Risk Of Diabetic Ketoacidosis Research Articles

Pharmacovigilance of Sodium-Glucose Cotransporter-2 Inhibitors for Genital Fungal Infections and Urinary Tract Infections: A Review of the Food and Drug Administration Adverse Event Reporting System Database.

Background: Postmarketing surveillance had previously identified the need for revisions in the labeling of the sodium-glucose cotransporter-2 (SGLT2) inhibitors drug class related to the risk of diabetic ketoacidosis. Other adverse events have been reported. Objective: To examine postmarketing surveillance data of the SGLT2 inhibitors, using the Food and Drug Administration Adverse Event Reporting System (FAERS) database, specifically to assess prevalence of urinary tract infections (UTIs) and genital fungal infections. Methods: FAERS case reports submitted between March 2013 and November 2015 were reviewed for 6 SGLT2 inhibitors (mono and combo therapies). The Medical Dictionary for Regulatory Activities (MedDRA) was used to define preferred terms (genital fungal infections: vulvovaginal mycotic infection, vulvovaginal candidiasis, urinary tract infection fungal, and genital candidiasis; UTI: urinary tract infection, genitourinary tract infection, kidney infection, cystitis, and pyelonephritis). Word frequencies were queried using the qualitative data analysis software NVivo 11 (QSR International), and results were then individually reviewed. Results: A total of 12 581 cases were received, but 466 were excluded (total n = 12 115). A total of 348 cases related to genital fungal infections were reported (2.9% of reports submitted): dapagliflozin = 53, empagliflozin/linagliptin = 6, canagliflozin = 267, canagliflozin/metformin = 3, empagliflozin = 17, and dapagliflozin/metformin HCl ER = 2. A total of 727 cases related to UTIs were reported (6% of reports submitted): dapagliflozin = 168, empagliflozin/linagliptin = 5, canagliflozin/metformin = 8, canagliflozin = 503, empagliflozin = 38, and dapagliflozin/metformin HCl ER = 5. Conclusions: A causal relationship between SGLT2 inhibitors and the adverse events reported cannot be established due to the nature of postmarketing surveillance. However, health care providers should counsel patients about these potential adverse events.

Treatment Modality-Dependent Risk of Diabetic Ketoacidosis in Patients with Type 1 Diabetes: Danish Adult Diabetes Database Study.

The aim of this study was to evaluate the incidence rates of diabetic ketoacidosis (DKA) according to treatment modality in patients with type 1 diabetes (T1D) in Denmark, either multiple daily injections (MDI) or continuous subcutaneous insulin infusion (CSII). A total of 20,902 T1D registered in the Danish Adult Diabetes Database were followed for an average of 5.4 years. Poisson regression analyses with risk time as offset were used to compare differences in rates of DKA between CSII and MDI. Model was adjusted for age, sex, diabetes duration, previous DKA events, and hemoglobin A1c (HbA1c). A modifying effect of number of CSII patients on the DKA rates was tested. During 113,731 person-years, 3100 DKA events were registered (53 among CSII). CSII patients were younger (42.3 vs. 47.9 years), a larger proportion was female (59% vs. 43%), had a shorter diabetes duration (19 vs. 21 years), and a lower HbA1c (61.9 vs. 66.6 mmol/mol). There was no significant difference in the incidence rate of DKA between CSII and MDI (rate ratio: 1.30, 95% confidence interval: 0.97-1.76). However, in clinics with at least 250 CSII patients, rates of DKA events were lower among CSII users, while the opposite was true for the smaller clinics (P = 0.016). Delivery of CSII in large diabetes clinics with sufficient support and patient education may ensure that CSII treatment does not lead to an increased risk of DKA.

Euglycemic Diabetic Ketoacidosis Associated With Sodium–Glucose Cotransporter Type 2 Inhibitors in Patients With Type 2 Diabetes Mellitus Receiving Oral Therapy

Introduction and Objective: Postmarketing reports and warnings of serious adverse events such as diabetic ketoacidosis (DKA) have raised concern regarding the safety of sodium–glucose cotransporter 2 inhibitors (SGLT2i). This report describes 2 cases of symptomatic SGLT2i-associated euglycemic DKA (euDKA) leading to hospitalization in patients with type 2 diabetes mellitus (DM) previously well controlled on oral medications. Case Reports: Subject 1 is a 55-year-old female admitted with euDKA precipitated by infection and managed with intravenous insulin. This case was notable for a delayed diagnosis of euDKA and lack of clinical improvement despite withholding dapagliflozin. Subject 2 is a 62-year-old male admitted with euDKA precipitated by infection. His clinical condition improved rapidly and euDKA responded to withdrawal of empagliflozin alone. Discussion: Applying the Naranjo adverse medication reaction probability scale to each case (subject 1 score = 3 points; subject 2 score = 4 points) suggests these are possible adverse reactions to SGLT2i. Data from randomized controlled trials suggest DKA events in adults with type 2 DM receiving SGLT2i are rare and similar to placebo. However, data from a large cohort suggest these events occur more frequently and are associated with a 2-fold increased risk of DKA. Conclusion: This class of medications may be associated with a higher real-world risk of DKA in adults with type 2 DM than previously reported. Patients prescribed these medications should receive vigilant assessment for features of traditional DKA as well as euDKA.

Inequalities in glycaemic control, hypoglycaemia and diabetic ketoacidosis according to socio‐economic status and area‐level deprivation in Type 1 diabetes mellitus: a systematic review

The aim of this systematic review was to examine the associations of individual-level as well as area-level socio-economic status and area-level deprivation with glycaemic control, hypoglycaemia and diabetic ketoacidosis in people with Type 1 diabetes mellitus. Ovid MEDLINE was searched to identify relevant cohort, case-control or cross-sectional studies published between January 2000 and June 2015. Search results were screened by title, abstract and keywords to identify eligible publications. Decisions on inclusion or exclusion of full texts were made independently by two reviewers. The Newcastle-Ottawa Scale was used to estimate the methodological quality of included studies. Quality assessment and extracted data of included studies were synthesized narratively and reported according to the PRISMA statement. Literature search in Ovid MEDLINE identified 1345 eligible studies. Twenty studies matched our inclusion and exclusion criteria. Two articles were additionally identified through hand search. According to the Newcastle-Ottawa Scale, most of the studies were of average quality. Results on associations of socio-economic status and area-level deprivation with glycaemic control and hypoglycaemia were contradictory between studies. By contrast, lower socio-economic status and higher area-level deprivation were associated with a higher risk for diabetic ketoacidosis in all except one study. Lower socio-economic status and higher area-level deprivation are associated with a higher risk of experiencing diabetic ketoacidosis in people with Type 1 diabetes mellitus. Access to care for socially deprived people needs to be expanded to overcome impairing effects on the course of the condition and to reduce healthcare disparities.

Altered Patterns of Early Metabolic Decompensation in Type 1 Diabetes During Treatment with a SGLT2 Inhibitor: An Insulin Pump Suspension Study.

Enthusiasm for the benefits of sodium-glucose cotransporter 2 inhibitors (SGLT2i) as an adjunctive treatment in type 1 diabetes (T1D) has been offset by the possible increased risk of diabetic ketoacidosis (DKA). Since pump-treated T1D patients are susceptible to DKA due to infusion site problems, this study was undertaken to assess how treatment with SGLT2i affects patterns of early metabolic decompensation following suspension of basal insulin. Ten T1D participants (age 19-35 years, duration 10 ± 8 years, A1c 7.4% ± 0.8%) underwent overnight pump suspension studies before and after treatment with canagliflozin (CANA). On both nights, basal insulin was suspended at 3 AM and plasma glucose (PG), β-hydroxybutyrate (BHB), free fatty acids (FFA), plasma insulin (PI), and glucagon were measured. Studies were terminated 6 h after suspension or if PG rose to >350 mg/dL or BHB >2.5 mmol/L. PI levels at the start of suspension were reduced by 30% after CANA treatment (44 ± 11 uU/mL vs. 31 ± 10 uU/mL, P < 0.01), but baseline PG, BHB, FFA, and glucagon levels were not significantly different. During the suspension, PG rose from 104 ± 10 to 301 ± 21 mg/dL before treatment, but only from 109 ± 8 to 195 ± 14 mg/dL after treatment (P = 0.002 vs. pretreatment values). On the other hand, CANA treatment did not significantly affect the magnitude of increases in FFA, BHB, and glucagon levels during the suspension study. These data indicate that SGLT2i do not accelerate the rate of ketogenesis following the interruption of basal insulin infusion in T1D. Rather, the failure of patients to promptly recognize early metabolic decompensation relates to the much more gradual rise in PG levels.

SGLT2 Inhibitors and Ketoacidosis: Pathophysiology and Management

Sodium-glucose cotransporter 2 inhibitors are antidiabetic drugs that increase urinary glucose excretion by inhibiting proximal tubular reabsorption of glucose in the kidney. Some sodium-glucose cotransporter 2 inhibitors have been shown to afford effective glycemic control and to decrease the risks of major adverse cardiovascular events. However, these drugs may increase the risk of diabetic ketoacidosis. This is a rare complication that occurs in less than 0.1% of treated patients with type 2 diabetes. The condition may be euglycemic, and is triggered by controllable precipitating factors such as surgery, infection, and insulin reduction or omission. It is important to understand individual patient profiles and to prevent diabetic ketoacidosis by appropriate prescribing, by withholding sodium-glucose cotransporter 2 inhibitors when indicated, and by counseling patients on sick day management. (Korean J Med 2017;92:443-449)

Diabetic Ketoacidosis Risk After Initiating a Sodium-Glucose Cotransporter 2 Inhibitor: A Population-Based Cohort Study

Background: Case reports submitted to the FDA suggest Sodium-glucose cotransporter 2 (SGLT2) inhibitors might be associated with an increased risk of diabetic ketoacidosis (DKA).

Population-based incidence of diabetic ketoacidosis in type 2 diabetes: medical claims data analysis in Japan.

Determination of the incidence rate of diabetic ketoacidosis (DKA) in type 2 diabetes mellitus (T2DM) is urgent, in response to the safety issue with use of the glucose lowering drugs, sodium-glucose cotransporter-2 inhibitors, and DKA. We extracted data of adult patients with T2DM from a medical claims database in Japan, which included 1 million individuals. The study period was 2005-2013, before the era of sodium-glucose cotransporter-2 inhibitors. The inclusion criteria were patients with a diagnosis of T2DM who had at least 1 prescription for a glucose-lowering drug. We further examined the number of DKA-related admissions and medication use prior to admission. Calculation of DKA incidence was on a patient-years basis, with 95% confidence interval using a Poisson distribution. Of 36,674 adult patients with T2DM, we identified 74 cases admitted for DKA, with an estimated DKA incidence of 0.48/1000 (95% confidence interval, 0.38-0.60/1000) patient-years. Of these 74 cases, approximately two-thirds of patients had no past or recent history of glucose-lowering drug use before admission for DKA. This study estimated that the incidence of DKA was 0.48/1000 patient-years in Japan, similar to previous studies. We also found that underuse of glucose-lowering medication was common among patients hospitalized for DKA. KEY POINTS The population-based incidence of DKA in T2DM is largely unknown. In Japan, the estimated DKA incidence was 0.48/1000 (95% CI, 0.38-0.60/1000) patient-years. Drug-induced DKA is an emerging research area, and our results can be applied to evaluating the risk of DKA.

Incidence and prevalence of diabetic ketoacidosis (DKA) among adults with type 1 diabetes mellitus (T1D): a systematic literature review

ObjectivesTo summarise incidence and prevalence of diabetic ketoacidosis (DKA) in adults with type 1 diabetes (T1D) for the overall patient population and different subgroups (age, sex, geographical region, ethnicity and...

Diabetic Ketoacidosis: Demographic Data, Clinical Profile and Outcome in a Tertiary Care Hospital

Background: Diabetic ketoacidosis (DKA) is an acute and life-threatening situation that accounts for the majority of diabetes-related morbidity and mortality in children and adolescents who suffer from type 1 diabetes mellitus (T1DM). Objectives: To investigate the demographic, clinical characteristics, and outcomes of DKA in young patients with established T1DM and newly diagnosed diabetes in a tertiary referral hospital. Methods: Data from all T1DM patients diagnosed with DKA episodes in the pediatric endocrine unit at Besat university hospital, Hameden, Iran during 2006 - 2013 were reviewed in a retrospective study. The data collected includes the demographic data (age, sex, place of residence, first presentation and established T1DM), clinical presentation (main presenting symptoms, average duration of presenting symptoms before hospitalization, precipitating factors, severity of DKA, level of consciousness), laboratory parameters (blood sugar, arterial blood gases, urine ketones, serum electrolytes) and the outcome. DKA was defined as a glucose level higher than 250 mg/dL, pH 15 mmol/L and ketonuria. Data was entered and analyzed on SPSS version 16. A P value less than 0.05 were defined as statistically significant. Results: The study population comprised 72 children satisfying the inclusion criteria of the study. Mean age of patients was 9.4 ± 4.08 years (range 5 months-18.2 years). The majority (61.1%) of patients were urban residents. DKA occurrence was higher (29.2%) in summer. Newly diagnosed diabetics accounted for 59 (81.9%) of the patients. The majority of the patients (54.2%) were aged 10 - 14 years. The median duration of symptoms before the hospitalization was 9.5 ± 9 days. The most commonly reported presenting symptoms were polyuria (86.1%), polydipsia (84.7%) followed by gastrointestinal symptoms. Nearly 40.2% of patients presented with an altered level of consciousness. About half of patients had a medical encounter before diagnosis. The mean initial blood glucose was 423 ± 96 mg/dL. Severe DKA was occurring more frequently than moderate and mild forms (47.2%, versus 34.7% and 18.1%, respectively). DKA was significantly more severe in girls (P = 0.004). Average time of recovery was 21 hours (range 4 - 75 h). The commonest complication was hypokalemia (34.7%) followed by hypernatremia (26.4%). There was a significant relationship between hypokalemia and clinical severity (P = 0.02), and between abdominal pain and severity of DKA (P = 0.003). No deaths occurred. Conclusions: DKA was most prevalent in newly diagnosed TIDM cases. Most cases had severe DKA. Female children, in particular, seem to be at increased risk for severe DKA. Newly diagnosed T1DM and insulin omission were the main factors associated with DKA. The age of presentation and clinical symptoms of studied subjects were similar to international studies. No lethal complication was recorded. High frequency of DKA at presentation of T1DM requires careful attention to issues of early diagnosis before development of ketoacidosis.

SGLT2 inhibitors increase risk of diabetic ketoacidosis

SGLT2 inhibitors increase risk of diabetic ketoacidosis

Active cocaine use does not increase the likelihood of hyperglycemic crisis

ObjectiveHyperglycemic crisis encompasses a group of diabetes emergencies characterized by insulin deficiency with high morbidity and mortality. Cocaine use is increasingly prevalent in the United States and may be associated with increased risk of diabetic ketoacidosis. The objective was to determine if active cocaine use at hospital admission could be considered a risk factor for development of hyperglycemic crisis. MethodsA retrospective case-control analysis was performed on 950 inpatients with hyperglycemia at an urban academic hospital. Patients admitted with non-emergent hyperglycemia were compared to patients who met criteria for diabetic ketoacidosis (DKA), hyperosmolar hyperglycemic state (HHS), and hyperosmolar ketoacidosis (HK), based on the absence or presence of cocaine metabolites on urine toxicology screen. Outcomes included frequency of cocaine use in patients with DKA, HHS, HK, and non-emergent hyperglycemia; phenotypic characteristics of cocaine users vs. non-users with hyperglycemia; phenotypic characteristics of patients with hyperglycemic crisis vs. non-emergent hyperglycemia. Results950 patients were admitted with hyperglycemia, 133 of which met criteria for hyperglycemic crisis. There was no significant difference in the frequency of cocaine use in individuals with non-emergent hyperglycemia compared to individuals with hyperglycemic crisis (16.9% vs. 17.2%, p=0.90). 16.9% of patients with DKA, 16.4% of patients with HHS, and 6.4% of patients with HK were cocaine users. ConclusionsWe found no association between active cocaine use at the time of hospital admission and development of hyperglycemic crisis, when compared to non-emergent hyperglycemia. The role of routine screening for cocaine use in patients with hyperglycemic crisis is unclear.

Effects of SGLT-2 inhibitors on diabetic ketoacidosis: A meta-analysis of randomised controlled trials.

Diabetic ketoacidosis (DKA) associated with SGLT-2 inhibitors (SGLT-2i) is a possible adverse event. In fact, SGLT-2i are capable of stimulating the release of glucagon and ketone re-absorption in the renal tubuli, thus increasing the concentration of ketone bodies. A Medline search for SGLT2i (dapagliflozin, empagliflozin, canagliflozin, ipragliflozin, ertugliflozin, luseogliflozin) was performed, collecting all randomized trials with a duration of treatment≥12weeks, enrolling patients with type 2 diabetes, and comparing a SGLT2i with placebo or other comparators. The principal outcome was the effect of SGLT2i on ketoacidosis as serious adverse event. Out of 72 trials reporting information on DKA, 9 reported at least one event of ketoacidosis; those eight trials enrolled 10,157 and 5396 in SGLT-2 inhibitors and comparator groups, respectively. No signal of increased risk for ketoacidosis was observed for SGLT2 inhibitors as a class (MH-OR [95% CI] 1.14 [0.45-2.88], p=0.78) or as individual molecule. The sensitivity analysis with continuity correction (inputing one event each in drug and comparator arms of each trial with zero events) suggested a reduced incidence of ketoacidosis in patients treated with SGLT-2 inhibitors (MH-OR 0.65 [0.47-0.90]; p=0.01). The results of clinical trials summarized in the present meta-analysis reassure us that, when the drug is properly prescribed, the risk of DKA is negligible.

Euglycemic ketosis in patients with type 2 diabetes on SGLT2-inhibitor therapy-an emerging problem and solutions offered by diabetes technology.

Diabetic ketoacidosis is an infrequent but life-threatening acute complication of diabetes, affecting predominantly patients with type 1 diabetes, children, and pregnant women, where ketosis is usually associated with marked hyperglycemia. Recently, an increasing number of cases have been reported of euglycemic diabetic ketoacidosis in patients with type 2 diabetes receiving sodium-glucose cotransporter 2 inhibitor treatment in routine practice. There is a minor, but not negligible diabetic ketoacidosis risk associated with this drug class, which was not seen in randomized clinical trials. However, sodium-glucose cotransporter2 inhibitors increase the risk of ketosis by increasing glucagon secretion in the pancreas and decreasing the renal excretion of 3-hydroxybutyrate and acetoacetate. When used in addition to insulin, any insulin dose reduction required to avoid hypoglycemia may lead to insufficient suppression of lipolysis and ketogenesis. sodium-glucose cotransporter2 inhibitor-induced loss of urinary glucose encourages euglycemia. Normo-glycemic or near-normoglycemic diabetic ketoacidosis represents a major threat to the health and well-being of a patient, because it may occur undetected and without any indicative hyperglycemia. In consequence, patients on sodium-glucose cotransporter2 inhibitors are recommended to perform regular blood ketone tests since they are not alerted to incipient diabetic ketoacidosis by glucose testing alone. This option is offered by several blood glucose meters that can also measure ketones with a separate ketone strip or in one case by an automatic parallel ketone assessment from the same strip. The need for extra testing and the associated costs may be a barrier to patient acceptance of this risk mitigation procedure. However, patients who are at risk for euglycemic diabetic ketoacidosis when being treated with sodium-glucose cotransporter2 inhibitors should be specially advised to monitor blood ketone levels on a regular basis.

The efficacy and safety of SGLT2 inhibitors for adjunctive treatment of type 1 diabetes: a systematic review and meta-analysis

To assess the efficacy and safety of the SGLT-2 inhibitors as adjunct therapy to insulin in T1DM, clinical trials indexed in PubMed, Cochrane Library, EMbase from inception through April 5, 2016. A meta-analysis was conducted on trials of SGLT-2 inhibitors in patients with T1DM on insulin therapy using RevMan 5.3 software. Of the 371 articles identified, ten met eligibility criteria. Seven clinical trials including four randomized controlled trials and 581 patients were included. Compared with the control group, SGLT-2 inhibitors group had significantly reduced fasting plasma glucose by 0.69 mmol/L [1.32; 0.07], glycosylated hemoglobin A1C by 0.37% [0.54; 0.20], body weight by 2.54 kg [3.48; 1.60] and total daily insulin dose by 6.22 IU [8.04; 4.40]. The total incidence of adverse events (AEs), hypoglycemia, and genital and urinary infections were also similar to placebo, while an increased incidence of diabetic ketoacidosis (DKA) (n = 16) was seen in SGLT-2 inhibitors group. The present study demonstrates that SGLT-2 inhibitors are effective as adjunct therapy to insulin in T1DM, heralding improved glycemic control, reduced body weight and total daily insulin dose without an increase in total AEs, hypoglycemia, or genital and urinary infections. However, the risk of DKA should be carefully monitored in future clinical trials.

Clinical Characteristics of Diabetic Ketoacidosis in Children with Newly Diagnosed Type 1 Diabetes in Addis Ababa, Ethiopia: A Cross-Sectional Study.

BackgroundDiabetic ketoacidosis (DKA) is one of the most serious acute complications of type 1 diabetes (T1D) and the leading cause of morbidity and mortality in children with T1D. This study was aimed at assessing the prevalence and associated factors of DKA in children with newly diagnosed T1D in Addis Ababa.MethodsA hospital based cross-sectional study was conducted in selected hospitals in Addis Ababa. Children below the age of 12 years with DKA who were admitted to the pediatric ward in the selected hospitals between January 2009 and December 2014 and the residence of Addis Ababa were included. DKA was defined as children below the age of 12 years who have blood glucose level ≥250mg/dl, ketonuria, and ketonemia and diagnosed being T1D patient for the first time. Descriptive statistics was performed using frequency distribution, mean, median, tables, and graphs. Logistic regression analysis was used to identify independent factors associated with the prevalence of DKA in children with newly diagnosed T1D.ResultsOf 395 DKA patients who were hospitalized during the five-year period, 142(35.8%) presented with DKA at first diagnosis of diabetes. On the other hand 253 (64.2%) children with DKA had longstanding T1D. Independent factors associated with DKA include: Age category 2–4.49years, 7–9.49 years and ≥9.5years (Adjusted odd ratio (AOR) = 3.14[1.21,8.06]), 3.44(1.39,8.49) and 4.02(1.68,9.60), respectively); parents’ knowledge on the sign and symptoms of DKA (AOR = 0.51[0.27, 0.95]); sign and symptoms of DKA before the onset of DKA (AOR = 0.35[0.21, 0.59]) and infection prior to DKA onset (AOR = 3.45[1.97, 6.04]).ConclusionsThe overall proportion of children diagnosed with DKA and new onset of T1D in Addis Ababa was high. In particular, children between 9–12 years of age and children whose parents did not know the sign and symptoms of DKA had a high risk of DKA at primary diagnosis of T1D.

Sodium-glucose Co-transporter-2 Inhibitors in Type 1 Diabetes—a Dangerous Ally

There is an unmet need for adjunctive non-insulin-based therapies in type 1 diabetes (T1D). Weight gain, recurrent hypoglycemia and suboptimal glycemic control remain significant challenges. Sodium-glucose co-transporter-2 (SGLT2) inhibitors and dual inhibitors of sodium-glucose co-transporter-1 (SGLT1) and SGLT2 may have a potential role as an add-on therapy to insulin. The benefits include improved glycemic control, weight reduction, and reduced insulin dose requirement. However, the risk of diabetic ketoacidosis with SGLT2 inhibitors is significant and the diagnosis may be delayed due to absence of significant hyperglycemia. At present, SGLT2 inhibitors are not approved for use in T1D, and the risks should be discussed at length with the patient. We propose strategies to minimize the risk of diabetic ketoacidosis associated with off-label use of SGLT2 inhibitors in T1D.

Diabetic Ketoacidosis in a Patient with Type 1 Diabetes on Sodium-glucose Co-transporter-2 Inhibitors—a Case Report

We describe a case of a 26-year-old female with long-standing type 1 diabetes (T1D), on multiple subcutaneous insulin injections, who had been taking empagliflozin for the past year. She was detected to have severe diabetic ketoacidosis (DKA) with relatively lower blood glucose values during hospitalisation for dengue fever. The factors that precipitated the DKA are discussed, along with the unique challenges in the management of her metabolic status. While sodium-glucose co-transporter-2 (SGLT2) inhibitors have several potential benefits as adjunctive add-on therapy to insulin in T1D, the evidence is limited to short-term studies. However, their off-label use is increasing and there have been concerns related to increased risk of diabetic ketoacidosis. At present, SGLT2 inhibitors are not approved for use in T1D, and the risks should be discussed at length with the patient.

SGLT2 inhibitors linked to increased risk of diabetic ketoacidosis

SGLT2 inhibitors linked to increased risk of diabetic ketoacidosis

Association of British Clinical Diabetologists (ABCD) position statement on the risk of diabetic ketoacidosis associated with the use of sodium-glucose cotransporter-2 inhibitors

Diabetic Ketoacidosis (DKA) has been reported in patients with diabetes taking SGLT-2 inhibitor drugs both in clinical trials and in real life situations, particularly amongst patients taking insulin. The US Food and Drug Administration (FDA) has issued a safety communication following 20 cases of DKA in patients receiving these drugs.1 This concern has also prompted an American Association of Clinical Endocrinologists and American College of Endocrinology position statement covering the use of SGLT-2 inhibitors in people with type 2 diabetes.2 The following is the ABCD position statement on this issue.