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

Farsani, Soulmaz Fazeli; Brodovicz, Kimberly G.; Soleymanlou, Nima; Marquard, Jan; Wissinger, Erika; Maiese, B.A.

doi:10.1136/bmjopen-2017-016587

Cited by 167 publications

(134 citation statements)

References 52 publications

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“…Percentages of patients with ≥1 inpatient, emergency department or endocrinologist encounter during the 12-month baseline period in the optimal glycaemic control and suboptimal glycaemic control groups with T1D, 3 and moreover in an international comparison of paediatric patients with T1D. 22 Corroborating previous findings, we found suboptimal glycaemic control to be associated with a significantly higher prevalence of nephropathy and retinopathy.…”

Section: F I G U R Esupporting

confidence: 74%

“…It has been estimated that up to 5% of adults with T1D will have an episode of DKA and 7%-9% will have an SH event in the course of a year. 3,4 After a 30-year duration of T1D with disease management by conventional treatment, an estimated 50% of patients will develop retinopathy, 25% nephropathy and 14% cardiovascular (CV) disease. 5 In patients receiving intensive treatment, the cumulative incidence of these complications is substantially lower.…”

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confidence: 99%

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Differences between patients with type 1 diabetes with optimal and suboptimal glycaemic control: A real‐world study of more than 30 000 patients in a US electronic health record database

Pettus

Zhou

Shepherd

et al. 2019

Diabetes Obesity Metabolism

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Aims To use electronic health record data from real‐world clinical practice to assess demographics, clinical characteristics and disease burden of adults with type 1 diabetes (T1D) in the United States. Materials and methods Retrospective observational study of adults with T1D for ≥24 months at their first visit with a T1D diagnosis code (“index date”) between July 2014 and June 2016 in the Optum Humedica database. Demographic characteristics, acute complications (severe hypoglycaemia [SH], diabetic ketoacidosis [DKA]), microvascular complications, cardiovascular (CV) events and health care resource utilization during the 12 months before the index date (“baseline period”) were compared between patients with optimal versus suboptimal glycaemic control (glycated haemoglobin [HbA1c] <7.0% vs. ≥7.0% [53 mmol/mol]) at the closest measurement to the index date. Results Of 31 430 adults with T1D, 79.9% had suboptimal glycaemic control (mean HbA1c 8.8% [73 mmol/mol]). These patients were more likely to be younger, African American, uninsured or on Medicaid, obese, smokers, have uncontrolled hypertension and have depression. Despite worse glycaemic control and increased CV risk factors of uncontrolled hypertension, obesity and smoking, rates of coronary heart disease and stroke were not higher in these patients. Patients with suboptimal glycaemic control also experienced more diabetes complications (including SH, DKA and microvascular disease) and utilized more emergency care, with more emergency department visits and inpatient stays. Conclusion This real‐world study of >30 000 adults with T1D showed that individuals with suboptimal versus optimal glycaemic control differed significantly in terms of health care coverage, comorbidities, diabetes‐related complications, health care utilization and CV risk factors. However, suboptimal control was not associated with increased risk of CV outcomes.

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Section: F I G U R Esupporting

confidence: 74%

mentioning

confidence: 99%

Differences between patients with type 1 diabetes with optimal and suboptimal glycaemic control: A real‐world study of more than 30 000 patients in a US electronic health record database

Pettus

Zhou

Shepherd

et al. 2019

Diabetes Obesity Metabolism

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“…DKA risk might correlate with patient characteristics such as concomitant illness, HbA1c, glycaemic control, and BMI. 30 The metaregression approach reported herein identified no association of baseline BMI, variation in body weight, variation in total daily insulin dose, or duration of follow-up with the risk of DKA with SGLT inhibitor use.…”

Section: Figurementioning

confidence: 67%

Effects of sodium‐glucose cotransporter (SGLT) inhibitors in addition to insulin therapy on glucose control and safety outcomes in adults with type 1 diabetes: A meta‐analysis of randomized controlled trials

Lü

Tang

Meng

et al. 2019

Diabetes Metabolism Res

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Summary Sodium‐glucose cotransporter (SGLT) inhibitors added to insulin therapy have been proposed as treatment strategy for type 1 diabetes (T1D). We thus conducted a meta‐analysis of randomized controlled trials (RCTs) to assess the efficacy and adverse effects of this combination in T1D. We searched the PubMed, EMBASE, and Cochrane Library databases and http://ClinicalTrials.gov for RCTs. Statistical analyses were performed using STATA 15. Ten eligible placebo‐controlled trials involving 5961 patients were included. Compared with placebo, SGLT inhibitors were associated with a reduction in HbA1c of −0.39% (95% CI, −0.43 to −0.36), an improved mean amplitude of glucose excursion (MAGE) of −14.81 mg/dL (95% CI, −19.08 to −10.54), and a reduction in body weight of −3.47% (95% CI, −3.78 to −3.16), as well as no increased relative risk of hypoglycaemia (1.01; 95% CI, 0.99‐1.02) or severe hypoglycaemia (0.91; 95% CI, 0.77‐1.07). SGLT inhibitors decreased fasting plasma glucose and insulin requirement but increased the risk of genital infection (3.57; 95% CI, 2.97‐4.29) and diabetic ketoacidosis (3.11; 95% CI, 2.11‐4.58). However, the very low dose empagliflozin (2.5 mg) did not increase the risk of diabetic ketoacidosis (risk ratio [RR] 0.67; 95% CI, 0.11‐3.95). SGLT inhibitors had no effect on overall adverse events, urinary tract infection, or bone fracture but slightly increased the risk of serious adverse events (1.35; 95% CI, 1.16‐1.58), severe adverse events (1.84; 95% CI, 1.20‐2.84), adverse events leading to discontinuation (1.50; 95% CI, 1.22‐1.84), drug‐related adverse events (1.78; 95% CI, 1.44‐2.19), and diarrhoea (1.54; 95% CI, 1.15‐2.05). Although adverse events exist, the available data provide evidence that the combination of SGLT inhibitors with basal insulin treatment is beneficial in patients with T1D.

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“…2,3 The incidence of DKA among patients with T1DM ranged from 8 to 56 per 1000 patient-years in larger studies in the United States, Canada, Europe, and Israel. 4 In comparison, a much lower DKA incidence of <2 per 1000 patient-years was reported in cohort studies of adults with T2DM in clinical practice. [5][6][7] Sodium glucose co-transporter 2 (SGLT2) inhibitors are oral antihyperglycemic agents (AHAs) that lower blood glucose by increasing urinary glucose excretion.…”

mentioning

confidence: 90%

Diabetic ketoacidosis in patients with type 2 diabetes treated with sodium glucose co‐transporter 2 inhibitors versus other antihyperglycemic agents: An observational study of four US administrative claims databases

Wang

Voss

Weaver

et al. 2019

Pharmacoepidemiology and Drug

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Purpose To compare the incidence of diabetic ketoacidosis (DKA) among patients with type 2 diabetes mellitus (T2DM) who were new users of sodium glucose co‐transporter 2 inhibitors (SGLT2i) versus other classes of antihyperglycemic agents (AHAs). Methods Patients were identified from four large US claims databases using broad (all T2DM patients) and narrow (intended to exclude patients with type 1 diabetes or secondary diabetes misclassified as T2DM) definitions of T2DM. New users of SGLT2i and seven groups of comparator AHAs were matched (1:1) on exposure propensity scores to adjust for imbalances in baseline covariates. Cox proportional hazards regression models, conditioned on propensity score‐matched pairs, were used to estimate hazard ratios (HRs) of DKA for new users of SGLT2i versus other AHAs. When I2 <40%, a combined HR across the four databases was estimated. Results Using the broad definition of T2DM, new users of SGLT2i had an increased risk of DKA versus sulfonylureas (HR [95% CI]: 1.53 [1.31‐1.79]), DPP‐4i (1.28 [1.11‐1.47]), GLP‐1 receptor agonists (1.34 [1.12‐1.60]), metformin (1.31 [1.11‐1.54]), and insulinotropic AHAs (1.38 [1.15‐1.66]). Using the narrow definition of T2DM, new users of SGLT2i had an increased risk of DKA versus sulfonylureas (1.43 [1.01‐2.01]). New users of SGLT2i had a lower risk of DKA versus insulin and a similar risk as thiazolidinediones, regardless of T2DM definition. Conclusions Increased risk of DKA was observed for new users of SGLT2i versus several non‐SGLT2i AHAs when T2DM was defined broadly. When T2DM was defined narrowly to exclude possible misclassified patients, an increased risk of DKA with SGLT2i was observed compared with sulfonylureas.

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

Cited by 167 publications

References 52 publications

Differences between patients with type 1 diabetes with optimal and suboptimal glycaemic control: A real‐world study of more than 30 000 patients in a US electronic health record database

Differences between patients with type 1 diabetes with optimal and suboptimal glycaemic control: A real‐world study of more than 30 000 patients in a US electronic health record database

Effects of sodium‐glucose cotransporter (SGLT) inhibitors in addition to insulin therapy on glucose control and safety outcomes in adults with type 1 diabetes: A meta‐analysis of randomized controlled trials

Diabetic ketoacidosis in patients with type 2 diabetes treated with sodium glucose co‐transporter 2 inhibitors versus other antihyperglycemic agents: An observational study of four US administrative claims databases

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