Insulin Autoimmune Syndrome (Hirata Disease): A Comprehensive Review Fifty Years After Its First Description
Open accessAbstract
Insulin autoimmune syndrome (IAS), also named Hirata's disease, is a rare condition characterized by hypoglycemic episodes due to the presence of high titers of insulin autoantibodies (IAA). IAS is a form of immune-mediated hypoglycemia, which develops when a triggering factor (ie, a medication or a viral infection) acts on an underlying predisposing genetic background. IAS pathogenesis involves the formation of insulin-IAA complexes that induce glycemic alterations with a double-phase mechanism: IAA prevent insulin to bind its receptor in the postprandial phase, possibly resulting in mild hyperglycemia; thereafter, insulin is released from the complexes irrespective of blood glucose concentrations, thus inducing hypoglycemia. The diagnosis of IAS is challenging, requiring a careful workup aimed at excluding other causes of hyperinsulinemic hypoglycemia. The gold standard for the definitive diagnosis is the finding of IAA in a blood sample. Because IAS is frequently a self-remitting disease, its management mostly consists of supportive measures, such as dietary modifications, aimed at preventing the development of hypoglycemia. Pharmacological therapies may occasionally be necessary for patients presenting with severe manifestations of IAS. Available therapies may include drugs that reduce pancreatic insulin secretion (somatostatin analogues and diazoxide, for instance) and immunosuppressive agents (glucocorticoids, azathioprine and rituximab). The purpose of this review is to provide a comprehensive analysis of the disease, by describing the burden of knowledge that has been obtained in the 50 years following its first description, took in 1970, and by highlighting the points that are still unclear in its pathogenesis and management.
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IAA that develop after exogenous insulin analog administration rarely cause IAS, because they tend to be characterized by a lower insulin binding capacity and higher affinity.
“Of note, IAA that develop after exogenous insulin analog administration rarely cause IAS, because they tend to be characterized by a lower insulin binding capacity and higher affinity [73].”
From Non-Diabetic Hypoglycemia: Evaluation and Management in Adults (2025) · cites this paper as [73]
The Pathogenesis section says antibodies that develop after exogenous insulin exposure usually have higher affinity and lower binding capacity and rarely cause glycemic disturbances. But it distinguishes those antibodies from IAA, which it defines as antibodies against native endogenous insulin; the claim incorrectly calls the exogenous-insulin antibodies IAA and says they rarely cause IAS rather than glycemic disturbances. (LLM, conf=0.85)
Experimental — accuracy not yet measuredThe mismatch between insulin bioavailability and blood glucose levels is central to the pathogenesis of IAS-induced hypoglycemia.
“This mismatch between insulin bioavailability and blood glucose levels is central to the pathogenesis of IAS-induced hypoglycemia [73].”
From Non-Diabetic Hypoglycemia: Evaluation and Management in Adults (2025) · cites this paper as [73]
Antecedent viral infections with measles, mumps, rubella, cocksakie B, and varicella zoster viruses have been implicated in IAS by stimulating a robust immune response.
“Antecedent viral infections with measles, mumps, rubella, cocksakie B, and varicella zoster viruses have been implicated by stimulating a robust immune response [73].”
From Non-Diabetic Hypoglycemia: Evaluation and Management in Adults (2025) · cites this paper as [73]
The pathogenesis of IAS involves the production of IAA with high insulin binding capacity but low affinity.
“The pathogenesis of IAS involves the production of IAA with high insulin binding capacity but low affinity [73].”
From Non-Diabetic Hypoglycemia: Evaluation and Management in Adults (2025) · cites this paper as [73]
Immunosuppression with glucocorticoids, azathioprine, and rituximab have been found helpful in severe IAS, although use is mostly limited to case reports and long-term outcomes are unknown.
“Immunosuppression with glucocorticoids, azathioprine, and rituximab have all been found to be helpful in severe cases, although their use is mostly limited to case reports, and long-term outcomes are unknown [73].”
From Non-Diabetic Hypoglycemia: Evaluation and Management in Adults (2025) · cites this paper as [73]
Other environmental triggers may play a role in IAS, including certain medications and viruses.
“However, other environmental triggers may play a role, including certain medications and viruses [73].”
From Non-Diabetic Hypoglycemia: Evaluation and Management in Adults (2025) · cites this paper as [73]
If clinical findings are suggestive of insulinoma but no tumor can be localized upon conventional imaging, rarer causes of recurrent spontaneous hypoglycemia in the adult patient must be considered: insulin autoimmune syndrome, also known as Hirata's disease, as well as functional β-cell disorders.
“If clinical findings are suggestive of insulinoma but no tumor can be localized upon conventional imaging, rarer causes of recurrent spontaneous hypoglycemia in the adult patient must be considered: insulin autoimmune syndrome, also known as Hirata's disease, as well as functional β -cell disorders [14,15].”
These findings are compatible with NIPHS/nesidioblastosis according to the diagnostic criteria described above.
“In conclusion, these findings are compatible with NIPHS/nesidioblastosis according to the diagnostic criteria described above (Figure 1) [14,15].”
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HLA Alleles Associate with Insulin Autoimmune Syndrome
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“Immunosuppression with glucocorticoids, azathioprine, and rituximab have all been found to be helpful in severe cases, although their use is mostly limited to case reports, and long-term outcomes are unknown [73].”
InfluentialInsulin Autoimmune Syndrome: A Chinese Expert Consensus Statement
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Takahashi, K., Anno, T., Takenouchi, H., Iwamoto, H., Horiya, M., Kimura, Y., Kawasaki, F., Kaku, K., Tomoda, K., & Kaneto, H. (2022) · Journal of Diabetes Investigation · doi:10.1111/jdi.13838 · Cited by 8 · see citing works
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Mete, T., & Cesur, M. (2023) · Intercontinental Journal of Internal Medicine · doi:10.51271/icjim-0021 · Cited by 7 · see citing works
Insulin autoimmune syndrome caused by esomeprazole in a Chinese patient
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Cdc42 Activation in Antinephrin Antibody–Induced Nephropathy
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Yu, X., Li, M., Liao, Y. H., Xie, Y., Xu, J., Long, Y., & Xiang, S. (2025) · Diabetology & Metabolic Syndrome · doi:10.1186/s13098-025-01952-w · Cited by 7 · see citing works
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Oh, J., Vasquez, E. C., Arango, S. A., Ramesh, M., & Castells, M. (2025) · The Journal of Allergy and Clinical Immunology In Practice · doi:10.1016/j.jaip.2025.02.028 · Cited by 6 · see citing works
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Insulin Receptor Autoantibody–mediated Hypoglycemia in a Woman With Mixed Connective Tissue Disease
Petersen, M. C., Graves, J. M., Yao, T., Schomburg, L., Minich, W. B., Parks, D. L., McGill, J. B., & Salam, M. (2021) · Journal of the Endocrine Society · doi:10.1210/jendso/bvab182 · Cited by 6 · see citing works
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Exogenous insulin autoimmune syndrome: A case report and review of literature
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Dieterle, M. P., Husari, A., Prozmann, S. N., Wiethoff, H., Stenzinger, A., Röhrich, M., Pfeiffer, U., Kießling, W. R., Engel, H., Sourij, H., et al. (2023) · Biomedicines · doi:10.3390/biomedicines11061741 · Cited by 5 · see citing works
“If clinical findings are suggestive of insulinoma but no tumor can be localized upon conventional imaging, rarer causes of recurrent spontaneous hypoglycemia in the adult patient must be considered: insulin autoimmune syndrome, also known as Hirata’s disease, as well as functional β-cell disorders [14,15].”
BackgroundResultInsulinoma Presenting With Postprandial Hypoglycemia in a Pregnant Woman With MEN-1
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Insulin autoimmune syndrome in a 3-year-old boy: the youngest to date in China and a narrow review
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Kumar, V., Gala, D., Rafi, I., Shah, M., Marowa, S., Kaul, D., Lukose, S., & Kazeem, S. (2023) · AACE Clinical Case Reports · doi:10.1016/j.aace.2023.04.012 · Cited by 5 · see citing works
Zhao, L.-L., He, J.-Y., Ye, S.-D., Chen, C., Zhu, J., Xiao, C.-C., Wu, T., & Liu, Z.-C. (2023) · BMC Endocrine Disorders · doi:10.1186/s12902-023-01410-6 · Cited by 5 · see citing works
Recurrent hypoglycemia induced by clopidogrel: A case report and mini review
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Wan, J., Geng, L., Fu, Y., Zhang, Q., Guan, G., Jiang, X., Xu, A., & Jin, P. (2025) · Diabetes Research and Clinical Practice · doi:10.1016/j.diabres.2025.112262 · Cited by 5 · see citing works
Zhou, L., Luo, Y., Wang, Y., Cheng, Y., Zhang, R., Zhang, S., Gong, S., Han, X., & Ji, L. (2023) · Frontiers in Clinical Diabetes and Healthcare · doi:10.3389/fcdhc.2023.1172208 · Cited by 4 · see citing works
Hirata Syndrome Clinical Presentation and Management
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A case report of insulin autoimmune syndrome induced by drugs for colorectal cancer
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He, D., Gong, H., Pan, J., Zhu, F., Jiang, X., & Su, H. W. (2023) · Zeitschrift für Gastroenterologie · doi:10.1055/a-2170-1691 · Cited by 4 · see citing works
Searching for the Culprit: When Diabetic Ketoacidosis Presents With Insulin Autoantibodies
Garcia-Avila, S. A., Samuel, A., Farooqi, I. N., Manickam, R., Ismail, M., Khaddash, S. I., & Gibiezaite, S. (2020) · AACE Clinical Case Reports · doi:10.1016/j.aace.2020.12.004 · Cited by 4 · see citing works
Case 23-2022: A 49-Year-Old Man with Hypoglycemia
Baughman, A. W., Wei, N., Hahn, P. F., Casey, B. W., & Zhang, M. L. (2022) · New England Journal of Medicine · doi:10.1056/nejmcpc2115858 · Cited by 4 · see citing works
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Insulin Autoimmune Syndrome – An After-Meal Roller Coaster Ride
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A Case of Exogenous Insulin Autoimmune Syndrome: A Case Report
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- Authors
- Cappellani, D., Macchia, E., Falorni, A., & Marchetti, P.
- Affiliations
- University of Pisa (IT)
- University of Perugia (IT)
- Corresponding author
- Cappellani, Daniele
- Venue
- Diabetes, Metabolic Syndrome and Obesity: Targets and Therapy
- Publisher
- Informa UK Limited
- Published
- 2020-04
- Volume
- Volume 13
- Pages
- 963-978
- ISSN
- 1178-7007 (ISSN-L)
- PMC
- PMC7136665
- OpenAlex
- W3014251084
- Cited by
- 138
- References
- 131
- Citations by year
- 2026: 23 · 2025: 24 · 2024: 23 · 2023: 24 · 2022: 22 · 2021: 17 · 2020: 4 · 2019: 1
- FWCI
- 2.39
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- Locations
- Diabetes Metabolic Syndrome and Obesity (publishedVersion, cc-by-nc)
- PubMed Central (publishedVersion, cc-by-nc)
- PubMed (publishedVersion)
- CINECA IRIS Institutial research information system (University of Pisa) (submittedVersion)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
- Dove Medical Press (Taylor and Francis Group) (submittedVersion, cc-by-nc)
- Topics
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Genetics › Diabetes and associated disorders
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Adrenal Hormones and Disorders
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
- Keywords
- insulin autoimmune syndrome, insulin autoantibodies, hyperinsulinemic hypoglycemia, insulin receptor binding, somatostatin analogues, diazoxide, immunosuppressive therapy, rituximab, glucocorticoids, azathioprine
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