Background: Many patients with type 2 diabetes mellitus (T2DM) do not have adequate glycemic control, leading to poor patient outcomes and high healthcare costs. Objective: This prospective pragmatic clinical trial evaluated V-Go, a wearable insulin delivery device, compared with standard treatment optimization (STO) among insulin-treated patients with T2DM in a realworld, community-based practice setting. Methods: Study sites, rather than individual patients, were randomized to V-Go or STO via cluster randomization. Patients were treated according to routine clinical practice and followed up to 4 months. T2DM medications and supplies were purchased utilizing usual insurance and co-pay systems. The primary analysis was an unadjusted treatment group comparison of glycosylated hemoglobinA1c (HbA1c) change from baseline to end of study (EOS). A cost of therapy analysis was completed on patients who had received comparable baseline T2DM treatment with multiple daily basal-bolus insulin injections (MDI). Results: Analysis included 415 patients (169 V-Go, 246 STO) enrolled from 52 US sites. Mean baseline HbA1c (9.6%) was higher in V-Go (9.9%, range 8.0% - 14.2%) than STO (9.3%, range 7.9% - 13.9%, p <.001). HbA1c decreased from baseline to EOS in both V-Go (-1.0%, p<.001) and STO (-0.5%, p<.001); V-Go had significantly larger decrease (p=.002). V-Go had a significant reduction (p<.001) in mean insulin total daily dose (TDD; 0.76 U/kg baseline, 0.57 U/kg EOS), not seen in STO (0.72 U/kg baseline and EOS). The MDI group included 95 (56.2%) V-Go and 113 STO (45.9%) patients. Mean baseline HbA1c was significantly higher in V-Go (9.9%) than STO (9.4%). V-Go also experienced larger decrease in HbA1c from baseline (-1.0%) than STO (-0.36%) (p=.006) with a decrease in TDD, while STO TDD remained unchanged. EOS mean per patient per day cost of diabetes treatment was lower for V-Go ($30.59) vs STO ($32.20) (p=.006). V-Go was more cost effective than STO ($24.02 per 1% drop in HbA1c vs $58.86, respectively). Conclusions: This pragmatic clinical trial demonstrated improved HbA1c levels, lower cost, and decreased insulin dose in patients with T2DM initiating V-Go vs STO in a real-world community-based practice setting. Observed baseline HbAlc indicated use of V-Go in more difficult to manage diabetes patients.
By the mean of a prospective multicenter observational study (East German Gastric Cancer Study - EGGCS), 1 139 consecutive patients with gastric cancer were enrolled in 80 East German surgical departments from January 1 to December 31, 2002. Out of them, 1,031 (90.5%) underwent surgical intervention. The resection rate was 86.4% (n = 891); the R0 resection rate (n = 726) was 81.5%. Gastrectomy was performed in 79.8 % (n = 649) of subjects with radical resections (n = 813). In approximately 70 % of the interventions with curative intention, lymph node resection of the D2 compartment was carried out. The postoperative hospital mortality was 8.3%. The results were compared with the data obtained in the German Gastric Cancer Study (GGCS 1992); relevant differences and aspects were discussed.
Lymphangiomas are rare benign tumors. In most cases, resection is necessary to obtain a precise histopathological analysis. There are capillary, caverous and cystic lymphangiomas. The therapy of choice is a complete excision. Recurrence has been reported after incomplete resection. We present the case of a 45-year-old man with a lymphangioma of the omentum minus and -review the literature.
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