Evaluation of Extended Infusion Set Performance in Adults with Type 1 Diabetes: Infusion Set Survival Rate and Glycemic Outcomes from a Pivotal Trial.

Background: Standard insulin infusion sets (IISs) are to be replaced every 2 to 3 days to avoid complications and diabetic ketosis due to set failure. This pivotal trial evaluated the safety and performance of a new extended-wear infusion set (EIS) when used for 7 days by adults with type 1 diabetes (T1D). Methods: This single-arm, nonrandomized trial enrolled adults (18-80 years of age) with T1D, who used their own MiniMed™ 670G system with insulin lispro or insulin aspart and the EIS for up to 7 days, across 12 consecutive wears. Safety endpoints included incidence of serious adverse events (SAEs), serious adverse device effects (SADEs), unanticipated adverse device effects (UADEs), severe hypoglycemia (SevHypo), severe hyperglycemia (SevHyper), diabetic ketoacidosis (DKA), and skin infection. The EIS failure rate due to unexplained hyperglycemia (i.e., suspected occlusion), the overall EIS survival rate, glycemic control outcomes (i.e., A1C, mean sensor glucose and time spent in established glucose ranges), total daily insulin delivered, and satisfaction with the EIS were determined. Results: The intention to treat population (n = 259, 48% men, 45.0 ± 14.1 years) wore a total of 3041 EIS devices. No SADE, UADE, or DKA events was reported. Overall rates of SAEs, SevHypo, SevHyper, and skin infection were 3.8, 2.5, 104.1, and 20.1 events per 100 participant-years. The rate of EIS failure due to unexplained hyperglycemia at the end of day 7 was 0.1% (95% confidence interval [CI]: 0.03-0.51) and 0.4% (95% CI: 0.16-1.00) for insulin lispro and aspart use, respectively. Overall EIS survival rate at the end of day 7 was 77.8% (95% CI: 76.2-79.3), glycemic control did not change, and participants reported greater satisfaction with the EIS compared with standard IISs worn before the study (P < 0.001). Conclusions: This investigation demonstrates that the EIS, when worn for up to 7 days, was safe and rated with high satisfaction, without adversely affecting glycemic control in adults with T1D. Clinical Trial Registration number: NCT04113694 (https://clinicaltrials.gov/ct2/show/NCT04113694).

Clinical outcomes of atrial fibrillation with hyperthyroidism.

BACKGROUND: Atrial fibrillation (Afib) is a common cardiac manifestation of hyperthyroidism. The data regarding outcomes of Afib with and without hyperthyroidism are lacking. HYPOTHESIS: We hypothesized that patients with Afib and hyperthyroidism have better clinical outcomes, compared with Afib patients without hyperthyroidism. METHODS: We queried the National Inpatient Sample database for years 2015-2017 using Validated ICD-10-CM codes for Afib and hyperthyroidism. Patients were separated into two groups, Afib with hyperthyroidism and without hyperthyroidism. RESULTS: The study was conducted with 68 095 278 patients. A total of 9 727 295 Afib patients were identified, 90 635 (0.9%) had hyperthyroidism. The prevalence of hyperthyroidism was higher in patients with Afib (0.9% vs 0.4%, P < .001), compared with patients without Afib. Using multivariate regression analysis adjusting for various confounding factors, the odds ratio of Afib with hyperthyroidism was 2.08 (CI 2.07-2.10; P < .0001). Afib patients with hyperthyroidism were younger (71 vs 75 years, P < .0001) and more likely to be female (64% vs 47%; P < .0001) as compared with Afib patients without hyperthyroidism. Afib patients with hyperthyroidism had lower prevalence of CAD (36% vs 44%, P < .0001), cardiomyopathy (24.1% vs 25.9%, P < .0001), valvular disease (6.9% vs 7.4%, P < .0001), hypertension (60.7% vs 64.4%, P < .0001), diabetes mellitus (29% vs 32%, P < .0001) and obstructive sleep apnea (10.5% vs 12.2%, P < .0001). Afib with hyperthyroidism had lower hospitalization cost ($14 968 ± 21 871 vs $15 955 ± 22 233, P < .0001), shorter mean length of stay (5.7 ± 6.6 vs 5.9 ± 6.6 days, P < .0001) and lower in-hospital mortality (3.3% vs 4.8%, P < .0001. The disposition to home was higher in Afib with hyperthyroidism patients (51% vs 42; P < .0001). CONCLUSION: Hyperthyroidism is associated with Afib in both univariate and multivariate analysis. Afib patients with hyperthyroidism have better clinical outcomes, compared with Afib patients without hyperthyroidism.