SUMMARY
Estimated all-cause mortality within 30-days of hypoglycemic emergencies is 0.8% in adults with type 1 diabetes and 1.7% with type 2 diabetes; and within 30-days of hyperglycemic emergencies, it is 1.2% with type 1 diabetes and 2.8% with type 2 diabetes. These rates changed little between 2011 and 2020.
INTRODUCTION
Hypoglycemic and hyperglycemic emergencies are serious and often preventable acute complications of diabetes management that are associated with impaired quality of life, morbidity, and both immediate and long-term mortality.[1–6] While prior studies have linked severe hypoglycemia and hyperglycemia to increased risk of death, there is limited contemporary data on all-cause mortality among people living with type 1 (T1D) and type 2 diabetes (T2D) in the aftermath of these events.
METHODS
This retrospective cohort study used medical and pharmacy claims data from OptumLabs® Data Warehouse (OLDW), a de-identified dataset of enrollees in commercial and Medicare Advantage health plans[7] across the U.S., and was exempt from Mayo Clinic Institutional Review Board review.
We identified adults (≥18 years old) who met Healthcare Effectiveness Data and Information Set (HEDIS) criteria for diabetes[8] between January 1, 2010 and December 31, 2019, and had 12 months of uninterrupted enrollment following this date, at which time they were eligible to enter the study cohort. This 12-month period was used to ascertain baseline covariates and establish diabetes type.[9] We then identified emergency department visits and hospitalizations for the primary diagnoses of hypoglycemia[9] and hyperglycemia (diabetic ketoacidosis, hyperglycemic hyperosmolar state)[10] that occurred after cohort entry; these events served as index dates. For patients who experienced multiple events of the same type, a random event was chosen as index.
For each diabetes and event type, we estimated Cox survival models with all-cause mortality as the outcome; patients were censored at the end of the study period or health plan disenrollment. Models were adjusted for age, sex, race/ethnicity, U.S. region, comorbidities, prior severe hypoglycemia and hyperglycemia, and (for T2D) glucose-lowering medication classes, and used to estimate 30-day and 1-year mortality rates. Analyses were conducted using SAS software version 9.4 (SAS Institute Inc., Cary, North Carolina) and Stata 16 (StataCorp, College Station, Texas).
RESULTS
Baseline data are summarized in Table 1. Among 4164 patients with T1D who experienced hypoglycemic emergencies, estimated all-cause mortality was 0.2% at 30 days and 1.7% at one year, with no change over time (p=0.81); Figure 1. Among 4698 patients with T1D experiencing hyperglycemic emergencies, estimated all-cause mortality was 0.1% at 30 days and 0.9% at one year, also stable over time (p=0.78).
Table 1.
Study Population.
| Type 1 Diabetes | Type 2 Diabetes | |||
|---|---|---|---|---|
| Hypoglycemia | Hyperglycemia | Hypoglycemia | Hyperglycemia | |
| N (%) | N (%) | N (%) | N (%) | |
|
| ||||
| Patient number | 4164 | 4698 | 49,931 | 17,128 |
|
| ||||
| Age, years, mean (SD) | 47.2 (18.4) | 36.7 (17.7) | 66.8 (11.7) | 57.7 (15.0) |
|
| ||||
| Age category, years | ||||
|
| ||||
| 18–44 | 1680 (40.3) | 3080 (65.6) | 2245 (4.5) | 2997 (17.5) |
|
| ||||
| 45–64 | 1553 (37.3) | 1152 (24.5) | 13,505 (27.0) | 7135 (41.7) |
|
| ||||
| 65–74 | 625 (15.0) | 322 (6.9) | 17,677 (35.4) | 4454 (26.0) |
|
| ||||
| ≥75 | 306 (7.3) | 144 (3.1) | 16,504 (33.1) | 2542 (14.8) |
|
| ||||
| Sex | ||||
|
| ||||
| Female | 2075 (49.8) | 2512 (53.5) | 27,066 (54.2) | 8917 (52.1) |
|
| ||||
| Male | 2089 (50.2) | 2186 (46.5) | 22,865 (45.8) | 8211 (47.9) |
|
| ||||
| Race/Ethnicity | ||||
|
| ||||
| White | 2997 (72.0) | 3359 (71.5) | 27,110 (54.3) | 9526 (55.6) |
|
| ||||
| Black | 609 (14.6) | 634 (13.5) | 13,484 (27.0) | 4359 (25.4) |
|
| ||||
| Hispanic | 248 (6.0) | 323 (6.9) | 5482 (11.0) | 1848 (10.8) |
|
| ||||
| Asian | 80 (1.9) | 69 (1.5) | 1288 (2.6) | 351 (2.0) |
|
| ||||
| Other/unknown | 230 (5.5) | 313 (6.7) | 2567 (5.1) | 1044 (6.1) |
|
| ||||
| Region | ||||
|
| ||||
| Midwest | 1203 (28.9) | 1432 (30.5) | 12,174 (24.4) | 3936 (23.0) |
|
| ||||
| Northeast | 586 (14.1) | 445 (9.5) | 7360 (14.7) | 2100 (12.3) |
|
| ||||
| South | 1793 (43.1) | 2121 (45.1) | 26,245 (52.6) | 9478 (55.3) |
|
| ||||
| West/Unknown | 582 (14.0) | 700 (14.9) | 4152 (8.3) | 1614 (9.4) |
|
| ||||
| Prior dysglycemic emergencies | ||||
|
| ||||
| Hypoglycemic emergency | 570 (13.7) | 379 (8.1) | 4135 (8.3) | 1137 (6.6) |
|
| ||||
| Hyperglycemic emergency | 468 (11.2) | 1211 (25.8) | 1185 (2.4) | 1939 (11.3) |
|
| ||||
| Comorbidities | ||||
|
| ||||
| Cardiovascular disease | 907 (21.8) | 588 (12.5) | 22,950 (46.0) | 5528 (32.3) |
|
| ||||
| Cerebrovascular disease | 379 (9.1) | 239 (5.1) | 10,367 (20.8) | 2503 (14.6) |
|
| ||||
| Peripheral vascular disease | 636 (15.3) | 453 (9.6) | 13,731 (27.5) | 3516 (20.5) |
|
| ||||
| Heart failure | 275 (6.6) | 156 (3.3) | 11,129 (22.3) | 2417 (14.1) |
|
| ||||
| Hypertension | 2323 (55.8) | 1753 (37.3) | 45,540 (91.2) | 13,730 (80.2) |
|
| ||||
| Chronic kidney disease, stages 3–4 | 421 (10.1) | 243 (5.2) | 10,897 (21.8) | 2248 (13.1) |
|
| ||||
| End-stage kidney disease | 137 (3.3) | 76 (1.6) | 2724 (5.5) | 471 (2.7) |
|
| ||||
| Retinopathy | 1374 (33.0) | 1042 (22.2) | 13,376 (26.8) | 3679 (21.5) |
|
| ||||
| Neuropathy | 1443 (34.7) | 1328 (28.3) | 20,147 (40.3) | 6333 (37.0) |
|
| ||||
| COPD | 376 (9.0) | 308 (6.6) | 10,783 (21.6) | 2829 (16.5) |
|
| ||||
| Cancer | 185 (4.4) | 126 (2.7) | 5088 (10.2) | 1227 (7.2) |
|
| ||||
| Cirrhosis | 26 (0.6) | 19 (0.4) | 925 (1.9) | 300 (1.8) |
|
| ||||
| Depression | 752 (18.1) | 1019 (21.7) | 7966 (16.0) | 3327 (19.4) |
|
| ||||
| Dementia | 67 (1.6) | 47 (1.0) | 2804 (5.6) | 682 (4.0) |
|
| ||||
| Glucose-lowering medications | ||||
|
| ||||
| Metformin | 166 (4.0) | 134 (2.9) | 18,066 (36.2) | 6034 (35.2) |
|
| ||||
| Sulfonylurea | -- | -- | 17,119 (34.3) | 3548 (20.7) |
|
| ||||
| SGLT2 inhibitor | -- | 46 (1.0) | 630 (1.3) | 554 (3.2) |
|
| ||||
| GLP-1 receptor agonist | 31 (0.7) | 30 (0.6) | 1552 (3.1) | 716 (4.2) |
|
| ||||
| DPP4 inhibitor | 23 (0.6) | -- | 4691 (9.4) | 1418 (8.3) |
|
| ||||
| Thiazolidinedione | 29 (0.7) | -- | 3241 (6.5) | 908 (5.3) |
|
| ||||
| Intermediate- or long-acting insulin | 2226 (53.5) | 2214 (47.1) | 21,772 (43.6) | 7299 (42.6) |
|
| ||||
| Short- or rapid-acting insulin | 3541 (85.0) | 4018 (85.5) | 14,139 (28.3) | 5534 (32.3) |
|
| ||||
| Other medications | 31 (0.7) | 30 (0.6) | 691 (1.4) | 153 (0.9) |
|
| ||||
| No fills | 328 (7.9) | 378 (8.0) | 7100 (14.2) | 3455 (20.2) |
Data are presented as N (%), except when noted otherwise. Patient age, sex, race/ethnicity, and U.S. region were identified from OLDW enrollment files at the time of their index date. Comorbidities (retinopathy, neuropathy, cardiovascular disease, cerebrovascular disease, heart failure, chronic kidney disease stages 3–4, end-stage kidney disease, dementia, chronic obstructive pulmonary disease, cancer [excluding non-melanoma skin cancers], cirrhosis, depression, hypertension)[18] and prior ED/hospital encounters for hypoglycemia[9] and hyperglycemia[10] were ascertained from all claims in 12 months preceding the index date. Glucose-lowering medications were ascertained from pharmacy fill claims during 120 days prior to the index date. As such, medications (including insulin) obtained outside of the patient’s health benefit, such as through a manufacturer’s patient assistance program, low-cost generic program at a retail pharmacy, or as a sample from a healthcare provider, would not be captured. Medications filled sporadically and outside the 120-day period would be missed as well.
COPD, chronic obstructive pulmonary disease. DPP-4, Dipeptidyl peptidase-4. GLP-1, Glucagon-like peptide 1. SGLT2, sodium-glucose co-transporter 2.
Figure 1. All-cause mortality after hypoglycemic and hyperglycemic emergencies among patients with type 1 diabetes, 2011–2020.
Estimated rates of 30-day and 1-year all-cause mortality after hypoglycemic and hyperglycemic emergencies are adjusted for patient age, sex, race/ethnicity, U.S. region, comorbidities, and (models for type 2 diabetes only) glucose-lowering medications used. Specifically, we first calculated the predicted baseline risks at d=30 and d=365 days from the model and then for each patient, getting the marginal linear prediction (LP) for each subgroup of interest, assuming as above that all remaining covariates took their mean value. The results were combined to calculate the predicted mortality risk for d=30 or d=365 as risk = 1-baselinedexp(LP) for each patient, and the mean reported for each year and subgroup. P-values assess for trends in event rates over time, with the null hypothesis of no change over time.
Among 49,931 patients with T2D experiencing hypoglycemic emergencies, estimated all-cause mortality was 1.5% at 30 days and 13.5% at one year, remaining stable over time (p=0.05); Figure 2. Among 17,128 patients with T2D experiencing hyperglycemic emergencies, estimated all-cause mortality was 2.0% at 30 days and 9.5% at one year, increasing significantly over time (p=0.01).
Figure 2. All-cause mortality after hypoglycemic and hyperglycemic emergencies among patients with type 2 diabetes, 2011–2020.
Estimated rates of 30-day and 1-year all-cause mortality after hypoglycemic and hyperglycemic emergencies are adjusted for patient age, sex, race/ethnicity, U.S. region, comorbidities, and (models for type 2 diabetes only) glucose-lowering medications used. Specifically, we first calculated the predicted baseline risks at d=30 and d=365 days from the model and then for each patient, getting the marginal linear prediction (LP) for each subgroup of interest, assuming as above that all remaining covariates took their mean value. The results were combined to calculate the predicted mortality risk for d=30 or d=365 as risk = 1-baselinedexp(LP) for each patient, and the mean reported for each year and subgroup. P-values assess for trends in event rates over time, with the null hypothesis of no change over time.
Mortality rates increased with older age after both hypoglycemic and hyperglycemic emergencies in both T1D and T2D (p<0.001 for all); Figure 3. While in T1D, there was no independent association between either sex or race/ethnicity and mortality after hypoglycemic and hyperglycemic emergencies, the estimated rate of death was higher among women than men and among Black patients than patients from other racial/ethnic groups (Figure 4). In T2D, men had a significantly higher risk of death than women (p<0.001 for both), while the risk of death was lower among non-White patients experiencing hypoglycemic emergencies and among Hispanic patients experiencing hyperglycemic emergencies (p<0.001 and p=0.02, respectively); Table 2.
Figure 3. Age-stratified all-cause mortality after hypoglycemic and hyperglycemic emergencies among patients with type 1 and type 2 diabetes, 2011–2020.
Estimated rates of 30-day and 1-year all-cause mortality after hypoglycemic and hyperglycemic emergencies; models are adjusted for patient age, sex, race/ethnicity, U.S. region, comorbidities, and (models for type 2 diabetes only) glucose-lowering medications used. In multivariate analysis, p-values across age groups within each event type and diabetes type are <0.001 for all.
Table 2.
All-cause mortality after hypoglycemic and hyperglycemic emergencies among patients with type 1 and type 2 diabetes, 2011–2020, stratified by race, ethnicity, and sex.
| Type 1 Diabetes | Type 2 Diabetes | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Hypoglycemic Emergency | Hyperglycemic Emergency | Hypoglycemic Emergency | Hyperglycemic Emergency | |||||||||
| 30-Day (%) | 1-Year (%) | p-value | 30-Day (%) | 1-Year (%) | p-value | 30-Day (%) | 1-Year (%) | p-value | 30-Day (%) | 1-Year (%) | p-value | |
| Gender | 0.65 | 0.33 | <0.001 | <0.001 | ||||||||
| Female | 0.21 | 1.77 | 0.15 | 0.95 | 1.41 | 12.44 | 2.03 | 9.58 | ||||
| Male | 0.18 | 1.51 | 0.11 | 0.71 | 1.70 | 14.82 | 1.98 | 9.34 | ||||
| Race/Ethnicity | 0.28 | 0.68 | <0.001 | 0.02 | ||||||||
| White | 0.17 | 1.46 | 0.13 | 0.81 | 1.62 | 14.16 | 2.05 | 9.67 | ||||
| Black | 0.34 | 2.86 | 0.27 | 1.75 | 1.51 | 13.24 | 2.10 | 9.88 | ||||
| Hispanic | 0.18 | 1.51 | 0.03 | 0.21 | 1.22 | 10.84 | 1.45 | 6.90 | ||||
| Asian | 0.12 | 1.01 | 0.08 | 0.50 | 1.44 | 12.65 | 2.72 | 12.66 | ||||
| Unknown | 0.25 | 2.13 | 0.17 | 1.10 | 1.66 | 14.46 | 2.20 | 10.34 | ||||
Estimated rates of 30-day and 1-year all-cause mortality after hypoglycemic and hyperglycemic emergencies; models are adjusted for patient age, sex, race/ethnicity, U.S. region, comorbidities, and (models for type 2 diabetes only) glucose-lowering medications used.
DISCUSSION
In all four cohorts, the risk of death after glycemic emergencies increased substantially with age and was higher among patients with T2D than those with T1D, though the gap narrowed in older patients. Most concerning was the lack of improvement in mortality following glycemic emergencies over the past decade and the increase in all-cause mortality among patients with T2D experiencing hyperglycemic emergencies.
The lower risks of death per severe dysglycemic event among non-White patients with T2D experiencing hypoglycemic and hyperglycemic emergencies must be interpreted in the context of the higher frequency of hypoglycemic and hyperglycemic emergencies experienced by Black and Hispanic compared to White individuals at baseline.[9, 10] We hypothesize that this points to more frequent dysglycemic events precipitated by less serious, and thus more preventable, circumstances such as greater reliance on hypoglycemia-prone medications, gaps in use of diabetes technologies, and inadequate access to diabetes self-management education and primary and specialty diabetes care. Thus, while there was no independent association between race/ethnicity and mortality in T1D, Black patients with T1D died more frequently than patients from other racial/ethnic backgrounds. Together, our findings underscore the importance of addressing barriers to glycemic control and self-management in Black and Hispanic patients with diabetes.
This is one of the first studies to examine mortality in the aftermath of acute diabetes complications experienced during the COVID-19 pandemic amidst concerns about deferred care.[11] We found that in T1D, mortality after hypoglycemic emergencies was higher in 2020 than in prior years. Considered in context of lower incidence of ED/hospital visits for severe hypoglycemia in 2020,[12] these data suggest that patients’ increased hesitancy to call for medical assistance may have resulted in more severe events with higher risk of death.
Our study has important limitations. It was conducted among patients with established diabetes of at least one year’s duration. Administrative claims data cannot capture dysglycemic events that do not culminate in an ED visit or hospitalization,[13–15] and we did not assess the impact of recurrent or less severe events on risk of death. We only included hypoglycemic and hyperglycemic emergencies that were listed as primary diagnoses on ED or hospital claims, which excluded dysglycemic events occurring in conjunction with or secondary to other health events. This was intentional, as our objective was to focus on dysglycemic emergencies precipitated by suboptimal glycemic control and not another health event, as those are likely to be prevented with optimal diabetes care. Mortality in patients experiencing severe hypoglycemia or hyperglycemia secondary to another health event is likely to be higher, and these events likely are more common in people with type 2 diabetes who have a higher burden of multimorbidity. We could not establish the cause of death or discern the independent impact of hypoglycemic and hyperglycemic emergencies from other mortality risk factors, though we did adjust our analyses for health conditions and medications that are associated with the risk of death. Finally, our study population was comprised of commercially insured and Medicare Advantage beneficiaries in the U.S., such that study findings may not generalize to other populations and settings.
In summary, hypoglycemic and hyperglycemic emergencies are associated with substantial mortality in both T1D and T2D, particularly among patients ≥45 years. Further research should explore whether mortality risk can be reduced with case management, diabetes self-management education/support, increased use of diabetes technologies,[16] consistent access to glucagon,[17] and improved transitions of care.
ACKNOWLEDGEMENTS
Funding: This effort was funded the National Institute of Health National Institute of Diabetes and Digestive and Kidney Diseases grant number K23DK114497 (McCoy).
Role of Funder:
Study contents are the sole responsibility of the authors and do not necessarily represent the official views of NIH. The study sponsor had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication
Footnotes
Conflict of Interest: In the past 36 months, Dr. McCoy received support from NIDDK, PCORI, and AARP® for research unrelated to this work. She also serves as a consultant to Emmi® (Wolters Kluwer) on the development of patient education materials related to prediabetes and diabetes. Dr. Galindo received research support to Emory University for investigator-initiated studies outside of this work from Novo Nordisk, Dexcom and Eli Lilly and consulting fees from Sanofi, Eli Lilly, Pfizer, Boehringer, and Weight Watchers. He is also funded by NIDDK. Dr. Umpierrez is partly supported by research grants from the Clinical and Translational Science Award program and NIDDK and has received research support (to Emory University) unrelated to this work from Astra Zeneca, Bayer, Abbott, and Dexcom. Dr. O’Connor has received research support from NIDDK, NHLBI, NCI, NICHD, NIMH, NIDA, and PCORI and has served as an unpaid consultant to the World Health Organization. Dr. Golden has received research support from NIDDK and serves on the Health Equity Advisory for Medtronic, Inc, and for Abbott.
Prior Presentation. This work was presented as a poster at the American Diabetes Association 82nd Scientific Sessions in New Orleans, LA on June 4, 2022.
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