Observational studyJournal of diabetes investigation2021
On-label use of sodium-glucose cotransporter 2 inhibitors might increase the risk of diabetic ketoacidosis in patients with type 1 diabetes.
Observational study in Journal of diabetes investigation, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
11 citing papers in PubMed, 1 synthesis or guideline pooled it, 19 citations in OpenAlex.
- Long-term effects of adding an SGLT-2 inhibitor to insulin therapy in patients with type 1 diabetes. An observational study and systematic review of real-world evidence.Journal of endocrinological investigation · 2025Pooled it
- Metabolic Impact of Sodium-Glucose Cotransporter 2 Inhibitor-Induced Ketogenesis in Type 2 Diabetes Mellitus.Journal of obesity & metabolic syndrome · 2026Article
- Heart Failure in Type 1 vs. Type 2 Diabetes Mellitus: Shared Pathways, Distinct Challenges.Journal of diabetes research · 2026Review
- Diabetic Ketoacidosis and Severe Hypoglycemia Risks with Ipragliflozin/Insulin Versus Insulin in Type 1 Diabetes: A Japanese Real-World Database Study.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2026Article
- Euglycemic Diabetic Ketoacidosis: Clinical Suspicion and Diagnosis.Clinical medicine insights. Endocrinology and diabetes · 2026Review
- Clinical use and monitoring of adverse effects of sodium-glucose cotransporter-2 inhibitors in persons with type 1 diabetes mellitus.Journal of diabetes investigation · 2025Article
- Update on slowly progressive type 1 diabetes.Journal of diabetes investigation · 2025Article
- Update on Measuring Ketones.Journal of diabetes science and technology · 2024Review
- A new era of diabetic kidney disease treatment with sodium-glucose cotransporter-2 inhibitors.Journal of diabetes investigation · 2022Article
- Current clinical state of type 1 diabetes in Saitama prefecture.Diabetology international · 2022Article
- On-label use of sodium-glucose cotransporter 2 inhibitors might increase the risk of diabetic ketoacidosis in patients with type 1 diabetes.Journal of diabetes investigation · 2021Observational
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
AIMS/
introductionThis study aimed to investigate the risk of diabetic ketoacidosis (DKA) in insulin-treated type 1 diabetes patients administered sodium-glucose cotransporter 2 (SGLT2) inhibitors in real-world clinical practice. MATERIALS AND
methodsWe carried out a real-world, retrospective, observational cohort study using Japanese Medical Data Vision, a diagnosis procedure combination database. We identified insulin-treated adult type 1 diabetes patients enrolled from December 2018 to October 2019. We assessed the incidence and risk of DKA in type 1 diabetes patients using SGLT2 inhibitors in an 'on-label' manner. Cox multivariate regression analyses were carried out to determine clinical factors linked to SGLT2 inhibitor-associated DKA.
resultsOf 11,475 type 1 diabetes patients, 1,898 (16.5%) were prescribed SGLT2 inhibitors. DKA occurred in 139 (7.3%) of these patients, with 20.2 incidences per 100 person-years. These patients also showed significantly higher DKA rates than did those not receiving SGLT2 inhibitors (hazard ratio 1.66, 95% confidence interval 1.33-2.06; P < 0.001). The mean time until DKA onset in SGLT2 inhibitor-treated type 1 diabetes patients was 30.6 ± 30.1 days. The risk of SGLT2 inhibitor-associated DKA increased in type 1 diabetes patients irrespective of sex, age or body mass index. However, the risk did not increase in type 1 diabetes patients receiving continuous subcutaneous insulin infusion, which warrants further investigation because of the small number of type 1 diabetes patients receiving continuous subcutaneous insulin infusion.
conclusions'On-label' SGLT2 inhibitor use might increase DKA risk among insulin-treated type 1 diabetes patients irrespective of sex, age or body mass index. Both type 1 diabetes patients and healthcare providers should be wary of DKA, especially during the first month of initiating SGLT2 inhibitors.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.