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OBJECTIVE To evaluate glucose control using fast-acting insulin aspart (faster aspart) compared with insulin aspart (IAsp) delivered by the MiniMed Advanced Hybrid Closed-Loop (AHCL) system in adults with type 1 diabetes. RESEARCH DESIGN AND METHODS In this randomized, open-label, crossover study, participants were assigned to receive faster aspart or IAsp in random order. Stages 1 and 2 comprised of 6 weeks in closed loop, preceded by 2 weeks in open loop. This was followed by stage 3, whereby participants changed directly back to the insulin formulation used in stage 1 for 1 week in closed loop. Participants chose their own meals except for two standardized meal tests, a missed meal bolus and late meal bolus. The primary outcome was the percentage of time sensor glucose values were from 70 to 180 mg/dL (time in range [TIR]). RESULTS Twenty-five adults (52% male) were recruited; the median (interquartile range) age was 48 (37, 57) years, and the median HbA1c was 7.0% (6.6, 7.2) (53 [49, 55] mmol/mol). Faster aspart demonstrated greater overall TIR compared with IAsp (82.3% [78.5, 83.7] vs. 79.6% [77.0, 83.4], respectively; mean difference 1.9% [0.5, 3.3]; P = 0.007). Four-hour postprandial glucose TIR was higher using faster aspart compared with IAsp for all meals combined (73.6% [69.4, 80.2] vs. 72.1% [64.5, 78.5], respectively; median difference 3.5% [1.0, 7.3]; P = 0.003). There was no ketoacidosis or severe hypoglycemia. CONCLUSIONS Faster aspart safely improved glucose control compared with IAsp in a group of adults with well-controlled type 1 diabetes using AHCL. The modest improvement was mainly related to mealtime glycemia. While the primary outcome demonstrated statistical significance, the clinical impact may be small, given an overall difference in TIR of 1.9%.
The results of investigations in 50 impotent patients with neurological disease are presented. Using intracorporeal papaverine, Doppler duplex scanning, cardiovascular reflex testing and skin thermal threshold monitoring, the vascular and neurological components were assessed in each of three clinical groups with probable or overt neuropathy. These comprised spinal injury, diabetes and pelvic trauma. Anatomical detail of the penis was well seen using these techniques. In 15 patients with spinal injuries, although the aetiology was predominantly neurological, six exhibited poor flow in the deep penile arteries following injection of papaverine. This was associated with poor erections in these patients, suggesting a vascular pathology. In 27 patients with diabetes the results showed a mixed pattern. Vascular disease was almost universal, combined with varying degrees of autonomic and peripheral neuropathy, and only three had full erections with papaverine. Those with pelvic trauma (8 patients) also had a mixed picture, although some had good erections following papaverine injection. Duplex Doppler scanning of the deep penile arteries correlated with the quality of papaverine-induced erection. Thermal testing was a highly sensitive indicator of small nerve fibre dysfunction, possibly at an earlier stage than standard autonomic testing. A vascular component to impotence was shown to be common in those with neurological impairment, and may alter management.
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