06674-w","type":"journal-article","created":{"date-parts":[[2026,2,3]],"date-time":"2026-02-03T20:46:00Z","timestamp":1770151560000},"page":"1191-1204","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":3,"title":["Analysis of glycaemic control with a connected smart pen cap in adults with type 1 diabetes: a randomised, open-label, parallel-group trial"],"prefix":"10.1007","volume":"69","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-4127-0483","authenticated-orcid":false,"given":"Fernando","family":"Sebastian-Valles","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0007-9737-2845","authenticated-orcid":false,"given":"Carolina","family":"Sager-La Ganga","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alicia","family":"Justel Enriquez","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sara","family":"Jimenez Blanco","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"V\u00edctor","family":"Navas-Moreno","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jose Alfonso","family":"Arranz Martin","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"M\u00f3nica","family":"Marazuela","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2026,2,3]]},"reference":[{"issue":"1","key":"6674_CR1","doi-asserted-by":"publisher","first-page":"61","DOI":"10.1111\/imj.15426","volume":"53","author":"DJ Holmes-Walker","year":"2023","unstructured":"Holmes-Walker DJ, Abraham MB, Chee M et al (2023) Glycaemic outcomes in Australasian children and adults with type 1 diabetes: failure to meet targets across the age spectrum. 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The electronic supplementary material was also corrected.","order":7,"name":"change_details","label":"Change Details","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"2 July 2026","order":8,"name":"change_date","label":"Change Date","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"Correction","order":9,"name":"change_type","label":"Change Type","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"A Correction to this paper has been published:","order":10,"name":"change_details","label":"Change Details","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"https:\/\/doi.org\/10.1007\/s00125-026-06786-3","URL":"https:\/\/doi.org\/10.1007\/s00125-026-06786-3","order":11,"name":"change_details","label":"Change Details","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"The authors acknowledge the Spanish Society of Diabetes (Sociedad Espa\u00f1ola de Diabetes) for its decisive support of this project through the \u2018XV Ayudas SED a Proyectos de Investigaci\u00f3n en Diabetes Dirigidos por J\u00f3venes Investigadores\u2019.","order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Acknowledgements"}},{"value":"Data sharing of de-identified participant data will be considered upon reasonable request after approval of a protocol and signing of a data transfer agreement with the corresponding author after publication of all secondary outcomes of this trial. Related documents are available from the corresponding author.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Data availability"}},{"value":"Open Access funding provided thanks to the CRUE-CSIC agreement with Springer Nature. This work was funded by the Proyectos de Investigaci\u00f3n en Salud PI19\/00584, PI22\/01404, and PMP22\/00021 (funded by the Instituto de Salud Carlos III) and iTIRONET-P2022\/BMD7379 (funded by the Comunidad de Madrid), and co-financed using funds provided to MM by the European Regional Development Fund (ERDF). The funders had no role in the study design, data collection, data analysis, data interpretation or writing of the report.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Funding"}},{"value":"The authors declare that none of them received financial support, payments or benefits from the manufacturer of the smart cap device. All potential competing interests unrelated to the present work are detailed below. FS-V has received congress registration fees and travel support from Menarini, Novo Nordisk, Lilly, Insulcloud and Abbott, with no personal payments. CS-LG has received congress registration fees and travel support from Novo Nordisk, Lilly, Abbott, Fresenius and Sanofi, with no personal payments. AJE has received honoraria for presentations or manuscript preparation from Abbott, Ambos, AstraZeneca, Boehringer, Clover SGM SL, Echosens, Fresenius, FSEEN, Fundesalud, K ACCESS, Lilly SAU, Nestl\u00e9, Novo Nordisk, Nutricia, Outcomes\u201910 SLU, Persei Vivarium SL, Prof\u00e1rmaco 2-SL, Sanidad y Ediciones SL, Sanofi, Sendimad, and You & Us SA. She has also received congress registration fees and travel support from Medtronic-IQVIA, Novo Nordisk, Lilly and Fresenius, with no personal payments. SJ-B has received honoraria for lectures from Menarini, Sanofi and Novo Nordisk. She has also received support for congress attendance from Novo Nordisk, Lilly and Sanofi (registration, transportation and accommodation; no direct payments). She also declares receiving educational collaboration and free drug samples from Novo Nordisk, Bayer, Lilly and Menarini (no personal payments). VN-M has received honoraria from Novo Nordisk for presentations and from Nestl\u00e9 Health Science, Nutricia and Fresenius Kabi for expert surveys. He has also received congress registration fees and travel support from Menarini, Novo Nordisk, Lilly, Dexcom and Abbott Nutrition, with no personal payments. JAAM has received congress registration fees and travel support from Menarini, Novo Nordisk, Lilly, Novalab, Abbott and Dexcom, with no personal payments. MM has received congress registration fees and travel support from Ascendis and Pfizer, and serves on advisory boards for Lundbeck and Amgen (not related to the present manuscript). The authors declare that there are no other relationships or activities that might bias, or be perceived to bias, their work.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Authors\u2019 relationships and activities"}},{"value":"FS-V and CS-LG substantially contributed to the conception and design of the study. FS-V, CS-LG, AJE, SJB, VN-M and JAAM were responsible for the acquisition of data. FS-V performed the statistical analyses. FS-V, CS-LG and MM contributed to the analysis and interpretation of the data. FS-V drafted the first version of the manuscript. CS-LG, AJE, SJB, VN-M, JAAM and MM critically revised the manuscript for important intellectual content. All authors approved the final version of the manuscript to be published and agree to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved. FS-V and CS-LG are the guarantors of this work and, as such, had full access to all the data in the study, take responsibility for the integrity of the data and the accuracy of the data analysis, and had final responsibility for the decision to submit for publication.","order":5,"name":"Ethics","group":{"name":"EthicsHeading","label":"Contribution statement"}}]}}