Early Metformin in Gestational Diabetes: A Randomized Clinical Trial.

Importance: Gestational diabetes is a common complication of pregnancy and the optimal management is uncertain. Objective: To test whether early initiation of metformin reduces insulin initiation or improves fasting hyperglycemia at gestation weeks 32 or 38. Design, Setting, and Participants: Double-blind, placebo-controlled trial conducted in 2 centers in Ireland (one tertiary hospital and one smaller regional hospital). Participants were enrolled from June 2017 through September 2022 and followed up until 12 weeks' postpartum. Participants comprised 510 individuals (535 pregnancies) diagnosed with gestational diabetes based on World Health Organization 2013 criteria. Interventions: Randomized 1:1 to either placebo or metformin (maximum dose, 2500 mg) in addition to usual care. Main Outcomes And Measures: The primary outcome was a composite of insulin initiation or a fasting glucose level of 5.1 mmol/L or greater at gestation weeks 32 or 38. Results: Among 510 participants (mean age, 34.3 years), 535 pregnancies were randomized. The primary composite outcome was not significantly different between groups and occurred in 150 pregnancies (56.8%) in the metformin group and 167 pregnancies (63.7%) in the placebo group (between-group difference, -6.9% [95% CI, -15.1% to 1.4%]; relative risk, 0.89 [95% CI, 0.78-1.02]; P = .13). Of 6 prespecified secondary maternal outcomes, 3 favored the metformin group, including time to insulin initiation, self-reported capillary glycemic control, and gestational weight gain. Secondary neonatal outcomes differed by group, with smaller neonates (lower mean birth weights, a lower proportion weighing >4 kg, a lower proportion in the >90% percentile, and smaller crown-heel length) in the metformin group without differences in neonatal intensive care needs, respiratory distress requiring respiratory support, jaundice requiring phototherapy, major congenital anomalies, neonatal hypoglycemia, or proportion with 5-minute Apgar scores less than 7. Conclusion and relevance: Early treatment with metformin was not superior to placebo for the composite primary outcome. Prespecified secondary outcome data support further investigation of metformin in larger clinical trials. Trial Registration: ClinicalTrials.gov Identifier: NCT02980276; EudraCT: 2016-001644-19.

Bites by the noble false widow spider Steatoda nobilis can induce Latrodectus-like symptoms and vector-borne bacterial infections with implications for public health: a case series.

CONTEXT: In recent years, the Noble false widow spider Steatoda nobilis (Thorell, 1875) has expanded its range globally and may represent a potential threat to native ecosystems and public health. Increasing numbers in synanthropic habitats have led to more human encounters and envenomations. Steatoda nobilis bites were previously classed as medically significant with similarities to bites from true black widows of the genus Latrodectus but deemed milder in onset, with symptoms generally ranging from mild to moderate. CASE DETAILS: In this manuscript we present 16 new cases of S. nobilis envenomations bringing the total number of confirmed cases reported in the literature to 24. We report new symptoms and provide discussion on the contributing factors to pathology following bites by S. nobilis. DISCUSSION: We report a range of pathologies including necrosis, Latrodectus-like envenomation symptoms that include debilitating pain, tremors, fatigue, nausea, hypotension, and vectored bacterial infections including cellulitis and dermatitis. Symptoms ranged from mild to severe, requiring hospitalisation in some cases.

A programmable and portable NMES device for drop foot correction and blood flow assist applications.

The Duo-STIM, a new, programmable and portable neuromuscular stimulation system for drop foot correction and blood flow assist applications is presented. The system consists of a programmer unit and a portable, programmable stimulator unit. The portable stimulator features fully programmable, sensor-controlled, constant-voltage, dual-channel stimulation and accommodates a range of customized stimulation profiles. Trapezoidal and free-form adaptive stimulation intensity envelope algorithms are provided for drop foot correction applications, while time dependent and activity dependent algorithms are provided for blood flow assist applications. A variety of sensor types can be used with the portable unit, including force sensitive resistor-based foot switches and MEMS-based accelerometer and gyroscope devices. The paper provides a detailed description of the hardware and block-level system design for both units. The programming and operating procedures for the system are also presented. Finally, functional bench test results for the system are presented.

A programmable and portable NMES device for drop foot correction and blood flow assist applications.

The Duo-STIM, a new, programmable and portable neuromuscular stimulation system for drop foot correction and blood flow assist applications is presented. The system consists of a programmer unit and a portable, programmable stimulator unit. The portable stimulator features fully programmable, sensor-controlled, constant-voltage, dual-channel stimulation and accommodates a range of customized stimulation profiles. Trapezoidal and free-form adaptive stimulation intensity envelope algorithms are provided for drop foot correction applications, while time dependent and activity dependent algorithms are provided for blood flow assist applications. A variety of sensor types can be used with the portable unit, including force sensitive resistor based foot switches and NMES based accelerometer and gyroscope devices. The paper provides a detailed description of the hardware and block-level system design for both units. The programming and operating procedures for the system are also presented. Finally, functional bench test results for the system are presented.

The development of a potential optimized stimulation intensity envelope for drop foot applications.

An optimized stimulation intensity envelope for use in hemiplegic drop foot applications has been developed. The traditional trapezoidal stimulation intensity approach has been examined and found to be inconsistent with the muscle activity patterns observed in healthy gait and therefore unsuitable. Experimental functional electrical stimulation (FES)-elicited tibialis anterior (TA) electromyography (EMG) data was taken over the ankle range of interest (occurring during active dorsiflexion and loading response) while also taking into account the type of TA muscle contraction occurring (concentric, eccentric, and isometric) and the speed of hemiplegic ankle joint rotation. Using the processed data, a model of normalized EMG versus pulsewidth was developed. Implementation of this model showed the unsuitability of the trapezoidal approach in the reproducing of a natural EMG profile. An optimized stimulation intensity profile is proposed which is expected to accurately reproduce the natural TA EMG profile during gait.