Efficacy of a connected insulin pen cap in people with noncontrolled type 1 diabetes: a multicenter randomized clinical trial
Open accessAbstract
OBJECTIVE: To assess the efficacy of the insulin pen cap Insulclock on improving glycemic control, treatment adherence, and user satisfaction in people with type 1 diabetes. RESEARCH DESIGN AND METHODS: This multicenter, open-label, randomized controlled trial comprised a 4-week run-in phase and a 6-week double-arm phase in which participants were randomly assigned into an active or masked mode. RESULTS: Fifty-five participants were evaluable (active group, n = 26, masked group, n = 29). The increase in time in range was higher in the active versus masked group (5.2% vs. −0.8%; P = 0.016). The active group showed a higher reduction in mean glucose, glucose management indicator, time above range, and high blood glucose index. On-time insulin doses increased in the active group and decreased in the masked group. CONCLUSIONS: Insulclock system use was associated with improved glycemic control, glycemic variability, hyperglycemia risk, and treatment adherence in people with uncontrolled type 1 diabetes.
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In a multicenter randomized controlled trial in people with type 1 diabetes, use of an insulin pen cap was associated with improved glycemic outcomes at 6 weeks, with an increase in time in range and a decrease in GMI and time above range.
“In a multicenter RCT in people with type 1 diabetes, the use of an insulin pen cap was associated with improved glycemic outcomes at 6 weeks in the insulin cap group, with an increase in TIR and decrease in GMI and TAR (154).”
From 7. Diabetes Technology: Standards of Care in Diabetes—2025 (2025) · cites this paper as [154]
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Battelino, T., Danne, T., Bergenstal, R. M., Amiel, S. A., Beck, R., Biester, T., Bosi, E., Buckingham, B. A., Cefalu, W. T., Close, K. L., et al. (2019) · Diabetes Care · doi:10.2337/dci19-0028 · Cited by 4,032 · cited 1× · see citing works
“0 mmol/L) (2) (primary objective), glucose management indicator (GMI), time above range (TAR), time below range, mean amplitude of glycemic excursions, SD, coefficient of variation, high blood glucose index (HGBI), and low blood glucose index.”
BackgroundThe relationships between time in range, hyperglycemia metrics, and HbA1c
Beck, R. W., Bergenstal, R. M., Cheng, P., Kollman, C., Carlson, A. L., Johnson, M. L., & Rodbard, D. (2019) · Journal of Diabetes Science and Technology · doi:10.1177/1932296818822496 · Cited by 479 · see citing works
Adolfsson, P., Hartvig, N. V., Kaas, A., Møller, J. B., & Hellman, J. (2020) · Diabetes Technology & Therapeutics · doi:10.1089/dia.2019.0411 · Cited by 139 · see citing works
Harvey, R. A., Dassau, E., Zisser, H., Seborg, D. E., & Doyle, F. J. (2014) · Journal of Diabetes Science and Technology · doi:10.1177/1932296814523881 · Cited by 68 · see citing works
<i>Insulclock</i> : A Novel Insulin Delivery Optimization and Tracking System
Gomez-Peralta, F., Abreu, C., Gomez-Rodriguez, S., & Ruiz, L. (2019) · Diabetes Technology & Therapeutics · doi:10.1089/dia.2018.0361 · Cited by 30 · see citing works
Self-citationGomez-Peralta, F., Abreu, C., Gomez-Rodriguez, S., Cruz-Bravo, M., María-Sanchez, C., Poza, G., & Ruiz-Valdepeñas, L. (2020) · Diabetes Technology & Therapeutics · doi:10.1089/dia.2019.0427 · Cited by 25 · see citing works
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7. Diabetes Technology: Standards of Care in Diabetes—2025
American Diabetes Association Professional Practice Committee, ElSayed, N. A., McCoy, R. G., Aleppo, G., Balapattabi, K., Beverly, E. A., Briggs Early, K., Bruemmer, D., Echouffo-Tcheugui, J. B., Ekhlaspour, L., et al. (2025) · Diabetes Care · doi:10.2337/dc25-s007 · Cited by 348 · see citing works
7. Diabetes Technology: Standards of Care in Diabetes—2026
Bajaj, M. S., McCoy, R. G., Balapattabi, K., Bannuru, R. R., Bellini, N. J., Bennett, A. K., Beverly, E. A., Early, K. B., ChallaSivaKanaka, S., Echouffo-Tcheugui, J. B., et al. (2025) · Diabetes Care · doi:10.2337/dc26-s007 · Cited by 194 · see citing works
Biester, T., Berget, C., Boughton, C. K., Cudizio, L., Ekhlaspour, L., Hilliard, M. E., Reddy, L., Sap, S. N. U., Schoelwer, M. J., Sherr, J. L., et al. (2024) · Hormone Research in Paediatrics · doi:10.1159/000543034 · Cited by 110 · see citing works
Danne, T. P. A., Joubert, M., Hartvig, N. V., Kaas, A., Knudsen, N. N., & Mader, J. K. (2024) · Diabetes Care · doi:10.2337/dc23-2176 · Cited by 42 · see citing works
Kang, S., Kang, S. M., Choi, J. H., Ko, S., Koo, B. K., Kwon, H.-S., Kim, M. K., Kim, S. Y., Kim, S., Kim, Y., et al. (2025) · Diabetes & Metabolism Journal · doi:10.4093/dmj.2025.0469 · Cited by 42 · see citing works
Use of diabetes technology in children
Schoelwer, M. J., DeBoer, M. D., & Breton, M. D. (2024) · Diabetologia · doi:10.1007/s00125-024-06218-0 · Cited by 25 · see citing works
Pérez, C. T., Chico, A. I., Azriel-Mira, S., Lardiés‐Sánchez, B., Peralta, F. G., de Diabetes-SEEN, T. Á., Jesús, A. F. A., Rodrigo, A. B., Bellido, V., Bellido-Guerrero, D., et al. (2023) · Diabetes Therapy · doi:10.1007/s13300-023-01417-1 · Cited by 21 · see citing works
Hellman, J., Hartvig, N. V., Kaas, A., Møller, J. B., Sørensen, M. R., & JENDLE, J. H. (2023) · Diabetes Obesity and Metabolism · doi:10.1111/dom.15316 · Cited by 18 · see citing works
First real-world experience with bigfoot unity: a 6-month retrospective analysis
Baliga, B. S., Tillman, J. B., Olson, B., Vaughan, S., Sheikh, F. N., & Malone, J. K. (2023) · Clinical Diabetes · doi:10.2337/cd22-0126 · Cited by 15 · see citing works
Gomez-Peralta, F., Abreu, C., Santos, E., Da Silva, A., San Frutos, A., Vega-Valderrama, L., García-Galindo, M., Franco-López, A., López Mardomingo, C., Cañuelo, B., et al. (2025) · Diabetes Technology & Therapeutics · doi:10.1089/dia.2024.0356 · Cited by 11 · see citing works
Self-citationPeralta, F. G., Valledor, X., Picado, A. L., Abreu, C., Fernández-Rubio, E., Cotovad, L., Pujante, P., García-Fernández, E., Azriel, S., Corcoy, R., et al. (2023) · Diabetes Technology & Therapeutics · doi:10.1089/dia.2023.0321 · Cited by 11 · see citing works
Self-citationSebastián‐Valles, F., Alfonso, J. M., Martín, J. A. A., Jiménez‐Díaz, J., Alday, I. H., Navas-Moreno, V., Joya, T. A., García, M. D. M. F., Gómez, G. L. R., Hierro, J. G., et al. (2024) · Acta Diabetologica · doi:10.1007/s00592-024-02347-5 · Cited by 11 · see citing works
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Heinemann, L., Sieber, J., & Kulzer, B. (2024) · Journal of Diabetes Science and Technology · doi:10.1177/19322968241274796 · Cited by 7 · see citing works
Wolpert, H. A., Rodbard, D., Xue, J., Johnson, J. L., & Dassau, E. (2025) · Diabetes Obesity and Metabolism · doi:10.1111/dom.16249 · Cited by 7 · see citing works
Laurenzi, A., Shannon, N., Adolfsson, P., Piazza, F. D., Voelker, B., IM, G. H., van den Heuvel, T. R. A., & Cohen, O. (2025) · Diabetic Medicine · doi:10.1111/dme.70161 · Cited by 5 · see citing works
Jawad, M., Afaq, S., Hussain, S., Jamal, S. F., Haq, Z., Hussain, A., Rehman, A., Khan, S., & Almuradi, M. A. A. (2025) · BMC Endocrine Disorders · doi:10.1186/s12902-025-02100-1 · Cited by 3 · see citing works
Adolfsson, P., Guerci, B., Hartvig, N. V., Kaas, A., Knudsen, N., & Mader, J. K. (2025) · Diabetes Obesity and Metabolism · doi:10.1111/dom.70051 · Cited by 3 · see citing works
Beyond glycemic metrics: Real-world benefits of connected insulin pens in type 1 diabetes
Chico, A. I., Pazos-Couselo, M., Nattero‐Chávez, L., Simó‐Servat, O., Durán-Martinez, M., Ugarte, E., Aguilera, E., Andía, V., Moreno-Fernández, J., Granados, M., et al. (2025) · Diabetes Research and Clinical Practice · doi:10.1016/j.diabres.2025.112377 · Cited by 2 · see citing works
Self-citationSebastián‐Valles, F., Ganga, C. S. L., Enríquez, A. J., Blanco, S. J., Navas-Moreno, V., Martín, J. A. A., & Marazuela, M. (2026) · Diabetologia · doi:10.1007/s00125-026-06674-w · Cited by 2 · see citing works
McGill, J. B., Donihi, A. C., Aktürk, H. K., Freeby, M., Gupta, A., Horton, W. B., Jadoon, M. N., Lathief, S., Miracle-López, S., Tan, C., et al. (2026) · Endocrine Practice · doi:10.1016/j.eprac.2026.06.011 · Cited by 2 · see citing works
Effect of Christmas Holidays on Type 1 Diabetes Mellitus in Users of Glucose Flash Systems
Sebastián‐Valles, F., Martín, J. A. A., Alfonso, J. M., Jiménez‐Díaz, J., Alday, I. H., Navas-Moreno, V., Joya, T. A., García, M. D. M. F., Gómez, G. L. R., Hierro, J. G., et al. (2024) · Endocrine Practice · doi:10.1016/j.eprac.2024.01.011 · Cited by 4 · see citing works
Tillman, J. B., Beck, R. W., Polonsky, W. H., Calhoun, P., Mouse, T., Bailey, R., Jacoby, J., Nandan, R., Sheikh, F. N., & Malone, J. K. (2025) · The Journal of Clinical Endocrinology & Metabolism · doi:10.1210/clinem/dgae778 · Cited by 1 · see citing works
Trends in the industry of clinical trials
Milovanov, S. S., Popov, V. V., & Teplova, N. V. (2024) · FARMAKOEKONOMIKA Modern Pharmacoeconomics and Pharmacoepidemiology · doi:10.17749/2070-4909/farmakoekonomika.2024.257 · Cited by 1 · see citing works
Revolutionizing the management of diabetes: The promise of connected insulin pens and caps
Peralta, F. G., & Abreu, C. (2024) · Endocrinología Diabetes y Nutrición · doi:10.1016/j.endinu.2024.04.003 · Cited by 1 · see citing works
Self-citationUpdate on recent advances in technology in type 1 diabetes
Aslam, A. A., Thabit, H., & Leelarathna, L. (2024) · British Journal of Diabetes · doi:10.15277/bjd.2024.440 · Cited by 1 · see citing works
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Joubert, M., & Bekka, S. (2023) · Médecine des Maladies Métaboliques · doi:10.1016/s1957-2557(23)00075-5
Peralta, F. G., Valledor, X., Abreu, C., Fernández-Rubio, E., Cotovad, L., Pujante, P., Azriel, S., Pérez-González, J., Vallejo, A., Ruiz-Valdepeñas, L., et al. (2024) · Biomedicines · doi:10.3390/biomedicines12071600
Self-citationRevolutionizing the management of diabetes: The promise of connected insulin pens and caps
Peralta, F. G., & Abreu, C. (2024) · Endocrinología Diabetes y Nutrición (English ed ) · doi:10.1016/j.endien.2024.04.005
Self-citationVarma, M., & Campbell, D. J. T. (2024) · Evidence-Based Nursing · doi:10.1136/ebnurs-2024-104109
Literature Review on Proper and Safe Use of Insulin
Nijhu, R. S., & Saha, S. (2024) · Jabirian Journal of Biointerface Research in Pharmaceutics and Applied Chemistry · doi:10.55559/jjbrpac.v1i5.386
Sebastián‐Valles, F., López-Hidalgo, J. J., Sierra, S. C., Navas-Moreno, V., Martín, J. A. A., Sampedro-Nuñez, M. A., & Marazuela, M. (2025) · Endocrine · doi:10.1007/s12020-025-04385-7
Bello, M. A. Y., Pesantez, M. J., Saalinger, M. N., Sanz, A. M., Shikh, S., Mesa, B., Chirinos, A. A., Macias, A. J., Nisenboym, T., Bernal‐Mizrachi, E., et al. (2026) · Diabetes Obesity and Cardiometabolic CARE · doi:10.2337/doc25-0072
Gomez-Peralta, F., Borrachero, J. M., Santos, E., Abreu, C., Valledor, X., Ruiz-Valdepeñas, L., & Corcoy, R. (2026) · Frontiers in Endocrinology · doi:10.3389/fendo.2026.1883791
Self-citationMicroneedle technology for diabetes therapy
Wang, W., & Wu, C. (2026) · Elsevier eBooks · doi:10.1016/b978-0-443-45544-5.00009-9
Insulin pens and the digital ecosystem
JENDLE, J. H., Adolfsson, P., Cardona‐Hernandez, R., Crenier, L., Molfetta, S. D., Ehrmann, D., Giorgino, F., Haluzı́k, M., Hirsch, I. B., Irace, C., et al. (2026) · Diabetologia · doi:10.1007/s00125-026-06858-4
Hirani, K., Blaschke, C., Olloqui, C., & Mittal, R. (2026) · Frontiers in Public Health · doi:10.3389/fpubh.2026.1915502
- Authors
- Gomez-Peralta, F., Abreu, C., Fernández-Rubio, E., Cotovad, L., Pujante, P., Gaztambide, S., Bellido, D., Menéndez Torre, E., Ruiz-Valdepeñas, S., Bello, H., Valledor, X., Pérez-González, J., & Ruiz-Valdepeñas, L.
- Affiliations
- 1Endocrinology and Nutrition Unit, Hospital General de Segovia, Segovia, Spain
- Hospital General De Segovia (ES)
- Hospital de Cruces (ES)
- Complejo Hospitalario Universitario de Ferrol (ES)
- Hospital Universitario Central de Asturias (ES)
- 4Endocrinology and Nutrition Unit, Hospital Universitario Central de Asturias, and Instituto de Investigación Sanitaria del Principado de Asturias (ISPA), Oviedo, Spain
- 5Research and Development Unit, Insulcloud S.L., Madrid, Spain
- ORCID
- Venue
- Diabetes Care
- Publisher
- American Diabetes Association
- Published
- 2022-12-21
- Volume
- 46
- Issue
- 1
- Pages
- 206-208
- ISSN
- 0149-5992 (ISSN-L)
- 1935-5548
- PMC
- PMC9797789
- OpenAlex
- W4310464466
- Cited by
- 36
- References
- 6
- Citations by year
- 2026: 7 · 2025: 8 · 2024: 16 · 2023: 5
- FWCI
- 5.37
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Diabetes Care (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Funders
- European Commission (739148)
- European Union (674505)
- Topics
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Education
- Health Sciences › Health Professions › General Health Professions › Mobile Health and mHealth Applications
- Keywords
- type 1 diabetes, glycemic control, glycemic variability, time in range, hyperglycemia, medication adherence, user satisfaction, uncontrolled diabetes
- MeSH terms
- Blood Glucose, Diabetes Mellitus, Type 1, Glucose, Humans, Hypoglycemic Agents, Injections, Insulin
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