International consensus on risk management of diabetic ketoacidosis in patients with type 1 diabetes treated with sodium-glucose cotransporter (SGLT) inhibitors
Open accessAbstract
Sodium–glucose cotransporter (SGLT) inhibitors are new oral antidiabetes medications shown to effectively reduce glycated hemoglobin (A1C) and glycemic variability, blood pressure, and body weight without intrinsic properties to cause hypoglycemia in people with type 1 diabetes. However, recent studies, particularly in individuals with type 1 diabetes, have demonstrated increases in the absolute risk of diabetic ketoacidosis (DKA). Some cases presented with near-normal blood glucose levels or mild hyperglycemia, complicating the recognition/diagnosis of DKA and potentially delaying treatment. Several SGLT inhibitors are currently under review by the U.S. Food and Drug Administration and European regulatory agencies as adjuncts to insulin therapy in people with type 1 diabetes. Strategies must be developed and disseminated to the medical community to mitigate the associated DKA risk. This Consensus Report reviews current data regarding SGLT inhibitor use and provides recommendations to enhance the safety of SGLT inhibitors in people with type 1 diabetes.
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Risk factors for DKA in individuals with type 1 or type 2 diabetes treated with SGLT inhibitors include very-low-carbohydrate diets, prolonged fasting, dehydration, excessive alcohol intake, and other common precipitating factors.
“Risk factors for DKA in individuals with either type 1 or type 2 diabetes treated with SGLT inhibitors include very-low-carbohydrate diets, prolonged fasting, dehydration, excessive alcohol intake, and other common precipitating factors (84,236).”
From 9. Pharmacologic Approaches to Glycemic Treatment: Standards of Care in Diabetes—2025 (2025) · cites this paper as [84]
In Patient Selection (Table 2; page not provided), the paper lists reduced carbohydrate intake, excessive alcohol use, dehydration, and other DKA risk factors during SGLT inhibitor therapy. The Background section also links prolonged fasting to ketosis. The consensus addresses patients with type 1 diabetes, however, so it does not establish this risk-factor list for patients with type 2 diabetes. (LLM, conf=0.86)
Experimental — accuracy not yet measuredNo risk mitigation strategies have been proven to lower the risk of DKA.
“While no risk mitigation strategies have been proven to lower the risk of DKA, a consensus statement on SGLT2 inhibitors and DKA suggested careful patient selection, appropriate insulin dose adjustment to avoid insulinopenia, starting with a low dose of SGLT2 inhibitors, and regular ketone measurements with prompt action to address elevated values as sensible precautions aimed at preventing DKA (”
From The management of type 1 diabetes in adults. A consensus report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD) (2021) · cites this paper as [216]
The Patient Selection, Insulin Dose Adjustments, Initiation and Dosing, and Ketone Monitoring sections recommend the precautions listed in the citing sentence. The Research Questions section says there is no evidence that daily ketone monitoring prevents DKA, but does not establish the broader claim that no risk-mitigation strategy has been proven to lower risk. The Initiation and Dosing section also reports lower DKA rates with lower SGLT inhibitor doses in clinical trials. Page numbers were not available in our copy. (LLM, conf=0.84)
Experimental — accuracy not yet measuredThere are multiple proposed pathways through which SGLT inhibition results in ketosis, such as increased production due to reduction in insulin doses, increases in glucagon levels leading to increased lipolysis and ketone production, and decreased renal clearance of ketones.
“There are multiple proposed pathways through which SGLT inhibition results in ketosis (increased b-hydroxybutyrate and acetoacetate), such as increased production due to reduction in insulin doses, increases in glucagon levels leading to increased lipolysis and ketone production, and decreased renal clearance of ketones (310,311).”
From 10. Cardiovascular Disease and Risk Management: Standards of Care in Diabetes—2025 (2025) · cites this paper as [311]
Individuals with type 1 diabetes and insulin-deficient type 2 diabetes are at increased risk for DKA with SGLT inhibitor therapy.
“Individuals with type 1 diabetes (84,236) and insulin-deficient type 2 diabetes are at increased risk for DKA with SGLT inhibitor therapy.”
From 9. Pharmacologic Approaches to Glycemic Treatment: Standards of Care in Diabetes—2025 (2025) · cites this paper as [84]
Adjunctive use of SGLT inhibitors in adults with type 1 diabetes increases the risk of DKA by an absolute rate of about 4% per year.
“Adjunctive use of sodium-glucose cotransporter (SGLT) inhibitors (see below) in adults with type 1 diabetes increases the risk of DKA by an absolute rate of about 4% per year, suggesting the need for intensive diabetes self-management education and monitoring (216,217).”
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- Authors
- Danne, T., Garg, S., Peters, A. L., Buse, J. B., Mathieu, C., Pettus, J. H., Alexander, C. M., Battelino, T., Ampudia-Blasco, F. J., Bode, B. W., Cariou, B., Close, K. L., Dandona, P., Dutta, S., Ferrannini, E., Fourlanos, S., Grunberger, G., Heller, S. R., Henry, R. R., Kurian, M. J., Kushner, J. A., Oron, T., Parkin, C. G., Pieber, T. R., Rodbard, H. W., Schatz, D., Skyler, J. S., Tamborlane, W. V., Yokote, K., & Phillip, M.
- Affiliations
- Kinderkrankenhaus auf der Bult (DE)
- University of Colorado Denver (US)
- University of Southern California (US)
- University of North Carolina at Chapel Hill (US)
- Universitair Ziekenhuis Leuven (BE)
- University of California San Diego (US)
- Advanced Resources International (United States) (US)
- University of Ljubljana (SI)
- Clinic University Hospital of Valencia, Valencia, Spain
- Atlanta Diabetes Associates (US)
- Inserm (FR)
- The diaTribe Foundation, San Francisco, CA
- University at Buffalo, State University of New York (US)
- Breakthrough T1D (US)
- Istituto di Fisiologia Clinica (IT)
- The Royal Melbourne Hospital (AU)
- Grunberger Diabetes Institute (US)
- University of Sheffield (GB)
- Close Concerns (United States) (US)
- McNair Interests, Houston, TX
- Tel Aviv University (IL)
- CGParkin Communications, Inc., Boulder City, NV
- Medical University of Graz (AT)
- Endocrine and Metabolic Consultants, Rockville, MD
- University of Florida Health (US)
- University of Miami (US)
- Yale University (US)
- Chiba University (JP)
- Corresponding author
- Parkin, Christopher G.
- ORCID
- Danne, Thomas
- Garg, Satish
- Peters, Anne L.
- Buse, John B.
- Mathieu, Chantal
- Pettus, Jeremy H.
- Alexander, Charles M.
- Battelino, Tadej
- Bode, Bruce W.
- Cariou, Bertrand
- Close, Kelly L.
- Dandona, Paresh
- Dutta, Sanjoy
- Ferrannini, Ele
- Fourlanos, Spiros
- Grunberger, George
- Heller, Simon R.
- Henry, Robert R.
- Kurian, Martin J.
- Kushner, Jake A.
- Oron, Tal
- Parkin, Christopher G.
- Pieber, Thomas R.
- Rodbard, Helena W.
- Schatz, Desmond
- Skyler, Jay S.
- Tamborlane, William V.
- Yokote, Koutaro
- Phillip, Moshe
- Venue
- Diabetes Care
- Publisher
- American Diabetes Association
- Published
- 2019-02-06
- Volume
- 42
- Issue
- 6
- Pages
- 1147-1154
- ISSN
- 0149-5992 (ISSN-L)
- 1935-5548
- PMC
- PMC6973545
- OpenAlex
- W2913123058
- Semantic Scholar
- c81fbccbc9c544cb12bc88838b302b1184853308
- Cited by
- 379
- References
- 42
- Citations by year
- 2026: 39 · 2025: 53 · 2024: 39 · 2023: 52 · 2022: 45 · 2021: 51 · 2020: 61 · 2019: 36
- FWCI
- 39.17
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Locations
- Diabetes Care (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Lirias (submittedVersion, other-oa)
- Carolina Digital Repository (University of North Carolina at Chapel Hill) (submittedVersion)
- eScholarship (California Digital Library) (submittedVersion)
- UNC Libraries
- Funders
- Amgen
- Bristol-Myers Squibb
- Eli Lilly and Company
- Pfizer
- AstraZeneca
- GlaxoSmithKline
- Sanofi
- Regeneron Pharmaceuticals
- Les Laboratories Pierre Fabre
- Intarcia Therapeutics
- Insulet Corporation
- MannKind Corporation
- Dexcom
- AstraZeneca HealthCare Foundation
- National Institute for Health and Care Research (NF-SI-0515-10079)
- KU Leuven
- Novo Nordisk
- Servier
- National Institutes of Health (UL1TR002489, UL1TR001863)
- National Center for Advancing Translational Sciences
- Janssen Pharmaceuticals
- Topics
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Treatment and Management
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Education
- Keywords
- diabetic ketoacidosis, type 1 diabetes, SGLT inhibitors, risk management, drug safety, hypoglycemia, glycemic variability, insulin therapy
- MeSH terms
- Sodium-Glucose Transporter 2 Inhibitors, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Glucose, Humans, Hypoglycemic Agents, Risk Management, Sodium, Diabetic Ketoacidosis
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
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