Multicenter, Randomized Trial of a Bionic Pancreas in Type 1 Diabetes.

BACKGROUND: Currently available semiautomated insulin-delivery systems require individualized insulin regimens for the initialization of therapy and meal doses based on carbohydrate counting for routine operation. In contrast, the bionic pancreas is initialized only on the basis of body weight, makes all dose decisions and delivers insulin autonomously, and uses meal announcements without carbohydrate counting. METHODS: In this 13-week, multicenter, randomized trial, we randomly assigned in a 2:1 ratio persons at least 6 years of age with type 1 diabetes either to receive bionic pancreas treatment with insulin aspart or insulin lispro or to receive standard care (defined as any insulin-delivery method with unblinded, real-time continuous glucose monitoring). The primary outcome was the glycated hemoglobin level at 13 weeks. The key secondary outcome was the percentage of time that the glucose level as assessed by continuous glucose monitoring was below 54 mg per deciliter; the prespecified noninferiority limit for this outcome was 1 percentage point. Safety was also assessed. RESULTS: A total of 219 participants 6 to 79 years of age were assigned to the bionic-pancreas group, and 107 to the standard-care group. The glycated hemoglobin level decreased from 7.9% to 7.3% in the bionic-pancreas group and did not change (was at 7.7% at both time points) in the standard-care group (mean adjusted difference at 13 weeks, -0.5 percentage points; 95% confidence interval [CI], -0.6 to -0.3; P<0.001). The percentage of time that the glucose level as assessed by continuous glucose monitoring was below 54 mg per deciliter did not differ significantly between the two groups (13-week adjusted difference, 0.0 percentage points; 95% CI, -0.1 to 0.04; P<0.001 for noninferiority). The rate of severe hypoglycemia was 17.7 events per 100 participant-years in the bionic-pancreas group and 10.8 events per 100 participant-years in the standard-care group (P = 0.39). No episodes of diabetic ketoacidosis occurred in either group. CONCLUSIONS: In this 13-week, randomized trial involving adults and children with type 1 diabetes, use of a bionic pancreas was associated with a greater reduction than standard care in the glycated hemoglobin level. (Funded by the National Institute of Diabetes and Digestive and Kidney Diseases and others; ClinicalTrials.gov number, NCT04200313.).

Recurrent ventral curvature after corporoplasty with tunica vaginalis flap.

INTRODUCTION AND OBJECTIVE: Optimal means to correct ventral curvature (VC) is debated. Our preferred technique for curvature greater than 45° is corporoplasty using tunica vaginalis flap (TVF). We describe our complications with TVF for ventral lengthening. METHODS: Forty-four boys who underwent ventral lengthening with a corporoplasty with TVF were identified in a prospective database for proximal hypospadias repair by a single surgeon from 2008 to 2021. Corporotomy was performed by incising the tunica albuginea of the corpora cavernosa transversely at the point of maximum curvature. Harvested TVF was tailored to the size of the corporotomy and anastomosed to the edges of the tunica albuginea and on laid to the corporal defect with the mesothelial side of the TVF abutting the erectile tissue. RESULTS: Median age at surgery was 1.0 years (IQR 0.72-1.82). Median follow-up time was 4.9 years (IQR 2.6-8.0). Thirteen patients (27%) were older than 10 years of age at last follow up (median 13.3, range 10-20). Twenty-two boys (50%) received preoperative testosterone. The most common location of the meatus after degloving was penoscrotal (41%). Median VC after degloving was 90° (IQR 80-100). The urethral plate was transected in 43/44 (98%) of boys, improving median VC to 60° (IQR 40-60). After corporotomy, the median longitudinal distracted distance was 15 mm (IQR 12-17). Urethral reconstruction was most commonly achieved with the transverse island preputial flap technique or its modifications (39/44; 89%). Erections were reported in 42 boys (95%). None developed corporal diverticula, and two patients (4.5%) had ascended testis associated with TVF harvest. Seven percent of boys had recurrent ventral curvature (RVC; 3/44). Median RVC was 30° (IQR 30-45). One patient had RVC at the penoscrotal junction (not at site of prior corporoplasty) identified 11 years post operatively at age 15, and underwent dorsal plication. The other 2 patients were diagnosed less than 1 year post operatively. Both patients received testosterone due to small glans size, had double-face tubularized transverse island preputial flap as urethral and ventral skin coverage, and had endocrine and genetic consultation. Both had scarring of the preputial flap and of the corporoplasty. Scar excision and superficial transverse incisions on the tunica albuginea corrected RVC. CONCLUSIONS: The five-year outcome of ventral penile lengthening using TVF for corporoplasty is favorable with 7% of boys with RVC, and 4.5% with ascended testes associated with TVF harvest. None developed corporal diverticula.

Initial outcomes at a nascent tertiary pediatric thyroid surgical center.

OBJECTIVES: Previous studies on pediatric thyroid surgical complications suggest that high-volume centers achieve improved outcomes. We hypothesize that initial outcomes from a nascent pediatric surgical practice may be comparable to higher volume centers. Furthermore, we determine whether a low-volume center can safely transition to an intermediate or high-volume center. METHODS: A retrospective chart review was performed for all pediatric patients undergoing thyroid surgery at a single institution from 2014 to 2020. Surgeries were performed by two pediatric otolaryngologists. All patients were managed postoperatively by a multidisciplinary team of physicians that included pediatric otolaryngologists and endocrinologists. Data collection focused on patient demographics and postoperative complications, including rates of recurrent laryngeal nerve injury and permanent hypoparathyroidism. RESULTS: From 2014 to 2020, a total of 31 patients underwent thyroid surgery at our pediatric thyroid surgery center, 9 of whom underwent neck dissection. The mean age of our cohort was 14.4 ± 3.9 years (range 8 months-20 years). Postoperative pathology results revealed that 15 patients (46.9%) were diagnosed with PTC, 6 (18.8%) with follicular adenoma, and 4 (15.6%) with benign thyroid tissue. One (2.0%) patient had permanent unilateral recurrent laryngeal nerve paralysis and one patient experienced permanent hypoparathyroidism (2.7%). CONCLUSIONS: Our initial low complication rate as a nascent pediatric thyroid surgery center suggests that favorable outcomes can be achieved at lower volume surgery centers. In order to increase patient access to high-volume pediatric thyroid surgery centers, new centers must start with lower volumes before ultimately becoming high-volume centers. Our study shows that this can be safely achieved. LEVEL OF EVIDENCE: IV.

Preferences of Type 1 Diabetic Patients on Devices for Islet Transplantation.

Transplantation of pancreatic islets within a biomaterial device is currently under investigation in clinical trials for the treatment of patients with type 1 diabetes (T1D). Patients' preferences on such implants could guide the designs of next-generation implantable devices; however, such information is not currently available. We surveyed the preferences of 482 patients with T1D on the size, shape, visibility, and transplantation site of islet containing implants. More than 83% of participants were willing to receive autologous stem cells, and there was no significant association between implant fabricated by one's own stem cell with gender (χ2 (1, n = 468) = 0.28; P = 0.6) or with age (χ2 (4, n = 468) = 2.92; P = 0.6). Preferred location for islet transplantation within devices was under the skin (52.7%). 48.3% preferred microscopic disks, and 32.3% preferred a thin device (like a credit card). Moreover, 58.4% preferred the implant to be as small as possible, 25.4% did not care about visibility, and 16.2% preferred their implants not to be visible. Among female participants, 81% cared about the implant visibility, whereas this number was 64% for male respondents (χ2 test (1, n = 468) = 16.34; P < 0.0001). 22% of those younger than 50 years of age and 30% of those older than 50 did not care about the visibility of implant (χ2 test (4, n = 468) = 23.69; P < 0.0001). These results suggest that subcutaneous sites and micron-sized devices are preferred choices among patients with T1D who participated in our survey.