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.

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.

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

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. Qualitative template analysis of narrative data in a 20% stratified random sample ( = 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™. Of the 2429 AEs, 92% included a clinical consequence in the narrative description, with critical hyperglycemia (i.

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

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. 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.

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

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. 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.

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.