Comprehension by Caregivers and Adolescents of Clinical Trial Information Delivered via Multimedia Video Versus Conventional Practice: Nonrandomized Controlled Trial.

BACKGROUND: Research participants often misunderstand the required elements of informed consent information, whether provided in written or oral format. Informed consent instruments with embedded evidence-based learning theory principles administered in multimedia electronic formats may improve comprehension and retention. OBJECTIVE: This study aims to determine whether study information comprehension and retention using an interactive multimedia video consent process was noninferior to comprehension and retention after an in-person face-to-face interaction with a conventional written consent document for caregivers and adolescents enrolled in a clinical trial. METHODS: Participants were caregivers and children aged 12 to 17 years who were enrolled in a clinical trial of asthma treatment. Consent information was presented as a multimedia web-based video consent interaction or as a conventional written consent document with in-person interaction between the prospective participants and the study staff. The trial used a parallel nonrandomized noninferiority design that compared the 2 consent methods. Caregivers and adolescents completed a 17-item open-ended comprehension questionnaire (score range 17-51) at enrollment and at the end of the study 20 weeks later. Comprehension and retention were compared between the consent formats. Noninferiority was established if the 95% CI upper bound of the difference in scores (conventional format minus web-based) was less than the noninferiority margin of 2.4; superiority was established if the upper bound of the CI was <0. RESULTS: In total, 54 caregiver and adolescent dyads completed the interactive multimedia web-based video consent, and 25 dyads completed the conventional consent. Overall, 33% (26/79) of all adolescents were Black, 57% (45/79) were male, and 61% (48/79) had a household income of

Development and Evaluation of the Pediatric Diabetes Routine Questionnaire for Parents of Young Children with Type 1 Diabetes.

This study describes the development and psychometric evaluation of the Pediatric Diabetes Routines Questionnaire for Parents of Young Children (PDRQ-PYC) with type 1 diabetes, a measure adapted from the school-age and adolescent versions of the PDRQ, to measure diabetes-specific routines in families with children under age 6 years with type 1 diabetes. Participants included 173 parents of young children with type 1 diabetes (YC-T1D) who completed measures of diabetes-specific routines, diabetes adjustment, self-efficacy, benefit finding, depression, child behavior problems, spousal support, and T1D treatment engagement. Exploratory factor analysis supported a one-factor model consisting of a unidimensional PDRQ-PYC total score. The PDRQ-PYC total score demonstrated good internal consistency, convergent validity, and criterion validity. The present study demonstrates that PDRQ-PYC is a valuable and feasible tool for measuring the consistency and regularity with which families of YC-T1D perform T1D management tasks. Along with the school-age and adolescent versions of the PDRQ, the PDRQ-PYC now provides the ability to assess diabetes-specific routines from early childhood through adolescence and findings support the notion that routines are associated with engagement in diabetes tasks.ClinicalTrials.gov Identifier NCT03222180 (first posted July 19, 2017).

Durability of Changes in Biomarkers of Cardiometabolic Disease: 1-Year Family-Based Intervention in Children with Obesity.

Background: The sustainability of health benefits in response to lifestyle-based interventions remains unclear in children with overweight and obesity, and cardiometabolic disease (CMD). We determined the changes in novel biomarkers of CMD in a 1-year family-based intervention (FBI) program, during 6-month active monitoring phase and at 12-month follow-up. Methods: Children with an age-adjusted body mass index (BMI) percentile ≥85 (N = 130; age 8-11 years) were recruited for a 1-year (6-month monitored and 6-month unmonitored) randomized controlled FBI program. Anthropometry and selected biomarkers of CMD were measured in 87 participants, randomly allocated to intervention (INT) and education-only (EDU) groups, at baseline, immediately after a 6-month active intervention or control period, and at 12-month unmonitored follow-up. Results: Samples from 87 participants (age 10.00 ± 0.11 years and Tanner stage ≤3) with obesity (BMI%ile = 97.45 ± 0.15) were available. Overall intervention effect (between groups), was observed for total (T) and high molecular weight (HMW) adiponectin, ratio of total to HMW adiponectin, fibrinogen, and interleukin (IL)-6 (P < 0.05 for all). However, between-group beneficial changes after adjusting for baseline levels were limited to BMI percentile, T and HMW adiponectin and their ratio, IL-6, and fibrinogen (P < 0.05 for all) mainly during the 6-month period of monitored intervention. Changes in traditional risk factors such as lipids and triglycerides were inconsistent. During the 6-month follow-up period, the changes in biomarkers leveled-off, except for T and HMW adiponectin, IL-6, and fibrinogen that continued to show benefits (P < 0.05) from the 6- to 12-month follow-up. Conclusions: The FBI program beneficially altered novel biomarkers of CMD during the monitored intervention phase in school-age children with obesity, but they mostly moved back toward baseline during the unmonitored follow-up phase. The changes in novel biomarkers of CMD appear to be more sensitive compared to the traditional risk factors. The study implies the need for refinements in lifestyle-based approaches in the preservation of cardiovascular health and calls for robust biomarkers to monitor the changes. The study was registered at ClinicalTrials.gov (NCT01146314).

A Provider-Focused Intervention to Promote Optimal Care of Pediatric Patients With Suspected Elbow Fracture.

OBJECTIVE: Emergency department (ED) and urgent care (UC) physicians' accurate assessment of the neurovascular and musculoskeletal (NV/MSK) examination in pediatric patients with suspected elbow fracture is crucial to the early recognition of neurovascular compromise. Our objective was to determine the impact of computer-based simulation (CBS) and computerized clinical decision support systems (CCDSS) on ED and UC physicians' assessment of the NV/MSK examination of pediatric patients with elbow fracture as noted in their documentation. METHODS: All ED UC physician participants received CBS training about management of pediatric patients with suspected elbow fracture. Participants were then randomized to receive CCDSS (intervention arm) when an eligible patient was seen or no further intervention (comparison arm.) Participants received feedback on the proportion of patients with discharge diagnosis of elbow fracturewith proper examination elements documented. RESULTS: Twenty-eight ED and UC physicians were enrolled - 14 in each arm. Over the span of 16 weeks, 50 patients with a discharge diagnosis of elbow fracture were seen - 25 in each arm. Twenty-two of 25 (88%) patients seen by intervention arm participants had a complete NV/MSK examination documented. Six of 25 (24%) patients seen by comparison arm participants had a complete NV/MSK examination documented. Elements most commonly missed in the comparison arm included documentation of ulnar pulse as well as radial, median, and ulnar nerve motor functions. CONCLUSIONS: Compared with single CBS training alone, repeated exposure to CCDSS after CBS training resulted in improved documentation of the NV/MSK status of pediatric patients with elbow fracture.

Topical Review: Crowdsourcing as a Novel Approach to Qualitative Research.

OBJECTIVE: To describe a novel, five-phase approach to collecting qualitative data from hard-to-reach populations using crowdsourcing methods. METHODS: Drawing from experiences across recent studies with type 1 diabetes and congenital heart disease stakeholders, we describe five phases of crowdsourcing methodology, an innovative approach to conducting qualitative research within an online environment, and discuss relevant practical and ethical issues. RESULTS: Phases of crowdsourcing methodology are: (I) Preparing; (II) Forming Crowds; (III) Collecting Crowdsourced Data; (IV) Coding and Analyzing Crowdsourced Data; and (V) Generating and Disseminating Findings. Iterative feedback from stakeholders is obtained in all five phases. Practical and ethical issues include accessing diverse stakeholders, emotional engagement of crowd participants, responsiveness and transparency of crowdsourcing methodology, and limited personal contact with crowd participants. CONCLUSIONS: Crowdsourcing is an innovative, efficient, feasible, and timely approach to engaging hard-to-reach populations in qualitative research.

Society of Pediatric Psychology Workforce Survey: Updated Factors Related to Compensation.

OBJECTIVE: The 2017 Society of Pediatric Psychology (SPP) Workforce Survey provides self-reported compensation by pediatric psychologists, identifies predictors of compensation, and establishes a better understanding of compensation within the context of gender and race/ethnicity minority status. METHODS: SPP members who attended the SPP Annual Conference (SPPAC; April 2017) were invited to complete the survey at the conference through electronic tablets provided on-site by the Workforce Survey Committee. The survey was subsequently distributed online to SPP members who did not complete the survey at SPPAC. The statistical analyses used for this salary data employed flexible semi-parametric models, cross-validation, and prediction models for both the overall sample and academic rank subgroups. RESULTS: Of 27 potential demographic and employment-related predictors from the 2017 SPP Workforce Survey, significant predictors of salary emerged within this sample: academic rank, time since obtaining doctoral degree, managing internal and external funds (of at least $50,000), years in primary employment position, obtaining Fellowship status in the American Psychological Association (APA), and managing other employees (at least 10 people). Given low response rates for males and individuals who identify as belonging to racial and ethnic minority subgroups, only limited, exploratory results are reported for these subgroups. CONCLUSIONS: These findings suggest that not only is longevity in one's career important but managing funds/personnel and obtaining professional designations are also predictors of higher salaries for pediatric psychologists, in general. Specific implications of salary according to the psychologist's academic rank, gender, and racial/ethnicity group status are also explored.

Development and Validation of the Parent-Preschoolers Diabetes Adjustment Scale (PP-DAS).

OBJECTIVE: This article extends work on a social-ecological model of caregiver adjustment and describes the: (a) development and (b) validation of the Parent-Preschoolers Diabetes Adjustment Scale (PP-DAS), a broad measure of caregiver adjustment. METHODS: Participants were caregivers (nstudy1 = 51; nstudy2 = 177) of very young children (<6 years old) with Type 1 diabetes (T1D). In study 1, researchers and stakeholders collaborated to develop 92 items using the 5 domains of a social-ecological model of caregiver adjustment to the challenges of raising a very young child with T1D, and parents and researchers provided feedback on these items. In study 2, confirmatory factor analysis (CFA) and exploratory factor analysis (EFA) were used to examine the factor structure of the PP-DAS. Reliability and validity were also examined. RESULTS: After review by parents and researchers, 52 items were removed resulting in the 40-item version used in study 2. The CFA demonstrated poor fit with the five proposed domains of the social-ecological model, so an EFA was conducted and supported a different five-factor solution. Twenty items were removed due to low factor loadings or communalities, resulting in a final 20-item measure. The PP-DAS demonstrated adequate internal consistency (α's = .73-.84), convergent validity with parent psychological functioning and self-efficacy in T1D management, and criterion validity with hemoglobin A1c and adherence. CONCLUSIONS: The PP-DAS is a valid and reliable measure of adjustment in caregivers of very young children with T1D. The PP-DAS may help identify caregivers who are having adjustment difficulties and would benefit from additional support.

Development and content validation of the Healthcare Transition Outcomes Inventory for young adults with type 1 diabetes.

BACKGROUND: The literature on the specification and measurement of the outcomes of the healthcare transition from pediatric to adult centered-care is scarce and methodologically weak. To address these gaps, we conducted a series of studies to develop a multidimensional, multi-informant (young adults, parents, and healthcare providers) measure of healthcare transition outcomes for young adults with type 1 diabetes (T1D), the Healthcare Transition Outcomes Inventory (HCTOI). The current study describes the development and refinement of the HCTOI item pool. METHODS: Following Patient Reported Outcomes Measurement Information System (PROMIS) standards, the research team conducted qualitative interviews to define six content domains of healthcare transition outcomes from the perspectives of multiple stakeholders, developed an initial item pool of the HCTOI based on the six domains, analyzed expert item ratings and feedback for content validation, and conducted cognitive interviews with informants (patients, parents, and healthcare providers) for further item pool refinement. RESULTS: Qualitative findings revealed six healthcare transition outcome domains: 1) Biomedical markers of T1D control; 2) Navigation of a new health care system; 3) Possession of T1D self-management skills and knowledge; 4) Integration of T1D care into emerging adult roles; 5) Balance of parental involvement with autonomy; and 6) Attainment of T1D "ownership." An initial pool of 88 items focused on the extent to which a young adult with T1D is successful on each of the six domains. Experts rated all content domains and all but six items as relevant. In addition to suggesting additional items, experts were concerned about the length of the measure, response burden, and whether every informant type would have sufficient knowledge to rate items in particular content domains. Cognitive interviews resulted in retaining all six content domains, but dropping some items and yielded fewer items for the healthcare provider version (47 items versus 54 items for the young adult- and parent-versions). CONCLUSIONS: Expert review and cognitive interviews confirmed that all six domains of HCT outcomes were relevant and both procedures resulted in retaining a sufficient number of clear and representative items for each content domain. The HCTOI represents the first multi-informant, rigorously developed item pool that comprehensively measures the multiple components of the transition from pediatric to adult specialty healthcare.

Effects of age, sex, race/ethnicity, and allergy status in obesity-related pediatric asthma.

RATIONALE: Obesity in children increases the risk for new asthma. How age, sex, race/ethnicity, and allergy status affect the relationship between obesity and asthma is unclear. This study describes the relationship between high body mass index (BMI) and incident asthma. METHODS: We conducted a retrospective cohort study to compare asthma incidence among normal weight, overweight, and obese 2 to 6, 7 to 11, and 12 to 17 year olds to define the effects of sex, race/ethnicity, and allergy status. Weight status was determined at baseline and asthma incidence was defined as ≥2 asthma encounters and ≥1 asthma prescriptions. We used multivariable Poisson regression to estimate adjusted incident asthma rates and risk ratios. RESULTS: Data from 192 843 2 to 6 year olds, 157 284 7 to 11 year olds, and 157 369 12 to 17 year olds were included. The relative risks (95% confidence interval [CI]) of new asthma among obese children in 2 to 6 year olds, 7 to 11 year olds, and 12 to 17 year olds were 1.25 (1.15, 1.37), 1.49 (1.32, 1.69) and 1.40 (1.21, 1.63), respectively. Among children with underlying allergic rhinitis, obesity did not increase the risk of new asthma. In children without allergic rhinitis, the risk for obesity-related asthma was highest in 7 to 11 year olds (risk ratio = 1.50 95% CI, 1.33, 1.60). Before age 12, females had a higher risk for obesity-related asthma; but after age 12, obese males had a higher asthma risk (interaction P-value < .05). CONCLUSION: Obesity is a major preventable risk factor for pediatric asthma that appears to vary along the pediatric age continuum and depends on sex, race/ethnicity and atopy status.

Impact of family-centered tailoring of pediatric diabetes self-management resources.

BACKGROUND: The American Diabetes Association recommends a family-centered approach that addresses each family's specific type 1 diabetes self-management barriers. OBJECTIVE: To assess an intervention that tailored delivery of self-management resources to families' specific self-management barriers. SUBJECTS: At two sites, 214 children 8-16 years old with type 1 diabetes and their parent(s) were randomized to receive tailored self-management resources (intervention, n = 106) or usual care (n = 108). METHODS: Our intervention (1) identified families' self-management barriers with a validated survey, (2) tailored self-management resources to identified barriers, and (3) delivered the resources as four group sessions coordinated with diabetes visits. Mixed effects models with repeated measures were fit to A1c as well as parent and child QOL during the intervention and 1 year thereafter. RESULTS: Participants were 44% youth (8-12 years) and 56% teens (13-16 years). No intervention effect on A1c or QOL was shown, combining data from sites and age groups. Analyzing results by site and age group, post-intervention A1c for teens at one site declined by 0.06 more per month for intervention teens compared to usual care (P < 0.05). In this group, post-intervention A1c declined significantly when baseline A1c was >8.5 (-0.08, P < 0.05), with an even larger decline when baseline A1c was >10 (-0.19, P < 0.05). In addition, for these teens, the significant improvements in A1c resulted from addressing barriers related to motivation to self-manage. Also at this site, mean QOL increased by 0.61 points per month more during the intervention for parents of intervention youth than for usual care youth (P < 0.05). CONCLUSIONS: Tailored self-management resources may improve outcomes among specific populations, suggesting the need to consider families' self-management barriers and patient characteristics before implementing self-management resources.

Benefit finding among parents of young children with type 1 diabetes.

Benefit finding, perceived positive effects of adversity, has been associated with psychological well-being in people with chronic illnesses and with better adherence for adolescents with type 1 diabetes (T1D). Our qualitative research with parents of young children (< 6 years old) with T1D indicated that benefit finding (BF) is a common parental coping mechanism, but no tools exist to measure BF in parents. We determined psychometric properties of the Diabetes Benefit Finding Scale for Parents (DBFS-P), a 16-item questionnaire adapted from the validated adolescent version. Parents of young children with T1D (n = 172) were participants in a randomized trial of an online intervention. We examined the DBFS-P factor structure through principal component analysis (PCA); internal consistency through Cronbach's alpha; convergent validity via bivariate correlations between the DBFS-P and measures of parental depression, anxiety, T1D self-efficacy, and hypoglycemia fear; and discriminant validity via bivariate correlations between the DBFS-P and measures of parental somatization and child behavior problems. PCA revealed one factor (56.47% variance) with Cronbach's α = 0.95. Convergent validity of the DBFS-P was supported by significant correlations with parental depression (r = -0.35, P < 0.001), anxiety (r = -0.20, P = 0.008), T1D self-efficacy (r = 0.36, P < 0.001), and hypoglycemia fear (r = 0.27, P < 0.001). Non-significant correlations with parental somatization (r = -0.06, P = 0.42) and child behavior problems (r = -0.12, P = 0.14) support its discriminant validity. The DBFS-P demonstrated good psychometric properties as a tool for assessing BF among caregivers.

Diabetes and Behavior in the 21st Century: Things That Make You Go "Hmmm . . . ".

Editor's Note: This article is adapted from the address Dr. Wysocki delivered as the recipient of the American Diabetes Association's Richard R. Rubin Award for 2018. This award recognizes a behavioral researcher who has made outstanding, innovative contributions to the study and understanding of the behavioral aspects of diabetes in diverse populations. Dr. Wysocki delivered the address in June 2018 at the association's 78th Scientific Sessions in Orlando, Fla.

Provider-Focused Intervention to Promote Comprehensive Screening for Adolescent Idiopathic Scoliosis by Primary Care Pediatricians.

Screening can detect adolescent idiopathic scoliosis (AIS). The objective was to determine if computer-based simulation (CBS) and computerized clinical decision-support systems (CCDSS) would improve primary care providers' AIS screening exams as noted in their documentation. All participants received AIS screening CBS training. Participants were then randomized to receive either CCDSS when an eligible patient was seen (intervention arm) or no further intervention (comparison arm). Eligible patients' documentation was analyzed looking for a complete AIS screening exam. Over the span of 17 weeks, 1051 eligible patients were seen; 468 by providers in the intervention arm, 583 in the comparison arm. In all, 292/468 (62%) of eligible patients seen in the intervention arm and 0/583 (0%) in the comparison arm had a complete AIS screening exam documented. Compared with single CBS training alone, repeated exposure to CCDSS after CBS training resulted in improved documentation of the screening exam for AIS.

A Web-Based Coping Intervention by and for Parents of Very Young Children With Type 1 Diabetes: User-Centered Design.

BACKGROUND: Management of type 1 diabetes (T1D) among children aged <6 years is exceptionally challenging for parents and caregivers. Metabolic and psychosocial outcomes among very young children with T1D (YC-T1D) are tightly associated with their parents' ability to meet these challenges. There is scant research testing interventions targeting these issues and few resources to equip health care providers with feasible and effective coping strategies for these parents. User-centered design (UCD) of a continuously accessible Web-based resource could be a mechanism for helping parents of YC-T1D cope more effectively with the complex challenges they face by providing them with information, solutions, and emotional support. OBJECTIVE: The objectives of this paper are to (1) describe the application of UCD principles to the development of a Web-based coping intervention designed by and for parents of very young children (<6 years old) with T1D; (2) illustrate the use of crowdsourcing methods in obtaining the perspectives of parents, health care providers, and Web development professionals in designing and creating this resource; and (3) summarize the design of an ongoing randomized controlled trial (RCT) that is evaluating the effects of parental access to this resource on pertinent child and parent outcomes. METHODS: This paper illustrates the application of UCD principles to create a Web-based coping resource designed by and for parents of YC-T1D. A Web-based Parent Crowd, a Health Care Provider Crowd, and a Focus Group of minority parents provided input throughout the design process. A formal usability testing session and design webinars yielded additional stakeholder input to further refine the end product. RESULTS: This paper describes the completed website and the ongoing RCT to evaluate the effects of using this Web-based resource on pertinent parent and child outcomes. CONCLUSIONS: UCD principles and the targeted application of crowdsourcing methods provided the foundation for the development, construction, and evaluation of a continuously accessible, archived, user-responsive coping resource designed by and for parents of YC-T1D. The process described here could be a template for the development of similar resources for other special populations that are enduring specific medical or psychosocial distress. The ongoing RCT is the final step in the UCD process and is designed to validate its merits.

Being Overweight or Obese and the Development of Asthma.

OBJECTIVES: Adult obesity is linked to asthma cases and is estimated to lead to 250 000 new cases yearly. Similar incidence and attributable risk (AR) estimates have not been developed for children. We sought to describe the relationship between overweight and obesity and incident asthma in childhood and quantify AR statistics in the United States for overweight and obesity on pediatric asthma. METHODS: The PEDSnet clinical data research network was used to conduct a retrospective cohort study (January 2009-December 2015) to compare asthma incidence among overweight and/or obese versus healthy weight 2- to 17-year-old children. Asthma incidence was defined as ≥2 encounters with a diagnosis of asthma and ≥1 asthma controller prescription. Stricter diagnostic criteria involved confirmation by spirometry. We used multivariable Poisson regression analyses to estimate incident asthma rates and risk ratios and accepted formulas for ARs. RESULTS: Data from 507 496 children and 19 581 972 encounters were included. The mean participant observation period was 4 years. The adjusted risk for incident asthma was increased among children who were overweight (relative risk [RR]: 1.17; 95% confidence interval [CI]: 1.10-1.25) and obese (RR: 1.26; 95% CI: 1.18-1.34). The adjusted risk for spirometry-confirmed asthma was increased among children with obesity (RR: 1.29; 95% CI: 1.16-1.42). An estimated 23% to 27% of new asthma cases in children with obesity is directly attributable to obesity. In the absence of overweight and obesity, 10% of all cases of asthma would be avoided. CONCLUSIONS: Obesity is a major preventable risk factor for pediatric asthma.

Electronically Verified Use of Internet-Based, Multimedia Decision Aids by Adolescents With Type 1 Diabetes and Their Caregivers.

Decision aids (DAs) are central to shared decision making (SDM) interventions, yet little is known about patients' actual DA use. Adequate utilization of DAs could optimize SDM effectiveness. Electronic DAs enable more objective tracking and analysis of actual DA utilization than do paper DAs. This report is part of an ongoing randomized controlled SDM trial enrolling adolescents with type 1 diabetes and their caregivers (n = 153) who were considering use of an insulin pump or continuous glucose monitor. Extensive stakeholder engagement guided creation of two online DAs. After completing baseline measures, 133 dyads were randomized to SDM (access to the pertinent DA) or Usual Care (clinic routines for preparing candidates for adopting these devices). Utilization data showed that 80% of caregivers and 66% of youths logged into a DA at least once; youths and caregivers, respectively, dedicated a mean of 44.7 and 55.0 minutes to website use and viewed 72.2% and 77.4% of the DA content. Median total duration from enrollment to last DA logout was 48.2 days for adolescents and 45.6 days for caregivers. Bivariate comparisons showed that non-Hispanic, Caucasian females from households with higher socioeconomic status were significantly more likely to login to the assigned DA at least once. Hierarchical multiple regression showed that adolescent males with lower levels of health literacy demonstrated fewer DA logins (F = 2.59; P < 0.009), but identified no significant predictors of adolescents' or caregiver' duration of DA use or proportion of DA content viewed. Future SDM trials should seek to promote DA use, especially by non-White adolescents, perhaps with direct assistance with the initial DA login. Trials employing electronic DAs should routinely report and analyze utilization data.

Pumps or Multiple Daily Injections in Pregnancy Involving Type 1 Diabetes: A Prespecified Analysis of the CONCEPTT Randomized Trial.

OBJECTIVE: To compare glycemic control, quality of life, and pregnancy outcomes of women using insulin pumps and multiple daily injection therapy (MDI) during the Continuous Glucose Monitoring in Women With Type 1 Diabetes in Pregnancy Trial (CONCEPTT). RESEARCH DESIGN AND METHODS: This was a prespecified analysis of CONCEPTT involving 248 pregnant women from 31 centers. Randomization was stratified for pump versus MDI and HbA1c. The primary outcome was change in HbA1c from randomization to 34 weeks' gestation. Key secondary outcomes were continuous glucose monitoring (CGM) measures, maternal-infant health, and patient-reported outcomes. RESULTS: At baseline, pump users were more often in stable relationships (P = 0.003), more likely to take preconception vitamins (P = 0.03), and less likely to smoke (P = 0.02). Pump and MDI users had comparable first-trimester glycemia: HbA1c 6.84 ± 0.71 vs. 6.95 ± 0.58% (51 ± 7.8 vs. 52 ± 6.3 mmol/mol) (P = 0.31) and CGM time in target (51 ± 14 vs. 50 ± 13%) (P = 0.40). At 34 weeks, MDI users had a greater decrease in HbA1c (-0.55 ± 0.59 vs. -0.32 ± 0.65%, P = 0.001). At 24 and 34 weeks, MDI users were more likely to achieve target HbA1c (P = 0.009 and P = 0.001, respectively). Pump users had more hypertensive disorders (P = 0.011), mainly driven by increased gestational hypertension (14.4 vs. 5.2%; P = 0.025), and more neonatal hypoglycemia (31.8 vs. 19.1%, P = 0.05) and neonatal intensive care unit (NICU) admissions >24 h (44.5 vs. 29.6%; P = 0.02). Pump users had a larger reduction in hypoglycemia-related anxiety (P = 0.05) but greater decline in health/well-being (P = 0.02). CONCLUSIONS: In CONCEPTT, MDI users were more likely to have better glycemic outcomes and less likely to have gestational hypertension, neonatal hypoglycemia, and NICU admissions than pump users. These data suggest that implementation of insulin pump therapy is potentially suboptimal during pregnancy.