bluuebunny/crossref_metadata_2025 huggingface dataset:
601-P: Participation in Diabefly Program and Significant Reduction in Diabetes Distress and Improvement in Motivation and Attitude towards Changing Health among People with Type 2 Diabetes
Authors: VERMA NEHA , LATHIA TEJAL , VASAN PALLAVI , GUPTA NISHUL , VERMA RITIKA , KALRA SANJAY , PADSALGE MAHESH V. , METHIL VINOD , SINGAL ARBINDER K. , SAMUDRA KIRTI
Published: May 2022

Introduction: Diabetes distress is a unique, often hidden, emotional burden and worry that an individual experiences while managing diabetes. Enhanced motivation and willingness are important components of one’s ability to manage the increasing demands of diabetes. Aim of this study is to analyse the effectiveness of digital therapeutics programs in providing evidence-based care that can help in better management of diabetes through long-term behaviour change.

Methods: This study was conducted with 100 participants diagnosed with type 2 DM across India. They were enrolled in the Diabefly® digital therapeutics program for 90 days. Highly customized virtual stress management and behaviour therapy sessions were given to each participant along with nutrition and fitness sessions. Various digital interventions were shared at regular intervals. Initial and final assessment was done using Diabetes Distress Scale and Motivation and Attitude towards Changing Health. t - test was used to analyse the data.

Results: Motivation levels among participants improved significantly by 9.39% from a baseline score of 33.70±4.24 to 37.42±4.50 (p=0.001) . Distress levels among participants decreased significantly by 24.21% from a baseline score of 1.90±0.77 to 1.35±0.45 (p=0.001) . Participants from joint families have higher interpersonal distress as compared to nuclear families (p=0.008) . Participants having diabetes for more than 5 years have higher physician distress (p=0.001) and interpersonal distress (p=0.005) as compared to newly diagnosed ones. Participants who are on insulin along with medications have higher physician distress (p=0.031) and interpersonal distress (p=0.020) in comparison to those who are just on medication or not on any medication.

Conclusion: Remote behavioural interventions as part of a comprehensive 90 days Diabefly® program can be very effective in managing diabetes adequately.

Disclosure

N.Verma: Employee; Fitterfly HealthTech Private Limited. K.Samudra: None. T.Lathia: Advisory Panel; Abbott, AstraZeneca, Biocon, Boehringer Ingelheim International GmbH, Novartis Pharmaceuticals Corporation, Novo Nordisk, Sanofi. P.Vasan: Employee; Fitterfly Health Tech Pvt Ltd. N.Gupta: Employee; Fitterfly HealthTech Pvt Ltd. R.Verma: Employee; Fitterfly Healthtech Pvt Ltd, Wellthy Therapeutics Pvt Ltd. S.Kalra: Speaker's Bureau; Boehringer Ingelheim International GmbH, Novo Nordisk A/S, Sanofi. M.V.Padsalge: None. V.Methil: None. A.K.Singal: Other Relationship; Fitterfly Healthtech Pvt Ltd.
603-P: Qualitative Results from an African-American Church–Based Diabetes Self-Management Support Program
Authors: HAWKINS JACLYNN M. , PROVENZANO ANTHONY M. , NWANKWO ROBIN , FUNNELL MARTHA M. , KLOSS KATHERINE A. , HALL DIANA , PIATT GRETCHEN
Published: May 2022

Diabetes-related health disparities, especially for African Americans (AA) , underscore the need for effective, culturally tailored approaches to promote and sustain diabetes self-management support (DSMS) over time. The Praise study, a cluster randomized hybrid type II implementation trial recruited 21 AA churches, 28 peer leaders, 21 parish nurses, and 371 participants (100% AA, 73.8% female, 64±11.3 years of age) to determine the effectiveness of three DSMS approaches [Parish Nurse (PN) + Peer Leader (PL) DSMS vs. PN DSMS vs. PL DSMS], in comparison to enhanced usual care in improving and sustaining A1c and diabetes distress. Monthly DSMS groups were independently planned and facilitated by 28 trained PLs (100% African American, 18% male) and 14 trained PNs. A post-trial qualitative process evaluation was conducted to evaluate DSMS and ongoing support. Five focus groups were held (n=30) . Individual semi-structured interviews were completed with PLs and PNs (N=7) . Data were analyzed using the Rapid Analysis Process to generate themes from transcripts. Most participants were motivated to enroll in the Praise study to learn more about how to manage their diabetes. Others stated that poor health status (such as high A1C) and a need for accountability motivated them to join. PN and PL were driven to serve in these roles by a desire to educate and support other members of their community with diabetes in a structured format. Few concerns about the study were reported; however, the amount of time commitment was a common topic. Some participants encountered significant technology difficulties with attending remote sessions and a host of other issues related to the pandemic. Suggested improvements included: 1) clear study expectations from the start; 2) integrating exercise, and meal prep; and 3) using of social media for recruitment. AAs with T2D are motivated to engage in ongoing DSMS facilitated by PLs and PNs in church-settings. Improvements in training and support of PLs is needed.

Disclosure

J.M.Hawkins: None. A.M.Provenzano: None. R.Nwankwo: Advisory Panel; WW (Weight Watchers) . M.M.Funnell: n/a. K.A.Kloss: None. D.Hall: None. G.Piatt: None.
61-OR: Machine Learning Framework Predicts Metabolic Subphenotypes Using Glucose Dynamics during Oral Glucose Tolerance Test
Authors: METWALLY AHMED A. , PERELMAN DALIA , PARK HEYJUN , GLOYN ANNA L. , MCLAUGHLIN TRACEY , SNYDER MICHAEL
Published: May 2022

Type 2 diabetes (T2D) is classically defined by measures of glycemia which do not take into account its physiologic basis, which differs between individuals. Defining the relative contribution of fundamental physiologic processes to glucose dysregulation would facilitate targeted treatment approaches for diabetes prevention and treatment. We propose that muscle insulin resistance, beta cell dysfunction, incretin defect, and hepatic insulin resistance are present to varying degrees in individuals predisposed to T2D, who can be thus classified according to their metabolic subphenotype. While this transformative approach to T2D is appealing, traditional metabolic tests are invasive and unavailable outside research units. We tested the ability of the shape of the glucose response curve during an oral glucose tolerance test (OGTT) to identify metabolic subphenotypes. 32 participants underwent gold-standard metabolic tests including frequently-sampled 3-hour OGTT, isoglycemic intravenous glucose infusion for quantification of incretin effect, steady-state plasma glucose measurement of insulin resistance, and calculated hepatic insulin resistance. We developed a machine learning framework to predict metabolic subphenotypes of an individual using dynamic features of the glucose time series during the OGTT. Metabolic testing revealed extensive inter-individual heterogeneity and the existence of four major metabolic subphenotypes. The features of the glucose time series identified insulin resistance, beta cell deficiency, and incretin deficiency with auROCs of 94%, 76%, and 75%, respectively. These were superior to standard clinical and laboratory measures of metabolic phenotypes. We suggest that identification of distinct metabolic subphenotypes using features of the glucose time series during OGTT may both enhance early identification of at-risk individuals as well as inform targeted therapeutic approaches to prevent and treat T2D.

Disclosure

A.A.Metwally: None. D.Perelman: None. H.Park: None. A.L.Gloyn: Other Relationship; Genentech, Inc., Roche Pharmaceuticals. T.Mclaughlin: Board Member; January, Inc., Research Support; Merck & Co., Inc., Novo Nordisk, Stock/Shareholder; Eiger BioPharmaceuticals. M.Snyder: Stock/Shareholder; January, Inc.

Funding

National Institutes of Health (R01DK110186-01) National Institute of Diabetes and Digestive and Kidney Diseases (U01-DK105535; U01-DK085545, UM1DK126185)
614-P: Fear of Hypoglycemia, Hypoglycemia Confidence, and Time in Range in Adolescents and Young Adults with Type 1 Diabetes (T1D)
Authors: MENON SRUTHI , DESALVO DANIEL , ERRAGUNTLA MADHAV , PAMIDIMUKKALA KALYAN , MCKAY SIRIPOOM , VILLEGAS CAROLINA , HILLIARD MARISA E.
Published: May 2022

Fear of hypoglycemia (FOH) and low hypoglycemia confidence (HC) can lead to hypoglycemia avoidance behaviors which may influence glycemia in people with T1D. Despite links with A1c, there are limited data on the correlation of FOH or HC with time in range (TIR) , which represents a more complete picture of glycemia. We explored FOH and HC in relation to CGM-derived glycemic metrics.

Methods: Participants (n=20, M age 16.3 ± 2.5y, 45% female, M A1c 7.3 ± 1.3%, 100% CGM use; 70% pump use) completed questionnaires assessing FOH and HC, and CGM data were collected over the next 12 weeks. Data were analyzed using Pearson correlations.

Results: Table 1 presents correlations between FOH, HC and glycemic metrics. FOH in young adults, specifically Worry, was associated with less time below range (<70 mg/dl; r = -0.75, p =.05) . No other statistically significant correlations between FOH, HC and TIR were detected.

Conclusion: Young adults’ worries related to FOH correlate with less level 1 hypoglycemia (<70 mg/dL) due to reasons other than hypoglycemia avoidance behaviors, which merits further study. The small sample size limited the power to detect additional significant associations of FOH/HC with TIR, though patterns suggest several possible links. Advanced technology such as closed-loop systems coupled with psychosocial interventions aimed at reducing FOH and improving HC may help optimize TIR.

Disclosure

S.Menon: None. D.Desalvo: Consultant; Dexcom, Inc., Insulet Corporation, Research Support; Insulet Corporation. M.Erraguntla: None. K.Pamidimukkala: None. S.Mckay: None. C.Villegas: None. M.E.Hilliard: None.

Funding

Food and Drug Administration (FDA)
618-P: Real-World Patient Perceptions of GLP-1 RAs and SGLT-2is with Cardiorenal Benefits
Authors: LAMBERT NATALIE , CLARK CALLAHAN , MCCOY ROZALINA G. , WONG ALYSSA , COOK DAVID J.
Published: May 2022

Patient perceptions and experiences may explain discrepancies between guideline recommendations and real-world utilization and adherence to cardiorenal protective GLP-1 RAs and SGLT-2is for type 2 diabetes (T2D) .

We identified 60,912 posts from public T2D Facebook groups (N=15 from 20to 2021 and extracted all narratives mentioning cardioprotective GLP-1 RAs and SGLT-2is by name (N=250) . We used open coding to categorize all mentions of risks/harms and benefits of these drugs as defined by the 2021 ADA Standards of Care (SOC) vs. described by individuals but not mentioned in the SOC.

Individuals reported 41 risks and 6 benefits not in the SOC. Posts rarely (<2.5%) mentioned cardiorenal benefits. Most (62.8%) were information-seeking and posed a question. Numbers of posts mentioning the potential treatment benefits/harms are in Figure 1. Overall, 43.6% of posts mention treatment aspects not discussed in the SOC.

People with T2D have a range of concerns and perceptions of the benefits/harms of to GLP-1RAs and SGLT2is. Cardiorenal protection appears to be of lower priority than other tangible benefits/harms. While these data are not representative of all people with T2D (i.e., those underrepresented in social media groups) , they underscore the importance of proactively engaging patients in conversation, eliciting and addressing questions/concerns, and providing evidence-based information on T2D treatment options.

Disclosure

N.Lambert: Consultant; Hugo Health, Research Support; Optum Labs. C.Clark: Employee; UnitedHealth Group, Stock/Shareholder; UnitedHealth Group. R.G.Mccoy: Consultant; Emmi. A.Wong: Employee; UnitedHealth Group. D.J.Cook: None.
620-P: Dietary Patterns in Diverse Adults with Type 2 Diabetes (T2D) : Self-Efficacy and Personal Control
Authors: MENDEZ-RODRIGUEZ HEIDY , JONAS VICTORIA H. , PAPPALARDO LINDSEY D. , FANG RAN , SCHECHTER CLYDE , WALKER ELIZABETH A. , HOOGENDOORN CLAIRE J. , GONZALEZ JEFFREY S.
Published: May 2022

Objectives: Diabetes self-efficacy (confidence in ability to perform diabetes self-care) and personal control (perceived ability to influence diabetes outcomes) have been associated with better T2D self-care and health outcomes. Social cognitive theory posits that both beliefs are necessary for optimal initiation and maintenance of behavior change. However, their independent effects are unclear in T2D, especially in relation to dietary behaviors. We examined the independent associations of self-efficacy and personal control with junk food dietary patterns (JFDP) among predominantly Latino and disadvantaged adults with T2D and explored potential mediating effects.

Methods: Adults with T2D (N = 812; Age = 59.2 (10.8) ; F = 57%; A1C = 9.3 (1.8) ; Latino = 86%; Spanish-speakers = 78.0%) enrolled in a trial of telephonic self-management support, completed self-report measures of diet (Starting the Conversation-STC) , diabetes self-efficacy, and diabetes personal control at baseline. A 5-item JFDP sub-scale of the 8-item STC was supported by factor analysis.

Results: Unlike personal control (r = 0.10, 95% CI = -0.06, 0.08) , self-efficacy was inversely correlated with JFDP (r = -0.16, 95% CI = -0.23, -0.10) . In multivariable analysis, higher self-efficacy had a small independent association with less JFDP (b = -0.02, SE = 0.003, 95% CI = -0.02, -0.01) but perceived control did not (b = -0.04, SE = 0.15, 95% CI = -0.35, 0.29) . Mediation analyses showed no evidence for personal control as a mediator of the relationship between self-efficacy and JFDP.

Conclusion: Among a predominantly Latino, disadvantaged adults with sub-optimally controlled T2D, diabetes self-efficacy was associated with lower reported consumption of junk foods, whereas no effect was observed for personal control. If these associations reflect causal relationships, interventions aiming to reduce junk food consumption in this vulnerable population may have more of an impact by targeting self-efficacy beliefs.

Disclosure

H.Mendez-rodriguez: None. V.H.Jonas: None. L.D.Pappalardo: None. R.Fang: None. C.Schechter: None. E.A.Walker: None. C.J.Hoogendoorn: None. J.S.Gonzalez: Consultant; Virta Health Corp.

Funding

National Institute of Health's National Institute of Diabetes Digestive and Kidney Diseases (1R18DK098742-01A1)
629-P: Unique Associations between Health Insurance and HbA1c in Adults with Type 1 Diabetes
Authors: KELLY CAITLIN , NGUYEN HUYEN , LIU JINGWEN , CHAPMAN KATHERINE S.M. , PETER MEGAN , LEON CAROLINA , LAFERRIERE KELSIE , RAVELSON JULIA , WOLF WENDY
Published: May 2022

Diabetes outcomes are affected by socioeconomic factors including health insurance. While some research has examined the impact of health insurance in people with type 1 diabetes (T1D) (e.g., disruptions in health insurance on health outcomes) , it is less clear whether health insurance type (e.g., private versus government-sponsored) shares a unique association with diabetes outcomes. Thus, we examined relationships between demographics, socioeconomic status, and health insurance type with HbA1c in adults in the T1D Exchange Registry - an online longitudinal study of people living with T1D. Participants (N = 7725) were 42.2 years old (SD = 14.6) on average and 75.4% reported their gender as female. Most participants (92.2%) reported their race as White and 5.1% identified as Hispanic. Many participants used insulin pumps (71.3%) and continuous glucose monitors (CGM, 83.0%) . Self-reported HbA1c was 7.3% (SD = 1.58) on average. Health insurance type was categorized into private (79.0%) , Medicaid (9.6%) , Medicare (9.5%) , or no health insurance (1.9%) . Health insurance type, demographic factors (i.e., age, gender, race, ethnicity) , socioeconomic factors (i.e., income, education level) , and diabetes technology use (i.e., insulin pump, CGM) were entered simultaneously into a linear regression with HbA1c as the outcome variable. Private insurance was used as the reference group. Statistical significance was set at p < .05. We found lower HbA1c was associated with identifying race as White (Β = -0.21) , having higher income (Β = -0.10) , having higher education (Β = -0.17) , using an insulin pump (Β = -0.46) and using CGM (Β = -0.72) . Higher HbA1c was associated with identifying as female (Β = 0.14) and having either Medicaid (Β = 0.23) or no health insurance (Β = 0.30) . These results suggest, above and beyond other socioeconomic and demographic factors, health insurance type may contribute to small but meaningful differences in HbA1c.

Disclosure

C.Kelly: None. H.Nguyen: None. J.Liu: None. K.S.M.Chapman: None. M.Peter: None. C.Leon: None. K.Laferriere: None. J.Ravelson: None. W.Wolf: None.
644-P: Effect of PharmacologIC (EPIC) Therapy on Insulin Sensitivity and Beta-Cell Function in Prediabetes (PreDM)
Authors: VELAZQUEZ ALBERTO O. CHAVEZ , ALI EMAD , MEROVCI AURORA , AGYIN CHRISTINA , TERASAWA TOMOKO , ABDUL-GHANI MUHAMMAD , TRIPLITT CURTIS L. , CERSOSIMO EUGENIO , DEFRONZO RALPH A.
Published: May 2022

Treating PreDM with medications that target specific pathophysiologic defects can slow/prevent the progression to type 2 diabetes mellitus (T2DM) . While the preventive effects of Pioglitazone (PIO) and Metformin (MET) previously have been described in PreDM, the benefit of newer antidiabetic agents in preventing PreDM progression to T2DM is less well established. OBJECTIVE: To examine the effect of one year of pharmacologic therapy on insulin sensitivity (Matsuda Index) , beta cell function (Disposition Index) , and adipose tissue insulin resistance (fasting FFA x FPI; Adipo IR) . METHODS: EPIC recruited 175 prediabetes subjects (FPG = 100-125 and/or 2-h PG = 140-199 mg/dl; OGTT) of whom 34 have completed 1-year of follow-up. Pre-DM subjects (21F/13M) received OGTT at baseline (BL) and were randomized to treatment with metformin (MET) (n= 7, age = 52 ± 4, BMI= 33 ± 3, A1c= 5.7 ± 0.01) ; PIO (n= 8, age= 49±3, BMI= 30 ± 2, A1c= 5.7 ± 0.08) ; saxagliptin (SAXA) (n= 8 Age= 48 ± 4 BMI= 31 ± 2, A1c= 5.8 ±0.1) ; or dapagliflozin (DAPA) (n= 11, Age= 55 ± 3 BMI= 31 ± 1, A1c=) for 12 months. RESULTS: FPG (p<0.for MET) and 2h-PG (p<0.for MET and PIO) decreased in all groups; A1c did not significantly change in any group. Weight decreased with MET (-4.4kg) and DAPA (-3.4kg) , increased with PIO (+2.1 kg) and remained unchanged with saxagliptin (-0.2 kg) . A nonsignificant increase in Matsuda Index was observed in all 4 groups. Disposition Index increased significantly for MET (3.0 to 5.6, p<0.05) and PIO (3.1 to 5.1, p<0.05) . %FFA suppression during OGTT improved only with PIO (54±8 to 71±5 %, p<0.01) . Adipo IR decreased in all groups (MET: 7.4 to 6.5; PIO: 7.2 to 4.5; DAPA: 8.5 to 6.8; SAXA: 9.2 to 6.9, all p<0.05) . CONCLUSION: Early pharmacological treatment of prediabetes improves whole body insulin sensitivity, beta cell function and Adipo IR. The superiority of one drug over another and their mechanism of action in preventing progression of prediabetes to T2DM will be determined by EPIC.

Disclosure

A.O.Chavez velazquez: None. E.Ali: None. A.Merovci: None. C.Agyin: None. T.Terasawa: None. M.Abdul-ghani: None. C.L.Triplitt: Consultant; Bayer AG, Speaker's Bureau; Eli Lilly and Company, Novo Nordisk. E.Cersosimo: Research Support; AstraZeneca. R.A.Defronzo: Advisory Panel; AstraZeneca, Boehringer Ingelheim International GmbH, Intarcia Therapeutics, Inc., Novo Nordisk, Research Support; AstraZeneca, Boehringer Ingelheim International GmbH, Merck & Co., Inc., Speaker's Bureau; AstraZeneca.

Funding

NIH R01-DK024092-34Astra-Zeneca ISSDAPA0002
65-OR: A Novel Electronic Medical Record–Based Diabetes Screening Program in the Emergency Department of an Urban Academic Medical Institution
Authors: DANIELSON KIRSTIE K. , RYDZON BRETT , EISENBERG YUVAL , LAYDEN BRIAN T. , LIN JANET
Published: May 2022

Despite decades of research on strategies to address disparities in diabetes screening, prevention and treatment, disparities particularly by race/ethnicity and socioeconomic status persist. An innovative approach to diabetes screening was therefore piloted in the Emergency Department (ED) at the University of Illinois Hospital in Chicago from February to April 2021. A best practices advisory (BPA) was built into the electronic medical records system that flagged ED patients at risk for diabetes for a provider to add a A1c test to an already planned blood specimen. The criteria were: all patients age >= 45 years, or patients age 18-44 years with a BMI >= 25; and, with no history of diabetes in the chart and no A1c performed in the last 3 years. Of the 8441 ED visits during the pilot timeframe, the BPA was triggered in 2691, and 2118 visits had a A1c resulted. Approximately half of the results (52%, n=1098) were abnormal. Of the abnormal results, 70% were in the prediabetes range (A1c 5.7-6.4%) and 30% in the diabetes range (A1c >= 6.5%; with 62 of the A1c results >=10%) . As A1c results were not immediately available in the ED, study staff successfully contacted 352 patients with an abnormal result by phone; the remaining were sent a letter informing them of their abnormal result. Of the 352, the average age was 52.2 years, 55% were female, 65% Non-Hispanic Black, 20% Hispanic, 15% Non-Hispanic White/Other. Half were on either Medicare or Medicaid, and 4% uninsured. The median income of the patients’ zipcodes fell at the 44th percentile of the U.S. income. During this initial phase, our novel screening in the ED identified a significant number of patients with undiagnosed diabetes, particularly minority and poor patients, indicating this approach could be leveraged to further stymie health disparities. Future research will now test the linkage of these new patients to diabetes education and care within the health care system.

Disclosure

K.K.Danielson: None. B.Rydzon: None. Y.Eisenberg: None. B.T.Layden: None. J.Lin: Research Support; Gilead Sciences, Inc., Novo Nordisk.

Funding

Novo Nordisk (G2111)
653-P: Post-Breakfast Glycemic Profiles in Hispanic/Latino Adults with or at Risk of Type 2 Diabetes
Authors: PAI AMRUTA , SANTIAGO RONY F. , BEVIER WENDY C. , GLANTZ NAMINO M. , BARUA SOUPTIK , SABHARWAL ASHUTOSH , KERR DAVID
Published: May 2022

Hispanic/Latinos in the U.S. bear an excess burden of type 2 diabetes (T2D) . In type 1 diabetes and insulin-treated T2D, continuous glucose monitoring (CGM) is an established technology to guide therapy, yet CGM use and studies are rare in people with/at-risk of non-insulin treated T2D and ethnic minorities. In this study, CGM was used to assess breakfast glycemic response in free-living adults with or at risk of non-insulin treated T2D. For 9-14 days, 35 Hispanic/Latino adults (28 female, median HbA1c 6.0% [IQR 5.5%, 6.8%]) wore blinded Abbott Freestyle Libre CGM and logged food via the MyFitnessPal app. Start and peak time of glycemic responses associated with a glucose rise ≥20 mg/dL between 5-a.m. were manually annotated. Median variation between annotated and logged time was 39 [20, 78] minutes. Participants were stratiﬁed using HbA1c into at risk for T2D, pre-T2D, and T2D. Median starting glucose (SG) ; maximum glucose rise (Max GR) ; time-to-peak (TTP) ; and incremental area under the curve over 2, 3, and 4 hours (iAUC2hr, iAUC3hr, iAUC4hr) were computed (Table 1) . The T2D group had signiﬁcantly higher post-breakfast glycemic measures than the at-risk group for all measures. The T2D group also had higher measures than pre-T2D for all but Max GR. Increases in response from at-risk to pre- to T2D in Hispanic/Latino adults suggest post-breakfast glycemic proﬁles may potentially be used to monitor diabetes progression.

Disclosure

A.Pai: Employee; Apple. R.F.Santiago: Research Support; Abbott. W.C.Bevier: Research Support; Abbott Diabetes. N.M.Glantz: Research Support; Abbott. S.Barua: None. A.Sabharwal: None. D.Kerr: Advisory Panel; Abbott Diabetes, Novo Nordisk A/S, Sanofi, Consultant; Evidation Health, Research Support; Novo Nordisk A/S, Stock/Shareholder; Glooko, Inc., Hi.Health.

Funding

Elsevier Foundation
657-P: Frequency Scanning Correlates Not Only with Glycemic Indices but Also with Fear of Hypoglycemia in Type 1 Diabetes Patients Using is-CGMS
Authors: HOHENDORFF JERZY , WITEK PRZEMYSLAW W. , KANIA MICHAL , SUDOL MARIA , HAJDUK KATARZYNA , STEPIEN ADAM , CYGANEK KATARZYNA , KIEC-WILK BEATA , KLUPA TOMASZ , MALECKI MACIEJ
Published: May 2022

Frequency scanning with intermittently scanned CGMS (is-CGMS) is associated with glycemic indices. No data is available for its correlation with fear of hypoglycemia (FOH) , a well-known factor affecting quality of life and glycemic control in type 1 diabetes (T1DM) . The aim of the study was to analyze the association of scanning frequency with glycemic indices and FOH in T1DM patients using is-CGMS. T1DM patients using is-CGMS were eligible. Clinical data, Ambulatory Glucose Profile (AGP) reports were obtained from medical records. FOH was assessed using Hypoglycemia Fear Survey II (HFS-II) . We included 77 consecutive patients (58 females) , 38 were treated with insulin pump, 39 with multiple daily injections. Their mean age was 34.1+/-10.2 years and T1DM duration 14.7 +/-12.0 years. Mean glycemic indices were as follows: mean glucose - 155.8+/-29.8 mg/dl; GMI - 53.3+/-7.5 mmol/mol; TIR - 66.4+/-17.8%; TB70 - 4.5+/-4.1%; TB54 - 0.6+/-1.2%; TA180 - 29.2 +/-17.9%; TA250 - 9.6+/-10.4%; %CV - 36.7+/-8.3. The average scanning frequency was 13.8+/-7.8 scans/d. Mean HFS II scores were 16.1+/-7.2 and 18.7+/-12.2 in behavior and worry subscale, respectively. Correlation was found between scanning frequency and mean glucose, GMI, TIR, TB70, TA180, TA250, %CV and HFS-B (p<0.for all statistics) .

In summary, for the first time, we report that higher scanning frequency is associated not only with better glycemic indices but also with less FOH in T1DM patients using is-CGMS. This constitutes a new argument for advising T1DM patients frequent scanning when using is-CGMS.

Disclosure

J.Hohendorff: Advisory Panel; Abbott. M.Malecki: Consultant; Abbott Diabetes, Boehringer Ingelheim International GmbH, Lilly Diabetes, Novo Nordisk, Speaker's Bureau; Ascensia Diabetes Care, AstraZeneca, Bayer AG, Merck & Co., Inc., Mundipharma, Servier Laboratories. P.W.Witek: Other Relationship; Abbott, Berlin-Chemie AG, Boehringer Ingelheim International GmbH, Medtronic, Merck & Co., Inc., Novo Nordisk, Roche Diabetes Care, Sanofi-Aventis Deutschland GmbH. M.Kania: None. M.Sudol: None. K.Hajduk: None. A.Stepien: None. K.Cyganek: Speaker's Bureau; Abbott Diabetes, Ascensia Diabetes Care, Bausch Health, Canada, Boehringer Ingelheim International GmbH, Lilly Diabetes, Medtronic, Novo Nordisk, Roche Diabetes Care. B.Kiec-wilk: n/a. T.Klupa: Advisory Panel; Abbott, BIOTON S.A., Sanofi, Research Support; Medtronic, Speaker's Bureau; Ascensia Diabetes Care, Boehringer Ingelheim International GmbH, Eli Lilly and Company, Novo Nordisk.
66-OR: Diabetes Quality of Care among Medicaid Patients and Variation by Medicaid State Spending: A Natural Experiments for Translation for Diabetes 2 Study
Authors: MOIN TANNAZ , HARWOOD JESSICA , DURU O. KENRIK , TSENG CHIHONG , MANGIONE CAROL
Published: May 2022

Background: Medicaid patients have high rates of diabetes complications. We examined quality of diabetes care among Medicaid patients and variation by Medicaid state spending.

Methods: Using 2015-16 United Healthcare claims (eligibility, medical, pharmacy) and lab data, we identified Medicaid patients with diabetes >21 yrs of age receiving care in practices with >1000 Medicaid patients (diabetes defined by diagnostic codes, A1c >6.5% or glycemic prescriptions) . Over an 18-month study period, we examined A1c testing, statin use, retinal and nephropathy screening rates. Logistic regression covariates included a categorical variable for per-beneficiary Medicaid spending terciles by state (low, middle or high) , age, gender, race, ethnicity, language, Medicaid eligibility category, indicator for type 1 vs. 2 diabetes, indicator for chronic eye diseases, comorbidity indicators, and a count of number of enrolled months. We adjusted for clustering at the 3-digit zip code level and excluded states with vision care carve-outs.

Results: Among 46,5Medicaid patients with diabetes, the overall unadjusted completion rates for individual diabetes care measures varied from 39% (retinal screening) to 86% (nephropathy screening) ; 27% (7,540) of patients completed all 4 care measures. Adjusted completion rates for all 4 measures did not vary by Medicaid spending level. As compared to Whites, Asian/Pacific Islanders and patients with missing race were more likely to complete all 4 measures (5.1% and 3.7% higher respectively, p=0.00) , while Native Americans were less likely (-6.1%, p=0.04) . Medicaid patients with dual Medicare were more likely to complete all 4 measures than TANF members (4.8%, p=0.00) .

Conclusions: Only 1 in 4 Medicaid patients with diabetes received all 4 diabetes care measures in our study. Interventions are needed to increase adherence to diabetes processes of care for underserved Medicaid patients with diabetes.

Disclosure

T.Moin: None. J.Harwood: None. O.Duru: None. C.Tseng: None. C.Mangione: n/a.

Funding

CDC/NIH/NIDDK U18DP006128
667-P: Impact of Direction of Long-Haul Travel on Glycemic Control in Adults with Type 1 Diabetes (T1D) Using Multiple Daily Injections (MDI) of Insulin
Authors: BEVIER WENDY C. , LIU HANQING , CASTORINO KRISTIN N. , KERR DAVID
Published: May 2022

Long-haul travel (flights >6 hours) can be very disruptive for people living with type 1 diabetes (T1D) . As part of a study comparing long-acting basal insulins during long-haul travel (Bevier & Castorino, et al) , we evaluated the impact of direction of travel on glucosecontrol (Abbott Freestyle Libre Pro) . Each journey began in Honolulu (HI) with a non-stop flight to New York (NY) lasting hours with a 6-hour time difference. After 72 hours, participants returned non-stop to HI. Each subject completed round trips (using either Glargine or Insulin Degludec as the basal insulin) . Participants traveled in the same direction for either basal insulin. To assess the impact of direction of travel, data using either basal insulin were combined. Overall, 21 participants (13 women, age 34.2±15.2 years, HbA1c 7.5±1.2%) completed both journeys. CGM-derived metrics comparing (a) initial 72 hours at each destination, (b) during each flight and (c) for the total journey are shown below. During sleep, TIR70-180 was 56±26% travelling East to West and 66±26% going from West to East. Although there were no significant differences in CGM-derived metrics irrespective of direction of travel, the data suggest that achieving the recommended time in range between 70-180 mg/dl is elusive for adults with T1D using MDI when travelling across multiple time zones.

Disclosure

W.C.Bevier: Research Support; Abbott Diabetes. H.Liu: Employee; Abbott Diabetes. K.N.Castorino: Consultant; Lilly Diabetes, Research Support; Abbott Diabetes, Dexcom, Inc., Drawbridge Health, Inc., Eyenuk, Inc., Laxmi Therapeutic Devices, Medtronic, National Institute of Diabetes and Digestive and Kidney Diseases, Novo Nordisk, Speaker's Bureau; Dexcom, Inc. D.Kerr: Advisory Panel; Abbott Diabetes, Novo Nordisk A/S, Sanofi, Consultant; Evidation Health, Research Support; Novo Nordisk A/S, Stock/Shareholder; Glooko, Inc., Hi.Health.

Funding

Novo Nordisk Investigator Sponsored Study - ISS-001227
668-P: Increased Step Count but No Improvements in Glucose Control: Using CGM as Visualization Tool in Adults with T2D
Authors: CRAWFORD MARGARET A. , CHERÑAVVSKY DANIEL R. , BARNARD KATHARINE , WANG XIAOHAN (ARIA) , GENGE PAUL , GREENAWALD KENNETH , TRESSLER MICHELLE
Published: May 2022

Background: Physical inactivity is common in people with T2D and behavior modification can be difficult due to lack of timely and knowledgeable feedback. Real-time CGM (rtCGM) visualization of impact of efforts on glucose can highlight opportunities for medication and behavior modification to clinicians and individuals.

Methods: Glucose and step data in an observational study were collected with Dexcom G6 rtCGMs and activity trackers for 12 weeks in US adults with T2D. Participants did not receive education beyond standard of care. Paired T-tests were used to evaluate changes in step count, % time in range, peak glucose, and hyper- and hypoglycemic events between first and last weeks. Results are presented for the full T2D population (n=183) and a subgroup who increased average daily step count by ≥ 1000 steps (n=63) .

Results: Morning steps significantly increased across all participants and steps in all meal-related time periods significantly increased for subgroup (Table 1) . There was not a sustained, significant glucose impact.

Conclusion: Adding steps alone, supported by rtCGM, did not result in improvements in glucose. Such visualization provides information for individuals and clinicians to understand opportunities for therapy optimization, including activity and medication regimen. This is promising preliminary data and further research with prescribed intervention is required.

Disclosure

M.A.Crawford: Employee; Dexcom, Inc. D.R.Cherñavvsky: Employee; Dexcom, Inc. K.Barnard: Advisory Panel; Roche Diabetes Care, Sanofi, Research Support; Dexcom, Inc., Novo Nordisk. X.Wang: None. P.Genge: Employee; Dexcom, Inc. K.Greenawald: None. M.Tressler: Employee; Dexcom, Inc.
674-P: Benchmarking Continuous Glucose Monitor Use across T1D Exchange Quality Improvement Pediatric Clinics
Authors: GARRITY ASHLEY , MUNGMODE ANN , COSSEN KRISTINA , GALLAGHER MARY PAT , FEUER ALEXIS J. , BRIMBERRY DANIEL , PRAHALAD PRIYA , SCOTT MARY L. , NELSON GRACE , EBEKOZIEN OSAGIE , ENG DONNA
Published: May 2022

Background: The T1D Exchange Quality Improvement Collaborative (T1Dx-QI) is a learning network of over forty US type 1 diabetes clinics. Clinics share best-practice ideas for quality improvement and use data for population health research. This study benchmarks continuous glucose monitor (CGM) use across pediatric clinics in the T1Dx-QI.

Method: T1Dx-QI clinics report monthly on critical metrics, including the percentage of patients with hemoglobin A1c (HbA1c) <7% or using CGM. Median values for each site were calculated using Lahey P run charts between July 2020 and June 2021. These results are shared non-anonymized internally among participating T1Dx-QI clinics.

Results: Across 17 T1Dx-QI clinics, the percentage of patients using CGM ranged from 23% to 85% (Figure 1; mean and median CGM use were 61.3% and 61.7%, respectively) . Median HbA1c values ranged from 7.4% to 9.2%. There were no observed differences in CGM use by patient population size.

Conclusion: The T1Dx-QI benchmarks key clinical metrics to support quality improvement, share best practices, and promote learning across clinics.

Disclosure

A. Garrity: None. A. Mungmode: None. K. Cossen: None. M. Gallagher: None. A.J. Feuer: None. D. Brimberry: None. P. Prahalad: None. M.L. Scott: None. O. Ebekozien: None. D. Eng: None.

Funding

The Leona M. and Harry B. Helmsley Charitable Trust
678-P: Racial and Ethnic Disparities in CGM Use among Adults with Diabetes
Authors: ALJEDAANI SAMIA M. , SIDDIQUI AYESHA S. , RAJA-KHAN NAZIA
Published: May 2022

Introduction: Continuous glucose monitoring (CGM) is increasingly being used in the management of diabetes. Racial disparities in use of CGM may contribute to disparities in health outcomes. Studies have shown disparities in use of CGM among different races. However, most of these studies were done in the pediatric population.

Objectives: To determine whether there are racial differences in the use of CGM in adults with type 1 or type 2 diabetes.

Methodology: In this cross-sectional study, the TriNetX query tool was used to search electronic medical records of patients seen at Penn State Health Hershey Medical Center. Inclusion Criteria were age 18 to 80 years old, and type 1 or type 2 diabetes. Patient measures collected include age, gender, race, ethnicity, using CGM or not, using insulin or not, and A1c.

Results: The total number of patients with type 1 or type 2 diabetes was 73,210. Among those, 1,330 patients were using CGM, including 1,090 White patients (1.88% of Whites with type 1 or type 2 diabetes) , 80 Black patients (1.39% of diabetic Blacks) , 79 Hispanic patients (1.82 % of diabetic Hispanics) , and 26 Asian patients (1.77% of diabetic Asians) . In patients with type 2 diabetes who are on insulin, CGM use was as the following: 2.03% of White patients, 1.% of Black patients, 1.09% of Hispanic patients, and 1.89% of Asian patients. Among insulin-treated patients with type 2 diabetes, mean A1c was 7.76% in those using CGM, compared to 7.89% in those not using CGM. Among patients with type 1 diabetes, 9.13% of White patients, 6.84% of Black patients, 7.57% of Hispanic patients and 8.82% of Asian patients were using CGM. In patients with type 1 diabetes, mean A1C was 8.43% in those using CGM and 8.36% in those not using CGM.

Discussion: Only patients who were billed for CGM during visits were included as CGM users in the study, which could result in fewer patients identified as CGM users. Rates of CGM use were lowest in Black and Hispanic adults indicating that racial and ethnic disparities exist in the use of CGM among adults with diabetes.

Disclosure

S.M.Aljedaani: None. A.S.Siddiqui: Advisory Panel; Alexion Pharmaceuticals, Inc. N.Raja-khan: None.
679-P: Costs and Cost-Effectiveness of the FreeStyle Libre System vs. Blood Glucose Self-Monitoring in Patients with Type 2 on MDI Insulin Treatment in Israel
Authors: GREENBERG DAN
Published: May 2022

Introduction: Frequent glucose monitoring is essential to obtaining glucose control. We assessed the costs and cost-effectiveness of using the FreeStyle Libre® Flash Continuous Glucose Monitoring system (FSL) compared to self-monitoring of blood glucose (SMBG) in people with type 2 diabetes treated with multiple daily insulin injections (T2D MDI) from a healthcare payer perspective in Israel.

Methods: We calculated the incremental cost per quality adjusted life year (QALY) gained. Glucose monitoring costs are based on actual costs of FreeStyle Libre®, strips and lancets, assuming full adherence to monitoring. Severe hypoglycemic events (SHE) and diabetic ketoacidosis (DKA) costs are based on real-world data from Israel and the Israeli Ministry of Health list price. Costs are presented in Israeli Shekel (ILS) and $US. The incidence rates of SHE and DKA are based on real-world data from a large cohort of patients in France. Due to the short time horizon of this analysis, we assumed no mortality differences between the two monitoring alternatives. Utility increments for the use of CGM vs. SMBG, decrease in HbA1C and disutility for SHE and DKA events are based on estimates from the literature. The analysis was conducted over a 5-year time horizon, applying an annual discount rate of 3% on costs and outcomes. One way sensitivity analyses were performed on difference in costs.

Results: FreeStyle Libre® use is associated with a cost increase of ILS 27,021 ($US 8,444) and an increase of 0.26 QALYs, generating an incremental cost-effectiveness ratio of ILS 103,977 ($US 32,493) per QALY gained. These results are highly sensitive to changes in costs of glucose monitoring.

Conclusion: Assuming a willingness to pay threshold of $US 43,600 per QALY gained (GDP per capita in Israel in 2020) , the FreeStyle Libre® system is a highly cost-effective glucose monitoring alternative to SMBG for T2D MDI patients in Israel.

Disclosure

D.Greenberg: Advisory Panel; Abbott Diabetes, Consultant; Geffen Medical, Israel.
68-LB: The First Real-World Experience with Bigfoot Unity—A Three-Month Retrospective Analysis
Authors: BALIGA BANTWAL , TILLMAN JOHN , OLSON BYRON P. , VAUGHAN SARAH , SHEIKH F. NAUREEN , MALONE JAMES K.
Published: May 2022

Background: In the US, approximately 10 million people with diabetes require insulin; the vast majority using MDI therapy. Diabetes is associated with sustained daily burdens due to complex, demanding, and often confusing self-care directives, which may be more pronounced with MDI. Bigfoot Unity is a unique, interconnected smart pen cap diabetes management system designed to address an unmet medical need to support MDI therapy, incorporating CGM data (Abbott FreeStyle Libre 2) , real-time alerts and clinician-directed dose recommendations.

Methods: The Bigfoot Unity System received FDA clearance in May 2021. We report a retrospective analysis on an initial cohort (N=49 at 11 clinics) with insulin-requiring diabetes managing MDI with Bigfoot Unity for 90 days. Deidentified data were evaluated to analyze glycemic metrics during use, and HbA1c obtained from medical records prior to use.

Results: Within the cohort, mean age was 60 years and 40 (82%) had T2D. The mean HbA1c prior to Bigfoot Unity use was 8.5±2.0% (N=43) . Mean GMI was 7.5±0.9% after 3 months use.

Discussion: These data show that for people using MDI with suboptimal glycemic control, using the Bigfoot Unity System has the potential for rapid and durable improvement in glycemic control. Considering the mean age of the cohort, results demonstrate close adherence to established glycemic targets including a short time spent in the hypoglycemia range. Further studies are planned to investigate this hypothesis.

Disclosure

B. Baliga: Speaker’s Bureau; Abbott Diabetes, Amarin Corporation, AstraZeneca, Bigfoot Biomedical, Inc., Boehringer Ingelheim International GmbH, Eli Lilly and Company, Intuity Medical, Inc., Merck & Co., Inc., Novo Nordisk, Stock/Shareholder; Amarin Corporation, Insulet Corporation, Merck & Co., Inc., Moderna, Inc., Senseonics. J. Tillman: Employee; Bigfoot Biomedical, Inc. B. P. Olson: Employee; Bigfoot Biomedical, Inc. S. Vaughan: Employee; Bigfoot Biomedical, Inc. F. Sheikh: Employee; Bigfoot Biomedical, Inc. J. K. Malone: Consultant; Eli Lilly and Company, Insulet Corporation, Thermalin Inc., Employee; Bigfoot Biomedical, Inc.

Funding

Bigfoot Biomedical
681-P: Evaluation of Data Processing Performance for Subcutaneous Glucose Monitoring with an Optical Investigational Device
Authors: MADER JULIA K. , SIEGL REBECCA , REINHARD ANNA K. , KOPANZ JULIA , SIMIC AMRA , HARTMANN MATTHIAS , GAMSEY SOYA J. , BANERJEE SAYANTI , KAMECKE ULRIKE , REBRIN KERSTIN
Published: May 2022

Background and Aims: Lumee Glucose is a small soft glucose-sensitive hydrogel (5.0 x 0.75 x 0.65mm hydrated) currently in clinical development and intended for permanent subcutaneous placement by injection to continuously monitor glucose. The sensor is comprised of a hydrogel scaffold containing fluorescent molecules that produce near infrared light proportional to glucose concentration when interrogated by an optical skin reader placed over the hydrogel. The reader utilizes a set of LEDs to excite the fluorophores within the hydrogel and communicates wirelessly with a tablet. Machine learning and quality data processing algorithms are also being assessed to establish monitoring accuracy using MARD.

Methods: Glucose monitoring including a carbohydrate-rich meal was conducted during 8-hour in-clinic visits in 28 subjects with insulin-treated diabetes (female, 48 yrs [20-82], BMI 26.2kg/m2 [19.7-40.3]) over a 3-month period. Frequent venous blood glucose measurements were obtained as reference (Super GL analyzer) . Sensor signals from a total of 188 monitoring traces and 3030 paired values were subjected to retrospective data processing with 3-point glucose reference calibration using machine learning and quality filters to remove potentially compromised optical signals.

Results: The average MARD for all 3030 paired values during the 6 to 91-day monitoring period was 12.3%. The MARD was 11.8% when applying additional signal quality filters.

Conclusions: Following injection, the hydrogel is suitable for long-term non-invasive glucose monitoring for a minimum period of three months. Projected performance parameters are within the range of currently available glucose monitoring devices. Quality signal processing algorithms revealed marginal performance improvements and should be further optimized with respect to compensating for signal perturbations resulting from motion, temperature, and ambient light changes.

Disclosure

J.K.Mader: Advisory Panel; Abbott Diabetes, Boehringer Ingelheim International GmbH, Eli Lilly and Company, Medtronic, Merck Sharp & Dohme Corp., Novo Nordisk A/S, Roche Diabetes Care, Sanofi-Aventis Deutschland GmbH, Speaker’s Bureau; Abbott Diabetes, Eli Lilly and Company, Medtronic, Merck Sharp & Dohme Corp., Novo Nordisk A/S, Roche Diabetes Care, Sanofi-Aventis Deutschland GmbH, Servier Laboratories, Stock/Shareholder; decide Clinical Software GmbH. K.Rebrin: Stock/Shareholder; Profusa, Inc. R.Siegl: None. A.K.Reinhard: None. J.Kopanz: None. A.Simic: None. M.Hartmann: None. S.J.Gamsey: None. S.Banerjee: None. U.Kamecke: Consultant; Profusa, Inc.
697-P: Inpatient Glycemic Control and Glucose Variability by Continuous Glucose Monitoring in Older Adults with Type 2 Diabetes
Authors: IDREES THAER , GALINDO RODOLFO J. , URRUTIA MARIA A. , CASTRO-REVOREDO IRIS A. , MORENO EMMELIN MARIE , MIGDAL ALEXANDRA L. , DAVIS GEORGIA M. , VELLANKI PRIYATHAMA , FAYFMAN MAYA , PASQUEL FRANCISCO J. , PENG LIMIN , UMPIERREZ GUILLERMO E.
Published: May 2022

Few studies have reported on differences in glycemic control and glucose variability by continuous glucose monitoring (CGM) in hospitalized insulin-treated older adults with type 2 diabetes (T2D) . Accordingly, we combined data from 3 inpatient randomized clinical trials using CGM in insulin-treated patients with T2D. Glycemic parameters were compared in 103 older adults (≥60 years) and 160 younger adults (<60 years) . Older adults, as compared to younger adults, had significantly lower HbA1c and blood glucose (BG) upon admission, and had lower overall mean daily CGM glucose values and higher percent time in range between 70-180 mg/dl during hospital stay. Glycemic variability (GV) did not differ between the two groups when assessed through direct univariate comparisons using coefficient of variation (CV) , mean amplitude of glucose excursion (MAGE) , and standard deviation (SD) ; however, a multivariate analysis adjusted for GFR, BMI, admission BG and HbA1c, indicated that older adults have higher GV during the hospital stay compared to younger adults. Conclusion: Our study indicates that older adults with T2D have better glycemic control on admission (BG and HbA1c) and had higher % time in range (70-180 mg/dl) , no difference in hypoglycemia, but greater GV during hospitalization compared to younger adults.

Disclosure

T.Idrees: None. F.J.Pasquel: Consultant; AI Health LLC, Boehringer Ingelheim International GmbH, Dexcom, Inc., Research Support; Dexcom, Inc., Insulet Corporation, Merck & Co., Inc. L.Peng: None. G.E.Umpierrez: Research Support; AstraZeneca, Dexcom, Inc., Novo Nordisk. R.J.Galindo: Advisory Panel; Sanofi, WW International, Inc., Research Support; Dexcom, Inc., Eli Lilly and Company, Novo Nordisk. M.A.Urrutia: None. I.A.Castro-revoredo: None. E.Moreno: None. A.L.Migdal: None. G.Davis: Consultant; Medscape, Research Support; Insulet Corporation. P.Vellanki: n/a. M.Fayfman: None.