bluuebunny/crossref_metadata_2025 huggingface dataset:
555-P: Modalities for Diabetes Technology Education—Perspectives and Priorities from Caregivers, Youth, and Clinicians
Authors: MEIGHAN SEEMA , MILLER VICTORIA , BALMER DORENE , STREISAND RANDI , ALICEA-TRELLES NICOLE , MARKS BRYNN E.
Published: June 2024

Introduction: The COVID-19 pandemic forced a rapid transition to telemedicine. The unique benefits and challenges of virtual diabetes technology education must be considered as we adapt educational methods to meet the individual needs and preferences of youth with type 1 diabetes (T1D) and their families.

Methods: Parent-youth dyads ages 8-12 and diabetes clinicians participated in ~45 minute semi-structured interviews about unmet diabetes technology educational needs. Interviews were recorded and transcribed. Modified inductive coding with two independent coders was used for thematic analysis. Twenty percent of interviews were double coded to ensure dependability of the data. Thematic saturation was achieved.

Results: Twenty parent-youth dyads (Mage child 10.7 yrs, 65% female youth, MT1D duration 3.9 yrs; Mage parent 40.6yrs, 85% mothers) and 8 clinicians (Mage 39.8 yrs, Mexperience 8.0 yrs) were interviewed. Three themes emerged: 1) Although virtual education minimized time away from work and school, families and clinicians overwhelmingly preferred in-person education because it allowed for better focus and hands-on troubleshooting as families programmed and placed devices. 2) Problematic internet connections, difficulties visualizing and hearing the education, and distractions in the home setting made telehealth visits less preferred. 3) Physical aspects of diabetes technology education are best suited for hands-on, in-person learning whereas intellectual concepts can be taught virtually.

Conclusions: T1D families without prior virtual education experience are unlikely to recognize that physical aspects of education are best suited to in-person training. Considering transportation, uncompensated time away from work, access to a reliable internet connection, a quiet space in the home, and an appropriately sized screen for telemedicine may help to guide families in choosing the best modality for diabetes technology education.

Disclosure

S. Meighan: Speaker's Bureau; Dexcom, Inc. V. Miller: None. D. Balmer: None. R. Streisand: None. N. Alicea-Trelles: None. B.E. Marks: Research Support; Tandem Diabetes Care, Inc., Dexcom, Inc., Medtronic, Digostics. Advisory Panel; International Society for Pediatric and Adolescent Diabetes, American Diabetes Association, T1D Exchange. Board Member; Juvenile Diabetes Research Foundation (JDRF).

Funding

National Institutes of Health (K23DK129827)
572-P: Perspectives on the SDOH and CGM Uptake in Latino Adults with Type 1 Diabetes
Authors: NEWLIN LEW KELLEY , PEREZ-BRESCIA MARYANN , CHANNAMSETTY VEENA , ALLEN NANCY A.
Published: June 2024

Introduction & Objective: Little is known about the social determinants of health (SDOH) and uptake of continuous glucose monitoring (CGM) in Latino adults with type 1 diabetes (T1D). This study explores SDOH as barriers to CGM uptake in Latino adults with T1D from the perspective of Latino health advocates (LHAs), diabetes health care providers (HCPs), and federally qualified health center (FQHC) HCPs.

Methods: In this qualitative study, convenience sampling was used to recruit: (1) LHAs (n=7); (2) diabetes HCPs (n=4); and (3) FQHC HCPs (n=5) to participate in focus groups, respectively. Participants were queried about SDOH as barriers to CGM uptake in Latino adults with T1D. Content analysis was used to analyze data.

Results: The LHA, diabetes HCP, and FQHC HCP groups all identified suboptimal health care quality as a potent barrier to CGM uptake, particularly in terms of poor translation (literal, abbreviated, and culturally insensitive translations) of key health concepts by certified Spanish/English medical interpreters. The LHA and diabetes HCP groups revealed that providers may limit health care access to CGM based on translation issues, insurance hassles, and unsuccessful CGM uptake experienced previously with Latinos. The FQHC HCP group identified unreliable transportation to clinic visits as an impediment to health care access for CGM while food and housing insecurity, due to a lack of economic stability, were barriers to CGM uptake. With respect to the social and community context, lack of family inclusion in clinic visits and negative family/neighborhood perceptions of CGM were viewed as salient barriers.

Conclusion: Findings indicate that interventions targeting CGM uptake in Latino adults with T1D address SDOH barriers.

Disclosure

K. Newlin Lew: None. M. Perez-Brescia: None. V. Channamsetty: None. N.A. Allen: Research Support; Dexcom, Inc. Consultant; Diathrive Health.

Funding

National Institutes of Health/ National Institute of Diabetes and Digestive and Kidney Diseases (R01DK135016)
579-P: ADA Diabetes Medical Management Plan Implementation—Barriers and Opportunities
Authors: MARCH CHRISTINE , MCMANEMIN JACQUELINE , PELLIZZARI MARGARET , RODRIGUEZ JANET , RODRIGUEZ HENRY , HARRIMAN KAREN , WOODWARD CRYSTAL
Published: June 2024

Introduction & Objective: The ADA’s Diabetes Medical Management Plan (DMMP), revised in 2021, provides medical orders for diabetes care in schools. The objective was to assess multistakeholder experiences with the revised DMMP, barriers to uptake, and potential strategies to enhance usability.

Methods: We conducted a national survey of diabetes providers and school nurses with the ADA Safe at School Working Group, National Association of School Nurses, and other professional organizations. Questions addressed processes for DMMP integration, perceived barriers, and recommendations.

Results: We received responses from 507 school nurses and 79 providers representing all US regions. Of these, 57% of school nurses and 62% of the providers had used the DMMP. Views of the DMMP were generally favorable; 100% of providers and 92% of nurses agreed that the DMMP was comprehensive and >60% felt it was the right length. The DMMP was usually completed on a computer by providers (82%), though only 31% could share the form electronically with schools. Common barriers reported by school nurses included delays in receiving the DMMP (57%) including updates (64%) and alternative forms from providers (41%); for providers, barriers included lack of health record integration (72%) and time required to complete the DMMP (50%). Both groups endorsed difficulty with parent engagement with DMMP completion (37% nurses, 44% providers). Over 750 comments suggested modifications to enhance usability; themes included fostering parent and provider input for all sections, streamlining references to accommodations, and providing more flexible formats to customize based on local practices.

Conclusion: Barriers at the health system level interfere with uptake of the DMMP. Multi-stakeholder input can co-create medical orders and school resources which can be customized to meet the needs of local centers. Electronic systems for bidirectional information transfer between schools and diabetes centers would facilitate adoption.

Disclosure

C. March: None. J. McManemin: None. M. Pellizzari: None. J. Rodriguez: None. H. Rodriguez: Consultant; Provention Bio, Inc. Speaker's Bureau; Sanofi. Other Relationship; Merck & Co., Inc., Sanofi. Research Support; Boehringer-Ingelheim, Dexcom, Inc., Eli Lilly and Company, MannKind Corporation, Medtronic, Novo Nordisk, Tandem, Teva. K. Harriman: None. C. Woodward: None.
616-P: Self-Reported Fasting Habits in Patients with Type 1 Diabetes Mellitus
Authors: WONG ALISON L. , OLDENBURG NIKI C. , CHOW LISA S.
Published: June 2024

Introduction & Objective: Although intermittent fasting (IF) has increased in popularity for weight loss, it’s unknown whether patients with Type 1 diabetes (T1DM) engage in IF. Roughly 60% of patients with T1DM are overweight or obese, but are generally not encouraged to fast due to concerns about hypoglycemia or ketoacidosis. We inquired about self-reported IF among patients with T1DM.

Methods: This was a REDCAP survey administered through the EPIC-based Electronic Health Record (EHR) at the University of Minnesota/Fairview Health System from Sept-Oct 2023. This was an anonymous, voluntary survey, sent through the EHR myChart system, to patients with T1DM, ages 18-89 years old. The survey asked about IF habits and if affirmative, inquired further on their fasting habits and impact on T1DM management.

Results: Surveys went out to 1551 patients. Of the 105 respondents, 28 (26.7%) reported IF. These patients [17F and 11M: mean(SD): age 42.8 (10.9) years, BMI: 27.9 (5.6) kg/m2, duration of T1DM diagnosis 23.3 (15.0) years] engaged in IF for an average of 40 months (SD=33.3). Of these patients, 5 engaged in IF (eat less/fast a few days per week) and 24 engaged in time-restricted eating [daily eating window 8.56 hours (2.8) - patients choice could overlap]. Self-reported average weight loss was 5.7 kg (SD=7.1) and only 3 used GLP-1s agonists. Four (14.3%) reported hypoglycemia related to fasting of which insulin adjustment, primarily basal reduction, was needed in 10 patients (55%). All patients wore a continuous glucose monitor (CGM), and 21 patients (75%) used an insulin pump. Overall satisfaction with IF was high, with 18 (64%) recommending it to friends/family and 21 (75%) recommending it to other T1DM patients. There were no self-reported cases of DKA in this population.

Conclusion: IF remains rare among patients with T1DM, but among those who participate, satisfaction was high. IF could be considered within the context of CGM usage, with monitoring for hypoglycemia and insulin adjustment as needed, in patients with T1DM who are overweight.

Disclosure

A.L. Wong: None. N.C. Oldenburg: None. L.S. Chow: Research Support; Dexcom, Inc.
631-P: Effectiveness of Freedom from Diabetes Protocol in Managing Prediabetes in Indian Population—A Quasi-experimental Study
Authors: TRIPATHI PRAMOD , KADAM NIDHI S. , TIWARI DIPTIKA , VYAWAHARE ANAGHA R. , SHARMA BABY , KATHRIKOLLY THEJAS , GANLA MALHAR H. , HIREMATH MAMATA , SABOO BANSHI D.
Published: June 2024

Introduction: Prediabetes, a crucial metabolic state, significantly increases the risk of type 2 diabetes (T2D). India's surging prediabetes cases outpace those of diabetes, highlighting an impending T2D crisis. Urgent attention and effective management strategies are crucial.

Aim: To assess the effectiveness of a one-year online lifestyle intervention program in prediabetes patients, while exploring gender-specific and BMI-based differences in outcomes.

Methods: This study analyzed data from 715 patients with prediabetes (HbA1c: 5.7%-6.4%; not on insulin or OHAs, aged >18 years) attending a one-year online lifestyle intervention program at the Freedom from Diabetes Clinic, India. The intervention consisted of personalized plant-based diet, physical activity, stress management, and medical management. The baseline and end-line assessments included anthropometric and biochemical parameters.

Results: The study population, consisting of 60% females and a mean age of 50.6±10 years, exhibited a median HbA1c of 6.0% (5.8-6.2). Post-intervention, a substantial reduction in HbA1c (<5.7%) and BMI (<25 kg/m2) was observed in 56% and 16.1% of patients, respectively (p<0.05). Women showed greater improvements in weight loss, BMI, fasting insulin, and HOMA-IR than men (p<0.05). Patients with a BMI greater than 25 kg/m2 showed greater weight loss (kg) (-6.7 vs. -1.8) and improvements in total cholesterol, triglycerides, and non-HDL compared to those with a BMI less than 25 kg/m2 (p<0.05). In both BMI categories, the improvement in HbA1c levels was comparable (p>0.1) and weight loss was positively correlated with HbA1c drop (p<0.01).

Conclusion: Women with prediabetes showed better outcomes in response to the lifestyle interventions than men. Weight loss relative to BMI improved the glycemic profile of both obese and non-obese patients. Comprehensive lifestyle interventions may serve as effective strategies for managing prediabetes.

Disclosure

P. Tripathi: None. N.S. Kadam: None. D. Tiwari: None. A.R. Vyawahare: None. B. Sharma: None. T. Kathrikolly: None. M.H. Ganla: None. M. Hiremath: None. B.D. Saboo: None.
649-P: Medical Students’ Recognition of Psychosocial Issues in a Behavioral Diabetes Case
Authors: WISNIEWSKI LUKE , BEVERLY ELIZABETH A.
Published: June 2024

Introduction & Objective: Psychosocial care should be provided to all people with diabetes. Psychosocial problems can impair a person’s ability to carry out diabetes self-care. Thus, addressing these problems is critical to improve outcomes. To better understand medical students’ awareness of psychosocial problems, we created a mock behavioral diabetes case for evaluation.

Methods: We conducted a descriptive, cross-sectional study with medical students of all four years at a school in the Midwest. Students were asked to provide a written description of a case of a 67-year-old man with type 2 diabetes. All students were provided laboratory results (HbA1c=9.8%), family history, and comments from the man. The comments noted that he recently retired from his job and moved to a new city. He referred to his diabetes as very hard, and he felt there was nothing he could do to make it better. The case concluded with the man saying he felt he should no longer bother with his diabetes because it would only get worse. We analyzed all written case summaries using content analysis in NVivo software.

Results: A total of 248 medical students participated (mean age=25.0±2.4 years, 65.1% women, 69.8% White, 6.3% Black, 16.4% Asian, 28.2% third-year students). Of the 248 students, 144 (58.1%) noted in their description a potential behavioral health concern, such as depression, anxiety, distress, and/or burnout. Interestingly, only one participant wrote about diabetes distress, despite this topic being taught in the curriculum, and only three participants noted his recent move and retirement. Conversely, 112 participants focused their descriptions on HbA1c, of which 90 referred to it as poorly controlled or uncontrolled diabetes.

Conclusion: Findings showed half of participating medical students recognized a potential psychosocial problem in the case. However, a third of participants used stigmatizing language to describe glycemic targets. More research at other medical schools is needed to confirm these findings.

Disclosure

L. Wisniewski: None. E.A. Beverly: None.
664-P: Preliminary Results of a New Scalable Digital Treatment for Diabetes Distress (DD) in Families of School-Age Children with Type 1 Diabetes (T1D)
Authors: PATTON SUSANA R. , PIERCE JESSICA S. , KAHHAN NICOLE , BENSON MATTHEW R. , FOX LARRY A. , CLEMENTS MARK A.
Published: June 2024

We present feasibility, acceptability, and efficacy of 3 delivery arms of a new scalable, digital treatment we designed to target DD in families of school-agers with T1D. We randomized 34 families (mean child age= 10+1.4 years; 53% male, 85% White, mean HbA1c= 7.24+0.71%) to 1 of 3 delivery arms differing only by number of telehealth visits: 0 visits= self-guided (SG), 3 visits= enhanced self-guided (ESG), or 8 visits= video visits (VV). All families had 24x7 access to digital treatment materials via their hospital’s patient portal app for 10 weeks. We recorded telehealth visit attendance (ESG & VV families) to examine feasibility. We compared parent and child treatment satisfaction by delivery arm to examine acceptability. We compared parent and child DD using the Problem Areas in Diabetes-Child (PPAIDC and PAIDC, respectively) by time and delivery arm to test efficacy. 81% of ESG families attended all 3 and 20% of VV families attended all 8 telehealth visits. Parents and children reported high satisfaction scores with no differences by delivery arm. There were significant pre-post reductions in PPAIDC (p=0.026) and PAIDC (p=0.026) scores but no differences by delivery arm. All 3 delivery arms appear acceptable and may reduce DD in families of school-agers with T1D. However, without the burden of telehealth visits, SG may be more feasible than the other delivery arms.

Disclosure

S.R. Patton: None. J.S. Pierce: None. N. Kahhan: None. M.R. Benson: Research Support; Novo Nordisk A/S. Other Relationship; American Diabetes Association. Research Support; Provention Bio, Inc., Sanofi-Aventis U.S., Beta Bionics. Stock/Shareholder; KiHealth Board Member. L.A. Fox: Advisory Panel; Ki Health. Research Support; Dexcom, Inc. M.A. Clements: Research Support; Abbott. Consultant; Glooko, Inc. Research Support; Dexcom, Inc.

Funding

National Institutes of Health (R01 DK127493)
669-P: How Do Emerging Adults (EAs) with Type 1 Diabetes (T1D) Seek Self-Care Information?
Authors: SHANK KAITLYN R. , VITALE REBECCA J. , ASHER NOA , KATYAL BIREN , GARVEY KATHARINE , LAFFEL LORI M.
Published: June 2024

Aim: As EAs with T1D become independent in self-care, they often confront diabetes management challenges. We sought to assess ways in which EAs seek information when faced with uncertainty in their diabetes care.

Methods: EAs (ages 18-25) with T1D participated in a qualitative study regarding their experiences of transitioning to self-management. In semi-structured interviews, participants were asked, “Tell me more about how you look for answers when you’re not sure what to do [in your diabetes management].” De-identified interview transcripts were analyzed using directed qualitative content analysis.

Results: Interviews were conducted with 24 participants, mean age 21.5 ± 1.8 years; 46% were male, 42% female, 13% trans/non-binary; 75% identified as non-Hispanic white. Mean age at diagnosis was 10.0 ± 6.3 years; 71% reported A1c <8%. Many used technology with 83% using pumps and 96% using CGM. Two main themes emerged regarding information sources, endorsed roughly equally by participants: (1) Seek out people with lived experience of T1D (either personal acquaintances or online) as the best knowledge source, (2) Identify people with formal education/training about diabetes management (e.g. clinical providers, device companies) for most reliable information. Two sub-themes emerged regarding verification of information from non-medical professionals: (1a) Look for agreement across multiple sources, and (1b) Differentiate between universal and individualized aspects of diabetes management.

Conclusion: While many EAs with T1D seek others with personal lived experience of T1D to problem-solve self-care challenges, others prefer to rely on people with formal education/training. Clinicians/educators should consider ways to offer virtual opportunities for EAs to seek support for their self-care between clinical encounters. Online forums may offer a way for EAs with T1D to connect. Providers can help EAs learn how to evaluate the reliability of their information sources.

Disclosure

K.R. Shank: None. R.J. Vitale: None. N. Asher: None. B. Katyal: None. K. Garvey: Advisory Panel; Sanofi. L.M. Laffel: Consultant; Dexcom, Inc. Advisory Panel; Medscape, Medtronic, Vertex Pharmaceuticals Incorporated. Consultant; Novo Nordisk. Advisory Panel; Lilly Diabetes, Provention Bio, Inc., Sanofi-Aventis U.S., Janssen Pharmaceuticals, Inc., MannKind Corporation.

Funding

Endocrine Fellows Foundation; NIH T32DK007529; NIH P30DK036836; Iacocca Foundation Senior Postdoctoral Fellowship
670-P: Self-Efficacy and Fatalism as a Pathway between Delay Discounting, Delay Aversion, and Glycemic Control
Authors: CAMPBELL JENNIFER A. , WALKER REBEKAH J. , EGEDE LEONARD E.
Published: June 2024

Background: Delay discounting (DD) is the cognitive process of comparing values between immediate and delayed rewards. Delay aversion (DA) refers to the negative emotional response when faced with a delay. Pathways between DD/DA and glycemic control are poorly understood. Based on prior evidence, self-efficacy and fatalism were hypothesized as key mechanisms through which DD/DA influences glycemic control.

Methods: Baseline data on 200 African Americans with T2DM enrolled in a diabetes intervention trial was analyzed. DD and DA were measured with the validated quick delay questionnaire, self-efficacy was measured with the validated perceived diabetes self-management scale, fatalism was measured using the validated diabetes fatalism scale, and glycemic control was measured via HbA1c. Structural equation modeling (SEM) was used to investigate the direct and indirect relationships between DD/DA and HbA1c via self-efficacy, and fatalism respectively using Stata V17.

Results: Sample mean age was 56.4 years, 33% were women, 61% had income <$25K, 31% were employed, and mean diabetes duration was 15 years. In the final SEM model for DD, self-efficacy was directly associated with HbA1c (r=-0.05; p<0.05). Fatalism was marginally associated with HbA1c (r=0.12; p<0.10). DD was significantly associated with self-efficacy (r=0.17; p<0.05) and fatalism (r=0.19; p<0.001). In the final SEM model for DA, self-efficacy was directly associated with HbA1c (r=-0.16; p<0.05) while fatalism was marginally associated with HbA1c (r=0.14; p<0.10). DA was significantly associated with self-efficacy (r=-0.27; p<0.001) and fatalism (r=0.32; p<0.001).

Conclusion: In African Americans with T2DM, delay discounting and delay aversion are associated with worse glycemic control indirectly via lower self-efficacy and marginally via higher diabetes fatalism. This study provides new evidence on potential mechanisms of action and potential pathways for interventions in this population.

Disclosure

J.A. Campbell: None. R.J. Walker: None. L.E. Egede: None.

Funding

National Institute of Diabetes and Digestive Kidney Disease (R01DK118038, R01DK120861, PI: Egede; K01DK131319, PI: Campbell); National Institute for Minority Health and Health Disparities (R01MD013826, PI: Egede/Walker; R01MD018012, R01MD017574, PI: Egede/Linde)
701-P: Exploring the Lived Experience of Self-Care in Young Adults with Type 2 Diabetes Mellitus
Authors: BERRY-PRICE HOLLY , HEMPHILL JEAN C. , HASELSCHWERDT MEGAN L. , WEIERBACH FLORENCE M. , TODT KENDREA L.
Published: June 2024

Introduction: The prevalence of prediabetes in adults aged 18 or older was as high as 38% between 2017-2020. Youth-onset T2DM is a more aggressive phenotype than T2DM that occurs later in life. Young adults with T2DM have poorer health outcomes, lose an average of 15 years of life, all resulting in significant economic burden impacting the person. Current self-management interventions do not improve health outcomes in young adults with T2DM.

Objective: The purpose of this research was to explore the self-care experiences of young adults living with T2DM.

Methods: Existential hermeneutic phenomenology informed the research. Inclusion criteria as follows: adults aged 18 to 30 with a self-reported diagnosis of T2DM, physical presence in the United States, English proficiency. Purposive and snowball sampling were used. Nineteen participants were interviewed: 16 self-identified as Black, 2 as White, and 1 as Latino. Interviews were transcribed verbatim. Transcripts were analyzed using an iterative approach for meaning units and themes. Thematic meanings were identified from the data.

Results: Overarching theme “Then & Now,” and 4 additional themes: health anxiety/death anxiety, I’m very supported, my routine/my duties/my rules, juggling, and 3 subthemes. Several factors were unique to young adults' perception of self-care. Perceptions of time, support networks, novel coping strategies, and search for disease literacy impacted self-care perceptions and understanding. Results suggest the need for future person-centered, self-care intervention research with young adults that could result in improved health outcomes.

Disclosure

H. Berry-Price: None. J.C. Hemphill: None. M.L. Haselschwerdt: None. F.M. Weierbach: None. K.L. Todt: None.
714-P: Influence of Eating Behavior Patterns on Online Weight Loss Program Engagement and Weight Loss
Authors: CLYNES SASHA , CHURCH TIMOTHY S. , JONES DAVID , WOODCOCK BRIAN
Published: June 2024

Objective: To determine if eating behavior phenotype affects engagement and weight loss in an online corporately sponsored weight loss program.

Methods: Participants (N=206,426, mean age=46.5, 74.5% women, 72.4% Non-Hispanic White; 62.7% with obesity; 29.3% with overweight; 8.5% with diabetes; 17.6% with pre-diabetes) were from employers and health plans. We adapted an Epstein questionnaire to categorize eating behavior patterns as social (eating in social situations in the absence of true hunger), emotional (eating when experiencing strong emotions like stress, sadness, anxiety, or anger), hunger (having persistent hunger throughout the day), rigid (having a set of strict rules for the diet; an all-or-nothing approach), or classic struggle (having none of the other eating behavior patterns).[i] Outcomes were number of attended classes (online educational videos) and maximum percent weight loss over time in program. Linear regression models were fit with age and gender as covariates. We also gathered qualitative feedback on the survey from a small sample of users (n= 127).

Results: 154,740 (75%) completed the survey. The social eating behavior was the most common phenotype (64% of participants), followed by emotional (49%), hunger (48%), rigid (24%), and classic struggle (12%). Mean participation was 11.3 online classes and mean weight loss was 3.2%. We did not find any clinically meaningful differences between the groups for in-class attendance or weight loss. Additionally, there were no meaningful differences in diabetic and pre-diabetic subgroups. The participants who provided qualitative feedback rated the eating behavior survey as valuable and believed their eating behavior patterns were accurate after viewing survey results.

Conclusion: A social eating pattern was the most prevalent phenotype in this sample. Participants with all eating behavior phenotypes engaged to a similar degree in online program classes and had similar amounts of weight loss.

Disclosure

S. Clynes: Consultant; Wondr Health. T.S. Church: None. D. Jones: Employee; Wondr Health. B. Woodcock: Employee; Wondr Health.
715-P: Multilevel Health Care System Factors Influencing Type 2 Diabetes Disparities in the United States—An Integrative Review
Authors: GODFREY TIMIAN , OWOLABI EYITAYO O. , SINGH MANTEJ , DIAZ MONICA , BRAXTON MORGAN , SHAIBI GABRIEL Q.
Published: June 2024

Introduction: In the United States, minority populations are disproportionately impacted by and experience worsened outcomes from type 2 diabetes (T2D). The National Institute of Minority Health and Health Disparities (NIMHD) Research Framework guided this study to synthesize the scientific evidence identifying health care system factors influencing T2D health disparities among minority populations in the US.

Methods: A literature search was conducted on PubMed, CINAHL, PsycINFO, and Scopus for articles published between 2017 and 2023 with outcomes of glucose homeostasis and T2D disparities in minority populations (as defined by NIMHD). Two reviewers independently extracted data for descriptive and narrative analysis.

Results: Among the 108 included studies, 33 (30.5%) reported associations between measures of glucose homeostasis and multilevel factors in the health care system. Within this domain, most studies were conducted at the community (30.3%) and individual (21%) levels, with only 15% including multiple levels. The overarching factors influencing T2D disparities included: 1) Treatment preferences, 2) Multidisciplinary approaches, 3) Technology enhanced education and support, 4) Language translation services, 5) Integrated clinical and community care approaches, 6) Access to services in rural areas, 7) Insurance access/coverage/stability, and 8) Racism and discrimination.

Conclusions: Studies included in this review highlight the complex interplay between the levels of influence in the NIMHD framework, the health care system, and the subsequent outcome of T2D disparities. More studies are needed across multiple levels of influence in the health care system to better understand drivers of these inequities and inform T2D health disparities research and practice.

Disclosure

T. Godfrey: None. E.O. Owolabi: None. M. Singh: None. M. Diaz: None. M. Braxton: None. G.Q. Shaibi: None.
724-P: Implementing an Early Type 1 Diabetes Clinic and Immunotherapy Treatment Program for Patients with Stage 1 and Stage 2 Type 1 Diabetes
Authors: SIMMONS KIMBER M. , CHESSHIR LEXIE , O'DONNELL HOLLY K. , WALKER SONYA C. , MARTINEZ ANDRES D. , ALONSO GUY T. , TRIOLO TAYLOR M. , GOTTLIEB PETER , FROHNERT BRIGITTE I. , STECK ANDREA
Published: June 2024

Introduction & Objective: In November 2022, teplizumab-mzwv was approved for delaying onset of stage 3 type 1 diabetes (T1D). We designed an early T1D clinic to identify individuals eligible for treatment and provide proper anticipatory guidance around treatment options.

Methods: In December 2022, we opened a weekly clinic staffed with a nurse, physician and psychologist. Individuals with islet autoimmunity and concern for dysglycemia are offered metabolic staging, which includes a fasting glucose level, HbA1C, 2-hour OGTT, and 10-day CGM wear. Patients are offered a health and behavior assessment with a psychologist to assess psychological factors affecting their medical condition (e.g., anxiety, coping). Metabolic staging results are obtained during clinic, and treatment options are discussed. If a patient desires teplizumab-mzwv therapy, we prescribe and initiate the prior authorization process.

Results: We have completed staging and education visits in 32 patients. Using ADA T1D staging criteria, 21/32 (66%) patients were stage 2, 9/32 (28%) stage 1, and two patients were diagnosed stage 3. Since April 2023, we have successfully infused a full 14-day course of teplizumab-mzwv in 10 patients with stage 2 T1D. Most patients treated were adolescents and young adults (age 10-32 years, median age 17.5±17.6 years), male (n=7/10) and non-Hispanic white (n=8/10). Approximately half of treated patients have a first degree relative with T1D (n=6/10). Five patients in stage 2 progressed to symptomatic T1D and were therefore no longer eligible for treatment. Four patients declined treatment, and two are under review for treatment by their insurance carriers at this time.

Conclusions: Individuals attending Early T1D clinic tolerated complete metabolic staging per ADA guidelines. Of those meeting criteria for teplizumab-mzwv treatment, most patients wanted to pursue therapy. We successfully treated approximately half of eligible patients to date.

Disclosure

K.M. Simmons: Advisory Panel; Provention Bio, Inc. Consultant; Provention Bio, Inc. Research Support; Provention Bio, Inc., Novartis AG. Consultant; Medtronic. L. Chesshir: None. H.K. O'Donnell: None. S.C. Walker: Other Relationship; Dexcom, Inc., Insulet Corporation. A.D. Martinez: None. G.T. Alonso: Advisory Panel; MannKind Corporation. T.M. Triolo: None. P. Gottlieb: Other Relationship; IM Therapeutics. Research Support; Imcyse. Advisory Panel; Imcyse. Consultant; Juvenile Diabetes Research Foundation (JDRF). Research Support; Hemsley Charitable Trust, Novartis AG, Provention Bio, Inc., Precigen, Inc. Advisory Panel; ViaCyte, Inc. Research Support; Nova Pharmaceuticals. B.I. Frohnert: None. A. Steck: None.
725-P: TOTUM-63 (T63), a Novel Plant-Based Polyphenol-Rich Substance, Improves Glucose Homeostasis and Modulates Gut Microbiota Diversity among Adults at Increased Cardiometabolic Risk
Authors: BOUCHARD-MERCIER ANNIE , OTERO YOLANDA F. , CHAVANELLE VIVIEN , MAROIS JULIE , PILON GENEVIÈVE , VARIN THIBAULT , MITCHELL PATRICIA L. , ERIK JOHANSEN ODD , BARGETTO MAXIME , SAPONE VERONIQUE , LE JOUBIOUX FLORIAN , CAZAUBIEL MURIELLE , BARD JEAN-MARIE , PELTIER SEBASTIEN , COUTURE PATRICK , VOHL MARIE-CLAUDE , SIRVENT PASCAL , MARETTE ANDRE
Published: June 2024

Introduction: T63 has been shown to improve fasting blood glucose (FG) in individuals with prediabetes or early type 2 diabetes. However, the mechanisms underlying these effects are still unknown. We sought to assess the effects of T63 on fasting and postprandial (PP) metabolic parameters as well as on the gut microbiota.

Methods: In this 8-wk, single arm, open label, clinical trial (NCT05369585), a daily dose of 5g of T63 was given by capsules. Eligible participants had a BMI ≥27 and <40kg/m2, and either triglycerides (TG) ≥1.35mmol/L, or FG ≥5.6 and ≤6.9mmol/L, or HbA1c ≥5.6 and ≤6.4%. Blood was sampled fasting and during a 6-hour test meal for analysis of glucose homeostasis, lipids, hs-CRP, fibrinogen and incretins. Assessments were made before and after an acute intake as well as after 8 wk of supplementation. The fecal microbiota was analysed by metagenomic sequencing and the Simpson’s reciprocal index used for determination of microbial diversity.

Results: A total of 19 participants were enrolled and supplemented, (mean±SD) age 55.4±11.3 yrs, BMI 31.3±4.1kg/m2, FG 5.5±0.4mmol/L, HbA1c 5.5±0.2%, TG 1.6±0.5mmol/L, hs-CRP 3.3±2.3mg/L. Following the first acute T63 intake, PP reductions in max glucose level (p=0.03), and GIP area under the curve (AUC, p=0.01) were observed. After 8 wk of T63, significant decreases in HbA1c (to 5.3±0.3%, p=0.005), hs-CRP (to 2.5±1.8mg/L, p=0.01), fibrinogen (p=0.04) and plasma lipids (TG, total-C, non-HDL-C, LDL-C and total-C/HDL-C ratio (p<0.05 for all)) were observed, while PYY increased (p=0.02). The PP pattern at wk 8 was characterized by reductions in the AUC of both glucose (p=0.04) and insulin (p=0.009). Gut microbiota α-diversity was increased by T63 at wk 8 (p=0.003).

Conclusion: These results provide novel insights on the effects of T63 on fasting and PP glucose metabolism, inflammation and lipids, in conjunction with an increased gut microbiota diversity.

Disclosure

A. Bouchard-Mercier: Employee; Valbiotis. Y.F. Otero: Employee; Valbiotis. V. Chavanelle: Employee; Valbiotis. J. Marois: None. G. Pilon: None. T. Varin: None. P.L. Mitchell: None. O. Johansen: Employee; Nestlé Health Science. M. Bargetto: Employee; Valbiotis. V. Sapone: None. F. Le Joubioux: Employee; Valbiotis. M. Cazaubiel: Employee; Valbiotis. J. Bard: Consultant; Valbiotis. Stock/Shareholder; Valbiotis. S. Peltier: Stock/Shareholder; Valbiotis. Board Member; Valbiotis. P. Couture: None. M. Vohl: None. P. Sirvent: Board Member; Valbiotis. A. Marette: Advisory Panel; Valbiotis. Research Support; Acasti Pharma, Inc. Advisory Panel; Plexus, Amancia.
739-P: Efficacy and Safety of Tirzepatide in Overweight (OW) and Obese (OB) Patients with Type 1 Diabetes (T1D)
Authors: SNELL-BERGEON JANET K. , KAUR GURLEEN , BEATSON CHRISTIE , GARG SATISH K.
Published: June 2024

Introduction & Objective: Today, most patients with T1D in the US are OW or OB, contributing to insulin resistance and suboptimal glucose control. The only FDA approved treatment for T1D, insulin, adversely affects weight. Tirzepatide is approved for managing T2D and causes weight loss. We assessed the use of tirzepatide in OW/OB subjects with T1D.

Methods: This was a retrospective single center real-world study in 62 adult OW/OB patients with T1D who were prescribed tirzepatide and followed for one year. The control group included 37 T1D patients (computer matched) with OW or OB who were not using any weight loss medications during the same period.

Results: The mean baseline age, duration of diabetes and HbA1c were similar in the 2 groups (Table 1a), while BMI and weight were higher in cases. There were significantly larger declines in BMI and weight in cases than controls across all time points (Table 1b). HbA1c decreased in cases as early as 3 months which was sustained throughout 1-year follow-up (Table 1 b). There was no reported increase in severe hypoglycemia or diabetic ketoacidosis throughout the study duration.

Conclusions: In this pilot off-label use study, we conclude that tirzepatide facilitated an average 18.5% weight loss and improved glucose control in OW/OB patients with T1D. We strongly recommend a large prospective randomized control trial in OW/OB patients with T1D.

Disclosure

J.K. Snell-Bergeon: None. G. Kaur: None. C. Beatson: None. S.K. Garg: Research Support; Eli Lilly and Company. Advisory Panel; Medtronic. Research Support; Medtronic. Advisory Panel; Novo Nordisk. Research Support; DarioHealth Corp., Dexcom, Inc., Diasome. Advisory Panel; Roche Diabetes Care.
748-P: Tirzepatide Adjunctive Therapy in Adults with Type 1 Diabetes Using Tandem Control-IQ
Authors: KARAKUS KAGAN E. , KLEIN MATTHEW P. , AKTURK HALIS K. , SHAH VIRAL N.
Published: June 2024

Objective: Safety and efficacy of adjunct therapy with Tirzepatide, a dual agonist, in adults with type 1 diabetes (T1D) using Tandem Control-IQ automated insulin delivery system is unknown. This study investigates changes in insulin requirements and glycemic outcomes in adults with T1D over 8 months of Tirzepatide treatment.

Methods: In this single-center, observational study, we collected demographic, A1c, weight (from electronic medical records), sensor glucose and insulin dose (from t:connect) for adults with T1D who were using Tandem Control-IQ and initiated Tirzepatide adjunct therapy for clinical indications (n=11, median age 36.2, 64% female and mean BMI of 38.6 kg/m2). Data were compared from baseline and over 8 months.

Results: The insulin requirements (total, basal and bolus insulin per day) were reduced significantly within 2 months (p<0.01 for all) of Tirzepatide therapy (2.5-5 mg/week), and thereafter, there was no clinically meaningful reduction in insulin dose (Figure 1-A). The frequency of user-initiated boluses did not differ throughout the study. Despite significant reduction in insulin dose, A1c (-0.46%), weight (mean weight reduction -10 kg) and significant improvement in time in range, there was no increase in time below 70 mg/dL (Figure 1-B).

Conclusion: Tirzepatide adjunct to Tandem Control-IQ improved glycemic and metabolic outcomes without increasing hypoglycemia.

Disclosure

K.E. Karakus: None. M.P. Klein: None. H.K. Akturk: Consultant; Medtronic. Research Support; Medtronic. Consultant; Dexcom, Inc. Research Support; MannKind Corporation, Tandem Diabetes Care, Inc. Consultant; Tandem Diabetes Care, Inc. V.N. Shah: Consultant; Dexcom, Inc., Insulet Corporation. Research Support; Insulet Corporation. Advisory Panel; Novo Nordisk. Research Support; Novo Nordisk. Advisory Panel; Sanofi, Medscape. Consultant; embecta, Tandem Diabetes Care, Inc.
758-P: PROs in Tirzepatide-Treated Adults with Type 2 Diabetes in SURPASS-1 to -6 by Age, Gender, BMI, and Weight Loss
Authors: BOYE KRISTINA , THIEU VIVIAN , DONG WENXIU , WILLIAMSON SUZANNE E. , SAPIN HELENE
Published: June 2024

Tirzepatide treatment statistically and meaningfully reduced HbA1c, and substantially reduced weight, in adults with T2D in the Phase 3 SURPASS studies. PROs in adults treated with tirzepatide 5, 10, or 15 mg in SURPASS-1 to -6 were explored by age, gender, BMI, and weight loss.

Data from all SURPASS-1 to -6 tirzepatide-treated adults were pooled, regardless of dose. Weight-related and health status PRO measures at baseline and endpoint - Ability to Perform Physical Activities of Daily Living (APPADL), Impact of Weight on Self-Perceptions (IW-SP), EQ VAS - were analyzed in participants grouped by age and BMI category at baseline, gender, and weight loss category achieved at endpoint. Analyses used ANCOVA models adjusted for baseline clinical characteristics; ceiling effects were explored in subgroup analyses.

In main and subgroup analyses, lower vs. higher baseline age group was associated with larger improvements in APPADL and EQ VAS scores but smaller improvements in IW-SP score in tirzepatide-treated adults. Lower vs. higher baseline BMI group and greater vs. lesser weight loss group at endpoint were associated with larger improvements across all PRO measures. Improvement in IW-SP score was greater for males vs. females, with no significant difference for other PROs.

Age, BMI, weight loss, and, to a lesser extent, gender all impacted PROs in tirzepatide-treated adults with T2D in the Phase 3 SURPASS studies.

Disclosure

K. Boye: Employee; Eli Lilly and Company. V. Thieu: Employee; Eli Lilly and Company. W. Dong: None. S.E. Williamson: Consultant; Eli Lilly and Company, Takeda Pharmaceutical Company Limited, GlaxoSmithKline plc, Novo Nordisk, Lundbeck. H. Sapin: None.
793-P: Biased GLP-1 Analog Ecnoglutide (XW003) Has Improved Efficacy Relative to Unbiased Peptides
Authors: WANJUN GUO , ZOU HAIXIA , ZHU ZHIYI , LI YAO , NING JING , ZHENG QING , LI YAN , ZHU RUI , JONES CATHERINE L. , FENAUX MARTIJN , XU SUSAN , JUNAIDI MOHAMMED K.
Published: June 2024

Introduction & Objective: Ecnoglutide (XW003) is a cAMP-biased GLP-1 analog being developed for the treatment of type 2 diabetes mellitus (T2DM) and obesity. The objective of this analysis was to compare the preclinical and clinical efficacy of ecnoglutide to unbiased GLP-1 peptides.

Methods: Ecnoglutide was assessed for cAMP production and β-arrestin recruitment in GLP-1R reporter cell lines. Glucose control was tested in db/db mice administered a single subcutaneous dose of GLP-1 analogs, with blood glucose recorded for 144 h. Body weight and insulin response were evaluated in db/db mice dosed with once daily injections of GLP-1 analogs for 42 days. A 20 week Phase 2 study was conducted in 145 patients with T2DM (ecnoglutide 0.4, 0.8, or 1.2 mg). Comparator clinical results were obtained from published reports.

Results: In vitro, cAMP induction was similar for ecnoglutide and semaglutide. EC50 values for β-arrestin recruitment were also similar, however, maximum recruitment and receptor internalization were lower for ecnoglutide. In mice, a single dose of ecnoglutide led to more sustainable decreases in blood glucose compared to semaglutide, extending glucose suppression by up to 48 h. In mice, ecnoglutide also significantly improved weight control and induced higher levels of insulin versus semaglutide. The increased preclinical potency of ecnoglutide translated into clinical efficacy. T2DM patients administered up to 1.2 mg ecnoglutide for 20 weeks had a -2.39% reduction in HbA1c. This compared to -1.14% reported for liraglutide (1.8 mg at 52 weeks), -1.55% to -1.86% for semaglutide (1.0 mg at 30-40 weeks), and -1.46% for dulaglutide (1.5 mg at 26 weeks). Furthermore, 1.2 mg ecnoglutide showed comparable HbA1c reductions to the biased dual GIP/GLP-1 receptor agonist, tirzepatide (15 mg), which reduced HbA1c by -2.30% at 40 weeks.

Conclusion: Bias for the cAMP pathway results in sustained signaling that correlates with increased clinical efficacy compared to unbiased GLP-1 analogs.

Disclosure

G. Wanjun: Employee; Sciwind Biosciences. H. Zou: Employee; Sciwind Biosciences. Z. Zhu: None. Y. Li: Employee; Sciwind Biosciences. J. Ning: None. Q. Zheng: Employee; Sciwind Biosciences. Y. Li: Employee; Sciwind Biosciences. R. Zhu: Employee; Sciwind Biosciences. C.L. Jones: Employee; Sciwind Biosciences. M. Fenaux: None. S. Xu: None. M.K. Junaidi: None.

Funding

Sciwind Biosciences
819-P: A Novel Premix Insulin GZR101 for Diabetes Management
Authors: CHEN WEI , XING WANCAI , ZHANG YINING , HE ANSHUN , GAO JING , SHI QIMIN , XUE FANGKAI , WANG YONGCHUN , ZHANG JUN , YU DONGLI , CUI CHENG , XIE TIAN , GAN ZHONGRU
Published: June 2024

Introduction: Inadequate glycemic control in patients with premix insulin regimen is often due to the short half-life and pronounced peak-to-trough ratio of basal insulin. This necessitates the development of a premix insulin containing basal insulins with an extended half-life and steady pharmacokinetic (PK) profile.

Objective: This study evaluated and characterized GZR33, an ultra-long half-life basal insulin, and GZR101 which is composed by GZR33 and insulin aspart.

Methods: The binding affinity of GZR33 to the human insulin receptor (hIR) was analyzed in vitro using surface plasmon resonance. IR activation was examined in CHO cells in the presence and absence of human serum albumin (HSA). Adipogenesis was measured in 3T3L1 MBX cells. Potency was tested in vivo in streptozotocin-induced T1DM rats and db/db T2DM mice, using insulin degludec (iDeg) and iDegAsp as controls. PK studies were assessed in Sprague-Dawley rats.

Results: GZR33 was constructed by linking a C22 fatty diacid side chain to desB30 human insulin via a 6×OEG linker. GZR33 exhibited strong hIRA and hIRB binding (dissociation constants: 2.86E-6 M and 1.28E-6 M). It activated IRA and IRB with EC50 of 370.13 ± 94.86 nM and 477.48 ± 64.28 nM, respectively, in 0.5% HSA, and induced adipogenesis with an EC50 of 2.45 ± 0.81 nM. PK studies showed a dose-dependent increase in maximum concentration and exposure, with a T½ of 5.45 h for GZR33 (2.3 h for iDeg). In T1DM rats and T2DM mice, GZR33 outperformed iDeg in reducing HbA1c and FBG, demonstrating a potency at least three-fold higher than iDeg. Additionally, GZR101's glucose-lowering effect was proportional to the GZR33 dosage in diabetic models.

Conclusion: Traditional basal insulins display a 24-hour glucose-lowering effect with noticeable peaks, leading to fluctuating blood glucose in patients. However, a basal insulin with over 3-day longevity and once-daily dosing, like GZR33, can achieve a nearly peak-less PK profile at steady-state. Consequently, GZR101 emerges as a promising once-daily premix insulin candidate.

Disclosure

W. Chen: None. W. Xing: None. Y. Zhang: None. A. He: None. J. Gao: None. Q. Shi: None. F. Xue: None. Y. Wang: None. J. Zhang: None. D. Yu: None. C. Cui: None. T. Xie: None. Z. Gan: None.
822-P: Influence of the Functionally Selective Insulin Analog NNC-965 vs. Insulin Glargine (IGla) on Cardiac Structure and Function
Authors: JORDAN JENS , GERLACH DARIUS , HARALDSSON HENRIK , HEISE TIM , HERBRAND THERESA , LYBY KARSTEN , TANK JENS , NISHIMURA ERICA , PLUM-MOERSCHEL LEONA , THÓRISDÓTTIR ÓLÖF , JOHANSSON LARS
Published: June 2024

NNC-965 selectively stimulates insulin receptors with greater Akt and less MAPK activation, which improved vascular function, insulin sensitivity (IS), and weight gain versus conventional basal insulin in diabetic rats. We hypothesized that improved vascular function on NNC-965 unloads the heart thereby improving left ventricular (LV) structure and function. We compared the effects of NNC-965 and IGla on flow-mediated dilation (FMD), IS, body weight, vascular function and cardiac function/structure (assessed by MRI) in 86 people with type 2 diabetes on basal insulin ± oral agents in a randomized, double-blind study over 26 weeks. NNC-965 improved FMD and IS versus IGla (table). Glycemic control and liver fat responded similarly to both insulins, but body weight and fat mass increased more with NNC-965. LV ejection fraction and LV stroke volume slightly decreased with NNC-965 and increased with IGla, but the differences were not significant. We observed no clinically relevant changes in LV mass, LV enddiastolic and endsystolic volume by either treatment.

In conclusion, NNC-965 showed some characteristics of a functionally selective insulin but increased body weight. The observed improvement in FMD might lead to long-term reductions in cardiovascular risk; however, studies with longer treatment duration may be needed to assess effects on cardiac function and structure.

Disclosure

J. Jordan: Research Support; Novo Nordisk A/S, Boehringer-Ingelheim. Speaker's Bureau; Menarini. Advisory Panel; Theravance. Stock/Shareholder; Eternygen. D. Gerlach: None. H. Haraldsson: Employee; Antaros Medical. T. Heise: Research Support; ADOCIA, AstraZeneca, Biocon, Crinetics Pharmaceuticals, Inc., Eli Lilly and Company, Genova, Novo Nordisk A/S. Consultant; Gan&Lee Pharmaceuticals. Speaker's Bureau; Eli Lilly and Company. Research Support; Altimmune Inc., Sanofi, Zealand Pharma A/S, BIOTON, Civica Foundation, Enyo Pharma, Gan&Lee Pharmaceuticals, Nanexa AB, SamChunDang Pharm. Co. T. Herbrand: None. K. Lyby: Employee; Novo Nordisk A/S. Stock/Shareholder; Novo Nordisk A/S. J. Tank: None. E. Nishimura: Employee; Novo Nordisk A/S. Stock/Shareholder; Novo Nordisk A/S. L. Plum-Moerschel: Other Relationship; Novo Nordisk A/S, Eli Lilly and Company, Zealand Pharma A/S, Betagenon, Nanexa, Neodyne, Biocon, Spiden, BIOTON, Gan & Lee Pharmaceuticals. Ó. Thórisdóttir: Employee; Novo Nordisk A/S. Stock/Shareholder; Novo Nordisk A/S. L. Johansson: Stock/Shareholder; Antaros Medical. Employee; Antaros Medical.