bluuebunny/crossref_metadata_2025 huggingface dataset:
511-P: Is It Reasonable to Treat Infected Diabetic Foot Ulcers by Autologous Cell Therapy in Patients with Severe Ischemia?
Authors: DUBSKY MICHAL , HUSÁKOVÁ JITKA , FEJFAROVA VLADIMIRA , SUTORIS KAROL , SOJÁKOVÁ DOMINIKA , JAROŠÍKOVÁ RADKA , KAHLE MICHAL
Published: June 2023

Aim: Autologous cell therapy (ACT) using bone marrow-derived mononuclear cells is an alternative treatment approach for patients no-option chronic limb-threatening ischemia (NO-CLTI). Diabetic foot infection (DFI) could negatively influence healing and amputation rates in patients with NO-CLTI. The aim of our study was to analyze the impact of DFI on the clinical outcomes of cell therapy in diabetic patients with NO-CLTI.

Methods: One-hundred-forty-nine ACT applications was performed in 124 patients with NO-CLTI who were treated in our foot clinic over 15 years were included in the study. ACT applications were divided in 2 groups - DFI group with the presence of clinical signs of infection (n=46) and non-DFI group (n=103). Both groups were compared in baseline values and the changes in transcutaneous oxygen pressure (TcPO2) were evaluated after 6 months. Major amputation, amputation-free-survival (AFS) and ulcer healing were assessed during the whole follow-up after ACT (3 months to 14.3 years).

Results: Median AFS in the non-DFI group was 4.6 years CI95=(3.7, 6.3), significantly higher compared to 1.4 years CI95=(0.5, 3.0) in the DFI group. Ulcer healing was significantly better in the non-DFI group with median time to heal 0.9 years CI95=(0.7, 1.1) compared to the DFI group where less than 40% of ulcers healed and lower bound of mean time to heal CI95=6.6 years. TcPO2 in DFI and no-DFI groups was without a significant difference at baseline. At 6 months it increased by 21.7 mmHg CI95=(18.0, 25.3) in the non-DFI group and by 29.8 mmHg CI95=(22.5, 37.2) in the DFI group. The difference between groups was significant (p=0.032).

Conclusions: Our study showed that patients with NO-CLTI and baseline presence of DFI treated by ACT had significantly lower AFS and significantly worse ulcer healing. Therefore, the indication of ACT in patients with clinical signs of infection should be carefully considered.

Disclosure

M.Dubsky: None. J.Husáková: None. V.Fejfarova: None. K.Sutoris: None. D.Sojáková: None. R.Jarošíková: None. M.Kahle: None.

Funding

National Institute for Research of Metabolic and Cardiovascular Diseases (EXCELES LX22NPO5104); European Union; Next Generation EU; MZO (00023001)
512-P: Single-Cell RNA-Sequencing Identifies Novel Molecular Targets of Endothelial MicroRNA-200b in the Diabetic Ischemic Wound
Authors: SINGH KANHAIYA , KUMAR MANISHEKHAR , MOHANTY SUJIT K. , KHANNA SAVITA , ROY SASHWATI , SEN CHANDAN K.
Published: June 2023

Injury-induced transient downregulation of endothelial miR-200b is required to jump-start wound angiogenesis, but the underlying mechanisms remain unclear. Single cell RNA sequencing was performed on ~15000 human endothelial cells under high (mimic treated) miR-200b conditions. Unsupervised clustering using CellRanger identified five cell clusters, three of which were responsive to changes in miR-200b abundance. Stable Isotope Labelling by Amino acids in Cell culture (SILAC) based proteomic analysis was employed to look for novel potential targets of endothelial miR-200b. A total of 3818 proteins were detected which were then filtered using statistical cut-offs (p value < 0.05; % change > 10%) identifying 319 proteins targeted by miR-200b. To determine the potential role of these candidates in regulating vascular function, miR-200b-429fl/fl-Tie2 Cre mice were generated where endothelial miR-200b levels could be specifically depleted in vivo. The therapeutic significance of endothelial miR-200b inhibition was studied using ischemic hindlimb in these mice. The significance of miR-200b depletion was also studied in streptozotocin-induced diabetic miR-200b-429fl/fl-Tie2 Cre mice. Perfusion imaging was performed using Laser Speckle imaging (Perimed Inc.) at different time-points (d3, d7, d10, d14). Inhibition of endothelial miR-200b rescued hindlimb ischemia with improved perfusion (n=11). Such effect of miR-200b inhibition on rescuing HL-ischemia was markedly increased in diabetic animals (n =8). Such rescue was associated with increased abundance of CD31+/vWF+ vasculogenic cells (n=6). This work identified miR-200b regulated endothelial cell clusters, the functional significance of which have been experimentally validated. These findings provide insight into novel mechanisms explaining how transient inhibition of miR-200b in the endothelial compartment improves angiogenic outcomes in the diabetic ischemic limb.

Disclosure

K.Singh: None. M.Kumar: None. S.K.Mohanty: None. S.Khanna: None. S.Roy: None. C.K.Sen: n/a.

Funding

National Institutes of Health (DK128845); U.S. Department of Defense (W81XWH-22-1-0146, W81XWH-21-1-0033)
52-LB: One-Year Results from VLCD vs. Time-Restricted Eating
Authors: NIJJAR AVNEET , KIWAN RASHA , CALINAWAN TESS L. , SHUBROOK JAY H.
Published: June 2023

There continues to be debate about eating patterns, glucose, and weight control in people with type 2 diabetes. Recently, very low carbohydrate diets (VLCD) have had success in clinical trials. Intermittent fasting or time-restricted eating (TRE) has gained community popularity. In this pilot study, we report follow-up data from a study that randomized participants to VLCD and TRE. A total of 32 participants completed the initial protocol (16 VLCD, 16 TRE). Participants were invited to participate in a 1-year observational follow-up period with phone assessment every 3 months to assess the long-term impacts of the protocol on HbA1c, lipid profile, anthropometrics, and medication regime. Twelve participants (8 VLCD, 5TRE) agreed to follow up. The mean HbA1c in the VLCD was 8.04% at baseline (N=5), mean HbA1c of 8.6% at 6 months (N=3), 8.2% at 9 months (N=1), and 8.63% at 12 months (N=3). For the VLCD group, mean weight was 262lbs at baseline (N=5), 259lbs at 3 months (N=1), 232.5lbs at 6 months (N=2), and 229.4lbs at 12 months (N=5). For the TRE group, the mean A1c was 8.65% at baseline (N=8), 8.5% at 3 months (N=2), 7.8% at 6 months (N=3), 9.4% at 9 months (N=4), and 8.25% at 12 months (N=2). The TRE mean weight was 231.25lbs at baseline (N=8), 237.4lbs at 6 months (N=2), 199.1lbs at 9 months (N=5), and 230.1lbs at 12 months (N=2). While the sample size was small, this study followed participants for 1-year after a 1-month nutritional intervention and illustrated that these dietary plans resulted in different success parameters.

Disclosure

A. Nijjar: None. R. Kiwan: None. T. L. Calinawan: None. J. H. Shubrook: Advisory Panel; AstraZeneca, Eli Lilly and Company, Nevro Corp., Consultant; Abbott Diabetes, Bayer Inc., Novo Nordisk.
52-OR: Effect of Oral Nonpeptide GLP-1 Receptor Agonist Orforglipron (LY3502970) in Participants with Obesity or Overweight—A Phase 2 Study
Authors: WHARTON SEAN , BLEVINS THOMAS , CONNERY LISA B. , ROSENSTOCK JULIO , RAHA SOHINI , MATHER KIEREN J. , HAUPT AXEL , ROBINS DEBORAH A. , PRATT EDWARD J. , KAZDA CHRISTOF M. , KONIG MANIGE
Published: June 2023

Orforglipron (OFG) is a novel once daily oral non-peptide GLP-1 receptor agonist (RA) which can be taken with or without food, in development for chronic weight management. The objective of this Phase 2 study was to assess the efficacy, safety, and tolerability of OFG in patients with obesity or overweight with ≥1 weight-related comorbidity. Participants (N=272) were randomized to placebo or OFG (12, 24, 36, or 45 mg) treatment. OFG doses were increased to target using different dose escalation schemes in each arm. The primary endpoint was to compare percent body weight (BW) change from baseline in OFG vs placebo at Week 26, while the study continued to 36 weeks. Secondary endpoints included change from baseline in waist circumference (WC) and BMI, and the percentage of participants achieving ≥5 or ≥10% weight loss. At baseline, mean BW was 108.7 kg, BMI was 37.9 kg/m2, and 94% of participants had a BMI ≥30 kg/m2. Mean percentage BW loss, mean change in BMI and WC, and the percentage of participants achieving ≥5% or ≥10% weight loss were significantly greater with all OFG doses vs placebo (Figure). The AE profile was similar to other GLP-1 RAs; most were GI-related and mild to moderate in severity. The novel non-peptide GLP-1 RA OFG led to greater reductions in BW, BMI, and WC compared with placebo. These promising data support continued development of OFG as an oral treatment for obesity.

Disclosure

S.Wharton: Advisory Panel; Novo Nordisk, Eli Lilly and Company, Boehringer Ingelheim International GmbH, Bausch Health, Canada, Research Support; Novo Nordisk, Eli Lilly and Company, Speaker's Bureau; Novo Nordisk, Eli Lilly and Company, Bausch Health, Canada. C.M.Kazda: Employee; Eli Lilly and Company. M.Konig: None. T.Blevins: Other Relationship; Medtronic, Research Support; Lilly Diabetes, Novo Nordisk, Dexcom, Inc., Abbott Diabetes, Tandem Diabetes Care, Inc., Medtronic, Speaker's Bureau; Lilly Diabetes, Novo Nordisk A/S. L.B.Connery: None. J.Rosenstock: Advisory Panel; Applied Therapeutics Inc., Boehringer Ingelheim Inc., Eli Lilly and Company, Novo Nordisk, Oramed Pharmaceuticals, Sanofi, Zealand Pharma A/S, Intarcia Therapeutics, Inc., Hanmi Pharm. Co., Ltd., Research Support; Applied Therapeutics Inc., Boehringer Ingelheim Inc., Eli Lilly and Company, Merck & Co., Inc., Novartis, Novo Nordisk, Pfizer Inc., Sanofi, Intarcia Therapeutics, Inc. S.Raha: Employee; Eli Lilly and Company. K.J.Mather: Employee; Eli Lilly and Company. A.Haupt: Employee; Lilly, Stock/Shareholder; Lilly. D.A.Robins: None. E.J.Pratt: Employee; Eli Lilly and Company.

Funding

Eli Lilly and Company
524-P: Knowledge, Attitudes, and Perceptions of Respiratory Syncytial Virus (RSV) among U.S. Adults with Diabetes
Authors: LA ELIZABETH , BUNNIRAN SUVAPUN , GARBINSKY DIANA , REYNOLDS MARIA , POSTON SARA , HARRINGTON LAURIANE
Published: June 2023

Rationale: Risk of complications and severe outcomes from respiratory syncytial virus (RSV) infection is increased in older adults and adults with certain chronic conditions in the United States (US). Among adults with diabetes, RSV hospitalization rates are ~2.4-11.4 times higher vs. adults without diabetes. Despite this burden, there are no previous evaluations of RSV knowledge, attitudes, and perceptions (KAP) among adults with diabetes. This study assessed RSV-related KAP among adults at risk of RSV infection, including adults with diabetes.

Methods: A cross-sectional, web-based survey of US adults aged 18-89 years was administered between May-June 2022 to evaluate respiratory infection and RSV-related KAP. Target survey sample sizes included ≥200 adults from 4 subgroups: adults aged 18-59 years with diabetes, ≥1 chronic pulmonary, or ≥1 cardiac condition, as well as older adults aged 60-89 years.

Results: A total of 339 adults aged 18-89 years with diabetes completed the survey (41.0%; n=339/827). Among those with diabetes, 78.2% (n=265/339) reported being knowledgeable about respiratory infections, although >60% (n=206/339) had never heard of RSV. Among those aware of RSV, 69.9% (n=93/133) rarely consider RSV as a cause of their cold/flu-like symptoms. Examples of identified knowledge gaps included respiratory infection causes (bacterial vs. viral), RSV seasonality, frequency of occurrence, and symptoms. Between 28.6-60.4% perceived that their risk of contracting RSV was lower than for 5 other respiratory infections, but only 19.6-38.9% perceived a lower severity of RSV.

Conclusions: This study highlights key RSV knowledge gaps and attitudes/perceptions among US adults with diabetes. Given the increased risk of severe RSV-related outcomes among these adults, findings can be used by health care providers to inform their patient education efforts related to RSV disease awareness.

Funding: GlaxoSmithKline Biologicals SA (study: 218693/HE-RSV-004 BOD)

Disclosure

E.La: Employee; GlaxoSmithKline plc., Stock/Shareholder; GlaxoSmithKline plc. S.Bunniran: Consultant; GlaxoSmithKline plc., Stock/Shareholder; Humana. D.Garbinsky: None. M.Reynolds: None. S.Poston: Employee; GlaxoSmithKline plc. L.Harrington: Employee; GlaxoSmithKline plc.
532-P: Know Your Diabetes by Heart—DSME/S Collaboration with Project Dulce and Dulce Digital Improves Knowledge and HbA1c
Authors: RUIZ MONICA , SPIERLING BAGSIC SAMANTHA R. , SANDOVAL HALEY , CHICHMARENKO MARIYA , FORTMANN ADDIE L. , WALKER CHRISTINE , PHILIS-TSIMIKAS ATHENA
Published: June 2023

Cardiovascular disease (CVD) and type 2 diabetes (T2D) are closely linked, yet many people with T2D are unaware of the risk. The ADA and AHA, supported the integration of Know Your Diabetes by Heart (KDBH) messaging into DSME/S programs to improve knowledge of CVD risk in T2D populations. Scripps Health, a large health system in San Diego, CA employed two distinct diabetes education methods to deliver enhanced KDBH messaging and determined change in knowledge and clinical outcomes after program delivery. Messages emphasizing the connection of CVD to T2D, and BP and cholesterol risk management were developed in English and Spanish and delivered via 1) Project Dulce (PD), an evidence-based culturally and linguistically modified 9-hour, 5-session traditional in-person and virtual telehealth DSME/S program, and 2) Dulce Digital (DD), an innovative 6-month diabetes education texting program within Scripps ambulatory clinics and partnering Federally Qualified Health Centers (FQHCs) serving diverse racial and ethnic low-income populations in California. Pre/post surveys assessed knowledge and self-management, and clinical metrics were evaluated via electronic health records. Of the N=333participants, 59% were Female, mean age 54 (SD 12.3) years and 42% were Spanish speakers, 70% were White, 54% Hispanic, 17% AA, Asian, NA, PI, and 18% other. Among those with baseline (BL, N=291) and Month 6 (M6, N=82), survey feedback demonstrated improved knowledge of the association of CVD toT2D (PD-94 ->98%, DD-65->85%), the leading cause of death as CVD (PD-51->60%, DD-34->45%) and an increased willingness to discuss the link between heart disease and diabetes. Mean change in HbA1c (N=86 paired values) between BL and M6, was -0.98 [-1.35, -0.61] (-p<0.0001). KDBH campaign in English and Spanish improved CVD risk knowledge and A1c with two methods of DSME/S, PD group live and DD texting in a community-based health system and FQHCs, serving low income diverse racial and ethnic communities.

Disclosure

M.Ruiz: None. S.R.Spierling bagsic: None. H.Sandoval: None. M.Chichmarenko: None. A.L.Fortmann: Employee; Dexcom, Inc. C.Walker: None. A.Philis-tsimikas: Advisory Panel; Dexcom, Inc., Novo Nordisk A/S, Sanofi, Other Relationship; Medtronic, Research Support; Novo Nordisk A/S, Lilly, Viking Therapeutics, NIH - National Institutes of Health.
536-P: Psycho-behavioral and Clinical Characteristics in Koreans with Type 2 Diabetes With or Without Perceived Hypoglycemia
Authors: CHA EUNSEOK , SHIN YUN-A , HYE JOUNG KYONG , JIN KIM HYUN , JIN KIM HYUK , FAULKNER MELISSA S.
Published: June 2023

Objective: To compare characteristics in Koreans with type 2 diabetes (T2D) with or without perceived hypoglycemia.

Methods: A cross-sectional, correlational design was used. Participants 20 years or older (N=177, men= 113 [63.8%]) were recruited from a university-affiliated diabetes clinic in Korea. Groups were divided by perceived hypoglycemia or not based on the Control Problem Scale. Socio-demographics (e.g., sex, age, years with T2D), psycho-behavioral factors including diabetes self-care activity (Summary of Diabetes Self-Care Activities Questionnaire), sleep quality (Pittsburgh Sleep Quality Index), health-related quality of life (QoL; SF-12) and diabetes-related clinical factors (HbA1C, random glucose, blood pressure and lipids) were assessed. Body mass index [BMI], skeletal muscle mass [SMM], total body water (TBW), body fat mass [BFM], and fat free mass [FFM] were assessed by a body composition analyzer (InBody970, Korea). Statistical analyses were performed using SPSS (version 26.0) to compare group differences.

Findings: One-third (n=67, 37.9%) perceived hypoglycemia in the past month (mean age [yr]= 59.1±12.7 vs. 62.1±12.8 and 35 participants experienced severe hypoglycemic reactions (e.g., passing out, needing help) during the past year. The hypoglycemia group reported a lower SF-12 score (88.5±14.1 vs. 96.1±15.2, p=.001), especially mental health functioning (T-score: 47.0±10.2 vs. 51.9±11.6, p=.005) and poor sleep quality needing professional counseling (n=43 [64.2%] vs. n=56 [50.9%]). Frequent monitoring of blood glucose and feet was performed while no differences for diet and exercise. The hypoglycemia group showed lower BMI (p=.018) and trend for lower SMM (p=.078), TBW (p=.086), BFM (p=.086) and FFM (p=.084).

Conclusions: Perceived hypoglycemia is associated with psycho-behavioral and clinical factors. Further investigation is warranted to examine risks for hypoglycemia related to muscle and body mass decline.

Disclosure

E.Cha: None. Y.Shin: None. K.Joung: None. H.Kim: None. H.Kim: None. M.S.Faulkner: None.

Funding

National Research Foundation of Korea (HNU X-Corps)
539-P: An Integrated Electronic Health Record and Community Health Worker Intervention Shows Clinically Significant Weight Loss among South Asian Patients at Risk for Diabetes
Authors: LIM SAHNAH , WYATT LAURA , BELLI HAYLEY , MAMMEN SHINU , ZANOWIAK JENNIFER , HUSSAIN SARAH , MOHAIMIN SADIA , ISLAM NADIA
Published: June 2023

Introduction: The DREAM Initiative is a two-arm randomized controlled trial (RCT) that analyzes the implementation and effectiveness of a community health worker (CHW) and electronic health record (EHR) intervention on weight loss promotion among South Asian Americans with prediabetes at primary care practices (PCPs) in New York City (NYC).

Methods: Participants in the intervention arm received five group-based, in-langue education sessions and follow-up phone calls; the control group was matched via sex, age, and BMI using the EHR portal and not contacted. The primary outcome was proportion of those who achieved weight loss of ≥5% between baseline and 6-months. Secondary outcomes included hemoglobin A1c, systolic and diastolic blood pressure (BP), low density lipoprotein cholesterol (LDL-C), and behavioral outcomes measured at 6 and 12 months follow-up. Generalized linear mixed effects models assessed change across groups, adjusting for baseline weight, sex, and clustering by PCP.

Results: A total of 952 individuals were randomized (476 per arm). Among treatment group participants, mean age was 48.3 years, 58% were female, all were born outside of the US, and mean years lived in the US was 11.3. In the treatment group, 87 out of 476 patients (18.3%) achieved 5% weight loss, compared to 27 out of 474 (5.7%) in the control group at 6 months (p<0.001). Mean weight in the treatment group decreased from 164.9 to 160.7 lbs., while in the control group, mean weight increased from 164.9. to 165.2 lbs. between baseline and 6-months (p<0.001). Secondary clinical outcomes will also be reported.

Conclusions: Results from a highly powered RCT indicate that the DREAM Initiative intervention was statistically significant in helping South Asian Americans with diabetes achieve weight loss at PCPs in NYC. Future work will test the effectiveness and scalability of the intervention across multiple sites in the eastern United States.

Disclosure

S.Lim: None. L.Wyatt: None. H.Belli: None. S.Mammen: None. J.Zanowiak: None. S.Hussain: None. S.Mohaimin: None. N.Islam: None.

Funding

National Institutes of Health (R01DK110048)
541-P: Role of Personalized Digital Lifestyle Program in Improving Outcomes in People with Diabetes—Real-World Evidence from Indian Cohort
Authors: FATEMA ZAREEN , KAMATH DEEPA , AGARWAL SAKSHI , ASWATHIAH SRINATH , SOORAGONDA BASAVARAJ
Published: June 2023

Background: Diabetes self-management is neglected practice among people with diabetes (PwD). OneCare-IMPACT Program provides lifestyle modification through easily accessible virtual DSME program leading to a positive behavioral change.

Methods: Study was conducted in PwD (n=173) enrolled in a 12-week OneCare-IMPACT program. Data were collected at baseline and 3 months for demographics, glycemic parameters, medicines and program engagement.

Results: Mean HbA1c (%) improved significantly from 8.9 ± 2.2 to 7.1 ±1.3, p <.001, effect size (d= 0.8). 56.1% had HbA1c<7% at 3-month compared to 18.5% at baseline. Significant change was seen in FPG and PPPG (mg/dl) of −54.85 (±71.02) and −77.58 (±100.79) respectively. Weight reduced significantly from 76.9 ± 17.5 kg to 74.1 ±16.2 kg (p <.001, d=0.7) and BMI by −0.8kg/m2, (p<.001). From baseline, 31% and 8% of patients reduced weight by ≥5% and ≥10% respectively. A majority of the patients had an absolute reduction in diabetes medications. A significant correlation (r=0.3) noted between weight decline and follow-up HbA1c (p=.005). Mean attendance in program was 75% which correlated well with the outcomes.

Conclusions: OneCare-IMPACT program enhances glycemic outcomes in PwD with a significant weight reduction encouraging for further RCTs to evaluate the role of digital DSMEs in developing countries like India.

Disclosure

Z.Fatema: Employee; Wellwork Technologies Private Limited, India. D.Kamath: Employee; Wellworks Technologies Pvt Ltd. S.Agarwal: Employee; Wellworks Technologies Private Limited. S.Aswathiah: None. B.Sooragonda: None.
546-P: Impact of the COVID-19 Public Health Emergency on Enrollment and Outcomes in the National Diabetes Prevention Program
Authors: ELY ELIZABETH
Published: June 2023

The National Diabetes Prevention Program is a partnership of public and private organizations working to build a nationwide delivery system for a lifestyle change program (LCP) to prevent or delay type 2 diabetes. Using data submitted to the Diabetes Prevention Recognition Program (DPRP), this study examines the impact of the COVID-19 public health emergency (PHE) on delivery of the LCP by looking at how adapting delivery from in-person to virtual allowed the 12-month intervention to continue. Participant start dates were categorized into 3 groups: 1) enrolled/concluded pre-PHE start, 2) enrolled pre-PHE start/concluded post-PHE start, and 3) enrolled/will conclude post-PHE start. As of October 2022, enrollment was at 658,385: 348,672 in group 1, 124,077 in group 2, and 185,636 in group 3. Mean reported weekly physical activity (PA) minutes and mean weight loss (WL) were calculated for each quarter of the LCP for each group. Despite the PHE causing abrupt changes in daily life, results show that participants whose time in the LCP overlapped or was entirely within the PHE, had strong PA and WL outcomes. Regardless of phase, participants who attended sessions in the 3rd quarter and the 4th quarter, on average, met programmatic goals of 150 PA minutes and 5% weight loss. These outcomes are indicative of lifestyle change, contributing to reducing the risk of developing type 2 diabetes.

Disclosure

E.Ely: None.
555-P: Identifying High-Priority Cardiovascular and Diabetes Topics for the Dissemination of Evidence-Based Best Practices—Results from a Statewide Needs Assessment
Authors: BEVERLY ELIZABETH A. , KOOPMAN GONZALEZ SARAH , DUNGAN KATHLEEN M. , WRIGHT JACKSON T. , BAUGHMAN KRISTIN R. , WEXLER RANDY , DWORKIN LANCE D. , SOLOMON GLEN D. , LAMB JAMES F. , KINSELLA AUDREY , LAMMERT LORI J. , NEVAR ANN , IRWIN GILLIAN , ROLLINS CLAIRE , KONSTAN MICHAEL W. , BOLEN SHARI D.
Published: June 2023

Background: The Ohio Cardiovascular and Diabetes Health Collaborative (Cardi-OH) unites the 7 medical schools in Ohio to improve cardiovascular (CV) and diabetes health outcomes and eliminate disparities in Ohio’s Medicaid population. The purpose of the Cardi-OH needs assessment was to identify high priority clinical topics for the dissemination of evidenced-based best practices to providers across the state.

Methods: The cross-sectional survey was distributed via REDCap (research electronic data capture) to Cardi-OH members and its external contacts (i.e., people who have engaged with Cardi-OH but are not members) in 2022. Question topics were identified by Cardi-OH members based on perceived gaps in existing content.

Results: A total of 88% (n=103) of 117 Cardi-OH members and 8% (n=98) of 1,204 external contacts participated. Of those, 51% (n=53) of Cardi-OH members and 47% (n=46) of external contacts provided direct clinical care. The top items for Cardi-OH members (clinical and non-clinical combined) were: 1) lifestyle prescriptions (n=50, 49%), 2) atypical diabetes (n=38, 37%), 3) COVID-19 and cardiovascular disease (CVD) (n=38, 37%), and 3) mental health and CVD (n=38, 37%). For external contacts, the top topics were: 1) lifestyle prescriptions (n=53, 54.1%), 2) mental health and CVD (n=39, 39.8%), 3) alcohol and CVD (n=27, 27.6%), and 3) CV complications (n=27, 27.6%). Regarding social determinants of health (SDOH), Cardi-OH members prioritized: 1) weight bias and stigma (n=44, 43%), 2) family-focused interventions (n=40, 39%), and 3) adverse childhood experiences (ACEs, n=37, 36%). External contacts selected: 1) family-focused interventions (n=51, 52%), 2) implicit bias (n=43, 43.9%), and 3) ACEs (n=39, 39.8%).

Conclusions: Shared prioritized topics included lifestyle, SDOH, and behavioral health; these may be useful to other professional organizations as they consider dissemination priorities.

Disclosure

E.A.Beverly: None. A.Kinsella: None. L.J.Lammert: None. A.Nevar: None. G.Irwin: None. C.Rollins: None. M.W.Konstan: None. S.D.Bolen: None. S.Koopman gonzalez: Research Support; Bristol Myers Squibb Foundation. K.M.Dungan: Board Member; Elsevier, Consultant; Eli Lilly and Company, Dexcom, Inc., Other Relationship; UpToDate, Research Support; Dexcom, Inc., Abbott, ViaCyte, Inc., Sanofi, Speaker's Bureau; Academy for Continued Healthcare Learning, Cardiometabolic Health Congress, Medscape, Integritas. J.T.Wright: Advisory Panel; Medtronic. K.R.Baughman: None. R.Wexler: None. L.D.Dworkin: None. G.D.Solomon: None. J.F.Lamb: None.

Funding

Ohio Department of Medicaid’s Medicaid Technical Assistance and Policy Program
558-P: Online Medical Education Advances Physicians’ Knowledge and Competence for the Use of Basal Insulin
Authors: TRIER JOACHIM , BAJAJ HARPREET S. , PHILIS-TSIMIKAS ATHENA
Published: June 2023

Background and aims: Despite various alternative treatment options basal insulin continues to play an important role in the management of patients with type 2 diabetes (T2D). The goal of this activity for primary care physicians (PCP) and diabetologists/endocrinologists (D/E) was to improve their understanding of the continued role of basal insulin in the management of T2D, address barriers to its initiation, and increase the awareness of novel once-weekly basal insulin formulations.

Materials and methods: Two diabetes experts joined a 24-min online video discussion with synchronized slides. Educational effect was assessed using a repeated-pair design with pre-/post-assessment. 3 multiple choice questions assessed knowledge/competence, 1 question rated on a Likert-type scale assessed confidence. A paired samples t-test was conducted on overall average number of correct responses and for confidence rating, a McNemar’s test was conducted at the question level (5% significance level). Cohen’s d with correction for paired samples estimated the effect size of the education on number of correct responses. Data collection from 10/25/22 to 12/13/22.

Results: • PCPs (n=73) improved their knowledge regarding basal insulin therapy in the management of T2D by 69% (p<.001) • D/E (n=126) improved their knowledge regarding the clinical profile of emerging once-weekly basal insulin formulations by 52% (p<.01) and their competence related to the identification of patients with T2D as suitable candidates for future treatment with once-weekly basal insulins by 192% (p<.001) • 40% of PCP (P<.001) and 31% of D/E (P<.001) increased their confidence in initiating basal insulin therapy in their patients with T2D

Conclusion: Participation of D/E and PCP in an online video expert discussion improved their understanding of basal insulin therapy, the profile of emerging once-weekly formulations and the identification of appropriate patients with T2D significantly.

Disclosure

J.Trier: None. H.S.Bajaj: Research Support; Amgen Inc., AstraZeneca, Boehringer Ingelheim International GmbH, Anji Pharmaceuticals, Eli Lilly and Company, Kowa Company, Ltd., Novo Nordisk, Pfizer Inc., Sanofi, Tricida, Inc. A.Philis-tsimikas: Advisory Panel; Dexcom, Inc., Novo Nordisk A/S, Sanofi, Other Relationship; Medtronic, Research Support; Novo Nordisk A/S, Lilly, Viking Therapeutics, NIH - National Institutes of Health.
562-P: Improved Glycemic and Cardiometabolic Parameters in Type 2 Diabetes Using AI-Enabled Digital Precision Care with Remote Monitoring
Authors: KN MANOHAR , SUNDARI B BHAVANI , KHAYUM KHADAR ABDUL , MOHAN DRISYA , MANI MOHANIESHWARI , PILLAI ANJU R. , S CHANDRAKUMAR , CHANNABASAVAIAH RAJKUMAR
Published: June 2023

In India, the average HbA1c in adults with type 2 diabetes is 8.9 ± 2.1% with associated increase in prevalence at 74.2 million is a major challenge in health care sector. Barriers includes insufficient knowledge on self management, medication adherence, emotional disturbances, nutrition and activity guidance and personalized care approach. Studies have suggested remote monitoring using technology, bridges the gap between the patient and health care professionals, at their home and at a lower cost. Use of technology for remote monitoring and personalized guidance in real world settings was evaluated using Credo Health precision care programme.

Method: The cohort consists of 72 type 2 diabetes members who enrolled for the diabetes management programme for 3 months at Credo Health. Informed consent was sought from the all the individuals and statistics was applied using GraphPad Prism V-5.0.

Results: Significant improvement was achieved at the end of 90 days in mean Glycosylated A1c (Figure 1) (8.7 ± 2.2; 7.2 ± 1.1, p: <0.0001), FPG (172.3 ±73.1; 128.5 ± 37.9, p: <0.001), PPPG (231.8 ± 95.8; 153.8 ± 41.1, p: <0.001), SBP (128.7 ± 18.3; 119.9 ± 11.8, p: <0.001), Serum TGL (206.4 ± 99.9; 161.0 ± 67.27, p: <0.05). Conclusion: Remote monitoring and personalized precision diabetes care management improved glycaemic and cardiometabolic outcomes in 3 months.

Disclosure

M.Kn: None. B.B: None. A.Khadar: None. D.Mohan: None. M.Mani: None. A.R.Pillai: None. C.S: None. R.Channabasavaiah: None.
564-P: The Need for Mentorship in Diabetes Is Now
Authors: BLUNDEN SARAH , ROY-FLEMING AMÉLIE , SOUTH COURTNEY , GILLIS CHELSIA , BRAZEAU ANNE-SOPHIE
Published: June 2023

Background: Mentorship for health care professionals is used to offer guidance, knowledge, and transfer experience. Clinical Dietitians (CD) play a key role in diabetes care. Offering mentorship might help build their confidence levels (CL) and grow the profession with the goal of improving outcomes and experiences for people living with diabetes (PWD). The objectives are, in CD (1) to assess the need for mentorship in diabetes and (2) to gather opinions on the structure and content for appropriate mentorship.

Methods: A 28-question online survey was developed, piloted with 8 CD through cognitive interviewing, and shared with CD across the province of Quebec (Canada). Descriptive analysis was used to determine the proportions (%) in survey responses, stratified by years of clinical experience (CE).

Results: From the 284 participants (97% women, mean age 31+/-10 years), 275 (97%) of CD identified a need for mentorship in diabetes. Desire to participate and in what function (mentee, mentor or both) was dependent on the years of CE. Formal mentorship was preferred by 41%, 30% informal and 29% a combination of both which was independent of the years of CE. Finally, 93.5% believe their confidence level in providing care for PWD would increase if they participated in mentorship.

Conclusion: Mentorship in diabetes was perceived as needed to increase Clinical Dietitians confidence level in caring for PWD and for interprofessional collaboration.

Disclosure

S.Blunden: Employee; Dexcom, Inc. A.Roy-fleming: None. C.South: None. C.Gillis: None. A.Brazeau: Other Relationship; Dexcom, Inc., Diabète québec, Ordre des diététistes nutritionnistes du Québec, Research Support; Canadian Institutes of Health Research, Fonds de recherche du Québec en Santé.
569-P: Interim Outcomes of a Patient Simulation Educational Activity for Advanced Practice Providers on the Management of Type 2 Diabetes
Authors: BRECHTELSBAUER ERIKA , GUSTAFSON JESSICA , BLACK ROBIN L.
Published: June 2023

Background: The number of incretin-based therapies for the management of T2D is growing, as is the number of NPs and PAs practicing in primary care, necessitating continuing education to improve knowledge and competence with T2D treatment. Practicing Clinicians Exchange (PCE) developed an educational program on GLP-1 RAs followed by virtual patient simulations to address educational and clinical application needs.

Methods: Following a series of live education, 2 virtual patient simulations were released in October 2022. NPs and PAs received immediate feedback on management decisions.

Conclusions: Patient simulations are effective educational strategy for NPs and PAs to improve competence and application of knowledge with incretin-based therapies for the management of patients with T2D. Patients in both cases were candidates for glycemic control, weight reduction, and CV risk reduction. Glycemic control was achieved by a greater percentage of learners in Case 1 vs Case 2 which could be due to a higher percentage of GLP-1 RA prescriptions (81% vs 65%). More learners achieved weight loss and recommended non-pharmacologic strategies in Case 2. Overall, most GLP-1 RAs prescribed had CV risk reduction benefits with a greater percentage prescribed in Case 1 (87.4% vs 83%). It is important to note a limitation of these findings is more learners completed Case 1 vs Case 2.

Disclosure

E.Brechtelsbauer: None. J.Gustafson: None. R.L.Black: None.

Funding

Novo Nordisk (73471747)
57-OR: Real-World Glycemic Outcomes of >5,900 Adults with Type 1 Diabetes Using the Omnipod 5 Automated Insulin Delivery (AID) System with Cloud-Based Data Management
Authors: LAL RAYHAN , ALEPPO GRAZIA , HUYETT LAUREN M. , SNOW KENNETH , MENDEZ JOSE J. , HADJIYIANNI IRENE , LY TRANG T.
Published: June 2023

The Omnipod 5 AID System is a novel tubeless hybrid closed-loop system that allows for personalized therapy through customizable glucose targets from 110-150mg/dL in 10mg/dL increments. The System enables automatic upload of data for all users initiating the system, facilitating unprecedented access to evaluate real-world outcomes. Continuous glucose monitoring (CGM) and insulin data from Omnipod 5 users with type 1 diabetes (T1D) aged ≥18y in the US with ≥90 days of data available in the cloud-based data management system were included. Data from 5,968 users with sufficient CGM data (≥75% of days with ≥220 readings) and using the lowest target (110mg/dL) for ≥50% of the time, aged 18 to 25y (n=840), 26 to 49y (n=3,127), 50 to 64y (n=1,423), and ≥65y (n=578) were available at the time of analysis. Users were aged mean±SD 42.8±15.0y with median 139 days of system use. Outcomes are shown in the Table for each age group. Median time in target range (70-180mg/dL) was 69.6%, 73.0%, 74.2%, and 77.4% for each age group, respectively. Time <70mg/dL in each age group was low: median 1.0%, 1.0%, 1.0%, and 0.9%, respectively. These results are the first to demonstrate that in over 5,900 adults using the Omnipod 5 System in a real-world setting, highly favorable glycemic outcomes are achievable and are similar to those first reported in a pivotal trial.

Disclosure

R.Lal: Advisory Panel; Provention Bio, Inc., Consultant; Abbott Diabetes, Biolinq, Capillary Biomedical, Inc., Deep Valley Labs, Gluroo, Tidepool, PhysioLogic Devices, Morgan Stanley. G.Aleppo: Advisory Panel; Medscape, Consultant; Bayer Inc., Insulet Corporation, Research Support; Dexcom, Inc., Eli Lilly and Company, Emmes, Insulet Corporation, Fractyl Health, Inc., WellDoc, Speaker's Bureau; Dexcom, Inc. L.M.Huyett: Employee; Insulet Corporation, Stock/Shareholder; Insulet Corporation. K.Snow: Employee; Insulet Corporation. J.J.Mendez: None. I.Hadjiyianni: Employee; Insulet Corporation, Stock/Shareholder; Insulet Corporation, Eli Lilly and Company. T.T.Ly: Employee; Insulet Corporation.

Funding

Insulet Corporation
570-P: Designing the Deaf Diabetes Can Together Intervention
Authors: LITCHMAN MICHELLE L. , ALLEN NANCY A. , IACOB ELI , MILLER NIC A. , HENDERSON MURDOCK , CANELA SIERRA M. , LEE SHINDUK
Published: June 2023

Deaf individuals who communicate using American Sign Language (ASL) are 3 times more likely to have diabetes than hearing people, yet experience challenges obtaining diabetes education due to a multitude of systematic barriers. One barrier is communication breakdown between the Deaf patient, an ASL interpreter, and clinician. Due to a lack of unified diabetes medical terms in ASL, confusion can occur when different ASL interpreters are used at diabetes appointments. In collaboration with an all-Deaf Community Advisory Board, a Certified Deaf Interpreter, Deaf health professionals, a universal access designer, and experts in Diabetes care, we co-designed an ASL Glossary of diabetes terms. The ASL Glossary confirmed, clarified, updated, and/or developed new signs and explanatory expansions during a 5-phase process. The ASL Glossary include 42 videos of diabetes terms and 28 explanatory expansions. New signs were developed for the term, ‘insulin’ to help distinguish insulin made within the body and exogenous insulin. A sign clarification was needed to establish the seriousness of prediabetes. The terms ‘diet’ and ‘fat’ were modified to be more politically correct. Technology, such as continuous glucose monitoring, insulin pumps, and smart pens required new signs and/or expansions. The ASL Glossary of diabetes terms addresses systemic barriers that exist in working with Deaf patients and research participants. The ASL Glossary of diabetes terms will support diabetes self-management education and support videos that are being created for the next phase of the Deaf Diabetes Can Together single-arm pilot study. Additionally, the ASL Glossary of diabetes terms will be used to support a future ASL interpreter training.

Disclosure

M.L.Litchman: None. N.A.Allen: Consultant; Diathrive Health, Dexcom, Inc. E.Iacob: None. N.A.Miller: None. M.Henderson: None. S.M.Canela: None. S.Lee: None.

Funding

Gordon and Betty Moore Foundation (GBMF9048); Margolis Foundation
571-P: Theory-Based Design of a Nutrition-Focused Approach at CGM Initiation for People with T2D
Authors: WILLIS HOLLY , JAKA MEGHAN , JOHNSON ELIZABETH A.
Published: June 2023

Background: CGM can improve glycemic outcomes and has the potential to help people with T2D adopt evidence-based nutrition recommendations. Effective interventions using CGM data to guide food choices that align with nutrition recommendations are sparse. The objective of this work is to describe development of a nutrition-focused approach (NFA) at CGM initiation using the behavior change wheel (BCW), a theory-based intervention development framework.

Methods: The BCW process included 3 parts: 1) specifying the target behavior and existing barriers according to the Capability Opportunity Motivation-Behavior (COM-B) Model and Theoretical Domains Framework (TDF); 2) identifying intervention content to address the barriers (e.g. broad strategies for behavior change and specific behavior change techniques (BCTs)); and 3) assessing feasibility of the intervention and selecting ways to implement content. Rapid literature review, stakeholder discussion, and content analysis were used to achieve these steps.

Results: The target behavior was defined as using CGM data to guide dietary changes that align with current nutrition recommendations and improve TIR. Via content analysis, 80 barriers were coded according to the COM-B and TDF constructs. After feasibility assessment and stakeholder discussions, 12 barriers were selected (e.g. an opportunity barrier is lack of tools supporting use of CGM data to guide food choices). These barriers were mapped to 5 behavior change strategies (i.e. intervention functions; such as training and enablement) and associated BCTs (e.g. habit formation and reframing). The final intervention includes three components: a 1-hr in-person session, a 30-min telehealth session, and nutrition-focused CGM-initiation materials.

Conclusion: Use of the BCW led to the development of a rigorous but pragmatic theory-driven intervention. Effectiveness of the nutrition-focused approach at CGM initiation intervention will be tested in clinical trials.

Disclosure

H.Willis: Other Relationship; Abbott Diabetes, Dexcom, Inc., Research Support; Abbott Diabetes. M.Jaka: None. E.A.Johnson: Speaker's Bureau; Medtronic, Medscape.

Funding

American Diabetes Association (7-22-JDFN-27 to H.W.)
58-LB: Associations between Diabetes Distress and CGM Metrics in Adults in the T1D Exchange Registry
Authors: KELLY CAITLIN S. , NGUYEN HUYEN , CHAPMAN KATHERINE S.M. , CORNELIUS EMILEE M. , PETER MEGAN , WOLF WENDY
Published: June 2023

Research on diabetes distress in continuous glucose monitor (CGM) users with T1D is divided. Some studies suggest CGM users experience less distress compared to non-users, whereas other studies find no differences in distress. While research shows higher distress is related to higher HbA1c, more work is needed to understand how distress is related to CGM metrics. Thus, we recruited adult CGM users with T1D (n = 199) from the T1D Exchange Registry to complete an online survey about diabetes characteristics and a screener of diabetes distress (DDS-2). CGM metrics (defined in Table 1) were computed from CGM data within 12 months prior to survey completion. Participants were grouped into lower (DDS-2 < 3, n = 120) or higher (DDS-2 ≥ 3, n = 79) diabetes distress. We used Welch’s t-tests to compare mean differences in blood glucose (BG) experiences and CGM metrics between participants with lower and higher diabetes distress. As shown in Table 1, participants with higher diabetes distress reported higher HbA1c, and - via CGM metrics - experienced more time in higher BG ranges and less time within standard target ranges, had higher blood glucose variability, and had higher GMI compared to those with lower distress. Associations between distress and CGM metrics replicated in a MANCOVA after adjusting for duration of T1D. Our results suggest, in CGM users, higher perceived diabetes distress is associated with more time in hyperglycemia.

Disclosure

C. S. Kelly: None. H. Nguyen: None. K. S. M. Chapman: None. E. M. Cornelius: None. M. Peter: None. W. Wolf: None.
582-P: Exercise Training Reverses NAFLD in Mice with Obesity Independent of Changes in Hepatic Mitochondrial Oxidative Capacity
Authors: HEINTZ ELIZABETH C. , DANTAS WAGNER S. , STAMPLEY JAMES E. , DAVIS GREGORY M. , IRVING BRIAN A. , AXELROD CHRISTOPHER L. , KIRWAN JOHN P.
Published: June 2023

Obesity is a primary cause of hepatic lipid accumulation, leading to nonalcoholic fatty liver disease (NAFLD). As there are no FDA-approved therapies for NAFLD treatment, weight loss through lifestyle intervention is the first-line therapy. Exercise improves hepatic function in patients with obesity related NAFLD. However, the mechanisms whereby exercise mediates the enhancement of liver function are largely unknown. This study evaluated the impact of exercise training on NAFLD in mice with obesity. At 8 weeks of age, mice were randomized to low-fat (LFD) or high-fat diet (HFD). After 4 weeks of dietary intervention, mice were randomized to either control (SED) or exercise training (ExT) with experimental diet for 10 weeks. ExT mice completed 45 minutes of moderate-intensity treadmill running 4 days/week. Body weight was measured weekly, and body composition and maximal treadmill running were evaluated at weeks 0, 4, and 14. Blood lactate accumulation was measured during the final treadmill test. Mice were euthanized 48 hours after the last exercise session for liver histopathology, blood chemistry, and ex vivo mitochondrial function analysis. Liver function was assessed via serum liver panel and quantification of hepatic lipids. High-resolution respirometry was used to determine maximal hepatic fatty acid oxidation, NADH- and succinate-linked oxidative phosphorylation (OXPHOS), and electron transfer capacity in tissue homogenates. HFD increased body mass, which was reduced with ExT. ExT increased maximal running time independent of diet. HFD worsened lactate metabolism, which was improved with ExT. HFD increased liver weight, which was decreased with ExT. HFD-induced increases in hepatic lipid and serum ALT and ALP were reversed with ExT. Hepatic mitochondrial OXPHOS and electron transfer were reduced with HFD relative to LFD. These data suggest that exercise-induced reversal of NAFLD is not mediated by hepatic mitochondrial oxidative capacity.

Disclosure

E.C. Heintz: None. W.S. Dantas: None. J.E. Stampley: None. G.M. Davis: None. B.A. Irving: None. C.L. Axelrod: None. J.P. Kirwan: None.

Funding

Nutrition Obesity Research Center (P30DK072476); Louisiana Clinical and Translational Science Center (U54GM104940); Centers of Biomedical Research Excellence (P20GM103528)
588-P: Probing the Role of Muscle Glycogen Resynthesis on Postexercise AMPK Activation and Metabolic Protein Abundance Using a Novel Genetic Model
Authors: KWAK SEONGEUN , ZHENG AMY , ARIAS EDWARD B. , WANG HAIYAN , PAN XIUFANG , DUAN DONGSHENG , YUE YONGPING , CARTEE GREGORY D.
Published: June 2023

Acute exercise can alter the abundance of key metabolic proteins in skeletal muscle. These effects are influenced by postexercise (PEX) refeeding. Muscle glycogen resynthesis is a putative mediator of these refeeding effects. However, it is challenging to test this idea, because glycogen resynthesis is only one of many outcomes with refeeding. Therefore, we devised a novel genetic model to modify muscle expression of glycogen synthase 1 (GS1) using injection of rat skeletal muscle with adeno-associated viral (AAV) vectors for short hairpin RNA targeting GS1 (shRNA-GS1). Contralateral muscles were injected with scrambled shRNA (shRNA-Scr). Rats were sedentary (SED) or exercised (120min swim-exercise). Muscles were collected immediately postexercise (IPEX) and 9-hours PEX (9hPEX), along with time-matched SED controls. The 9hPEX and their SED-control rats were either refed (RF) or not-refed (NRF). Muscles were analyzed for glycogen and phosphorylation and abundance of key metabolic proteins. Muscles injected with shRNA-GS1 vs shRNA-Scr had lower GS1 abundance in all groups. Regardless of genotype, in IPEX vs SED rats: glycogen fell to similarly low values and phosphorylation of AMPK Thr172 (pAMPK) and its substrate ACC Ser79 (pACC) were comparably increased. Muscle glycogen was increased in all groups of 9h-RF rats, but it was lower for shRNA-GS1 vs shRNA-Scr from RF-9hPEX rats. In the NRF-9hPEX rats, pAMPK and pACC were greater for shRNA-GS1 vs shRNA-Scr muscles. Muscle pyruvate dehydrogenase kinase-4 abundance from 9hPEX rats (both NRF and RF) was greater for shRNA-GS1 vs shRNA-Scr. Hexokinase II (HKII) abundance was greater for 9hPEX vs SED in NRF rats regardless of genotype. In RF-9hPEX rats, HKII abundance was greater for shRNA-GS1 vs shRNA-Scr. These results support the idea that some PEX effects on metabolic protein abundance are influenced by muscle GS1 abundance and the extent of glycogen resynthesis

Disclosure

S.Kwak: None. A.Zheng: None. E.B.Arias: None. H.Wang: None. X.Pan: None. D.Duan: None. Y.Yue: None. G.D.Cartee: None.

Funding

National Institutes of Health (R01DK071771); University of Michigan