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Peer-reviewedCC BY 4.0Diabetologia

Insulin pens and the digital ecosystem

13 more authors
28 affiliations
  1. 1School of Medicine, Department of Health Sciences, Örebro University, Örebro, Sweden
  2. 2Department of Diabetes, Högsbo Hospital, Gothenburg, Sweden
  3. 3Division of Paediatric Endocrinology, Hospital Sant Joan de Déu, Barcelona, Spain
  4. 4Department of Endocrinology, Hôpital Universitaire de Bruxelles - Hôpital Erasme, Brussels, Belgium
  5. 5Endocrinology Unit, University Hospital ‘Consorziale Policlinico’ of Bari, Bari, Italy
  6. 6Research Institute Diabetes Academy Bad Mergentheim (FIDAM), Bad Mergentheim, Germany
  7. 7Section of Internal Medicine, Endocrinology, Andrology and Metabolic Diseases, Department of Precision and Regenerative Medicine and Ionian Area, University of Bari Aldo Moro, Bari, Italy
  8. 8Diabetes Centre, Institute for Clinical and Experimental Medicine, Prague, Czech Republic
  9. 9UW Medical Center-Montlake, Seattle, WA USA
  10. 10University of Washington School of Medicine, Seattle, WA USA
  11. 11Department of Health Science, University Magna Grᴂcia, Catanzaro, Italy
  12. 12Salford Care Organisation, Northern Care Alliance, Salford, UK
  13. 13Diabetes Research Institute, Sutter Mills Peninsula Medical Center (Sutter Health Research Institute), San Mateo, CA USA
  14. 14Center for Digital Diabetology, Hamburg, Germany
  15. 15Division of Endocrinology and Diabetology, Medical University of Graz, Graz, Austria
  16. 16Steno Diabetes Center Copenhagen, Herlev, Denmark
  17. 17Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark
  18. 18Department of Health Science and Technology, Aalborg University, Aalborg, Denmark
  19. 19Steno Diabetes Center Northern Denmark, Aalborg, Denmark
  20. 20Department of Metabolism, Digestion and Reproduction, Faculty of Medicine, Imperial College London, London, UK
  21. 21Department of Endocrinology and Nephrology, Nordsjællands Hospital Hillerød, Hillerød, Denmark
  22. 22Departement of Endocrinology and Diabetology, Montpellier University Hospital, and Institute of Functional Genomics, CNRS, Inserm, University of Montpellier, Montpellier, France
  23. 23Specialist Diabetes Practice Northeim, Outpatient Education and Treatment Centre, Northeim, Germany
  24. 24Department of Diabetes and Endocrinology, Heart and Diabetes Center NRW, University Hospital Ruhr University Bochum, Bad Oeynhausen, Germany
  25. 25Department of Endocrinology, General Hospital Sint-Lucas, Ghent, Belgium
  26. 26Department of Diabetes & Endocrinology, Royal Derby Hospital, University Hospitals of Derby and Burton NHS Trusts, Derby, UK
  27. 27Translational Medical Sciences, School of Medicine, University of Nottingham, Derby, UK
  28. 28Science Consulting in Diabetes GmbH, Düsseldorf, Germany

Abstract

Insulin has been used for over a century for the treatment of diabetes and, since the mid-1980s, there has been a rapid development of insulin administration tools. Over the last decade, several medical products used for diabetes management have been connected to a digital ecosystem. This connectivity includes sophisticated monitoring of not only glucose levels but also of insulin delivery (type, dose, time of dosing). It facilitates interactions between people with diabetes, various diabetes technology devices and healthcare professionals. This white paper aims to discuss and categorise different types of insulin pens, connected insulin pens and caps, as well as smart insulin pen systems (SPSs) that are available on the market. Connected pens capture data to provide information about the details of the insulin applied. SPSs are paired with a continuous glucose monitoring (CGM) system and, by means of integrated algorithms, can provide individualised dose calculation based on a variety of factors. These SPSs can also recommend insulin doses based on current and projected glucose and insulin data; this feature requires a connection to a CGM system. Yet what are the clinical advantages of SPSs? What added value does this system bring to individuals living with diabetes and their healthcare providers? In a narrative review, we discuss the current regulatory pathways and market environment as well as the influencing factors of connected insulin pens vs SPSs. We aim to provide a rationale and justification for this categorisation based on (smart) design aspects, regulatory considerations and clinical outcomes. This review concludes that while standard insulin pens remain a safe and commonly offered option, connected insulin pens and SPSs are likely to show improvement in glycaemic management, treatment adherence and patient satisfaction, and represent a significant advancement in diabetes care. However, further research including high-quality clinical and health economic studies will be vital in substantiating the value of both connected insulin pens and SPSs and driving broader acceptance among payers and healthcare systems.

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BibTeX
@article{jendle2026insulin,
  title = {{Insulin pens and the digital ecosystem}},
  author = {Johan Jendle and Peter Adolfsson and Roque Cardona-Hernandez and Laurent Crenier and Sergio Di Molfetta and Dominic Ehrmann and Francesco Giorgino and Martin Haluzik and Irl B. Hirsch and Concetta Irace and Amy Jolley and David C. Klonoff and Jens Kröger and Julia K. Mader and Kirsten Nørgaard and Jannie Toft Damsgaard Nørlev and Nick Oliver and Ulrik Pedersen-Bjergaard and Eric Renard and Sandra Schlueter and Signe Schmidt and Susanne Reger-Tan and Inge van Boxelaer and Emma G. Wilmot and Lutz Heinemann},
  journal = {Diabetologia},
  year = {2026},
  month = sep,
  doi = {10.1007/s00125-026-06858-4},
  url = {https://hal.science/hal-05782848v1},
  note = {CC BY 4.0},
}
RIS
TY  - JOUR
TI  - Insulin pens and the digital ecosystem
AU  - Johan Jendle
AU  - Peter Adolfsson
AU  - Roque Cardona-Hernandez
AU  - Laurent Crenier
AU  - Sergio Di Molfetta
AU  - Dominic Ehrmann
AU  - Francesco Giorgino
AU  - Martin Haluzik
AU  - Irl B. Hirsch
AU  - Concetta Irace
AU  - Amy Jolley
AU  - David C. Klonoff
AU  - Jens Kröger
AU  - Julia K. Mader
AU  - Kirsten Nørgaard
AU  - Jannie Toft Damsgaard Nørlev
AU  - Nick Oliver
AU  - Ulrik Pedersen-Bjergaard
AU  - Eric Renard
AU  - Sandra Schlueter
AU  - Signe Schmidt
AU  - Susanne Reger-Tan
AU  - Inge van Boxelaer
AU  - Emma G. Wilmot
AU  - Lutz Heinemann
PY  - 2026
DA  - 2026/09/23
JO  - Diabetologia
DO  - 10.1007/s00125-026-06858-4
UR  - https://hal.science/hal-05782848v1
AB  - Insulin has been used for over a century for the treatment of diabetes and, since the mid-1980s, there has been a rapid development of insulin administration tools. Over the last decade, several medical products used for diabetes management have been connected to a digital ecosystem. This connectivity includes sophisticated monitoring of not only glucose levels but also of insulin delivery (type, dose, time of dosing). It facilitates interactions between people with diabetes, various diabetes technology devices and healthcare professionals. This white paper aims to discuss and categorise different types of insulin pens, connected insulin pens and caps, as well as smart insulin pen systems (SPSs) that are available on the market. Connected pens capture data to provide information about the details of the insulin applied. SPSs are paired with a continuous glucose monitoring (CGM) system and, by means of integrated algorithms, can provide individualised dose calculation based on a variety of factors. These SPSs can also recommend insulin doses based on current and projected glucose and insulin data; this feature requires a connection to a CGM system. Yet what are the clinical advantages of SPSs? What added value does this system bring to individuals living with diabetes and their healthcare providers? In a narrative review, we discuss the current regulatory pathways and market environment as well as the influencing factors of connected insulin pens vs SPSs. We aim to provide a rationale and justification for this categorisation based on (smart) design aspects, regulatory considerations and clinical outcomes. This review concludes that while standard insulin pens remain a safe and commonly offered option, connected insulin pens and SPSs are likely to show improvement in glycaemic management, treatment adherence and patient satisfaction, and represent a significant advancement in diabetes care. However, further research including high-quality clinical and health economic studies will be vital in substantiating the value of both connected insulin pens and SPSs and driving broader acceptance among payers and healthcare systems.
SN  - 0012-186X
SN  - 1432-0428
ER  -