OBJECTIVES:The purpose of this study was to examine longer-term outcomes of a school-based randomized controlled trial comparing a telehealth-delivered adolescent depression prevention program, Interpersonal Psychotherapy-Adolescent Skills Training (IPT-AST), to services as usual (SAU) across 17 public schools. METHOD:Adolescents (N = 242; Mage = 14.80 years, SD = .70; 65% female; 21% Black; 13% Hispanic/Latinx) with elevated depression screening scores completed surveys through 15-month follow-up (approximately 1-year post-intervention). Adolescents completed a diagnostic interview to measure depression diagnoses at baseline and 15-month follow-up. Depression symptoms and diagnoses were primary outcomes and anxiety symptoms were secondary. RESULTS:Hierarchical linear modeling results indicated that adolescents in both IPT-AST and SAU demonstrated similar decreases in depression and anxiety symptoms during the follow-up and total study periods, supporting hypotheses regarding the follow-up period but not the total study. Baseline depression diagnostic status moderated intervention effects on anxiety symptoms such that, among adolescents without a depression diagnosis at baseline, those in IPT-AST showed greater reductions in anxiety symptoms than those in SAU. Exploratory analyses indicated SAU adolescents were more likely to endorse elevated depression symptoms (i.e. above a clinical cutoff) compared to IPT-AST adolescents. The hypothesis regarding depression diagnoses was partially supported; although diagnosis rates and timing to episode onset did not differ between IPT-AST and SAU, exploratory restricted mean survival time analyses demonstrated that adolescents in IPT-AST gained approximately one month free of diagnosis compared to those in SAU. CONCLUSION:Findings highlight the importance of school-based depression prevention programming for reducing longer-term risk.
OBJECTIVE:The effectiveness of psychotherapy for suicidal youth remains a public health priority. Dialectical behavior therapy (DBT; Linehan, 1993) has been recognized as a well-established treatment for suicidal youth (Witt et al., 2021). Although promising, little work has explored mechanisms of change in DBT for suicidal youth (Asarnow et al., 2021). This study aimed to examine covariation in rates of change between symptoms and theorized mechanistic variables during a randomized controlled trial of DBT for suicidal youth. METHOD:The present study was a secondary data analysis of a randomized controlled trial of DBT for 173 suicidal youth (ages 12-18; McCauley et al., 2018). Multilevel modeling was used to examine the association between person-level rates of change for self-harm (suicide attempts and nonsuicidal self-injury), suicidal ideation, DBT skills, emotion dysregulation, and reasons for living. RESULTS:Both treatment groups showed statistically significant covariation between reductions in self-harm and suicidal ideation. Rates of change in self-harm and suicidal ideation decreased with improvement in emotion regulation for both treatments. An increase in endorsed reasons for living significantly covaried with reductions in self-harm and suicidal ideation within the DBT condition only. CONCLUSIONS:Study results support the potential value of efforts to reduce suicidal ideation and self-harm through improving emotion regulation and demonstrate common and unique mechanisms of change across treatments for youths at elevated suicide/self-harm risk. (PsycInfo Database Record (c) 2026 APA, all rights reserved).
Background:Anxiety and depressive disorders remain highly prevalent and insufficiently treated, with many individuals experiencing persistent or untreated symptoms, limited access to evidence-based care, or insufficient support between clinical encounters. Adults with disabilities represent a particularly underserved subpopulation, often facing compounded barriers to mental health care and higher rates of anxiety and depression. Digital therapeutics offer a scalable opportunity to address these gaps by extending structured, evidence-based interventions beyond traditional care settings. Objective:This pilot study evaluated Rauha, a novel digital therapeutic created by Toivoa Inc, that integrates cognitive behavioral therapy (CBT)-based modules with live weekly sessions led by a National Board-Certified Health and Wellness Coach (NBC-HWC), delivering structured, smartphone-based psychoeducation and interactive therapeutic exercises combined with personalized mental health coaching to support behavior change. Methods:Thirteen adults with mobility and/or hearing disabilities and clinically elevated anxiety and/or depression were enrolled in a single-arm, within-participants design. Participants completed 8 weeks of CBT modules delivered via smartphone, accompanied by synchronous virtual mental health coaching. Anxiety and depression were assessed using the Hamilton Anxiety and Hamilton Depression Rating Scales, respectively, at baseline, post treatment, and at the 4-week follow-up. Results:Mean reductions were significant for both anxiety (-13.05, SD 2.51; P<.001) and depression (-12.83, SD 1.55; P<.001), exceeding thresholds for clinical significance and sustained through follow-up. Post treatment, 84.6% (11/13) of participants showed clinically significant improvement in both anxiety and depression. At follow-up, 76.9% (10/13) and 92.3% (12/13) of participants showed clinically significant improvement in anxiety and depression, respectively. Between baseline and follow-up time points, these reductions corresponded to mean shifts from moderate to mild anxiety on the Hamilton Anxiety Rating Scale and from moderate to mild/nondepressed on the Hamilton Depression Rating Scale. Participants reported strongly favorable acceptability, experience, and usability ratings for the Rauha treatment program, demonstrating 100% treatment retention and an average replay rate of 5.5 for personalized smartphone content. Conclusions:The findings suggest that a combined digital CBT and NBC-HWC approach can yield clinically meaningful and durable symptom reductions in depression and anxiety, coupled with high user acceptability and engagement, for adults with disabilities. These findings provide preliminary evidence supporting Rauha as a scalable, evidence-informed mental health intervention with the strong potential to improve access and address key barriers to care.
Background:The use of artificial intelligence (AI) to analyze health care data has become common in behavioral health sciences. However, the lack of training opportunities for mental health professionals limits clinicians' ability to adopt AI in clinical settings. AI education is essential for trainees, equipping them with the literacy needed to implement AI tools in practice, collaborate effectively with data scientists, and develop skills as interdisciplinary researchers with computing skills. Objective:As part of the Penn Innovation in Suicide Prevention Implementation Research Center, we developed, implemented, and evaluated a virtual workshop to educate psychiatry and psychology trainees on using AI for suicide prevention research. Methods:The workshop introduced trainees to natural language processing (NLP) concepts and Python coding skills using Jupyter notebooks within a secure Microsoft Azure Databricks cloud computing and analytics environment. We designed a 3-hour workshop that covered 4 key NLP topics: data characterization, data standardization, concept extraction, and statistical analysis. To demonstrate real-world applications, we processed chief complaints from electronic health records to compare the prevalence of suicide-related encounters across populations by race, ethnicity, and age. Training materials were developed based on standard NLP techniques and domain-specific tasks, such as preprocessing psychiatry-related acronyms. Two researchers drafted and demonstrated the code, incorporating feedback from the Methods Core of the Innovation in Suicide Prevention Implementation Research to refine the materials. To evaluate the effectiveness of the workshop, we used the Kirkpatrick program evaluation model, focusing on participants' reactions (level 1) and learning outcomes (level 2). Confidence changes in knowledge and skills before and after the workshop were assessed using paired t tests, and open-ended questions were included to gather feedback for future improvements. Results:A total of 10 trainees participated in the workshop virtually, including residents, postdoctoral researchers, and graduate students from the psychiatry and psychology departments. The participants found the workshop helpful (mean 3.17 on a scale of 1-4, SD 0.41). Their overall confidence in NLP knowledge significantly increased (P=.002) from 1.35 (SD 0.47) to 2.79 (SD 0.46). Confidence in coding abilities also improved significantly (P=.01), increasing from 1.33 (SD 0.60) to 2.25 (SD 0.42). Open-ended feedback suggested incorporating thematic analysis and exploring additional datasets for future workshops. Conclusions:This study illustrates the effectiveness of a tailored data science workshop for trainees in psychiatry and psychology, focusing on applying NLP techniques for suicide prevention research. The workshop significantly enhanced participants' confidence in conducting data science research. Future workshops will cover additional topics of interest, such as working with large language models, thematic analysis, diverse datasets, and multifaceted outcomes. This includes examining how participants' learning impacts their practice and research, as well as assessing knowledge and skills beyond self-reported confidence through methods such as case studies for deeper insights.
BACKGROUND:Glucagon-like peptide-1 receptor agonists (GLP1-RAs) are approved in patients aged ≥10 yr for type 2 diabetes mellitus and aged ≥12 yr for obesity. We examined the effect of GLP1-RAs on the retention of gastric contents in fasting adolescents. METHODS:This prospective cohort study examined adolescent patients (10-18 yr) at a single institution between June 2023 and November 2024. Three groups were compared: a GLP1-RA group; a group at-risk for delayed gastric emptying not on GLP1-RAs; and a healthy control group. All patients fasted 8 h for solids and 1 h for clears liquid. Gastric contents were examined utilising gastric ultrasound qualitatively on a 3-point scale, and quantitatively. The primary outcome was the number of adolescents on GLP1-RAs with residual gastric contents (presence of solids or gastric fluid volume ≥1.5 ml kg-1). RESULTS:In total, 67 patients were analysed: 20 in the GLP1-RA group; 27 in the at-risk group; and 20 in the control group. The median age was 14.8 (interquartile range [IQR] 13.2-16.6) yr, and median fasting durations for solids and clears were 13 h (IQR 12-14) and 12 h (IQR 3.5-13), respectively. In the GLP1-RA group, 16/20 patients (80%) had solids present on gastric ultrasound, compared with 17/27 patients (63%) in the at-risk group and 1/20 patient (5%) in the control group (unadjusted P <0.001; adjusted P <0.02, with propensity score adjustment for age, body mass index, sex, race, and NPO time). CONCLUSIONS:We observed that 80% of adolescents on GLP1-RAs had solids on gastric ultrasound despite having fasted for over 12 h.
BACKGROUND:Spanish-speaking Latina mothers experience elevated rates of perinatal depression and anxiety (PDA) yet face substantial barriers to culturally responsive care. Behavioral Activation (BA) is a scalable intervention targeting activity engagement and environmental reward, but its relevance in community-based, non-treatment-seeking Latina populations remains unclear. METHODS:This cross-sectional study examined BA process variables, psychosocial stressors, and structural and demographic predictors of PDA in a community sample of Spanish-speaking pregnant and postpartum Latinas (N = 674) recruited nationally via digital platforms. Logistic regression and bootstrapped multivariate models were used to identify predictors of depression, anxiety, and co-occurring symptoms. RESULTS:Nearly one-third of participants met criteria for depression (31.9%), 27% for anxiety, and 22% for co-occurring symptoms. In univariate models, higher activity engagement and environmental reward were associated with lower odds of PDA, whereas perceived stress, discrimination, unemployment, and lack of insurance were associated with increased risk. In multivariate analyses, activity level and perceived stress emerged as the only consistent independent predictors. Models including these variables demonstrated strong discriminative ability (AUCs = 0.87-0.91) with balanced sensitivity and specificity (0.79-0.83). CONCLUSIONS:BA processes and perceived stress are robust, modifiable predictors of PDA among Spanish-speaking Latinas in community settings. These findings support scalable screening and intervention strategies targeting activity engagement and stress. Culturally grounded, peer-delivered BA interventions may help reduce disparities in perinatal mental health.
Chronic lung allograft dysfunction (CLAD) is a major barrier to long-term lung transplantation success. Microbial factors have been linked to CLAD risk, and sequence-based methods have been applied recently to identify potential microbial drivers, although patient heterogeneity and follow-up time have been limitations. We undertook a longitudinal cohort study of 186 patients transplanted for diseases other than cystic fibrosis. Dense lung sampling was carried out over the first year, and patients were followed for a median of 6.04 years. Bronchoalveolar lavage was analyzed by bacterial 16S ribosomal RNA gene sequencing and quantification. Postimplant bronchoalveolar lavage was assayed for cytokines and underwent metabolomics analysis. Seventy patients (38%) developed CLAD. CLAD development and shorter time to CLAD were associated with higher lung bacterial burden, particularly 6 months posttransplant, low Streptococcus/Prevotella ratio in lung 6 weeks posttransplant, and elevated lung IP10/CXCL10 immediately after implantation. Each factor was associated with distinct timing of CLAD onset. These factors, together with previously recognized clinical features, stratified patients into groups differing by >3-fold CLAD risk. Thus, increased lung bacteria and altered composition during the first year posttransplant and of IP10/CXCL10 immediately after implantation are associated with CLAD after transplantation for non-cystic fibrosis lung disease. Early events in the allograft may establish conditions affecting later graft failure, identify potentially modifiable mechanisms of injury, and provide biomarkers for CLAD risk.
Background Primary graft dysfunction (PGD) is severe lung injury following lung transplantation. Variable radiograph interpretation and changes in mechanical ventilation and extracorporeal membrane oxygenation (ECMO) support for hypoxemia may limit the current PGD definition’s validity. Methods We assessed whether changes in the PGD definition accounting for oxygen delivery method (intubated, non-intubated, ECMO) were associated with differential graft survival. Severe PGD was grade 3 at 48 or 72 hours after transplant. We estimated crude and standardized time from transplantation to death or re-transplantation with each alternate defining criterion. We secondarily evaluated whether excluding chest radiography led to severe PGD re-classification. Results Among 3170 recipients, 749 (24%) had severe PGD by current definition. By revised oxygen delivery definition, 182 non-intubated recipients and 372 intubated recipients had severe PGD, and 177 recipients had severe PGD requiring ECMO. Recipients with severe PGD requiring ECMO had highest 1-year mortality (cumulative incidence of death 0.20, 95%CI 0.17-0.24), followed by intubated severe PGD (0.15, 95%CI 0.13-0.17). Non-intubated recipients had similar mortality with and without severe PGD (non-intubated with PGD: 1-year cumulative incidence of death 0.11, 95%CI 0.09-0.13; non-intubated without severe PGD: 0.10, 95%CI 0.09-0.11). Exclusion of radiographs reclassified 814 recipients, including 89 (11%) re-classified as severe PGD. On review of radiographs from recipients re-classified as severe PGD, most frequent findings were effusions, atelectasis, and pneumonia. Conclusion A revised PGD definition stratified by mode of oxygen delivery identifies groups with differential mortality. Chest radiography is critical to excluding alternative causes of lung injury in recipients with severe hypoxemia.
INTRODUCTION:Emerging adult sexual and gender minorities (EA-SGM) experience disproportionately high rates of suicide. The Safety Planning Intervention can reduce suicide risk, but its effectiveness for this population may be limited without additional support. The Supporting Transitions to Adulthood to Reduce Suicide (STARS) program was developed to address this gap by integrating a mobile application and peer mentorship to promote consistent Safety Plan use. METHODS:Participants (n = 64) were randomized to receive either SPI alone or SPI plus STARS. Participants were followed for 6 months. RESULTS:STARS was highly acceptable and associated with significantly greater use of the Safety Plan at 2 months compared to SPI alone. While both groups demonstrated significant reductions in suicidal ideation over time, participants in STARS showed sustained nonsignificant improvements through 6 months, whereas SPI alone experienced a slight increase after 4 months. STARS participants used their Safety Plan significantly more frequently than SPI alone (39% vs. 15% for monthly use) at 2 months. CONCLUSIONS:STARS is a feasible and acceptable intervention that enhances Safety Plan engagement and longer-term reductions in suicidal ideation among EA-SGM. These promising findings provide preliminary support for a fully powered effectiveness trial to evaluate STARS' outcomes. TRIAL REGISTRATION:ClinicalTrials.gov identifier: NCT05018143.
Suicidal ideation (SI) is a public health concern that remains poorly characterized during the perinatal period. It is most often assessed by the final items in two depression screening instruments, the Edinburgh Postnatal Depression Scale (EPDS) and the Patient Health Questionnaire-9 (PHQ-9). We sought to examine and compare SI trajectories identified by these measures and their changes from pregnancy to postpartum.This study reports on data from a supplemental study to the Understanding and Preventing Women’s Relapse of Depression (UPWARD) study on perinatal depression (NIMH, NCT03623620; supplement entitled UPWARD-S). Participants were ineligible for UPWARD if they endorsed SI at baseline; but eligible for UPWARD-S if they were pregnant and had a history of major depressive disorder. Participants in UPWARD-S (N=38) completed phone interviews and surveys from pregnancy through six months postpartum. Group-based trajectory modeling was conducted during pregnancy and postpartum using item 10 of the EPDS and item 9 of the PHQ-9.Trajectory analyses resulted in three group models. For both time periods, there were two groups showing relatively stable trajectories in the frequency of SI endorsement, one high and one low. During pregnancy, a third group began high and declined, and, during postpartum, a third group began low and increased. Trajectory patterns were broadly similar across items; however, the proportion of participants classified within each group differed by measure. Our findings demonstrated distinct and relatively stable trajectories and modest agreement between items. Findings from this study could inform larger studies to advise perinatal screening and intervention strategies.
OBJECTIVE:To evaluate whether depression prevention programs can reduce adolescents' within-persons' depression and anxiety symptoms from pre-prevention assessed levels, which were obtained via naturalistic repeated measures for 1-year before randomization and intervention delivery, to post-prevention levels ascertained through 21-months follow-up. METHOD:This randomized controlled trial included 204 adolescents (mean [SD] age 14.26 [1.65] years; 56.4 % female). Prior to delivery of interventions (Coping With Stress, cognitive-behavioral program, or Interpersonal Psychotherapy-Adolescent Skills Training, interpersonal program), youths' depression and anxiety symptoms were assessed every 3-months for 1-year naturalistically to establish pre-prevention symptom levels. Then, youth participated in preventive interventions and had internalizing symptoms outcomes measured repeatedly through 3-months follow-up and then longer-term through 21-months follow-up. RESULTS:Longitudinal slopes of youths' pre-prevention depression (b = -0.30, p = .004) and anxiety (b = -0.54, p = .013) symptoms naturalistically decreased across 4 time points from -12-months through -3-months assessments. Compared to -12-months pre-prevention symptom levels, preventive interventions significantly decreased within-person symptoms of depression (d = 0.67 [0.39,0.95], p < .001 at 3-months follow-up; d = 0.45 [0.17,0.73], p < .001 at 21-month follow-up) and anxiety (d = 0.88 [0.59,1.16], p < .001 at 3-months follow-up; d = 0.74 [0.45,1.02], p < .001 at 21-months follow-up). CONCLUSION:This study used a novel head-to-head comparative effectiveness trial design with repeated internalizing symptoms assessments prior to randomization and interventions delivery to evaluate how much prevention can adjust within-person symptom changes over time and shift symptoms from pre-prevention ascertained levels to lowered post-prevention levels maintained across follow-ups. Findings support the utility of evidence-based depression prevention programs to bend individuals' internalizing symptom trajectories when anxiety and depression levels normatively rise throughout adolescence. CLINICAL TRIAL REGISTRATION INFORMATION:Bending Adolescent Depression Trajectories Through Personalized Prevention; https://www. CLINICALTRIALS:gov/; ClinicalTrials.gov (NCT019148167) Insitutional review boards of both study sites approved all procedures.
Transplanted islet functional β-cell mass is measured by the β-cell secretory capacity derived from the acute insulin response to glucose-potentiated arginine (AIRpot), however, data are limited beyond one-year post-transplant for individuals with type 1 diabetes. We evaluated changes in β-cell secretory capacity in a single-center longitudinal analysis and examined relationships with measures of islet cell hormone metabolism and clinical measures of graft function (mixed-meal tolerance test [MMTT] C-peptide, BETA-2 score, and continuous glucose monitoring [CGM]). Eleven individuals received purified human pancreatic islets over one or two intra-portal infusions to achieve insulin-independence and were followed over a median (IQR) 6 (5-7) years. β-cell secretory capacity remained stable over 3-years before declining. Fasting glucagon and proinsulin secretory ratios under glucose-potentiation were inversely correlated with AIRpot. A functional β-cell mass of 40% normal predicted insulin-independence and was strongly predicted by MMTT C-peptide-to-glucose and BETA-2 score. A functional β-cell mass of >20% predicted excellent glycemic outcomes including ≤1% time <60 mg/dL, ≤2% time >180 mg/dL and ≥90% time-in-range 70-180 mg/dL. β-cell replacement approaches should target a functional β-cell mass >40% to provide sufficient islet reserve for sustained insulin-independence. MMTT C-peptide-to-glucose and BETA-2 score can inform changes in functional β-cell mass in the clinical setting.
Introduction and Objective: Prior real-world studies of youth with type 1 diabetes (T1D) did not identify significant differences in time in range (TIR) between Insulet Omnipod 5 (OP5) and Tandem Control IQ (CIQ) users. In this follow-up study, we assessed differences in glycemia between youth with low bolus frequency. Methods: This single center, retrospective study included youth managing T1D with OP5 or CIQ who averaged ≤3 boluses/day over a 90-day period (6/15/24-9/12/24). Propensity scores following nearest-neighbor 1:1 matching with a caliper width requirement of 0.2 were used to account for between group differences. A multiple linear regression model adjusting for covariates (race/ethnicity, insurance, sex, T1D duration, CGM active time, manual boluses/day) assessed for differences in TIR by AID system in the propensity matched sample. Results: A total of 202 youth had low bolus frequency (CIQ n=75, OP5 n=127). CIQ users had a longer T1D duration (8.8 vs 7.9yrs, p=0.0001), higher CGM active time (91.7% vs 80.4%, p=0.0001), higher time in automated mode (81.3% vs 62%, p=0.0001), and higher total daily insulin dose (59.6 vs 49.5 units/day, p=0.0001). Propensity score matching paired CIQ users (n=49) with OP5 users (n=49). All between group differences were eliminated with propensity matching, with the exception of time in automated mode which remained higher for CIQ users (80% vs 64.0%, p=0.01). Demographics of the matched sample included: age 17.0yrs, 54.1% female, 68.4% NHW, 32.7% publicly insured. Median CGM active time was 87.7% and median manual bolus frequency was 2.2 boluses/day. Adjusted TIR was 8.0% higher (95% CI 2.9-13.1 p=0.002) in CIQ (54.9%) vs OP5 users (46.9%). Conclusion: In youth with T1D who bolus infrequently, CIQ use was associated with greater time in automated mode and greater TIR though neither group attained TIR goals. This information should be discussed when counseling families choosing an AID system. P. Chatty: None. R.J. Gallop: None. A. Rearson: None. S. Gera: None. J.N. Mountain: None. N. Alicea-Trelles: None. B.E. Marks: Consultant; Insulet Corporation. Board Member; International Society for Pediatric and Adolescent Diabetes. Research Support; Tandem Diabetes Care, Inc, Dexcom, Inc., Medtronic. Advisory Panel; T1D Exchange. B.E.M. is supported by the National Institutes of Health (PI: Marks, NIH: K23DK129827).
Spanish-speaking Latinas in the United States encounter significant barriers when seeking culturally responsive treatment for perinatal mental health disorders, resulting in treatment disparities and elevated rates of mental health symptoms. To address these challenges, peer-delivered support may be one promising strategy. This study examined the efficacy of Alma, a peer-delivered behavioral activation (BA) program comprising 6-8 sessions. Participants (N = 126) were Spanish-speaking Latina mothers experiencing elevated depression symptoms during the perinatal and early parenthood period. Participants were recruited through three community partner sites across rural and urban settings. Participants reported high satisfaction with the program and experienced decreases in depression symptoms, anxiety symptoms, and perceived stress. Importantly, significant clinical improvements occurred early in the program, indicating a rapid relief of symptoms. This symptom reduction was associated with improvements in putative mechanisms of BA, including activity level and environmental reward. Limitations of this study include participant attrition and the absence of a control group. Together, the findings indicate that Alma is a promising program to address depressed mood, anxiety, and stress among Spanish-speaking Latina mothers during the perinatal/early parenthood period, offering accessible and culturally responsive mental health support. Moreover, by meeting the mental health needs of Spanish-speaking
Objectives: An emerging concept in the chronic pain literature, high-impact chronic pain (HICP), refers to pain that occurs very frequently and results in major disruption of daily life. Previous epidemiologic investigations have noted that lower educational attainment, age, and race appear to be associated with the frequency of HICP, but condition-specific investigations of HICP have been less common. Methods: Here we investigate HICP status and its clinical/demographic correlates in the Multidisciplinary Approach to the study of chronic Pelvic Pain research network Symptom Pattern Study. Results: Participants were 476 urologic pelvic pain syndrome (UCPPS) patients, 64% of whom were female. Of these, 22% were classified as having HICP, based on responses to the several questions about pain interference in daily life. We confirmed that African-American individuals and those with lower educational attainment were more likely to experience HICP (both P<0.05). Additionally, those with HICP demonstrated much greater levels of disability, genitourinary pain, urinary symptoms, widespread pain, pelvic floor tenderness, and were more likely experience pain in response to consuming standardized amounts of water (all P<0.05). Binary logistics regression showed that genitourinary pain, widespread pain, and race were the strongest prediction of pain in multivariate models. Furthermore, HICP status was associated with more self-reported healthcare utilization over the subsequent 18 months (P<0.05). Discussion: These findings suggest that HICP affects more than 1 out of 5 UCPPS patients, with significant associated morbidity. Demographic and clinical characteristics associated with HICP may be useful for identifying at-risk UCPPS patients.
Introduction and Objective: Adherence to OGTT screening for CF-related diabetes (CFRD) is poor. We assessed the accuracy of glucose measurements not requiring phlebotomy during an OGTT. Methods: Standard OGTT with plasma glucose sampling at 0, 60, and 120-min was conducted in youth ≥10y with CF. Glucoses were measured simultaneously using a self-administered OGTT kit (Digostics GTT@Home), home glucometer (Contour Next) and hospital glucometer (StatStrip). Dexcom G7 continuous glucose monitor (CGM) interstitial glucose was recorded at 0, 60, and 120-min and at 5 min intervals for 20 min after each time point accounting for lag. Absolute glucose, median differences, and categorical glucose tolerance [normal (NGT), impaired (IGT), indeterminate (IGT), CFRD] were assessed for all methods (Table 1). Results: Plasma glucose tolerance was categorized as: NGT (n=8), IGT (n=5), and CFRD (n=1). Alternative measurement approaches correctly categorized CFRD, except the GTT@Home. Agreement for categorical diagnoses of glucose tolerance was strongest for CGM at 20-min post-OGTT time point (85.7%) and StatStrip (78.6%). Categorical agreement was poorest for the GTT@Home (54.5%). Conclusion: CGM, home glucometer, and hospital glucometer correctly diagnosed CFRD in one subject. Alternative approaches to glucose measurement did not reliably assess other glucose tolerance categories. S. Meighan: None. D.M. Johnson: None. R.J. Gallop: None. A. Kelly: None. M.S. Putman: Consultant; Anagram Therapeutics. Research Support; Dexcom, Inc. Other Relationship; Vertex Pharmaceuticals Incorporated. B.E. Marks: Consultant; Insulet Corporation. Board Member; International Society for Pediatric and Adolescent Diabetes. Research Support; Tandem Diabetes Care, Inc, Dexcom, Inc., Medtronic. Advisory Panel; T1D Exchange. Cystic Fibrosis Foundation (004524122)
BACKGROUND:Elexacaftor/tezacaftor/ivacaftor (ETI) is a highly effective therapy that improves lung disease in people with cystic fibrosis (pwCF), but its effect on glucose tolerance and insulin secretion is unclear. METHODS:PROMISE is a multicenter prospective, observational study of ETI in pwCF ≥12 years and at least one F508del allele. The PROMISE Endocrine substudy (PROMISE-ENDO) enrolled participants at 10 CF Centers where hemoglobin A1c (HbA1c) was collected and 3-hour oral glucose tolerance tests (OGTT) conducted to examine glucose tolerance, glucose excursions, and insulin secretory rates (deconvolution of C-peptide) and sensitivity (oral minimal model) prior to ETI and 12 to 18 months and 24-30 months following ETI initiation. Longitudinal mixed effects models were used to test within-subject ETI effects. RESULTS:At baseline, 79 participants completed OGTTs (39 [49%] male, median [IQR] age 19.6 [14.7, 27.3] years, BMI z-score 0.12 [-0.51, 0.65]). At 12-18 months n = 68 and at 24-30 months n = 58 completed OGTTs. At 24-30 months, fasting glucose (mg/dL) decreased (94 [92, 96] to 90 [88, 93], P = .02) in the subset not on insulin therapy (n = 61), but no differences in 1-hour or 2-hour glucose were found. HbA1c decreased from 5.8% (5.6%, 5.9%) to 5.5% (5.4%, 5.6%), P < .001 by 24-30 months. Although insulin sensitivity (mU/L-1 min-1) decreased (8.4 [7.2, 9.5] vs 6.8 [5.8, 7.9], P = .03), no changes in oral disposition index were found, P = .14. CONCLUSION:After 2 years of ETI, fasting glucose and HbA1c showed modest decreases. Glucose tolerance varied, and overall measures of insulin secretion did not deteriorate.