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Background Type 1 diabetes (T1D) care requires multiple daily self-management behaviors (SMBs). Preliminary studies on SMBs rely mainly on self-reported survey and interview data. There is little information on adult T1D SMBs, along with corresponding compensation techniques (CTs), gathered in real-time. Objective The article aims to use a patient-centered approach to design iDECIDE, a smartphone application that gathers daily diabetes SMBs and CTs related to meal and alcohol intake and exercise in real-time, and contrast patients' actual behaviors against those self-reported with the app. Methods Two usability studies were used to improve iDECIDE's functionality. These were followed by a 30-day pilot test of the redesigned app. A survey designed to capture diabetes SMBs and CTs was administered prior to the 30-day pilot test. Survey results were compared against iDECIDE logs. Results Usability studies revealed that participants desired advanced features for self-tracking meals and alcohol intake. Thirteen participants recorded over 1,200 CTs for carbohydrates during the 30-day study. Participants also recorded 76 alcohol and 166 exercise CTs. Comparisons of survey responses and iDECIDE logs showed mean% (standard deviation) concordance of 77% (25) for SMBs related to meals, where concordance of 100% indicates a perfect match. There was low concordance of 35% (35) and 46% (41) for alcohol and exercise events, respectively. Conclusion The high variability found in SMBs and CTs highlights the need for real-time diabetes self-tracking mechanisms to better understand SMBs and CTs. Future work will use the developed app to collect SMBs and CTs and identify patient-specific diabetes adherence barriers that could be addressed with individualized education interventions.

LBA8501 Background: Plasma cfDNA genomic analysis is used widely for the care of advanced lung cancer, but its suitability for early stage lung cancer detection is not well established. CCGA (NCT02889978) is a prospective, multi-center, observational study launched for the development of a noninvasive assay for cancer detection. Methods: Blood was prospectively collected (N = 1627) from 749 controls (no cancer diagnosis) and 878 participants (pts) with newly-diagnosed untreated cancer in this preplanned substudy, including 127 pts with lung cancer. Three prototype sequencing assays were performed: paired cfDNA and white blood cell (WBC) targeted sequencing (507 genes, 60,000X) for single nucleotide variants/indels; paired cfDNA and WBC whole genome sequencing (WGS) for copy number variation (30X); and cfDNA whole genome bisulfite sequencing (WGBS) for methylation (30X). For each assay, a classification model using 10-fold cross-validation was developed for all pts with cancer, then evaluated in the pts with lung cancer; sensitivity was estimated at 95% specificity. Results: We evaluated pts with lung cancer (127) and a subset of controls (580) with similar ages (mean±SD yrs: 67±9, 60±13), 85% and 43% were ever-smokers, and 46% and 22% were men, respectively. Of 3055 nonsynonymous mutations detected across 122 evaluable pts with lung cancer, > 50% were detected in WBC consistent with clonal hematopoiesis (CH). Accounting for CH, sensitivity in 63 stage I-IIIA pts evaluable across all 3 assays was 48% (35-61, targeted), 54% (41-67, WGS), and 56% (43-68, WGBS); in 54 stage IIIB-IV pts it was 85% (73-93, targeted), 91% (80-97, WGS), and 93% (82-98, WGBS) . Similar sensitivities were observed across histological subtypes (adenocarcinoma, squamous cell, small cell). Comparison to tumor WGS and multi-assay classification will be reported. Conclusions: Early stage lung cancers are detectable in cfDNA using a genome-wide sequencing approach. For lung cancer detection using targeted assays, CH must be accounted for to minimize false positives. Assay optimization is ongoing to allow further clinical development in the intended use population. Clinical trial information: NCT02889978.

INTRODUCTION: Contraception is an important resource for Somali women as this population is at increased risk for adverse pregnancy outcomes. This study compares postpartum contraception use between Somali and non-Somali women. METHODS: A retrospective cohort study was performed utilizing the Rochester Epidemiology Project. All Somali women aged 18 and older who experienced liveborn, singleton births in Olmsted County, Minnesota, in 2009-2015 (n=317) and an age-matched non-Somali cohort (n=317) were identified. Postpartum contraception was defined as use of any method within 12 months after the first delivery in the time period of interest. Contraception use was compared using a chi-square test. Factors associated with contraception use were evaluated using multivariable logistic regression. RESULTS: Somali women were significantly less likely to use contraception than non-Somali women (62.1% versus 89.3%, p<0.001). Of those who used contraception, both Somali and non-Somali women reported comparable use of long-acting reversible contraception (LARC) (19.8% versus 23.7%, p=0.31) and non-LARC hormonal contraception (40.1% versus 45.2%, p=0.26). Somali women were more likely to use less reliable methods including natural family planning and barrier methods (57.3% versus 21.1%, p<0.001). Among Somali women, postpartum contraception use was less likely with older maternal age (OR 0.12 for oldest versus youngest quartile, 95% CI 0.04-0.37) and more likely with pre-pregnancy contraception use (OR 15.46, 95% CI 5.18-46.18). CONCLUSION: Our study represents the first assessment in the literature of contraception use in Somali women in the United States. Somali women are less likely to utilize postpartum contraception, highlighting an opportunity for improvement in counseling practices.

Studies have found variability in self-care behaviors in patients with type 1 diabetes, particularly when incorporating exercise and alcohol consumption. The objective of this study was to provide results from a survey to understand (1) insulin pump behaviors, (2) reported self-management behaviors for exercise and alcohol, and (3) perceptions of the effects of exercise and alcohol on blood glucose (BG) control. Fourteen participants from an outpatient endocrinology practice were recruited and administered an electronic survey. Compensation techniques for exercise and alcohol, along with reasons for employing the techniques were identified. Also identified were factors that participants said affected BG control with regard to exercise and alcohol. These results confirm the considerable inconsistency patients have about incorporating exercise and alcohol into decisions about self-management behaviors.

INTRODUCTION: The Pregnancy Reasonably Excluded Guide (PREG) questionnaire is based on traditional methods of excluding pregnancy including sterilization, menopause, and the World Health Organization criteria. The PREG has been validated and shows a 99-100% negative predictive value for pregnancy (Selected practice recommendations for contraceptive use, 2013: adapted from the world health organization selected practice recommendations for contraceptive use, 2nd edition. MMWR Recomm Rep 2013; 62:1‒60.). Pregnancy testing in our outpatient surgical settings varied by provider. This study compared utilization of pregnancy tests in the outpatient gynecologic surgery setting after implementation of universal PREG administration. METHODS: All women undergoing outpatient gynecologic surgery were prospectively evaluated between March and September 2016. Administration of the PREG to women 18-49, excluding those undergoing procedures related to pregnancy, was implemented in July and rates of pregnancy testing pre- and post-implementation were compared using Fisher’s exact test. RESULTS: 369 patients underwent an outpatient gynecologic procedure during the study period (excluding a two week washout period after implementation). In the pre-implementation group, 136 met inclusion criteria with 45 pregnancy tests performed (33.1%). After implementation, 80 patients met inclusion criteria and 17 pregnancy tests were performed as indicated by PREG response (21.3%), demonstrating over one third reduction in pregnancy test administration (p = 0.086). No pregnancy tests were positive and no false negative evaluations were identified. Physician and nursing staff requested continued use of the PREG after the trial. CONCLUSION: PREG administration on admission for outpatient gynecologic surgery consistently and effectively identifies patients in whom pregnancy testing improves the value of care.

Background: We propose a methodology to analyze complex real-life glucose data in insulin pump users. Methods: Patients with type 1 diabetes (T1D) on insulin pumps were recruited from an academic endocrinology practice. Glucose data, insulin bolus (IB) amounts, and self-reported alcohol consumption and exercise events were collected for 30 days. Rules were developed to retrospectively compare IB recommendations from the insulin pump bolus calculator (IPBC) against recommendations from a proposed decision aid (PDA) and for assessing the PDA’s recommendation for exercise and alcohol. Results: Data from 15 participants were analyzed. When considering instances where glucose was below target, the PDA recommended a smaller dose in 14%, but a larger dose in 13% and an equivalent IB in 73%. For glucose levels at target, the PDA suggested an equivalent IB in 58% compared to the subject’s IPBC, but higher doses in 20% and lower in 22%. In events where postprandial glucose was higher than target, the PDA suggested higher doses in 25%, lower doses in 13%, and equivalent doses in 62%. In 64% of all alcohol events the PDA would have provided appropriate advice. In 75% of exercise events, the PDA appropriately advised an IB, a carbohydrate snack, or neither. Conclusions: This study provides a methodology to systematically analyze real-life data generated by insulin pumps and allowed a preliminary analysis of the performance of the PDA for insulin dosing. Further testing of the methodological approach in a broader diabetes population and prospective testing of the PDA are needed.

Background: There is a lack of systematic ways to analyze how diabetes patients use their insulin pumps to self-manage blood glucose to compensate for alcohol ingestion and exercise. The objective was to analyze “real-life” insulin dosing decisions occurring in conjunction with alcohol intake and exercise among patients using insulin pumps. Methods: We recruited adult type 1 diabetes (T1D) patients on insulin pump therapy. Participants were asked to maintain their daily routines, including those related to exercising and consuming alcohol, and keep a 30-day journal on exercise performed and alcohol consumed. Thirty days of insulin pump data were downloaded. Participants’ actual insulin dosing behaviors were compared against their self-reported behaviors in the setting of exercise and alcohol. Results: Nineteen T1D patients were recruited and over 4000 interactions with the insulin pump were analyzed. The analysis exposed variability in how subjects perceived the effects of exercise/alcohol on their blood glucose, inconsistencies between self-reported and observed behaviors, and higher rates of blood glucose control behaviors for exercise versus alcohol. Conclusion: Compensation techniques and perceptions on how exercise and alcohol affect their blood glucose levels vary between patients. Improved individualized educational techniques that take into consideration a patient’s unique life style are needed to help patients effectively apply alcohol and exercise compensation techniques.

Background: Successful diabetes management requires behavioral changes. Little is known about self-management behaviors (SMB) in adults on insulin pump (IP) therapy. Objective: Analyze and characterize observed common diabetes SMB in adult participants with type 1 diabetes (T1D) using IPs and to correlate behaviors with glycemic outcomes based on participant’s individual glucose targets. Materials and Methods: One month of IP data from adults with T1D were downloaded. Computer programs were written to automatically quantify the observed frequency of expected behaviors such as: insulin bolusing, checking blood glucose (BG), and recording carbohydrate intake, and other interactions with the IP. Results: Nineteen participants were recruited and 4,249 IP interactions were analyzed to ascertain behaviors. Intersubject variability of adherence to minimally expected behaviors was observed: daily documentation of carbohydrates and BG checks in 76.6 (31.7)% and 60.0 (32.5)%, respectively, and bolusing without consulting the IPBC in 13.0 (16.9)% of delivered boluses, while daily insulin bolus delivery was consistent 96.8 (5.7)%. Higher frequency of adherence to daily behaviors correlated with a higher number of glucose readings at target. Conclusion: Results indicate variability in SMB and do not always match recommendations. Case-scenarios based on observed real-life SMB could be incorporated into interviews/surveys to elucidate ways to improve SMB.