Basal–Prandial Insulin Delivery in Type 2 Diabetes Mellitus via the V-Go?: A Novel Continuous Subcutaneous Infusion Device

Background

The V-Go™ is a once-daily disposable device that allows coverage of basal and prandial insulin requirements over a period of 24 hours. The aim of this proof-of-concept study was to evaluate the clinical functionality, safety, and pharmacodynamics of the V-Go delivering insulin aspart and redistributing a single basal dose of insulin glargine as a constant basal infusion supplemented with prandial insulin in subjects with type 2 diabetes mellitus.

Methods

In six subjects receiving once-daily subcutaneous (SC) injections of insulin glargine (≥15 U/day) with or without concomitant oral antidiabetic drugs, glargine was discontinued following a 3-day baseline phase. The V-Go was then applied to the lower abdomen of the subjects once daily for 7 days (days 1–3 inpatient, days 4–7 outpatient). Each V-Go provided a continuous 24-hour preset basal infusion rate of insulin aspart (0.6 U/h) and up to three daily prandial doses at mealtimes. Capillary blood glucose concentrations were measured at 11 time points per day during the baseline and inpatient phases and at 4 time points per day during the outpatient phase. Additionally, glucose profiles were measured continuously on all days.

Results

The V-Go was well tolerated and operated as anticipated. The mean ± SEM prestudy daily dose of SC insulin glargine was 33.3 ± 13.8 U; the mean daily total insulin aspart dose infused with the V-Go was 31.5 ± 7.5 and 32.3 ± 7.8 U for the inpatient and outpatient periods, respectively. Fasting blood glucose values were similar to those observed at baseline throughout the study, with nonsignificant (NS) reductions in readings collected during the outpatient phase before lunch (-35 ± 27 mg/dl) and before dinner (-38 ± 25 mg/dl). The 2-hour postprandial glucose trended lower from 231 to 195 mg/dl (NS) at breakfast, 234 to 166 mg/dl (NS) at lunch, and 222 to 171 mg/dl (NS) at dinner. Bedtime blood glucose decreased (mean change from baseline -52 ± 21 mg/dl; P = 0.0313), as did nighttime (3:00 AM) measurements (-20 ± 9 mg/dl; P = 0.0313). Overall glycemic control tended to improve, as shown by continuous glucose monitoring changing from 173 to 157 mg/dl (P = 0.063, NS) and 156 mg/dl (P = 0.219) during inpatient and outpatient periods, respectively. Glycemic variability assessed by the M value similarly tended to decrease from 33 ± 9 to 25 ± 4 (NS) and 21 ± 4 (NS) for inpatient and outpatient periods, respectively.

Conclusions

These first data suggest that use of the V-Go is an attractive alternative to SC insulin injection therapy because metabolic control appears to be maintained or even improved without increasing daily insulin doses.     

Electromagnetic Environmental Effects Testing of Medical Devices Including Those Used for the Treatment of Diabetes

Background

Electromagnetic emissions from technologies that surround us can produce interference with implanted and externally worn medical devices. Electromagnetic environmental effects (E3) testing of medical devices at the Georgia Tech Research Institute (GTRI) began almost four decades ago and continues to incorporate new devices and new sources of electromagnetic emissions as they are developed and become available. The GTRI Medical Device Test Center provides real-world exposure fields to identify interactions and help manufacturers prevent disruptions from the environments in which their devices must function.

Methods

Typically, the medical device is mounted in or on a torso simulator containing a saline solution that simulates the electrical characteristics of the body. The torso simulator and the device under test are then moved through the fields generated by production security and logistical system technologies using a computer-controlled positioning system. These tests are conducted with different orientations of the medical device to the electromagnetic source, simulating the way in which device wearers interact with these systems in representative situations.

Results

Particular E3 test results measured on specific devices in the GTRI Medical Device Test Center are proprietary; however, the results of tests to date with current medical devices used for the treatment of diabetes have been encouraging. These devices have included implantable and externally worn insulin infusion pumps and continuous glucose monitoring systems from different manufacturers.

Conclusion

Since E3 tests of diabetes treatment devices to date in the test center have centered on devices from only a few of the many current manufacturers, further testing is warranted. In addition, increased functionality, which is being added to existing devices, will create new possibilities for interference in the future.     

Determination of immunoreactive somatostatin in rat plasma and responses to arginine,glucose and glucagon infusion

Summary A method for the determination of immunoreactive somatostatin in rat plasma is described. Blood specimens were collected into aprotinin and EDTA. Plasma was separated, immediately diluted with acidified acetone and ultrasonicated. The resultant supernatant was lyophilised. The dilution curve of the material thus extracted was parallel to that of synthetic somatostatin. The material was eluted mainly in a similar position to that of synthetic somatostatin on Sephadex G-25 (f) column chromatography. The somatostatin immunoreactivity was degraded significantly from the pre-incubated value of 846±86 pg/ml (n=4, mean±SEM) to 102±16 pg/ml in the same manner as that of synthetic somatostatin when incubated with one ml of fresh rat plasma at 37 °C for 30 min. The mean recovery in quadruplicate of immunoreactive somatostatin at concentrations of 100, 200 and 400 pg/ml was 83±7, 95±4 and 76±4%, respectively. Using this method, plasma immunoreactive somatostatin responses to arginine, glucose and glucagon infusion were measured in pentobarbital anaesthetized rats. The mean basal plasma immunoreactive somatostatin concentration in the jugular vein was 35±3 pg/ml (n=7), while that in the hepatic portal vein was 120±17 pg/ml (n=7). Infusion of arginine, glucose and glucagon all resulted in 2–3 fold increases in portal plasma immunoreactive somatostatin concentration.     

Management of Pediatric Migraine Headache in the Emergency Room and Infusion Center

Migraine is a common disorder that starts at an early age and takes a variable pattern from intermittent to chronic headache with several exacerbations throughout a lifetime. Children and adolescents are significantly affected. If an acute headache is not aborted by outpatient migraine therapy, it often causes severe disability, preventing the child from attending school and social events. Treating the acute severe headache aggressively helps prevent prolonged disability as well as possible chronification. Multiple medications are available, mostly for the outpatient management of an attack and include the use of over‐the‐counter anti‐inflammatory medications as well as prescribed medications in the triptan group. These therapies do sometime fail and the exacerbation can last from days to weeks. If the headache lasts 72 hours or longer it will fall in the category of status migrainosus. Status migrainosus is described as a severe disabling headache lasting 72 hours or more by the ICHD3 criteria. Disability is a major issue in children and adolescents and aggressive acute measures are to be taken to control it as soon as possible. Early aggressive intravenous therapy can be very effective in breaking the attack and allowing the child to be quickly back to normal functioning. This article reviews what is available for the treatment of pediatric primary headaches in the emergency room.     

Teaching facial fracture repair: A novel method of surgical skills training using three-dimensional biomodels

BACKGROUND:

The facial fracture biomodel is a three-dimensional physical prototype of an actual facial fracture. The biomodel can be used as a novel teaching tool to facilitate technical skills training in fracture reduction and fixation, but more importantly, can help develop diagnostic and management competence.

OBJECTIVE:

To introduce the ‘facial fracture biomodel’ as a teaching aid, and to provide preliminary evidence of its effectiveness in teaching residents the principles of panfacial fracture repair.

METHODS:

Computer three-dimensional image processing and rapid prototyping were used to generate an accurate physical model of a panfacial fracture, mounted in a silicon ‘soft tissue’ base. Senior plastic surgery residents in their third, fourth and fifth years of training across Canada were invited to participate in a workshop using this biomodel to simulate panfacial fracture repair. A short didactic presentation outlining the ‘patient’s’ clinical and radiological findings, and key principles of fracture repair, was given by a consultant plastic surgeon before the exercise. The residents completed a pre- and postbiomodel questionnaire soliciting information regarding background, diagnosis and management, and feedback.

RESULTS:

A total of 29 residents completed both pre- and postbiomodel questionnaires. Statistically significant results were found in the following areas: diagnosis of all fracture patterns (P=8.2×10⁻⁷ [t test]), choice of incisions for adequate exposure (P=0.04 [t test]) and identifying sequence of repair (P=0.019 [χ² test]). Subjective evaluation of workshop effectiveness revealed a statistically significant increase in ‘comfort level’ only among third year trainees. Overall, positive feedback was reported among all participants.

CONCLUSIONS:

Biomodelling is a promising ancillary teaching aid that can assist in teaching residents technical skills, as well as how to assess and plan surgical repair.     

Selecting the best and brightest: A comparison of residency match processes in the United States and Canada

BACKGROUND:

Selecting candidates for plastic surgery residency training remains a challenge. In the United States, academic measures (United States Medical Licensing Exam Step I scores, medical school class rank and publications) are used as primary criteria for candidate selection for residency. In contrast, Canadian medical education de-emphasizes academic measures by using a pass-fail grading system. As a result, choosing residents from many qualified applicants may pose a challenge for Canadian programs without objective measures of academic success.

METHODS:

A 25-question online survey was distributed to program directors of Canadian plastic surgery residency-training programs. Program directors commented on number of yearly residents and applicants; application sections (ranked in importance using a Likert scale); interview invitation and rank-order list determination; and their satisfaction with the selection process.

RESULTS:

Ten Canadian plastic surgery program directors responded (90.9% response rate). The most important application components determining invitation to interview were letters of reference from a plastic surgeon (mean importance of 5.0 on the Likert scale), clinical electives in plastic surgery (mean 4.6) and electives with their program (mean 4.5). Applicants invited for interview were assessed on the quality of their responses to questions, maturity and personality. The majority of program directors agreed that a clinical elective with their program was important for consideration on their rank-order list. Program directors were neutral on their satisfaction with the selection process.

CONCLUSION:

Canadian plastic surgery residency programs emphasize clinical electives with their program and letters of reference from colleagues when selecting applicants for interviews. In contrast to their American counterparts, Canadian program directors rely on clinical interactions with prospective residents in the absence of objective academic measures.     

超声引导下腹横肌平面阻滞复合瑞芬太尼靶控输注在胰管结石体外震波碎石术中的应用

目的 评价超声引导下腹横肌平面阻滞联合瑞芬太尼靶控输注应用于胰管结石体外震波碎石术(ESWL)中的效果。方法 随机选择60例首次接受ESWL治疗胰管结石的患者,分为R组和TR组(每组n=30)。R组患者仅接受瑞芬太尼靶控输注(TCI),TR组患者接受瑞芬太尼TCI前30min接受超声引导下腹横肌平面阻滞。采用Dixon序贯法计算两组患者的瑞芬太尼半数有效量(EC₅₀),记录患者围术期视觉模拟疼痛量表(VAS)、Ramsay镇静量表、血流动力学参数、呼吸参数和不良事件。结果 R组和TR组患者瑞芬太尼EC₅₀分别为3.448ng/ml(95%CI:1.636~3.946)和2.523ng/ml(95%CI:0.744~2.991),差异具有统计学意义(P＜0.05)。两组患者疼痛和镇静评分相当。两组患者血流动力学和呼吸参数均无明显差异。与R组相比,TR组不良事件发生率更低(10% vs 56.7%,P＜0.001),瘙痒发生率更低(6.7% vs 26.7%,P=0.038)。结论 腹横肌平面阻滞联合瑞芬太尼靶控输注可为胰管结石ESWL提供满意的镇痛和镇静,且不良事件发生率更低。     

Telemedicine and type 1 diabetes: Is technology per se sufficient to improve glycaemic control?

AimIn the TELEDIAB-1 study, the Diabeo system (a smartphone coupled to a website) improved HbA_1c by 0.9% vs controls in patients with chronic, poorly controlled type 1 diabetes. The system provided two main functions: automated advice on the insulin doses required; and remote monitoring by teleconsultation. The question is: how much did each function contribute to the improvement in HbA_1c?MethodsEach patient received a smartphone with an insulin dose advisor (IDA) and with (G3 group) or without (G2 group) the telemonitoring/teleconsultation function. Patients were classified as “high users” if the proportion of “informed” meals using the IDA exceeded 67% (median) and as “low users” if not. Also analyzed was the respective impact of the IDA function and teleconsultations on the final HbA_1c levels.ResultsAmong the high users, the proportion of informed meals remained stable from baseline to the end of the study 6 months later (from 78.1 ± 21.5% to 73.8 ± 25.1%; P = 0.107), but decreased in the low users (from 36.6 ± 29.4% to 26.7 ± 28.4%; P = 0.005). As expected, HbA_1c improved in high users from 8.7% [range: 8.3–9.2%] to 8.2% [range: 7.8–8.7%] in patients with (n = 26) vs without (n = 30) the benefit of telemonitoring/teleconsultation (−0.49 ± 0.60% vs −0.52 ± 0.73%, respectively; P = 0.879). However, although HbA_1c also improved in low users from 9.0% [8.5–10.1] to 8.5% [7.9–9.6], those receiving support via teleconsultation tended to show greater improvement than the others (−0.93 ± 0.97 vs −0.46 ± 1.05, respectively; P = 0.084).ConclusionThe Diabeo system improved glycaemic control in both high and low users who avidly used the IDA function, while the greatest improvement was seen in the low users who had the motivational support of teleconsultations.