Severe Insulin Pump-Related Adverse Events: Potential Root Causes and Impact of the COVID-19 Pandemic.

OBJECTIVE: To explore insulin pump-associated severe adverse events (SAEs) involving intensive care unit (ICU) admissions and deaths and examine the impact of the COVID-19 pandemic on these SAEs. METHODS: Qualitative template analysis of narrative data in reported insulin pump-associated SAEs occurring between May 1, 2019, and January 31, 2021, involving MiniMed 670G, MiniMed 630G, Omnipod, Omnipod DASH, and t:slim X2 insulin pumps. RESULTS: Over the 21-month measurement period, 460 SAEs involving an ICU admission and 288 SAEs involving a death were reported to the Food and Drug Administration. Problems with the pump or pod reservoir/cartridge were among the most frequently cited potential root causes in SAEs involving ICU admissions and deaths overall. However, problems with the infusion set or site and the pump battery or power emerged in the top three potential root causes of SAEs involving an ICU admission, whereas the patient sleeping at the time of the event and the tasks of changing the pod/infusion set, including reservoir/cartridge and programming the pump emerged in the top three for SAEs involving a death. The median monthly number of reported SAEs involving ICU admissions and deaths decreased during the pandemic, but their potential root causes were unchanged. CONCLUSIONS: Although insulin pumps are generally safe, SAEs related to their components and external factors can and do occur. By learning from the potential root causes of insulin pump-associated SAEs, providers and patients can implement corrective actions to prevent future events, thereby reducing harm.

Insulin Pump Alarms During Adverse Events: A Qualitative Descriptive Study.

OBJECTIVE: Explore alarm signals cited in insulin pump-associated adverse events (AEs), describe the clinical consequences and other root cause informing remarks that cooccurred with the alarm signals, and identify opportunities for improvements to patient education, instructional materials, and alarm systems to prevent future AEs. RESEARCH DESIGN AND METHODS: We explored the type, frequency, and associated clinical consequences of alarm signals cited in a pre-coded data set of 2294 insulin pump-associated AEs involving the MiniMed 670G, MiniMed 630G, and t:slim X2. We also explored the clinical consequences and other root cause informing remarks that cooccurred with the top 10 most frequently cited alarm signals. RESULTS: Overall, 403 AEs narratives cited at least one alarm signal. Of the 40 unique alarm signals cited, 42.5% were "alarms," 25.0% were "alerts," and 32.5% were not referenced in the instructional materials packaged with the corresponding pump. The top 10 most frequently cited alarm signals included two obstruction of flow alarms, which accounted for 49.9% of all AEs citing at least one alarm, and two unreferenced alarms. The most frequent cooccurring root cause informing remark varied across the top 10 alarm signals and revealed valuable insight into why these alarms may have occurred. CONCLUSIONS: Our findings demonstrate the value of analyzing alarm signals cited in insulin pump-associated AEs and reveal multiple opportunities for providers to educate patients on how to respond to alarm signals and manage their pumps to avoid AEs, and for insulin pump manufacturers to update instructional materials and improve alarm systems to support appropriate patient response.

Insulin Pump-Associated Adverse Events: A Qualitative Descriptive Study of Clinical Consequences and Potential Root Causes.

Objective: To explore the clinical consequences and potential root causes of insulin pump-associated adverse events (AEs) reported in the Food and Drug Administration's Manufacturer and User Facility Device Experience (MAUDE) database. Research Design and Methods: Qualitative template analysis of narrative data in a 20% stratified random sample (n = 2429) of reported AEs that occurred during the first 6 months of 2020 involving five insulin pump models marketed at that time: (1) MiniMed™ 670G, (2) MiniMed™ 630G, (3) Omnipod®, (4) Omnipod DASH®, and (5) t:slim X2™. Results: Of the 2429 AEs, 92% included a clinical consequence in the narrative description, with critical hyperglycemia (i.e., blood glucose [BG] >400 mg/dL; 47%) and critical hypoglycemia (i.e., BG <54 mg/dL; 24%) being the most common consequence cited. Only 50% of the AE narratives included information to support the identification of a root cause. The most cited root cause informing remarks were issues with the pump or pod reservoir/cartridge (9%), the occurrence of an obstruction of flow alarm (8%), and problems with the infusion set or site (8%). Some clinical consequences and root cause informing remarks were cited more frequently in AE narratives involving specific insulin pump models, but manufacturer variability in the amount and type of information reported may have affected these findings. Conclusions: Our findings show general themes found in insulin pump-associated AE that providers can use to raise patient awareness of potential risks associated with insulin pump use and develop strategies to prevent future AEs. Improvements in AE investigation and reporting processes are still necessary.

Cost-effectiveness of empagliflozin versus weekly semaglutide as add-on therapy for Type 2 diabetes.

Aim: Perform a cost-effectiveness analysis of addition of subcutaneous semaglutide versus empagliflozin to usual treatment for patients with Type 2 diabetes and cardiovascular disease in US setting. Materials & methods: A Markov decision model estimated the impact of each strategy using cardiovascular complication rates based on EMPA-REG and SUSTAIN-6 trials. Modeled cohorts were followed for 3 years at 1-month intervals beginning at age 66. Results: Compared with empagliflozin, semaglutide resulted in cost of US$19,964 per quality-adjusted life-year gained. In one-way sensitivity analysis, only semaglutide cost >US$36.25/day (base case US$18.04) resulted in empagliflozin being preferred at a willingness-to-pay threshold of US$50,000/quality-adjusted life-year gained. Conclusion: For patients with Type 2 diabetes and cardiovascular disease, semaglutide is likely more cost-effective than empagliflozin added to usual treatment.

ADDRESSING PITFALLS IN MANAGEMENT OF DIABETIC KETOACIDOSIS WITH A STANDARDIZED PROTOCOL.

Objective: To determine the efficacy and safety of a diabetic ketoacidosis (DKA)-Power Plan (PP) for guiding intravenous (IV) insulin infusions prior to anion gap (AG) closure and administering subcutaneous (SC) insulin ≥1 hour before discontinuing IV insulin. Methods: Retrospective chart review of patients with DKA before (pre-PP) (n = 60) and following (post-PP) (n = 60) implementation of a DKA-PP. Groups were compared for percentage of patients for whom IV insulin therapy was continued until AG closure, the percentage of patients receiving SC insulin ≥1 hour before discontinuation of IV insulin, and percentage of patients with rebound DKA during the index hospitalization. Results: Admission plasma glucose (514 mg/dL vs. 500 mg/dL; P = .36) and venous pH (7.2 vs. 7.2; P = .57) were similar in pre- and post-PP groups. Inappropriate discontinuation of IV insulin occurred less frequently in post-PP patients (28% vs. 7%; P = .007), with a lower frequency of rebound DKA (40% vs. 8%; P = .001) following acute management. More post-PP patients received SC insulin ≥1 hour before discontinuation of IV insulin (65% vs. 78%; P = .05). Conclusion: Implementation of a DKA-PP was associated with appropriate discontinuation of IV insulin in more patients, more frequent administration of SC insulin ≥1 hour prior to discontinuation of IV insulin, and fewer episodes of rebound DKA. Abbreviations: ADA = American Diabetes Association; AG = anion gap; BG = blood glucose; DKA = diabetic ketoacidosis; DKA-PP = DKA-Power Plan; ICU = intensive care unit; IQR = interquartile range; IV = intravenous; IVF = IV fluid; LOS = length of stay; SC = subcutaneous.

Management of Refractory Noninsulinoma Pancreatogenous Hypoglycemia Syndrome with Gastric Bypass Reversal: A Case Report and Review of the Literature.

Background. Roux-en-Y gastric bypass (RYGB) is a commonly performed, effective bariatric procedure; however, rarely, complications such as postprandial hypoglycemia due to noninsulinoma pancreatogenous hypoglycemia syndrome (NIPHS) may ensue. Management of refractory NIPHS is challenging. We report a case that was successfully treated with RYGB reversal. Case Report. A 58-year-old male with history of RYGB nine months earlier for morbid obesity presented for evaluation of postprandial, hypoglycemic seizures. Testing for insulin level, insulin antibodies, oral hypoglycemic agents, pituitary axis hormone levels, and cortisol stimulation was unrevealing. Computed tomography (CT) scan of the abdomen was unremarkable. A 72-hour fast was completed without hypoglycemia. Mixed meal testing demonstrated endogenous hyperinsulinemic hypoglycemia (EHH) and selective arterial calcium stimulation testing (SACST) was positive. Strict dietary modifications, maximal medical therapy, gastrostomy tube feeding, and stomal reduction failed to alleviate symptoms. Ultimately, he underwent laparoscopic reversal of RYGB. Now, 9 months after reversal, he has markedly reduced hypoglycemia burden. Discussion. Hyperfunctioning islets secondary to exaggerated incretin response and altered intestinal nutrient delivery are hypothesized to be causative in NIPHS. For refractory cases, there is increasing skepticism about the safety and efficacy of pancreatic resection. RYGB reversal may be successful.