Addressing Health-Related Social Needs and Mental Health Needs in the Neonatal Intensive Care Unit: Exploring Challenges and the Potential of Technology.

Unaddressed health-related social needs (HRSNs) and parental mental health needs in an infant's environment can negatively affect their health outcomes. This study examines the challenges and potential technological solutions for addressing these needs in the neonatal intensive care unit (NICU) setting and beyond. In all, 22 semistructured interviews were conducted with members of the NICU care team and other relevant stakeholders, based on an interpretive description approach. The participants were selected from three safety net hospitals in the U.S. with level IV NICUs. The challenges identified include navigating the multitude of burdens families in the NICU experience, resource constraints within and beyond the health system, a lack of streamlined or consistent processes, no closed-loop referrals to track status and outcomes, and gaps in support postdischarge. Opportunities for leveraging technology to facilitate screening and referral include automating screening, initiating risk-based referrals, using remote check-ins, facilitating resource navigation, tracking referrals, and providing language support. However, technological implementations should avoid perpetuating disparities and consider potential privacy or data-sharing concerns. Although advances in technological health tools alone cannot address all the challenges, they have the potential to offer dynamic tools to support the healthcare setting in identifying and addressing the unique needs and circumstances of each family in the NICU.

Angiomyofibroblastoma of the Vulva.

Angiomyofibroblastoma (AMF) is a rare benign soft-tissue tumor that most frequently affects the lower genital tract of young to middle-aged women. It mainly consists of two components: stromal cells and prominent vasculature. Clinically, it is usually asymptomatic and resembles Bartholin's cyst. Although it is a benign tumor, cases with recurrence and sarcomatous transformation have been reported. Due to the overlapping of histopathological picture, diagnostic perplexity often arises between AMF and aggressive angiomyxoma (AAM). AMF being benign in nature is treated by local excision, whereas AAM is a more infiltrative lesion that has a higher tendency for local recurrence.

Development and Validation of Age-Specific Resilience Instruments for Early Childhood Assessment: A Taiwan Birth Cohort Study.

BACKGROUND: We sought to develop and validate age-specific instruments for measuring early childhood resilience at ages 3, 5 and 8 in the Taiwan Birth Cohort Study, a national longitudinal study. METHODS: Using data from 18,553 mother-infant pairs, we conducted exploratory factor analysis (EFA) on a simple random half of our sample. We then used the remaining half of these data for confirmatory factor analysis (CFA) to further assess the fit of 3 CFA models (ie, first-order, second-order, and bifactor). Psychometric properties, distributions, and inter-item and inter-factor correlations of each instrument were also evaluated. RESULTS: EFA and CFA showed that the bifactor model of resilience (which included a general resilience factor and 5 specific factors) had the best fit for all 3 resilience scales, with 19 items at year 3, 18 items at year 5, and 19 items at year 8. All 3 resilience scales showed good psychometric properties, including construct validity, internal consistency, and normal distributions. For predictive validity, we found that in the face of adversity (measured by the High Risk Family Score), individuals with high resilience scores at age 3 had better general health scores at ages 3, 5, and 8 compared to those with low resilience scores. CONCLUSIONS: We describe the development and validation of age-appropriate survey instruments to assess resilience in young children at the population level. These instruments can be used to better understand how resilience can impact child health over time, and to identify key factors that can foster resilience.

Feasibility of Specimen Self-collection in Young Children Undergoing SARS-CoV-2 Surveillance for In-Person Learning.

Importance: There is an urgent need to assess the feasibility of COVID-19 surveillance measures in educational settings. Objective: To assess whether young children can feasibly self-collect SARS-CoV-2 samples for surveillance testing over the course of an academic year. Design, Setting, and Participants: This prospective pilot cohort study was conducted from September 10, 2020, to June 10, 2021, at a K-8 school in San Mateo County, California. The research consisted of quantitative data collection efforts: (1) demographic data collected, (2) student sample self-collection error rates, and (3) student sample self-collection time durations. Students were enrolled in a hybrid learning model, a teaching model in which students were taught in person and online, with students having the option to attend virtually as needed. Data were collected under waiver of consent from students participating in weekly SARS-CoV-2 testing. Main Outcomes and Measures: Errors over time for self-collection of nasal swabs such as contaminated swabs and inadequate or shallow swabbing; time taken for sample collection. Results: Of 296 participants, 148 (50.0%) were boys and 148 (50.0%) were girls. A total of 87 participants (29.2%) identified as Asian; 2 (0.6%), Black or African American; 13 (4.4%), Hispanic/Latinx; 103 (34.6%), non-Hispanic White; 87 (29.2%), multiracial; and 6 (2.0%), other. The median school grade was fourth grade. From September 2020 to March 2021, a total of 4203 samples were obtained from 221 students on a weekly basis, while data on error rates were collected. Errors occurred in 2.7% (n = 107; 95% CI, 2.2%-3.2%) of student encounters, with the highest rate occurring on the first day of testing (20 [10.2%]). There was an overall decrease in error rates over time. From April to June 2021, a total of 2021 samples were obtained from 296 students on a weekly basis while data on encounter lengths were collected. Between April and June 2021, 193 encounters were timed. The mean duration of each encounter was 70 seconds (95% CI, 66.4-73.7 seconds). Conclusions and Relevance: Mastery of self-collected lower nasal swabs is possible for children 5 years and older. Testing duration can be condensed once students gain proficiency in testing procedures. Scalability for larger schools is possible if consideration is given to the resource-intensive nature of the testing and the setting's weather patterns.

Bilateral true muscle transplantation for correction of very large angle exotropia.

A 59-year old man with very large exotropia and bilateral limitation of adduction, underwent bilateral true muscle transplantation, involving the sutured transfer of resected segment of medial rectus (MR) onto the distal end of lateral rectus (LR), prior to recession of the thus elongated LR muscle. Following this he was left with mild residual exotropia and improved adduction, which has remained stable for 6 months following surgery.

Prospective Pilot Study Evaluating SARS-CoV-2 Transmission-Limiting Measures in an On-Site School.

OBJECTIVES: The purpose of our study is to evaluate the feasibility and reliability of a comprehensive set of preventive measures in limiting secondary transmission of COVID-19 in schools. METHODS: A prospective cohort study was conducted to evaluate SARS-CoV-2 transmission in an independent K-8 school in San Mateo County, California. The research was conducted between September 14, 2020 through March 22, 2021 and consisted of: 1) demographic and epidemiological questionnaires; 2) daily symptom reporting; 3) weekly RT-PCR testing; and 4) periodic on-site qualitative observations. RESULTS: One hundred eighty (79%) students and 63 (74%) on-site staff/contractors were enrolled. Participants reported symptoms in 144 (<1%) daily surveys of the 19,409 collected. Among those who reported symptoms and exposures, none tested positive during the 22-week study period. Of all participants, a total of 6 tested positive for SARS-CoV-2 at least once by RT-PCR; all were asymptomatic at time of testing. No in-school transmission occurred. Mask adherence was high among all grades, and incidents of improper mask use mostly occurred during noninstruction time. Physical distancing was well-enforced during class time and snack breaks, although adherence during noninstruction time waned as the school year progressed. CONCLUSIONS: Our comprehensive, prospective study following COVID-19 transmission over 22 weeks in a K-8 school demonstrates that: 1) surveillance testing is important for detecting asymptomatic infections in schools; 2) monitoring symptoms may not be necessary and/or sufficient for COVID-19; and 3) younger children can adhere to key mitigation measures (eg, masking) which have the potential to limit transmission.

Cold abscess of dental origin in a 7-year-old child.

Abscess related to an infected tooth is mostly associated with pyogenic infection, but sometimes, it can be asymptomatic and indicate a chronic condition. This case report shows cold abscess with a draining sinus due to dental origin. A 7-year-old female patient complained of pain with respect to grossly decayed tooth and recurrent swelling with no response to medications. After investigations and management of the lesion, it was concluded as abscess due to chronic granulomatous infection. Cold abscess is a classical manifestation of tuberculosis with no signs of inflammation. More than 60% of cases of this pathology occur in patients below 15 years old. It needs various clinical, histopathological, and laboratory investigations. Although rare, it should be considered as a differential diagnosis when no improvement occurs postroutine therapy to prevent serious complications. Furthermore, various precautions should be taken by the clinicians to prevent cross-infection.

Evaluation of Potential Application of Wharton's Jelly-Derived Human Mesenchymal Stromal Cells and its Conditioned Media for Dermal Regeneration using Rat Wound Healing Model.

Mesenchymal stromal cells and the derived conditioned media represent an area of tremendous medical interest and, among other clinical applications, are currently being extensively explored for wound healing. The aim of this study was to comparatively evaluate the wound healing potential of xeno-free human umbilical cord-derived mesenchymal stromal cells (MSCs) and the conditioned media (CM) in a full-thickness excision wound model in rats. The evaluation parameters included rate of wound healing, serum cytokine analyses, collagen content, histopathology, and hyperspectral imaging as an independent qualitative and quantitative tool. Both the cell-based and cell-free approaches scored better in lower inflammation, as evidenced in lower IL-10 and stable IL-6 levels, and improved rate of wound healing (p < 0.0001). More importantly, no adverse reaction or rejection was observed although human MSCs and CM were used in a xenogeneic model. The presence of hFGF, hHGF, hGCSF, hIL-1Ra, hVEGF, and hIL-6 in the secretome may elucidate the regenerative potential of the xeno-free cell-based and cell-free approaches which have translational value for advanced wound care. The results revealed the therapeutic potential of both the cell-based and cell-free approaches for wound healing.

PretermConnect: Leveraging mobile technology to mitigate social disadvantage in the NICU and beyond.

Preterm birth (PTB) - delivery prior to 37-weeks gestation - disproportionately affects low-income and minority populations and leads to substantial infant morbidity and mortality. The time following a PTB represents an optimal window for targeted interventions that encourage mothers to prioritize their own health and that of their babies. Healthcare teams can leverage digital strategies to address maternal and infant needs in this postpartum period, both in the neonatal intensive care unit and beyond. We therefore developed PretermConnect, a mobile app designed to educate, engage, and empower women at risk for PTB. This article describes the participant-centered design approach of PretermConnect, with preliminary findings from focus groups and co-design sessions in different community settings and suggested future directions for mobile technologies in population health. Apps such as PretermConnect can mitigate social disadvantage by serving as remote monitoring tools, providing social support, preventing recurrent PTB and lowering infant mortality rates.

Antimicrobial activity and cytotoxicity trait of a bioactive peptide purified from Lactococcus garvieae subsp. bovis BSN307T.

A bioactive peptide of 8595 Da was purified from the cell free supernatant of Lactococcus garvieae subsp. bovis BSN307T . MALDI MS/MS peptide mapping and the data base search displayed no significant similarity to any reported antimicrobial peptide of LAB. This peptide at a dose concentration of 200 µg ml-1 inhibited the growth of both Gram-positive and Gram-negative bacteria by 58-89% and a dose of 500 µg ml-1 scavenged 50% of DPPH-free radicals generated. Interestingly, cytotoxicity assay demonstrated that 17 µg ml-1 of peptide selectively inhibited 50% proliferation of mammalian cancer cell lines HeLa and MCF-7 whereas normal H9c2 cells remained unaffected. Fluorescent microscopic analysis after DAPI nuclear staining of HeLa cells showed characteristics of apoptosis and activation of caspase-3 was ascertained by caspase-3 fluorescence assay.

Influence of Health Beliefs on Adherence to COVID-19 Preventative Practices: International, Social Media-Based Survey Study.

BACKGROUND: Health behavior is influenced by culture and social context. However, there are limited data evaluating the scope of these influences on COVID-19 response. OBJECTIVE: This study aimed to compare handwashing and social distancing practices in different countries and evaluate practice predictors using the health belief model (HBM). METHODS: From April 11 to May 1, 2020, we conducted an online, cross-sectional survey disseminated internationally via social media. Participants were adults aged 18 years or older from four different countries: the United States, Mexico, Hong Kong (China), and Taiwan. Primary outcomes were self-reported handwashing and social distancing practices during COVID-19. Predictors included constructs of the HBM: perceived susceptibility, perceived severity, perceived benefits, perceived barriers, self-efficacy, and cues to action. Associations of these constructs with behavioral outcomes were assessed by multivariable logistic regression. RESULTS: We analyzed a total of 71,851 participants, with 3070 from the United States, 3946 from Mexico, 1201 from Hong Kong (China), and 63,634 from Taiwan. Of these countries, respondents from the United States adhered to the most social distancing practices (χ23=2169.7, P<.001), while respondents from Taiwan performed the most handwashing (χ23=309.8, P<.001). Multivariable logistic regression analyses indicated that self-efficacy was a positive predictor for handwashing (odds ratio [OR]United States 1.58, 95% CI 1.21-2.07; ORMexico 1.5, 95% CI 1.21-1.96; ORHong Kong 2.48, 95% CI 1.80-3.44; ORTaiwan 2.30, 95% CI 2.21-2.39) and social distancing practices (ORUnited States 1.77, 95% CI 1.24-2.49; ORMexico 1.77, 95% CI 1.40-2.25; ORHong Kong 3.25, 95% CI 2.32-4.62; ORTaiwan 2.58, 95% CI 2.47-2.68) in all countries. Handwashing was positively associated with perceived susceptibility in Mexico, Hong Kong, and Taiwan, while social distancing was positively associated with perceived severity in the United States, Mexico, and Taiwan. CONCLUSIONS: Social media recruitment strategies can be used to reach a large audience during a pandemic. Self-efficacy was the strongest predictor for handwashing and social distancing. Policies that address relevant health beliefs can facilitate adoption of necessary actions for preventing COVID-19. Our findings may be explained by the timing of government policies, the number of cases reported in each country, individual beliefs, and cultural context.

Evaluation of single stage adjustable strabismus surgery (SSASS) under topical anesthesia in patients with symptomatic diplopia.

We wish to assess effectiveness of using topical anesthesia without sedation in single-stage adjustable strabismus surgery (SSASS). Sixteen consecutive adults with diplopia and those willing to undergo SSASS, participated in a prospective study between September 2018-August 2019. They underwent detailed ophthalmic evaluation, ocular alignment measurement by prism cover test (PCT), and sensory evaluation. Subsequently they underwent SSASS under topical anesthesia (2% lidocaine gel). Surgery was performed using conventional technique; ocular alignment was then reassessed in sitting position by alternate cover test using prisms, for which with Snellen's chart was used as distance target and Lang's fixation stick as near target. Absence of diplopia was considered the end point of measurement. Any adjustment, if required, was performed intraoperatively, after recleaning the operative area with povidone iodine and redraping the eye. Participants were reassessed 1 day, 1 month, and 3-month after procedure, ocular deviation, and presence or absence of diplopia was documented. Fifteen males and one female patient participated in the study. Mean age of the study population was 31.29 years (range 19-65 years). Of these, 62.5% of patients required intraoperative modification of planned surgical dose. Patients with esotropia, vertical deviations, and combined deviations obtained surgical success, which remained stable till 3-month review. Patients with exotropia had initial surgical success rates of 100% immediately following surgery (day 1 postoperative evaluation), but it decreased to 83.33% and 66.67% during one and 3-months follow-up visits. In this study all patients tolerated the procedure well, without systemic adverse occurrence, including vasovagal reflex and without the need for additional anesthesia. SSASS is a good option in patients with diplopia and variable ocular deviations. Topical anesthesia allows intraoperative adjustment of surgical dosing, with aim of orthophoria or relief from diplopia, leading to satisfactory results. Postoperative drift may occur in exotropia. Case selection and preoperative counseling are necessary for cooperation during surgery, under topical anesthesia.

Nasal loop myopexy as a primary procedure to correct exotropia hypotropia complex in high myopia.

PURPOSE: To evaluate success of nasal loop myopexy as a primary procedure in correcting the ocular deviation in primary position when combined with recession and resection procedure (R&R) in exotropia hypotropia complex in high myopia and to explore the probable cause for deviation. CASE REPORTS: We present a case series of three adult males with exotropia hypotropia complex and high myopia with large angle exotropia and hypotropia, with deflection of the courses of superior and medial recti seen intraoperatively. We performed a conventional recession and resection procedure, which was combined with a nasal loop myopexy between the superior rectus (SR) and medial rectus (MR) in the same session, under local anesthesia, to correct the deflected course of SR and MR; with the aim of correcting the deviation in primary position and improving ocular motility, mainly elevation in abduction. RESULTS: We present a case series of three adult males with exotropia hypotropia complex, who were operated between March 2017 and October 2017. In all the three cases described above, it was noted that the preoperative exotropia and hypotropia improved following the combination of nasal loop myopexy with a conventional recession and resection procedure, as shown by improvement in ocular deviation in the primary position (measured by prism bar cover test, PBCT). First patient improved from 50 prism exotropia with 16 prism hypotropia to 5 prisms exophoria and 6 prisms hypotropia in left eye. Second patient improved from 45 prism right exotropia and 10 prism hypotropia to 10 prisms exotropia and 6 prism hypotropia. Third patient improved from 40 prism left exotropia and 20 prisms hypotropia to 10 prism esotropia and 5 prisms hypotropia. Ocular motility showed no restriction following surgery in any of the gazes. Limitation of elevation in abduction, caused due to SR deflection, improved due to repositioning of SR and MR in their anatomical positions in all the cases. In the first patient elevation in abduction improved from -4 to -1; in the second and third patients, it improved from -2 to 0. None of the three adult patients experienced any side effects following the procedure. CONCLUSION: The combination of recession and resection procedures with nasal loop myopexy was found to be effective in correcting the ocular deviation and limitation to elevation in abduction by correcting the deflected course of superior rectus and medial rectus to result in an effective improvement of elevation in abduction. One case had an overcorrection of exotropia. There were no other major complications.

Clinical evaluation of graded Anderson's procedure in idiopathic infantile nystagmus.

Aim: To study the efficacy of graded, bilateral, single, horizontal yoked rectus muscle recession for correction of anomalous head posture (AHP) in idiopathic infantile nystagmus (IIN). We hypothesize that the above procedure would sufficiently correct AHP in IIN. Methods: Case records of patients who presented with IIN and AHP due to eccentric null position were included in a retrospective study following IRB approval. Best-corrected visual acuity (binocular Snellen's acuity for distance, in both null position and primary position), anterior segment evaluation using slit lamp biomicroscopy, fundus examination, ocular motility examination and stereopsis (using TNO for adults and older children, Titmus fly test for younger children) were recorded. In all cases recession of the yoke muscles was performed with a gradation of recession, depending on the initial head turn as elaborated in Table 1. AHP was recorded before surgery and 1 and 3 months after surgery. Visual acuity and stereopsis before and after surgery were recorded. Results: Mean AHP improved from 22.5 ± 6.12 degrees of head turn preoperatively to 7.58 ± 3.62 degrees at 1-month postoperative visit (p < .001). The mean binocular visual acuity improved from 0.47 ± 0.15 preoperatively to 0.25 ± 0.17 after surgery (p < .001). Conclusion: Graded yoke muscle recession based on the initial head turn was found to be successful in correcting moderate AHP in patients with IIN. This procedure leaves behind two recti muscles for further surgical intervention in cases with residual AHP.

Adherence syndrome following inferior oblique anteropositioning - a case report.

INTRODUCTION: We report a case of inferior oblique (IO) muscle adherence with fat adherence, which developed following unilateral IO anteriorization (IOAT). METHODS: A 14-year-old child with V pattern left exotropia, bilateral IO overaction, bilateral dissociated vertical deviation (DVD), and strabismic amblyopia (OS) underwent recess/resect procedure along with IOAT. He developed consecutive esotropia and drooping of upper eyelid with marked limitation of levoelevation (-4). Differential diagnoses of antielevation syndrome and adherence syndrome were considered. On surgical exploration, forced duction test (FDT) was positive for elevation, left inferior oblique (LIO) muscle insertion was found anterior to the inferior rectus (IR) insertion along with fat adhesions which were released and IO muscle was reattached 3 mm behind and 2 mm lateral to IR insertion, along with advancement of left lateral rectus. RESULTS: Following resurgery, the patient had six prisms left esophoria and a hypotropia 9 prisms, with minimal limitation of levoelevation (-1). One month later, it was seen that the hypotropia had increased to 18 prism diopters and limitation of elevation was -2. CONCLUSIONS: Adherence syndrome is a rare and severe complication of IO weakening procedures. The initial postoperative improvement achieved in elevation and hypotropia in primary position was not maintained over subsequent follow-ups.

Prostaglandin E1 for maintaining ductal patency in neonates with ductal-dependent cardiac lesions.

BACKGROUND: Prostaglandin E1 (PGE1) is used to keep the ductus arteriosus patent and can be life-saving in neonates with ductal-dependent cardiac lesions. PGE1 is used to promote mixing of pulmonary and systemic blood flow or improve pulmonary or systemic circulations, prior to balloon atrial septostomy or surgery. PGE1 therapy may cause several short-term and long-term adverse effects. The efficacy and safety of PGE1 in neonates with ductal-dependent cardiac lesions has not been systematically reviewed. OBJECTIVES: To determine the efficacy and safety of both short-term (< 120 hours) and long-term (≥120 hours) PGE1 therapy in maintaining patency of the ductus arteriosus and decreasing mortality in ductal-dependent cardiac lesions. SEARCH METHODS: We searched the literature in October 2017, using the search strategy recommended by Cochrane Neonatal. We searched electronic databases (CENTRAL (in the Cochrane Library), MEDLINE, CINAHL, Embase); abstracts of the Pediatric Academic Societies; websites for registered trials at www.clinicaltrials.gov and www.controlled-trials.com; and in the reference list of identified articles. SELECTION CRITERIA: Randomized or quasi-randomized trials using PGE1 at any dose or duration to maintain ductal patency in term or late preterm (≥ 34 weeks' gestation) infants with ductal-dependent cardiac lesions and which reported effectiveness and safety in the short term or long term. DATA COLLECTION AND ANALYSIS: We followed the standard Cochrane methods for conducting a systematic review. Two review authors (SA and MP) independently assessed the titles and abstracts of studies identified by the search strategy to determine eligibility for inclusion. We obtained the full-text version if eligibility could not be done reliably by title and abstract. We resolved any differences by discussion. We designed electronic forms for trial inclusion/exclusion, data extraction, and for requesting additional published information from authors of the original reports. MAIN RESULTS: Our search did not identify any completed or ongoing trials that met our inclusion criteria. AUTHORS' CONCLUSIONS: There is insufficient evidence from randomized controlled trials to determine the safety and efficacy of PGE1 in neonates with ductal-dependent cardiac lesions. Evidence from observational trials have informed clinical practice on the use of PGE, which is now considered the standard of care for ductal-dependent cardiac lesions. It is unlikely that randomized controlled studies will be performed for this indication but comparative efficacy of newer formulations of PGE1, different doses of PGE1 and studies comparing PGE with PDA stents or other measures to keep the ductus open may be ethical and necessary.

Epoxyazadiradione Purified from the Azadirachta indica Seed Induced Mitochondrial Apoptosis and Inhibition of NFκB Nuclear Translocation in Human Cervical Cancer Cells.

Epoxyazadiradione (EAD) is an important limonoid present in Neem (Azadirachta indica) plant. In the present study, we have purified EAD from Neem seed and studied its anticancer potential in human cervical cancer (HeLa) cells. Cell proliferation inhibition studies indicated that the GI50 value of EAD is 7.5 ± 0.0092 µM in HeLa cells, whereas up to 50 µM concentrations EAD did not affect the growth of normal H9C2 cells. The control drug cisplatin inhibited the growth of both HeLa and H9C2 cells with a GI50 value of 2.92 ± 1.192 and 4.22 ± 1.568 µM, respectively. Nuclear DNA fragmentation, cell membrane blebbing, phosphatidylserine translocation, upregulation of Bax, caspase 3 activity and poly (ADP ribose) polymerase cleavage and downregulation of BCl2 in HeLa cells on treatment with EAD indicated the apoptotic cell death. Increase in caspase 9 activity and release of active cytochrome c to the cytoplasm on treatment with EAD confirmed that the apoptosis was mediated through the mitochondrial pathway. Epoxyazadiradione also inhibited the nuclear translocation of nuclear factor κB in HeLa cells. Thus, our studies demonstrated EAD as a potent and safe chemotherapeutic agent when compared with the standard drug cisplatin that is toxic to both cancer and normal cells equally. Copyright © 2017 John Wiley & Sons, Ltd.

Development and validation of an electrochemiluminescent ELISA for quantitation of oral insulin tregopil in diabetes mellitus serum.

AIM: Tregopil, a novel PEGylated human insulin is in clinical development for oral delivery in diabetes treatment. The aim of the study was to develop and validate a sensitive and specific ELISA method for quantitating Tregopil in diabetes subjects on basal Glargine, since most commercially available insulin kits either do not detect Tregopil or show significant reactivity to Glargine. METHODS: An electrochemiluminescent ELISA was developed and validated for Tregopil quantitation in diabetes serum. RESULTS: The method has a LLOQ of 0.25 ng/ml, shows minimum cross-reactivity to Glargine and was successfully tested using a subset of samples from Tregopil-dosed Type 1 diabetes mellitus patients. CONCLUSION: The ELISA method is sensitive and can be used to support accurate measurement of Tregopil with no cross-reactivity to Glargine and its metabolites in clinical studies.