bluuebunny/crossref_metadata_2025 huggingface dataset:
637-P: Longitudinal Metabolic and Microbial Responses to Habitual Dietary Changes in Individuals at Risk for Type 2 Diabetes
Authors: PARK HEYJUN , SHEN XIAOTAO , PERELMAN DALIA , BERRY PRANAV , BATTERSBY RACHEL , CELLI ALESSANDRA , BEJIKIAN CAROLINE , SNYDER MICHAEL
Published: June 2024

Introduction & Objective: Despite normal glucose levels, individuals with insulin resistance (IR) are more likely to develop Type 2 diabetes as compared to those with insulin sensitivity (IS). Moreover, the gut microbiome changes in response to diet and is associated with glucose regulation. Nonetheless, it is unclear whether and how metabolic and microbial responses to longitudinal changes in habitual diet would differ by one’s insulin resistance status.

Methods: We utilized biological samples obtained from a cohort study where 71 healthy adults (mean 53.4y) were longitudinally followed every quarter for one year. At each visit, participants completed dietary assessments using food records. They also provided blood and stool samples for plasma metabolomics and gut microbiome analyses using untargeted liquid chromatography-mass spectrometry and 16S rRNA sequencing, respectively. Furthermore, the insulin suppression test determined the insulin resistance status of the participants.

Results: We found that 22 nutrients, including total fiber and soluble fiber, significantly changed over the study period and/or differed between IS and IR individuals (p<0.05). Notably, our correlation analysis showed fewer and weaker associations between longitudinal changes in nutrients and metabolites in participants with IR than those with IS (q<0.05). The pathway enrichment analysis further confirmed that dietary change-related metabolites were associated with several metabolic pathways in IS participants, which were not as observed in those with IR. The pathways include steroid hormone biosynthesis, sphingolipid metabolism, and pyrimidine metabolism. Similarly, the numbers and degree of correlations between changes in nutrients and gut microbiome were reduced in IR compared to IS.

Conclusion: People with insulin resistance might need careful dietary interventions likely due to compromised nutrient signaling related to microbial and metabolic processes.

Disclosure

H. Park: None. X. Shen: None. D. Perelman: None. P. Berry: None. R. Battersby: None. A. Celli: None. C. Bejikian: None. M. Snyder: Stock/Shareholder; January, Inc., Personalis, Inc, Iollo, Qbio, RTHM, Enovone, Marble Therpeutics, Fodsel, Mirvie. Advisory Panel; Applied Cognition.

Funding

National Institutes of Health (NIH 5R01AT01023204, 5RM1HG00773509, U54DK102556, R01DK110186-03, R01HG008164, S10OD020141, UL1 TR001085, P30DK116074)
66-PUB: Remission Patterns and Associated Factors for Hypertension (HT) and Dyslipidemia (DL) Accompanied by Remission of Type 2 Diabetes Mellitus (DM)—Comprehensive Analysis
Authors: MON KHIN LAY , FUJIHARA KAZUYA , FERREIRA EFREM D. , GOTO WAKANA , YAMASHITA YUKO , KODAMA SATORU , SONE HIROHITO , STUDY GROUP JDDM
Published: June 2024

That DM coexists with HT and/or DL is well known. To clarify this association, using a specialist clinic database from 1989 to 2022, we analyzed data on 2,630 Japanese with DM at baseline aged ≥18 years and HbA1c ≥6.5% and/or glucose-lowering drug prescription. Factors related to remissions of HT and DL in DM patients also in remission during follow-up were studied. DM remission was defined as HbA1c <6.5% for 3 months after cessation of a glucose-lowering drug. Remission of HT was defined as SBP <130 mmHg and that of DL as HDLC and non-HDLC of ≥40 mg/dL and <150 mg/dL, respectively without any drug. In addition to DM remission, 495 (26%), 419 (26%), and 96 (8%) achieved remissions of HT, DL and both HT and DL, respectively (Fig). Baseline HbA1c was positively associated with HT or DL remission (p for trends= 0.02, <0.01) along with DM remission. Baseline body mass (BMI) index was inversely associated with all (HT, DL and DM) remissions (p for trends ≤0.01). Compared with BMI changes from -2.9 to 2.9%, BMI reductions were significantly associated with all remissions (p for trend ≤0.01). About 25% of participants achieved either HT or DL remission while only 8% achieved remission of both. Although BMI change was a common factor in all remissions, remission of HT in people with DM requires physiological approaches differing from weight loss.

Disclosure

L. Khin: None. K. Fujihara: None. E.D. Ferreira: None. W. Goto: None. Y. Yamashita: None. S. Kodama: None. H. Sone: Research Support; Novo Nordisk, Astellas Pharma Inc., Kowa Company, Ltd., Kyowa Kirin Co., Ltd., Eisai Inc., Sumitomo Dainippon Pharma Co., Ltd.
672-P: Feasibility of Caregiver Diabetes Distress Screening in Routine Clinical Care of Youth with Type 1 Diabetes
Authors: ALKHATIB EINAS , CLARY LAUREN , EDDINGTON ANGELICA , STREISAND RANDI , MAJIDI SHIDEH
Published: June 2024

Introduction: Caregiver diabetes distress (DD) consists of sadness or burn out; 1/3 of parents report severe distress up to 1-4y after youth T1D diagnoses. PAID-PR (Problem Areas in Diabetes Survey - Parent Revised) assesses DD in research; however, less is known about its clinical utility. We aimed to identify the feasibility of implementing PAID-PR screening at a diverse academic pediatric diabetes center during routine clinic visits.

Methods: The PAID-PR was offered in English to caregivers of all T1D patients, by the front desk at appt. check-in, or via RedCap before telehealth visits or at local sites. Adult psychosocial resources were provided to all, regardless of score. Forms were scored after visits; scores >80 were referred to Diabetes Psychologists.

Results: A total of 391 caregivers completed the PAID-PR; response rates were highest in person (>90%), vs. RedCap (25%). In total, 27% (n=107) scored >56 (DD). Of those with DD, 21% (n=23) scored >80 and were referred to psychology. Demographics are in Table 1. PAID-PR correlated to A1c (p=0.038) and inversely to child age (p=0.014). Of those with severe distress, 30% are Hispanic/Latino.

Discussion: Clinic caregiver DD screening was feasible; however, limitations were scoring/administration time constraints; we plan to screen annually. Since the PAID-PR was in English, some caregivers with DD were missed. Future directions are screening in more languages.

Disclosure

E. Alkhatib: None. L. Clary: None. A. Eddington: None. R. Streisand: None. S. Majidi: Other Relationship; Sanofi.
677-P: Diabetes Distress, Strengths, and Glycemic Outcomes in Young Adults (YA) with Type 1 Diabetes (T1D) Transferring to Adult Care
Authors: CAMEY STEPHANIE , CARREON SAMANTHA A. , MINARD CHARLES G. , LYONS SARAH , STREISAND RANDI , TANG TRICIA S. , MCKAY SIRIPOOM , ANDERSON-THOMAS BARBARA J. , DEVARAJ SRIDEVI , HILLIARD MARISA E.
Published: June 2024

Introduction & Objective: Transfer from pediatric to adult care is challenging and YA with T1D are at risk for suboptimal outcomes. Protective factors are less studied during this vulnerable period. We aimed to explore associations between psychosocial factors and HbA1c as YA with T1D left pediatric care.

Methods: At baseline of an RCT, n=100 YA (Mean age=19.9±1.3 yrs, HbA1c=8.8±2.0%, 56% pump, 76% CGM) self-reported demographic/clinical variables and completed measures of diabetes strengths and diabetes distress. HbA1c was from electronic health records or dried blood spot. Multiple regressions evaluated associations between diabetes strengths, diabetes distress, and HbA1c, controlling for covariates.

Results: Domains of diabetes distress (management r=0.51; powerlessness r=0.19) and strengths (diabetes-related confidence r= -0.25) significantly correlated with HbA1c. The full regression model (Table) explained 39% of variance in HbA1c; public insurance, non-Hispanic ethnicity, no pump use, and higher diabetes distress significantly predicted higher HbA1c.

Conclusion: When leaving pediatrics, diabetes distress appears particularly relevant to glycemic outcomes, outweighing diabetes strengths. Addressing diabetes distress and supporting device use in culturally-informed ways may help improve glycemic outcomes as YA with T1D transfer to adult care.

Disclosure

S. Camey: None. S.A. Carreon: None. C.G. Minard: None. S. Lyons: None. R. Streisand: None. T.S. Tang: None. S. Mckay: None. B.J. Anderson-Thomas: None. S. Devaraj: None. M.E. Hilliard: None.

Funding

National Institutes of Diabetes and Digestive and Kidney Disease (1R01DK119246); National Institute of Diabetes and Digestive and Kidney Disease (K26 DK138332)
679-P: "COVID Is Not My Concern; Diabetes Is"—Understanding COVID-19 Vaccine Hesitancy among Underserved Adults with Diabetes Using the 3 Cs Model
Authors: MAIZEL JENNIFER , BAUTISTA TAIS A. , PRUDE ISA N. , FILIPP STEPHANIE L. , HECHAVARRIA MELANIE , HALLER MICHAEL J. , WESTEN SARAH , DIXON BRITTNEY , MAAHS DAVID M. , LAL RAYHAN , ADDALA ANANTA , WALKER ASHBY F.
Published: June 2024

Introduction & Objective: People with diabetes have increased risks for severe COVID-19 illness and are a priority group for vaccination. This study aimed to determine reasons for COVID-19 vaccine hesitancy among underserved adults with diabetes.

Methods: A survey of adults with insulin-requiring diabetes (n=450) receiving care at federally qualified health centers in CA and FL examined COVID-19 vaccine uptake and reasons for hesitancy. Surveys were completed from Nov. 2021-Jul. 2022. This study analyzed open-ended responses to a question assessing why patients were not vaccinated for COVID-19. Out of 80 patients who reported being unvaccinated, 67 answered the open-ended question (mean age=46.6 ± 15.1 years, 65.7% female). A thematic analysis using the 3 Cs of Vaccine Hesitancy Model (complacency, confidence, and convenience reasons) was used. Reasons for hesitancy that did not fit the 3 Cs were coded as demographic or unspecific. Descriptive statistics (n, %) determined the frequency of reasons reported; some patients noted multiple reasons.

Results: Patients reported 80 reasons for vaccine hesitancy. Most were lack of confidence (n=31, 38.8%), e.g., misinformation, distrust in research, and fears about vaccine efficacy and safety, or were unspecific (n=29, 36.3%), e.g., “I don’t want it”. Convenience reasons (n=11, 13.8%) included scheduling, eligibility, and health issues, e.g., vaccine allergies or surgeries. Complacency reasons (n=7, 8.8%) included low concern about COVID-19 compared to diabetes and low COVID-19 exposure due to limited social outings. Demographic reasons (n=2, 2.5%) were due to religious views.

Conclusion: COVID-19 vaccine hesitancy among underserved adults with diabetes can be attributed to various factors e.g., distrust in research, inconvenience, higher concern about diabetes management, and religious views. Multilevel interventions are needed to reduce vaccine hesitancy among this population.

Disclosure

J. Maizel: None. T.A. Bautista: None. I.N. Prude: None. S.L. Filipp: None. M. Hechavarria: None. M.J. Haller: Consultant; Sanofi. Advisory Panel; SAB Biotherapeutics, Inc. Consultant; MannKind Corporation. S. Westen: None. B. Dixon: None. D.M. Maahs: Advisory Panel; Medtronic. Consultant; Abbott, LifeScan Diabetes Institute, Sanofi, Provention Bio, Inc., Bayer Inc., Kriya Therapeutics, BioSpex. R. Lal: Consultant; Abbott, Adaptyx Biosciences, Biolinq, Capillary Biomedical, Inc., Deep Valley Labs, Gluroo, PhysioLogic Devices, Portal Insulin, Tidepool. Advisory Panel; Lilly Diabetes. A. Addala: None. A.F. Walker: None.

Funding

The Leona M. and Harry B. Helmsley Charitable Trust (G-2005-03934)
682-P: The Diabetes Management Questionnaire (DMQ) Is a Valid Measure of Self-Management in Emerging Adults (EAs) with Type 1 Diabetes (T1D)
Authors: VITALE REBECCA J. , TINSLEY LIANE J. , VOLKENING LISA K. , GARVEY KATHARINE , LAFFEL LORI M.
Published: June 2024

Aim: EAs with T1D may benefit from innovative diabetes treatments, given their challenges in meeting glycemic targets. Thus, a measure of self-management responsive to newer regimens is important for this population. In this study, performance of the DMQ, initially validated in 8-18 year olds, was evaluated in EAs.

Methods: EAs (ages 18-25) with T1D completed an online study, providing demographic and diabetes management data along with survey responses. Surveys included DMQ, RISQ (measure of self-care readiness), and PAID-EA (measure of diabetes distress in EAs). The 20-item DMQ assesses self-care over the past month with response options on a 5-point Likert scale. Total scores range from 0-100; higher scores indicate greater self-management. We assessed internal consistency (Cronbach’s alpha, item-to-total correlations) and concurrent validity of the DMQ.

Results: The sample of 141 EAs (30% male, 61% female, 9% trans/non-binary) had mean age 21.5 ± 2.2 years and T1D duration 12.2 ± 5.4 years; 84% were non-Hispanic white and 57% were students. Self-reported A1c was 7.3 ± 0.9%; 93% used CGM, 79% used a pump, and 68% used AID. DMQ Cronbach’s α was 0.86. Item-to-total correlations were all >0.2 aside from 1 item regarding ketone monitoring. DMQ scores were inversely correlated with A1c (r=-.26, p<.01), and diabetes distress (PAID-EA, r=-.26, p<.01), and positively correlated with CGM TIR (r=.22, p=.02) and self-care readiness (RISQ, r=.36, p<.01). DMQ did not correlate with age (p=.27) or T1D duration (p=.19). DMQ-EA scores did not differ by pump use (p=.99) or gender (p=.05), but scores were higher among CGM users than non-users (74 vs. 60, p<.01).

Conclusion: The DMQ, completed in <5 minutes, demonstrated strong psychometric properties as a measure of self-care in EAs with T1D. An up-to-date adherence survey that performs well in emerging adults using advanced diabetes technologies offers measurement opportunities in research and clinical settings.

Disclosure

R.J. Vitale: None. L.J. Tinsley: None. L.K. Volkening: 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 (T32DK007529NIH P30DK036836); Iacocca Foundation Senior Postdoctoral Fellowship
69-OR: Preclinical Studies Indicate That Insparin Is a New Class of Antidiabetes Agent
Authors: DHURANDHAR NIKHIL , HEGDE VIJAY
Published: June 2024

Introduction and Objectives: We observed that human adenovirus-36 (Ad36) infection improves glycemic control in mice via the product of its E4orf1 gene (termed Insparin). Our objective was to determine Insparin’s potential as an anti-diabetic agent for humans. We conducted a series of studies over the years as described below.

Methods: 1) We used various cell lines to identify the molecular pathway underlying the glycemic effect of Insparin. 2) As a proof of concept, transgenic or vector-mediated delivery of Insparin was used in various animal models of hyperglycemia to test efficacy of glycemic improvement and safety. 3) The FDA has approved drugs that are delivered via nanoparticles. For practical therapeutic use of Insparin in humans, efficacy of nanoparticle-based delivery of Insparin was tested in animal models.

Results: 1) Insparin upregulates glucose uptake in fat cells and skeletal muscle cells, in insulin independent manner, and reduces glucose release by hepatocytes. In a cell, via its PDF protein binding motif, Insparin binds with Drosophila Disk Large Protein (DLG1), activates Ras and in turn upregulates Phosphatidyl inositol kinase (PI3K). Upregulation of PI3K pathway leads to activation of downstream molecular partners, resulting in membrane translocation of Glucose transporter 4 and uptake of glucose. 2) High fat fed mice inducibly expressing Insparin in adipose tissue, or receiving viral vector-mediated Insparin, show lower endogenous insulin secretion and yet, faster clearance of glucose load from the blood, and reduced fat accumulation and inflammation in the liver. No overt signs of adverse effects are noted. 3) Nanoparticle mediated delivery of Insparin improves glucose clearance and reduces HbA1c levels in high fat fed mice.

Conclusion: Preclinical studies show that Insparin is a new class of agent that acts through DLG1 to improve diabetes or fatty liver and spares endogenous insulin. Clinical studies are needed to test safety and then efficacy of Insparin.

Disclosure

N. Dhurandhar: Advisory Panel; Medifast, Inc. Research Support; Insparin Inc, Borealis Foods, National Cattleman's Beef Association, Novo Nordisk. V. Hegde: Research Support; Insparin Therapeutics.

Funding

Insparin Therapeutics
732-P: Relationships among Food Addiction and Glycemic Control in Patients with Type 2 Diabetes Mellitus and Healthy Controls
Authors: SMELTZER JOLENE T. , KUMAR RAJESH , FONG TIM W. , WOO MARY A. , CHOI SARAH E.
Published: June 2024

Introduction/Objective: Unhealthy food behaviors (such as food addiction [FA]) are associated with poor glycemic control and health outcomes in type 2 diabetes (T2DM). However, little is known about the associations of FA with glycemic status in T2DM. This study examined the relationships between FA and glycemic outcome (A1c) in persons with T2DM compared to healthy controls.

Methods: Sixty-four participants (32 T2DM, 32 healthy controls) between the ages 40-65 years completed the Yale Food Addiction Scale 2.0 (YFAS) and A1c was measured by finger stick blood test. Spearman’s rho correlation analyses of YFAS (FA diagnoses, total score, and symptomatology) and A1c variables were conducted.

Results: No group differences were found in the prevalence of FA diagnosis, YFAS 2.0 total scores between the groups. There were positive correlations/higher A1c (poorer glycemic control) between two FA symptomatologies (higher food tolerance; food use in physically hazardous situations) (r= 0.254, r= 0.417, P <0.05).

Conclusion: In this study, persons with food tolerance and/or consumed foods during hazardous situations had poorer glycemic outcomes. Screening people with T2DM with a subset of questions from YFAS 2.0 that are linked to A1c could identify FA behaviors that may impact glycemic management and help to identify potential interventions which could optimize T2DM care and diet self-management and eventually improve outcomes in individuals with T2DM.

Disclosure

J.T. Smeltzer: None. R. Kumar: None. T.W. Fong: None. M.A. Woo: None. S.E. Choi: None.

Funding

National Institutes of Health (1R01 NR017190-01)
742-P: A Phase 3 Evaluation of cAMP Signaling Biased GLP-1 Analog Ecnoglutide (XW003) in Adults with Type 2 Diabetes
Authors: ZHU DALONG , WANG WEIMIN , TONG GUOYU , MA JIANHUA , WEN BINHONG , ZHENG XIN , SHI BIMIN , PANG SHUGUANG , BING SHAOHUI , ZHENG QING , LEI GUAN , JIANG FEIFEI , LIU XINGQUAN , BU YUE , NING JING , ZHU ZHIYI , YANG LIU , YANG MING , FENAUX MARTIJN , JUNAIDI MOHAMMED K. , XU SUSAN
Published: June 2024

Introduction & Objective: Ecnoglutide (XW003) is a cAMP signaling biased GLP-1 analog being developed for the treatment of type 2 diabetes mellitus (T2DM) and obesity. The primary objective of this study was to evaluate the efficacy of ecnoglutide administered for 24 weeks in adults with T2DM.

Methods: We conducted a Phase 3 randomized, double-blind, placebo-controlled study of ecnoglutide, enrolling 211 adults with T2DM at 33 sites in China. Participants were randomized to receive 0.6 or 1.2 mg ecnoglutide or placebo as once weekly injections for 24 weeks, including dose escalation. All participants then received ecnoglutide (0.6 or 1.2 mg) for a total duration of 52 weeks. Change in mean HbA1c, body weight, and BMI, as well as safety and tolerability were evaluated.

Results: At baseline, participants had mean HbA1c of 8.54, 8.51, and 8.51% and BMI of 27.2, 26.4, and 27.2 kg/m2, for ecnoglutide 0.6, 1.2 mg, and placebo groups, respectively. After 24 weeks, participants receiving ecnoglutide achieved significant HbA1c reductions of 1.96 to 2.43% from baseline (P≤0.0003 for both cohorts vs placebo). At 24 weeks, 76.1% of participants receiving 1.2 mg ecnoglutide achieved HbA1c ≤6.5%, 35.2% had HbA1c <5.7%, and 43.7% had body weight reductions ≥5% from baseline. Ecnoglutide was safe and well tolerated. The proportion of participants reporting any adverse event (AE) ranged from 77.5 to 78.3% for ecnoglutide groups and 60.6% for placebo. Four (2.9%) treatment-related ≥Grade 3 AEs and one (0.7%) treatment-related serious AE occurred in the ecnoglutide groups. One participant from each cohort discontinued due to an AE. The most frequently reported AEs were decreased appetite, diarrhea, and nausea, which were mostly mild to moderate and transient.

Conclusion: Ecnoglutide resulted in robust HbA1c declines of up to 2.43% from baseline after 24 weeks of treatment in adults with T2DM, with up to 35.2% of participants reaching normoglycemia (HbA1c <5.7%) and 43.7% with weight reductions ≥5%.

Disclosure

D. Zhu: None. W. Wang: None. G. Tong: None. J. Ma: None. B. Wen: None. X. Zheng: None. B. Shi: None. S. Pang: None. S. Bing: Employee; Sciwind Biosciences, Keymed Biosciences. Q. Zheng: Employee; Sciwind Biosciences. G. Lei: None. F. Jiang: Employee; Sciwind Biosciences, PrimeGene Biosciences. X. Liu: None. Y. Bu: None. J. Ning: None. Z. Zhu: None. L. Yang: Employee; Sciwind Biosciences. M. Yang: Employee; Sciwind Biosciences. M. Fenaux: None. M.K. Junaidi: None. S. Xu: None.

Funding

Sciwind Biosciences
77-OR: Time in Range Is Associated with Glucagon/C-Peptide Index Ratio in Type 2 Diabetes Patients
Authors: KAMIGISHI MIKI , CHUJO DAISUKE , TAKIKAWA AKIKO , INAGAWA SHINYA , ENKAKU ASAKO , OHGAKU SEIICHIRO , SATO ATSUSHI , MATSUKOSHI SHINNOSUKE , HONOKI HISAE , FUJISAKA SHIHO , TOBE KAZUYUKI
Published: June 2024

Introduction & Objective: Paradoxical increase of postprandial glucagon is considered to be a factor inducing hyperglycemia in type 2 diabetes (T2D). Although continuous glucose monitoring (CGM) is often used to evaluate glycemic control in T2D patients, no studies on the association between glycemic stability and functional balance of pancreatic alpha to beta cells have been reported. We aimed to investigate the association between CGM data and the ratio of glucagon to insulin secretion.

Methods: We recruited 62 T2D patients who were admitted to our hospital, and patients with <45 ml/min/1.73 m2 of eGFR were excluded. We analyzed the data obtained from CGM, including time in range (TIR), time below range (TBR), time above range (TAR), average glucose (AVG), and standard deviation of glucose (SD), and the ratio of plasma glucagon level to C-peptide index (G-CPIR) before and after meal tolerance test or other metabolic factors.

Results: Postprandial G-CPIR was inversely correlated with TIR (r = -0.230, P = 0.009), correlated with TAR (r = 0.234, P = 0.014), and AVG (r = 0.251, P = 0.006). Upon comparing the CGM data between the group with high postprandial G-CPIR (HG group) and low G-CPIR (LG group), divided using the median values, TIR was significantly lower (62.4±21.5 vs. 78.5±18.8, P = 0.0053), AVG (166.7±33.5 vs. 145.5±27.9, P = 0.0153) and SD (46.2±14.3 vs. 38.2±11.8, P = 0.0310) were higher than those in LG group. Body fat mass was inversely correlated with SD (r = -0.448, P = 0.014), and subcutaneous fat area (SFA) and visceral fat area (VFA) were correlated with TIR (SFA: r = 0.339, P = 0.006, VFA: r = 0.310, P = 0.032), inversely correlated with TAR (SFA: r = -0.326, P = 0.010, VFA: r = -0.298, P = 0.040) and SD (SFA: r = -0.411, P = 0.001, VFA: r = -0.454, P = 0.001).

Conclusion: Our study suggests that CGM indicators, including TIR, are associated with the functional balance of pancreatic alpha to beta cells and body fat mass.

Disclosure

M. Kamigishi: None. D. Chujo: Research Support; Kyowa Kirin Co., Ltd. A. Takikawa: None. S. Inagawa: None. A. Enkaku: None. S. Ohgaku: None. A. Sato: None. S. Matsukoshi: None. H. Honoki: None. S. Fujisaka: None. K. Tobe: None.
8-OR: Longitudinal Patterns of Heterogeneity in Metabolic Decompensation among Diabetes Prevention Program Outcomes Study (DPPOS) Participants over 20 Years
Authors: KOBAYASHI EMILY , LINDEN NATHANIEL , EDELSTEIN SHARON , TEMPROSA MARINELLA , RANGAMANI PADMINI , MAJITHIA AMIT R. , DIABETES PREVENTION PROGRAM RESEARCH GROUP THE
Published: June 2024

Introduction & Objective: Type 2 Diabetes (T2D) complications cause morbidity and mortality, but occur heterogeneously among those at risk. While some individuals maintain stable health over time, others decompensate. Using data from the DPPOS, this study aimed to identify unbiased, data driven subgroups of adults at risk for T2D with heterogeneous metabolic trajectories and clinical outcomes over time.

Methods: Data from 1736 DPP participants over 39 semi-annual visits with repeated clinical parameters (glycemia, insulin, lipids, body mass index (BMI), waist circumference, blood pressure (BP), microalbuminuria (MA) and eGFR) were analyzed. A 3-dimensional tensor of individuals x clinical parameters x visits was constructed. Nonnegative tensor decomposition was performed and the resulting factors were clustered using K-means. Cohesion and separation were computed to select an optimal number of clusters. Cumulative incidence of T2D and kidney dysfunction (eGFR < 60 mL/min) were tabulated for each cluster.

Results: Nine longitudinal clusters of varying sizes were identified. One cluster represented a healthy group with stable clinical parameters (n=556). Kidney dysfunction was found in two clusters with differing patterns and trajectories: 1) slowly declining eGFR without MA or T2D (n=198), 2) MA, elevated BP and delayed eGFR decline (n=138). Other clusters segregated by patterns of glycemia and insulin resistance (IR) ranging from stable IR, glycemia and elevated BMI (n=253), to rapidly accelerating IR, dysglycemia and T2D (n=34).

Conclusion: Temporal trajectories of clinical parameters revealed marked heterogeneity in metabolic decompensation over time for DPPOS participants. A minority had accelerated metabolic and renal decompensation, important groups to target for early intervention. These groups also form the basis for novel biomarker discovery efforts to improve prediction of future complications.

Disclosure

E. Kobayashi: None. N. Linden: None. S. Edelstein: None. M. Temprosa: None. P. Rangamani: None. A.R. Majithia: None.
835-P: A Unique Form of Pancreatogenic Diabetes—Experiences with the Treatment of Patients Who Underwent Pancreatectomy
Authors: KIS JANOS T. , SZEMÁN ANDREA , ARAPOVICSNE DR KISS KRISZTINA , GROSZ ANDREA J. , MÉSZÁROS PÉTER , DUBOCZKI ZSOLT , HARDY VAJK , SCHANDL LASZLO , WINKLER GABOR T.
Published: June 2024

Objective: Pancreatogenic diabetes (T3cDM) is most often caused by chronic pancreatitis, pancreatic cancer, hemochromatosis, cystic fibrosis, and most rarely by pancreas removal. It is often associated with T2DM, so several parallel pathological processes are behind hyperglycemia, in which case it cannot be clearly established to what extent each disease process (pancreatic disease, insulin resistance, T2DM, etc.) is involved in the development of hyperglycemia.

Methods: T3cDM in patients with total pancreatic resection is of purely pancreatogenic origin. Our working group created a register for patients who underwent pancreatic resections to optimize the treatment of this most fragile type of diabetes.

Results: So far, 49 (22M, 67 years) patients who did not have diabetes before pancreatectomy have been added to our database. The average total daily insulin requirement of the patients was 34 U (bolus: 23.3 U, basal:10.6 U). The imbalanced (68%) bolus requirement is explained by the fact that the daily carbohydrate intake often had to be increased to over 300 grams, even with massive pancreatic enzyme replacement. The most proven treatment was human fast-acting insulin given in addition to iGlar300 or degludec base. After six months, the average HbA1c value of the patients was 7.3%, and the average weight loss was 2.6 kg. Due to acute complications of diabetes, none of the patients was admitted to ER.

Conclusion: To our knowledge, our registry is the only database that collects and follows data of patients who underwent total pancreatectomy. Despite the unique challenges (insulin, glucagon, and digestive enzyme deficiency immediately after surgery, weight loss, gastric dissection), satisfactory metabolic control was achieved by educating the patients and their relatives. Our experiences with patients who underwent total pancreatectomy can benefit the care of T3cDM of another origin.

Disclosure

J.T. Kis: None. A. Szemán: None. K. Arapovicsne Dr Kiss: None. A.J. Grosz: None. P. Mészáros: None. Z. Duboczki: None. V. Hardy: None. L. Schandl: None. G.T. Winkler: None.
837-P: Closed-Loop Insulin Delivery Improves Glycemic Control In Paediatric Patients with Type 1 Diabetes—A Systematic Review
Authors: CHANDANAA KISTIPATI HARI , VISHNUBHAI ZEEL P. , ASHRAF SAAD , GHOSH SHANKHANEEL , TUMMALA NAYANIKA , ROY POULAMI , DEB NOVONIL , MADDINENI GAUTAM
Published: June 2024

Background: Type 1 Diabetes (T1D) in pediatric patients presents significant challenges in achieving optimal glycemic control. Closed-loop insulin delivery systems offer a modern approach to managing blood glucose levels by using continuous glucose monitoring data to adjust insulin delivery. This review aims to evaluate the impact of closed-loop insulin delivery on glycemic control in pediatric patients with T1D.

Methods: We searched PubMed, Scopus, Embase, and the WoS from their inception until June 2023 to identify relevant studies. We included studies focusing on closed-loop insulin delivery systems in children aged 0 to 18 with T1D. Our primary goal was to measure improved glycemic control by analyzing HbA1c changes.We extracted data and used established tools to assess the quality of the studies.

Results: 15 studies met the inclusion criteria, encompassing various closed-loop systems, including Continuous Subcutaneous Insulin Infusion (CSII), Dexcom G4, Florence D2, Omnipod 5, Medtronic Minimed, Minilink®REAL, Animas, and CamAPS FX. The studies demonstrated heterogeneous findings in glycemic control improvement, with significant reductions in HbA1c levels observed in most systems. Some variations were noted in outcomes, attributed to differences in study populations, system types, and study durations. A few studies reported adverse events such as diabetic ketoacidosis and sensor issues.

Conclusion: Closed-loop insulin delivery systems promise to enhance glycemic control in pediatric patients with T1D. While many studies reported favorable outcomes, further research is needed to understand system-specific effects, ensure safety, and address young patients' unique challenges. Standardizing outcome measures and conducting cost-effectiveness analyses are critical for broader adoption and successful integration into clinical practice.

Disclosure

H. Kistipati: None. Z.P. Vishnubhai: None. S. Ashraf: None. S. Ghosh: None. N. Tummala: None. P. Roy: None. N. Deb: None. G. Maddineni: None.
9-OR: ADA Presidents' Select Abstract: Targeting Inflammation with Salsalate in Type 1 Diabetes Neuropathy (TINSAL-T1DN Trial)
Authors: ANG LYNN , HUANG YIYUAN , MARTIN CATHERINE , MIZOKAMI-STOUT KARA R. , KUEI LIN YU , VASBINDER ALEXI , BANERJEE MOUSUMI , HAYEK SALIM , FELDMAN EVA L. , BUSUI RODICA
Published: June 2024

Introduction & Objective: Diabetic peripheral neuropathy (DPN) and cardiovascular autonomic neuropathy (CAN) are highly prevalent complications of diabetes without effective disease-modifying treatments. Chronic inflammation and the NFkB pathway have emerged as important mechanisms. We aimed to assess the effectiveness and safety of salsalate, a NFkB blocker, in individuals with type 1 diabetes (T1D) and DPN.

Methods: This was a phase 2/3, randomized, double-blind clinical trial of salsalate 3 grams daily vs placebo for 12 months. The primary outcome was the change in intraepidermal nerve fiber density (IENFD) at the distal thigh at 12 months. Secondary outcomes included IENFD at distal leg, nerve conduction studies and measures of CAN (standardized cardiovascular autonomic reflex tests, heart rate variability). Linear regressions were used to assess percent changes in all outcomes between groups.

Results: Fifty-five participants with T1D (mean age 51±12 years, baseline HbA1c 8.4±1.7%, duration 29±14 years) and mild to moderate DPN completed the trial. No significant differences were found in the primary outcome after 12 months. However, positive trends were noted in several secondary outcomes (salsalate vs placebo): sural amplitude (15% vs -10%; p=0.058), sural nerve conduction velocity (9% vs -4%; p=0.16), and measures of CAN (root mean square of the differences of successive RR intervals 34% vs 7%, expiration/inspiration ratio 6% vs -1%, and the 30:15 ratio 19% vs -5%) (p >0.05 for all). After adjusting for age, gender, diabetes duration, HbA1c, BMI, baseline IENFD at distal leg and thigh, sural amplitude significantly improved (31%; p= 0.031) with salsalate.

Conclusion: In this small T1D cohort, salsalate treatment did not significantly change IENFD at distal thigh at 12 months. Trends toward improvement in the sural amplitude and other outcomes suggest salsalate’s potential as a disease-modifying therapy in T1D neuropathy, necessitating larger trials.

Disclosure

L. Ang: None. Y. Huang: None. C. Martin: None. K.R. Mizokami-Stout: None. Y. Lin: None. A. Vasbinder: None. M. Banerjee: None. S. Hayek: None. E.L. Feldman: None. R. Busui: Board Member; American Diabetes Association. Consultant; Procter & Gamble, AstraZeneca, Averitas Pharma, Inc., Bayer Inc., Lexicon Pharmaceuticals, Inc., Nevro Corp., Ono Pharmaceutical Co., Ltd., Novo Nordisk, Roche Diagnostics. Advisory Panel; ADA/ACC Diabetes by Heart Program.

Funding

NIH/NIDDK-1-R01-DK-107956-01
926-P: Early Sodium–Glucose Cotransporter 2 Inhibitors–Induced Change in Haematocrit as a Predictor of Mortality and Cardiovascular Risk—A Real-World Study
Authors: TOULIS KONSTANTINOS A. , WANG JINGYA , TAN LUYUAN , NIRANTHARAKUMAR KRISHNARAJAH , NAUCK MICHAEL A.
Published: June 2024

Introduction & Objective: Statistical and mechanistic evidence suggest that sodium-glucose co-transporter 2 inhibitors (SGLT2i)-induced change in haematocrit may affect cardiovascular risk. Since the magnitude of change is variable but manifested early, we explored whether the within 6-month changes in haematocrit in subjects initiated with SGLT2i could help identify those who would benefit most in terms of cardiovascular risk reduction.

Methods: Using real-world data in GPRD GOLD and Aurum, a series of open cohort studies were performed in individuals with diabetes mellitus type 2 (T2DM). Primary outcome was composite end-point including all-cause mortality, myocardial infarction ischaemic heart disease and stroke. Based on linearity analyses and clinical interpretability, individuals were categorised into three subgroups of the observed absolute haematocrit change (“negative”, “positive” = 0-4, “highly positive”=>4). Primary analysis was conducted with competing cox proportional hazard model with restricted cubic spline.

Results: A total of 37,2336 individuals, over 40 years-old, with T2DM under treatment with SGLT2i were included and followed for ~2.4 years with a total observation worth of ~86000 person-years. The subgroup with the negative haematocrit change was found to be at a significantly increased risk of manifesting the composite outcome [adjusted hazard ratio and 95% confidence intervals, aHR (95% CI): 1.23 (1.12, 1.36)], death from any cause [1.33 (1.19,1.49]) and heart failure [1.35 (1.14, 1.60)], compared to the reference group. 0-9.83%). Sensitivity analyses did not alter the findings.

Conclusion: Among individuals with T2DM at low baseline risk of cardiovascular disease, an early increase in haematocrit after SGLT2i institution may be regarded as an indicator of future cardiovascular benefit.

Disclosure

K.A. Toulis: None. J. Wang: None. L. Tan: None. K. Nirantharakumar: Consultant; Boehringer-Ingelheim. Research Support; GlaxoSmithKline plc. M.A. Nauck: Advisory Panel; AstraZeneca, Boehringer-Ingelheim, Eli Lilly and Company. Speaker's Bureau; Eli Lilly and Company. Advisory Panel; Merck & Co., Inc. Speaker's Bureau; Merck & Co., Inc. Advisory Panel; Novo Nordisk. Speaker's Bureau; Novo Nordisk, Medscape. Advisory Panel; Pfizer Inc., Structure Therapeutics, Inc., Sun Pharmaceutical Industries Ltd. Speaker's Bureau; Medical Learning Institute, Medfyle. Advisory Panel; Regor. Other Relationship; Inventiva Pharma.

Funding

EFSD Future Leaders Mentorship Programme for Clinical Diabetologists (supported by an unrestricted educational grant from AstraZeneca)
95-OR: Diurnal Variation of Islet Autoantibodies in Established Type 1 Diabetes
Authors: DIMEGLIO LINDA A. , BEAM CRAIG , PEARSON JAMES A.
Published: June 2024

Introduction: Accurate pancreatic islet autoantibody (Aab) measurement is vital for risk-screening, early-stage treatment, and prevention study eligibility assessment in persons with and at risk of type 1 diabetes (T1D). Although Aab measurement has been standardized by addressing lab assay differences, intra-individual variation in these assays by time of day has not yet been carefully assessed.

Objective: To assess the extent of Aab diurnal variation in persons with established T1D.

Methods: Ten persons (mean age 27y) within 1-19y post T1D diagnosis had 6 blood samples taken at 4-h intervals starting at 09:00. Aab titers were measured by radiobinding assays and diurnal patterns investigated using a “Cosinor” method.

Results: We observed daily within-subject differences in Insulin Aab (IAA) titers (max-min) with a median daily difference of 18 units and variation as great as 80 units in one individual. Aab titer differences affected assay sensitivity; one person was IA-2 Aab positive on samples taken at 09:00, 13:00 and 21:00, yet negative at the other 3 times. IAA levels followed a 24-h single phase cosine curve (p=0.0028) with peak IAA titer estimated at 04:08 hrs (95% confidence interval: 01:34 to 06:34). Zinc Transporter 8 Aabs also varied according to this pattern (ZnT8RA p=0.0057 and ZnT8WA p<0.0001) with morning peaks: ZnT8RA peak at 07:06 (04:07, 09:55), ZnT8WA at 08:55 (05:41, 12:10). Variance components analyses implied that sample time of day was a greater source of variation than intra-assay variation alone for IAA, GADA and ZnT8WA.

Conclusion: Circulating islet Aab titers vary significantly over 24 hrs, and Aab detection can be time-of-day dependent. Since our pilot data suggest several Aab peak in the morning, morning may be the best time of day for Aab detection. Our findings only reflect variations occurring in established T1D and therefore should be investigated in other T1D populations. Diurnal variation as a source of Aab variation must be considered in future efforts to improve Aab measurements.

Disclosure

L.A. DiMeglio: Research Support; Dompé, Lilly Diabetes, MannKind Corporation, Medtronic, Provention Bio, Inc., Sanofi, Zealand Pharma A/S, Amgen Inc. Advisory Panel; Vertex Pharmaceuticals Incorporated, Abata Therapeutics. C. Beam: None. J.A. Pearson: None.

Funding

JDRF INO-2017-458-A-N Indiana NIH UL1TR001108
972-P: Hyperglycemia from Real-World Dawn Phenomenon Is Nearly Eliminated with the MiniMed 780G System (MM780G)
Authors: MCVEAN JENNIFER , SHIN JOHN , NIU FANG , DIAZ-GARELLI FRANCK , VIGERSKY ROBERT A.
Published: June 2024

Introduction: Many people with T1D experience an early-morning rise in glucose (i.e., dawn phenomenon, DP). The MM670G/770G with 5-min auto basal insulin reduced the burden of managing DP.1 With MM780G frequent (every 5-min) autocorrections, we hypothesized that DP hyperglycemia would be reduced further. In this analysis, the impact of the MM780G against real-world DP in adolescents and adults with T1D was evaluated.

Methods: Prevalence of DP was defined as an elevation (>20mg/dL) in sensor glucose (SG) from 3AM to 6AM, compared to 12AM to 3AM, at least 30% of nights. DP was assessed among MM780G users (aged ≥16 years) in the U.S. who consented to share data. DP and glycemic outcomes (mean glucose, time in ranges and insulin delivery) were assessed in 6026 overall users and 1303 who used recommended settings (RS, a glucose target of 100mg/dL with active insulin time of 2 hours for 95% of the time).

Results: Transition from the MM770G to the MM780G decreased DP rates from 12.2% to 4.5% in all users, and to 3.0% in RS users. Glycemic outcomes were significantly improved with the MM780G (Table), consistent with the trend observed in DP rates. The % of total insulin delivered as auto bolus from 3AM to 6AM was 10.6% and 11.3% for use of all settings and RS, respectively.

Conclusion: Hyperglycemia from real-world DP was nearly eliminated by the MM780G system due to the ability of its algorithm to autocorrect frequently overnight.

Disclosure

J. McVean: Employee; Medtronic. J. Shin: None. F. Niu: None. F. Diaz-Garelli: Employee; Medtronic. R.A. Vigersky: Employee; Medtronic.
982-P: The Dexcom Community Glucose Monitoring Project for People with Type 2 Diabetes—One-Year Outcomes
Authors: GRACE THOMAS , LAYNE JENNIFER E. , HICKS CHRISTIAN , GREEN COURTNEY R. , WALKER TOMAS C.
Published: June 2024

Background & Objective: Access to CGM for people with type 2 diabetes (T2D) remains limited, especially for those treated in the primary care setting. The objective of this study, a collaboration between a primary care practice and the local public health department, was to evaluate the glycemic impact of CGM access on adults with T2D.

Methods: CGM systems (Dexcom G6 and G7) were provided to eligible participants with T2D who were ≥18 years of age, CGM-naïve, and did not have health insurance coverage for CGM. Outcomes included changes in A1C and CGM metrics from baseline to one year.

Results: Participants (n=177) were (mean ± SD) 59.1 ± 12.0 years, 41.2% female, BMI 35.5 ± 8.5, duration of diabetes 11.1 ± 9.3 years. After one year, A1C decreased from 9.4% ± 1.6 to 7.1% ± 1.3 (-2.3% ± 1.9, p<0.001). The proportion of participants meeting the ADA target of A1C <7.0% increased from n=1 (0.6%) at baseline to n=91 (51.4%) at one year. Those meeting the HEDIS target of A1C <8.0% increased from 19.2% at baseline to 85.9% at one year. CGM outcomes (n=109) after near-continuous use included an increase in TIR of 9.9% ± 29.4 (p<0.001) and a large increase in TITR (p<0.001, Table).

Conclusion: Self-guided use of CGM by primary care patients with T2D for one year was associated with clinically meaningful improvements in A1C and TIR.

Disclosure

T. Grace: Speaker's Bureau; Sanofi, Novo Nordisk, Eli Lilly and Company, Dexcom, Inc. Employee; Dexcom, Inc. J.E. Layne: Employee; Dexcom, Inc. Stock/Shareholder; Dexcom, Inc. Employee; Verily Life Sciences. C. Hicks: Employee; Dexcom, Inc. C.R. Green: Employee; Dexcom, Inc. T.C. Walker: Employee; Dexcom, Inc. Stock/Shareholder; Dexcom, Inc.
999-P: Trends and Characteristics of Continuous Glucose Monitoring Initiation in Older Adults with Diabetes—A Cohort Study
Authors: ALKABBANI WAJD , PAIK JULIE M. , KIM DAE H. , MUNSHI MEDHA , WEXLER DEBORAH J. , PATORNO ELISABETTA
Published: June 2024

Introduction & Objective: The use of continuous glucose monitoring (CGM) devices improves glycemic outcomes and minimizes hypoglycemia in older adults with diabetes. Herein, we assessed the temporal trends and characteristics of CGM initiation in this population.

Methods: Using Medicare fee-for-service data (2013-19), we identified two cohorts of patients aged ≥65 years with type 2 and type 1 diabetes and estimated the annual proportion of CGM initiation. In each cohort, we 1:4 matched new users of CGM to patients unexposed to CGM, using risk set sampling. Index date was the date of CGM initiation or, for controls, the closest physician visit within +/-7 days. We used logistic regression to assess patient characteristics associated with CGM initiation.

Results: The annual proportion of CGM initiators increased from 7 to 33/100,000 patients with type 2 diabetes and from 111 to 393/100,000 patients with type 1 diabetes. Low frailty and white race were associated with higher odds of CGM initiation in both cohorts. CGM initiators with type 2 diabetes were more likely to have history of hypoglycemia, and to be on insulin, glucagon-like peptide 1 receptor agonists, or sulfonylureas.

Conclusion: CGM initiation has significantly increased over time among older adults with type 2 and type 1 diabetes; however racial and ethnic disparities were observed.

Disclosure

W. Alkabbani: None. J.M. Paik: None. D.H. Kim: None. M. Munshi: Consultant; Sanofi. D.J. Wexler: Other Relationship; Novo Nordisk. E. Patorno: Research Support; Boehringer-Ingelheim, Food and Drug Administration (FDA), National Institutes of Health, Patient-Centered Outcomes Research Institute.
Pemanfaatan Cairan Asam Laktat dari Fermentasi Limbah Kubis (Brassica Oleracea) untuk Pengawetan Buah Tomat dan Anggur
Authors: Maulinasari Dhita , Sugiharto Agung , Khuzaimah Siti , Estiyantara Nurhadi
Published: June 2024

Larutan limbah kubis (Brassica oleracea) merupakan hasil akhir dari fermentasi limbah kubis. Solusi ini dapat digunakan sebagai pengawet alami untuk buah-buahan. Limbah kubis menghasilkan asam laktat. Asam laktat bersifat asam dan digunakan untuk menurunkan pH dan menekan pertumbuhan bakteri lain, termasuk yang mudah rusak. Asam laktat ini dapat dibentuk melalui proses fermentasi yang berlangsung dengan adanya aktivitas spontan Lactobacillus. Tujuan dari penelitian ini adalah untuk mengetahui efektifitas limbah kubis (Brassica Oleracea) dalam mengawetkan buah anggur dan tomat melalui uji organoleptik. Penggunaan larutan limbah kubis (Brassica Oleracea) sebagai pengawet alami yang sederhana dan efektif, serta memberikan fakta kepada masyarakat tentang limbah kubis yang dapat digunakan sebagai pengawet alami yang tidak berbahaya. Penelitian ini dilakukan dengan enam perlakuan yaitu buah anggur dan tomat tanpa perendaman (kontrol), buah anggur dan tomat direndam selama 1 hari, 2 hari hingga 5 hari. Variasi perendaman  buah anggur dan tomat  ini berpengaruh nyata terhadap rasa, warna, aroma, dan tekstur yang dibuktikan dengan melakukan uji organoleptik. Berdasarkan hasil uji organoleptik, untuk buah anggur tanpa perendaman mengalami penyusutan yang cukup signifikan di hari ke-5 yaitu dengan berat 4,623 gr, sedangkan untuk buah anggur dengan perendaman mengalami penyusutan pada hari ke-6 dengan berat 1.675 gr. Untuk buah tomat tanpa perendaman, mengalami penyusutan yang cukup signifikan di hari ke-5 yaitu dengan berat 4.239 gr, sedangkan untuk buah tomat dengan perendaman mengalami penyusutan pada hari ke-6 dengan berat 0.881 gr
Lactic Acid: Industrial Synthesis, Microorganisms-Producers and Substrates: A Review
Authors:   Lviv Polytechnic National University, Stepan Bandera st., 12, Lviv, Ukraine, Kiiv Dmytro , Vasylyuk Sofiya ,   Lviv Polytechnic National University, Stepan Bandera st., 12, Lviv, Ukraine, Lubenets Vira ,   Lviv Polytechnic National University, Stepan Bandera st., 12, Lviv, Ukraine
Published: June 2024

The article contains comprehensive information on groups of bacteria producing lactic acid, which have high metabolic activity and can be used in industrial production. In addition, an overview of the most common fermentation methods (batch, continuous, multiple), as well as cheap carbon sources: starch and cellulose-containing, industrial and food waste is provided.
Effect of Interest Rate Spread on Performance of Commercial Banks in Kenya
Authors: Ndiritu George , Iraya Cyrus , Okiro Kennedy , Nyandemo Samuel
Published: June 2024

The interest rate spread has, over a long time, generated a lot of attentiveness in the banking sector in Kenya. This has been due to the huge gap that prevailed between the deposit rate and the lending rate and its impact on the performance of the banking sector. Thus, the objective of the study is to determine the effect of interest rate spread on the performance of commercial banks in Kenya. A descriptive research design was employed, utilizing secondary data from 42 commercial banks in Kenya spanning from 2008 to 2018. A random effects model was used to assess the existence of the causal effect between the two variables. The findings revealed a positive and significant relationship between interest rate spread and the performance of the banks.