bluuebunny/crossref_metadata_2025 huggingface dataset:
938-P: Dynamic Interference Testing Results with the Dexcom G6 Continuous Glucose Monitoring Device
Authors: PFÜTZNER ANDREAS , JENSCH HENDRICK , SRIKANTHAMOORTHY GEETHAN , KUHL CHRISTIAN , SETFORD STEVEN J. , GRADY MIKE , HOLT ELIZABETH H. , THOMÉ NICOLE
Published: June 2023

Background: Continuous glucose monitoring (CGM) by means of needle sensors is becoming a standard option to gather the necessary glucose information for treatment of patients with type 1 and type 2 diabetes mellitus. Little is known, however, about the reaction of the glucose oxidase-based sensor technologies to potentially interfering nutritional, endogeneous or pharmaceutical substances. Here we report on results obtained with the Dexcom G6 needle sensor with our in-vitro dynamic intererence testing method.

Method: We used HPLC pump-controlled substance gradients to expose Dexcom G6 needle sensors in a 3D-printed test cartridge to varying concentrations of potentially interfering substances at a fixed glucose concentration of 200 mg/dL. We tested 68 substances in triplicate using YSI Stat 2300 Plus as the glucose reference method. Interference was assumed if a CGM needle sensor showed more than ±10% difference from baseline with a tested substance at the given test concentration.

Results: Interference was seen with the following substances: acetaminophen (>+100% bias from baseline), hydroxyurea (>+100%), uric acid (+33%), mannose (+20%), N-acetyl-cysteine (+18%), gentisic acid (+18%), galactose (+17%), ethyl alcohol (+12%), L-dopa (+11%), dithiothreitol (−18%), L-cysteine (−25%), while no interference was seen with other tested substances. In addition, the needle sensors subsequently ceased to operate when exposed to dithiothreitol, L-cysteine, gentisic acid, and mesalazine (suspected sensor fouling).

Conclusions: Employing our standardized dynamic interference testing protocol, several nutritional and pharmacological substances were identified as influencing the Dexcom G6 signal. If confirmed by clinical trials, such interference will have to be considered when making treatment decisions using Dexcom G6 results in daily routine care.

Disclosure

A.Pfützner: Consultant; Novo Nordisk A/S, Research Support; LifeScan Diabetes Institute, Speaker's Bureau; AstraZeneca, Stock/Shareholder; Lifecare A/S, Diakard. H.Jensch: None. G.Srikanthamoorthy: None. C.Kuhl: None. S.J.Setford: Employee; LifeScan Scotland Ltd. M.Grady: Employee; Lifescan. E.H.Holt: Employee; LifeScan Inc. N.Thomé: None.

Funding

European Union’s Horizon 2020 Research and Innovation Program (951933); LifeScan Global Corporation
939-P: Dynamic Interference Testing Results with the Libre 2 Continuous Glucose Monitoring Device
Authors: JENSCH HENDRICK , THOMÉ NICOLE , SRIKANTHAMOORTHY GEETHAN , WEINGÄRTNER LEA , SETFORD STEVEN J. , HOLT ELIZABETH H. , GRADY MIKE , KUHL CHRISTIAN , PFÜTZNER ANDREAS
Published: June 2023

Background: Sensors for continuous glucose monitoring (CGM) are increasingly used by people with type 1 and type 2 diabetes. However, the reaction of the glucose oxidase-based sensor technologies to potentially interfering nutritional, endogenous, or pharmaceutical substances is barely understood. We have developed an in-vitro test method for continuous and dynamic CGM interference testing and explored the sensitivity of the Libre 2 sensor to a panel of 68 individual substances.

Method: In each interference experiment, three sensors were exposed to substance gradients from zero to supra-physiological concentrations generated by HPLC-pumps at a fixed glucose concentration of 200 mg/dL. YSI Stat 2300 Plus was used as the glucose reference method. Interference was assumed if the CGM sensors showed a mean bias of more than ±10% from baseline with a tested substance at any given substance concentration.

Results: Interference was seen with the following substances: xylose (difference from baseline: +178%), galactose (+134%), mannose (+130%), hydroxyurea (+84%), ascorbic acid (+48%), dithiothreitol (+46%), methyldopa (+16%), ibuprofen (+14%), red wine (+12%), N-acetyl-cysteine (+11%), icodextrin (+10%), while no interference was seen with the other substances. Suspected sensor fouling, in that the needle sensors subsequently ceased to operate after exposure to a substance, was not observed with Libre 2.

Conclusions: Our standardized dynamic interference testing protocol identified several nutritional and pharmacological substances that substantially influenced the Libre 2 signal. Clinical trials are now necessary to investigate, whether our findings are of relevance for routine care.

Disclosure

H.Jensch: None. N.Thomé: None. G.Srikanthamoorthy: None. L.Weingärtner: None. S.J.Setford: Employee; LifeScan Scotland Ltd. E.H.Holt: Employee; LifeScan Inc. M.Grady: Employee; Lifescan. C.Kuhl: None. A.Pfützner: Consultant; Novo Nordisk A/S, Research Support; LifeScan Diabetes Institute, Speaker's Bureau; AstraZeneca, Stock/Shareholder; Lifecare A/S, Diakard.

Funding

European Union’s Horizon 2020 Research and Innovation Program (951933); LifeScan Global Corporation
94-OR: Myeloid-Specific ERa Deletion Disrupts Mitochondrial Function Driving Iron Accumulation and Cardiometabolic Disease
Authors: IWASAKI HIROTAKA , LEYVA BRAYDEN K. , MA ALICE , YANG NICOLE L. , TRAN PETER H. , ZHOU ZHENQI , HEVENER ANDREA L.
Published: June 2023

Sex differences in metabolism and cardiometabolic disease risk are well described. Because estrogen action is thought to underlie female-biased protection of immunometabolism and cardiometabolic health, we selectively deleted the estrogen receptor alpha (ERa, encoded by Esr1) from myeloid cells of mice to understand the impact of estrogen action on macrophage function. Our previous findings in other glucoregulatory cell types point to an important role of ERa in the control of mitochondrial form and function. Mitochondria play a critical role in innate immunity, and disruption of mitochondrial function is linked to the pathogenesis of cardiometabolic disease. In addition to a primary role in energy production, mitochondria are central in the regulation of iron homeostasis, a critical process governing immune cell function. Myeloid-specific Esr1 knockout mice (MACER) showed increased diet-induced glucose intolerance, insulin resistance, adiposity, and atherosclerotic lesion area compared with f/f controls. A key phenotype of MACER mice was marked accumulation of iron in liver, spleen, gonadal white adipose tissue, and bone marrow-derived macrophages compared with f/f controls. Specifically, iron accumulated in mitochondria from macrophages within tissues of MACER mice. Iron accumulation was linked with alteration of mitochondrial inner and outer membrane morphology and mtDNA replication machinery, and associated with increased transferrin receptor (Tfrc) expression and cellular inflammation driven by interleukin-1-β. We utilized chromatin immunoprecipitation approaches to identify novel ERa-regulated chromatin structures and target genes that modulate immunometabolism of macrophages. Our findings indicate that Esr1 is critical in the regulation of mitochondrial metabolism and iron homeostasis in macrophages, and the action of ERa is critical for the protection against inflammation and cardiometabolic-related disease.

Disclosure

H.Iwasaki: None. B.K.Leyva: None. A.Ma: None. N.L.Yang: None. P.H.Tran: None. Z.Zhou: None. A.L.Hevener: None.

Funding

National Institutes of Health (DK128957)
942-P: A1C-Glucose Management Indicator (GMI) Discordance among Continuous Glucose Monitor (CGM)–Wearing Adults with T2D
Authors: JHUANG AN-TING , BACON SAM , KAMRUDIN SAMIRA , THOMPSON NELS , CLARK CALLAHAN
Published: June 2023

ADA Standards of Medical Care considers 14-day CGM-based GMI an A1c surrogate for clinical management. To date, supporting evidence is from T1D or insulin-treated T2D populations. As CGM demand and access grows, quantifying A1c-GMI discordance in diverse T2D populations can inform practice. We evaluated this discordance, stratified by T2D drugs and A1c. CGM-wearing adults with T2D, an overlapping A1c and GMI date (10/2019 to 3/2022), and CGM data sufficiency (DS) ≥ 70% were included. Prior 3 month pharmacy claims defined drug histories. We calculated the Pearson correlation coefficient (r) and A1c-GMI differences by subgroup. A1c-GMI pairs existed for 2,760 people (mean [SD] age 55 [9]; 46% F; 58% had A1c <7%). Overall, pairs highly correlated (56% differed by <0.5%; r=0.80). Non-insulin T2D drug users (N=1,674) had slightly higher concordance than basal insulin (N=437) and basal-bolus insulin users (N=317), with 58%, 50%, and 56% discordance <0.5% (r=0.79, 0.77, 0.77). On average, A1c underestimated GMI for non-insulin users and overestimated GMI for basal and basal-bolus insulin users. Concordance decreased at A1c extremes, with 61-76% concordance for A1cs from 5.7% to 8%. Sensitivity analyes with lower DS had similar results. A1c-GMI discordance varied by T2D drug class and A1c, highlighting how CGM-derived measures can provide personalized insights for diverse T2D populations.

Disclosure

A.Jhuang: Employee; UnitedHealth Group, Stock/Shareholder; UnitedHealth Group. S.Bacon: Employee; Optum Labs, Research Support; Level2. S.Kamrudin: Employee; UnitedHealth Group. N.Thompson: Employee; Level2, Stock/Shareholder; UnitedHealth Group. C.Clark: Employee; UnitedHealth Group, Stock/Shareholder; UnitedHealth Group.
945-P: Effect of Real-Time Continuous Glucose Monitoring vs. Flash Glucose Monitoring on Glycemic Control and Glycemic Variability in Patients with Type 1 Diabetes—A Systematic Review and Meta-analysis
Authors: CHEN DANRUI , LIU ZHIGU , LIN BEISI , YANG YANLING , YANG DAIZHI , YAN JINHUA , XU WEN
Published: June 2023

Objectives: Previous studies have shown that real-time continuous glucose monitoring (rtCGM) and flash glucose monitoring (FGM) led to different impacts on glycemic control and glycemic variability in patients with T1D. This meta-analysis aimed to summarize data and compare the effect of the rtCGM and FGM in patients with T1D. Methods: A systematic literature searches of all relevant studies comparing the clinical effectiveness of rtCGM and FGM in T1D on Cochrane Library, PubMed, Embase, Web of Science, and Scopus before October 2022 were performed. Two independent reviewers searched and assessed all literatures according to the standard of Cochrane systematic review. Data extraction and quality assessment were conducted. Stata 15.1 software was used for data analysis. The random effects model was used since there was heterogeneity between studies. Results: Eight studies including three randomized controlled trials and five observational studies conducting in 1649 TID patients were enrolled in this meta-analysis. It was found that there was no difference in reduction of HbA1c levels between rtCGM and FGM. In terms of indexes of glycemic variability, compared to FGM, rtCGM led to better TIR (3.9~10 mmol/L) (SMD = 0.721, 95%CI: 0.438 ~ 1.003, P<0.001), lower TBR (<3.9mmol/L) (SMD = -1.441, 95%CI: -2.090 ~ -0.791, P<0.001), lower TAR (TAR>10.0mmol/L: SMD = -0.299, 95%CI: -0.583 ~ -0.015, P = 0.039; TAR>13.9 mmol/L: SMD = -0.395, 95%CI: -0.702 ~ -0.088, P = 0.012), lower standard deviation (SMD = -0.769, 95%CI: -1.097 ~ -0.442, P<0.001), and lower glucose coefficient of variation (SMD = -0.859, 95%CI: -1.159 ~ -0.559, P<0.001) as well. However, there was no difference between rtCGM and FGM in lowering mean glucose and TBR (<3.0mmol/L). Conclusions: rtCGM accounted for favorable outcomes on improving glycemic variability indices but not HbA1c reduction compared to FGM in patients with T1D.

Disclosure

D.Chen: None. Z.Liu: None. B.Lin: None. Y.Yang: None. D.Yang: None. J.Yan: None. W.Xu: None.

Funding

SHMHDF (DMRFP_II_14)
949-P: Hypoglycemia Detection during Real-Time Continuous Glucose Monitoring in a Real-World Hospital Setting
Authors: BELASCO REBEKAH , FORTMANN ADDIE L. , SPIERLING BAGSIC SAMANTHA R. , BASTIAN ALESSANDRA , LOHNES SUZANNE , RITKO ANNA , SANDOVAL HALEY , CHICHMARENKO MARIYA , SORIANO EMILY C. , TALAVERA LAURA , PHILIS-TSIMIKAS ATHENA
Published: June 2023

Continuous glucose monitoring (CGM) in the hospital can detect hypoglycemia that may go unnoticed by point-of-care testing (POCT). Following the non-objection of the FDA to the use of CGM in the hospital, using the Dexcom G6 CGM system, the “CGM as Standard of Care” (CGM as SOC) program was implemented at Scripps Mercy Hospital San Diego with a 24/7 remote-monitoring team (RMT) using a Digital Dashboard (DD). The DD alerts for glucose ≤80mg/dL and prioritizes patients by clinical risk. Using these alerts, the RMT notifies on-site bedside nurses (RN). Hypoglycemic events, defined as >15 minutes of consecutive glucose readings <70mg/dL, identified in retrospective evaluation of CGM data were analyzed to 1) evaluate appropriateness of response to events and 2) assess the accuracy of the events. 86/745 (12%) unique admissions enrolled in the CGM as SOC program between January 2021-June 2022 experienced a hypoglycemic event during the RMT period. These patients averaged 60.2 years of age, 62% male, 48% Hispanic and 87% with a type 2 diabetes diagnosis. Median number of events per admission = 1.90, for a total of 163 events. All alerts were acknowledged by the RMT, documentation that bedside RN was alerted was found on 134/163 (82%) events. It is possible that the RMT neglected to document RN outreach in the remaining 29 (18%). 90/163 events (55%) were treated as appropriate clinically, with insulin dosing changes as needed. In the remaining 69/163 (42%) events, patients were determined to not be (or no longer be) in an actionable hypoglycemia range that warranted treatment when evaluated by the RN. A small portion (10/69, 14%) were caused by documented compression on device resulting in artificially low CGM values. There were 4 (3%) events with insufficient documentation. These findings provide preliminary support of the value of an RMT in hypoglycemia surveillance in a real-world hospital setting. Additional data and recommendations for process refinements will be presented.

Disclosure

R.Belasco: None. L.Talavera: None. A.Philis-tsimikas: Advisory Panel; Dexcom, Inc., Novo Nordisk A/S, Sanofi, Other Relationship; Medtronic, Research Support; Novo Nordisk A/S, Lilly, Viking Therapeutics, NIH - National Institutes of Health. A.L.Fortmann: Employee; Dexcom, Inc. S.R.Spierling bagsic: None. A.Bastian: None. S.Lohnes: Consultant; Dexcom, Inc. A.Ritko: None. H.Sandoval: None. M.Chichmarenko: None. E.C.Soriano: None.
95-OR: A New Composite Blood Biomarker Performs Well in the Diagnosis of NASH, Advanced Hepatic Fibrosis, and High-Risk NASH
Authors: HO LEE DAE
Published: June 2023

Background and Aims: Plasma aldo-keto reductase family 1 member B10 (AKR1B10) well reflects the progression of NAFLD. Thus, we aimed to evaluate whether composite blood biomarkers including AKR1B10 and cytokeratin 18 (CK-18) have acceptable for the diagnosis NASH, advanced liver fibrosis, and high-risk NASH (NASH + significant fibrosis), respectively.

Methods: A total of 116 subjects in our pooled cohort (24 healthy controls and 92 patients with biopsy-proven NAFLD (48 patients with NAFL and 44 patients with NASH) were analysed to assess composite blood-based and imaging-based biomarkers, which included the markers below either singly or in combination: AKR1B10, CK-18, AST, ALT, enhanced liver fibrosis (ELF) score, FIB-4, proton density fat fraction (MRI-PDFF), MR elastography-liver stiffness measurement (MRE-LSM), and the known MRI-AST (MAST) and FibroScan-AST (FAST) scores

Results: Composite blood biomarker comprised of AKR1B10, CK-18, AST, and ALT showed excellent performance for the diagnosis of, NASH, advanced fibrosis, and high-risk NASH, with AUROC curve values of 0.934 (95% CI: 0.888-0.981), 0.902 (95% CI 0.832-0.971) and 0.918 (95% CI 0.862-0.974), respectively. However, the performances of this blood composite biomarker were all inferior to various MR-based composite biomarkers (MRI-PDFF/MRE-LSM/ALT/AST for NASH, AUROC = 0.964; MRE-LSM + FIB-4 for advanced fibrosis, AUROC=0.982; and the MAST score for high-risk NASH, AUROC=0.947), with a better performance than the FAST score (AUROC=0.909) for the diagnosis of high-risk NASH.

Conclusion: Although slightly inferior to the MR imaging-based composite biomarkers, blood composite biomarker composed of AKR1B10, CK-18, AST, and ALT showed excellent performance in the diagnosis of progressive forms of NAFLD.

Disclosure

D.Lee: None.
953-P: The Use of isCGM Improves the Mental Aspect of Quality of Life in Overweight Individuals with Impaired Glucose Tolerance or Mild Diabetes Mellitus
Authors: NISHIKAGE SEIJI , NAKAGAWA YASUSHI , HIROTA YUSHI , YOSHIMURA KAI , UEDA MARIKO , YAMAMOTO AKANE , TAKAYOSHI TOMOFUMI , MATSUOKA ATSUKO , TAKAHASHI MICHIKO , YOKOTA KAZUKI , NAKAMURA TOMOAKI , SAKAGUCHI KAZUHIKO , OGAWA WATARU
Published: June 2023

Objective: We aimed to investigate the relationship between the use of intermittently scanned continuous glucose monitoring (isCGM) and quality of life (QoL) in overweight individuals with impaired glucose tolerance (IGT) or mild type 2 diabetes mellitus (T2DM).

Methods: Forty overweight individuals (BMI ≥25kg/m2) having IGT or mild T2DM (without taking antidiabetic drugs and with HbA1c ≤7.0%) were recruited. We randomly divided the subjects into two groups: those using isCGM in addition to diet and exercise therapy (isCGM group) and those treated with diet and exercise therapy alone (control group). We conducted a 6-month intervention and assessed QoL using SF36 before and after the intervention.

Results: One participant in the isCGM group withdrew the consent. We thus analyzed 19 participants in the isCGM group (53.8±11.5 years old, BMI 35.2±5.7 kg/m2, HbA1c 6.2±0.3%) and 20 participants in the control group (54.3±14.0 years old, BMI 31.6±6.8 kg/m2, HbA1c 6.2±0.3%). There were no differences in changes in each subscale of the SF36 and component summary scores between the isCGM and control groups. In the isCGM group, Mental Component Summary (MCS) improved significantly after the intervention (43.6/48.2, p<0.05). Changes in SD and Time Above Range (TAR) were negatively correlated with changes in general health perception (GH) (r= -0.50, p<0.05; r= -0.53, p<0.05). The number of scans positively correlated with vitality, mental health, and MCS before and after the intervention.

Conclusions: The use of isCGM improved MCS in overweight individuals with IGT or drug-naïve T2DM. The improvement in SD and TAR with the use of isCGM likely contributed to the improvement in GH. In addition, the number of scans correlated with MCS, suggesting that vitality and mental health are essential for the effective use of isCGM.

Disclosure

S. Nishikage: None. Y. Nakagawa: None. Y. Hirota: Other Relationship; Lilly, Sanofi K.K., Terumo Corporation, Sumitomo Dainippon Pharma Co., Ltd. Research Support; Sumitomo Dainippon Pharma Co., Ltd. K. Yoshimura: None. M. Ueda: None. A. Yamamoto: None. T. Takayoshi: None. A. Matsuoka: None. M. Takahashi: None. K. Yokota: None. T. Nakamura: None. K. Sakaguchi: Research Support; Sumitomo Dainippon Pharma Co., Ltd. W. Ogawa: Advisory Panel; Abbott Japan Co., Ltd. Research Support; Boehringer Ingelheim Japan, Inc., Eli Lilly Japan K.K., Novo Nordisk, Teijin Pharma Limited, Kowa Company, Ltd., Sumitomo Dainippon Pharma Co., Ltd., Abbott Japan Co., Ltd. Speaker's Bureau; Sumitomo Dainippon Pharma Co., Ltd.
96-OR: Liver Fibrosis Scores in Novel Subclusters of Patients at Risk for Type 2 Diabetes
Authors: MINELLI FAIAO VITORIA , SANDFORTH ARVID , KATZENSTEIN SARAH , FRITSCHE ANDREAS , FRITSCHE LOUISE , MACHANN JÜRGEN , SCHICK FRITZ , HÄRING HANS-ULRICH , WAGNER ROBERT , PETER ANDREAS , BIRKENFELD ANDREAS L. , STEFAN NORBERT , JUMPERTZ VON SCHWARTZENBERG REINER
Published: June 2023

Metabolic diseases such as type 2 diabetes (T2D) are linked to the development of fatty liver, steatohepatitis and liver fibrosis. We have previously described novel clusters of patients at risk for T2D. Three clusters (3, 5 and 6) either had a high risk to progress to T2D or to develop cardiorenal complications. While high-risk clusters differ in liver fat content, it remains unknown if they also harbor a different risk for hepatic fibrosis. Thus, we determined clinically applicable scores of liver fibrosis in 1115 subjects at risk for T2D from the TUEF/TULIP study, which were categorized into high-risk clusters (n=602). Liver fat content was determined by 1H-magnetic resonance spectroscopy. The AST-to-platelet-ratio index (APRI), fibrosis-4 score (FIB-4) and NAFLD fibrosis score (NFS) were used to determine fibrosis risk. ANCOVA model analysis adjusted for liver fat content was performed. Of the high-risk clusters (3: n= 83, 5: n= 203, 6: n= 316), cluster 6 had the highest BMI 44.1±9.7 kg/m² (vs. cluster 3: 29.7±3.1 kg/m², p<0.001 and cluster 5: 42.8.0±8.7, p=0.32) and cluster 5 had the highest liver fat content (13.4±8.8% vs. cluster 3: 8.0±6.5, p<0.001 and cluster 6: 9.0±6.7, p<0.001). All fibrosis scores correlated with liver fat content (e.g. FIB-4: r= 0.45, p< 0.0001). Although FIB-4, APRI and NFS were generally low, they were highest in cluster 5, but despite highest liver fat content, they did not differ from cluster 3 and 6 (e.g. FIB-4: cluster 5: 0.19±0.45 vs. cluster 3: 0.14±0.01, p=0.59 and cluster 6: 0.12±0.15, p=0.39). Interestingly, cluster 3 with the lowest liver fat content exhibited higher FIB-4 compared to cluster 6 (p=0.02). According to clinically applicable scores, the most insulin resistant cluster 5 has the highest FIB-4 score. The insulin deficient cluster 3 has a relatively high FIB-4 score despite relatively low liver fat content and BMI. Further studies are needed to investigate the clinical relevance of these findings.

Disclosure

V.Minelli faiao: None. A.Peter: None. A.L.Birkenfeld: None. N.Stefan: Advisory Panel; Pfizer Inc., Research Support; Sanofi, Speaker's Bureau; AstraZeneca, Boehringer Ingelheim (Canada) Ltd., Lilly Diabetes, Novo Nordisk, Sanofi-Aventis Deutschland GmbH. R.Jumpertz von schwartzenberg: Other Relationship; Sanofi, Amgen Inc., Lilly, Novo Nordisk. A.Sandforth: None. S.Katzenstein: None. A.Fritsche: Advisory Panel; Novo Nordisk, Lilly, Sanofi, Boehringer-Ingelheim, Speaker's Bureau; AstraZeneca, SYNLAB Holding Deutschland GmbH. L.Fritsche: None. J.Machann: None. F.Schick: None. H.Häring: None. R.Wagner: Advisory Panel; Daiichi Sankyo, Speaker's Bureau; Novo Nordisk, Sanofi.
961-P: Comparison of Glucose Metrics by Capillary Blood Glucose and Continuous Glucose Monitoring among People with Type 2 Diabetes on Hemodialysis
Authors: GALINDO RODOLFO J. , GERGES AMANY Y.G. , MOAZZAMI BOBAK , PENG LIMIN , TUTTLE KATHERINE R. , UMPIERREZ GUILLERMO
Published: June 2023

Background: Reliability of HbA1c in subjects with end-stage kidney disease treated with hemodialysis is poor. Capillary blood glucose (CBG) is widely used, but is limited to 2-4 values/day. Clinical guidelines recommend using continuous glucose monitoring (CGM) to assess glycemic control in this population, but there is limited data.

Methods: Prospective observational study of insulin treated adults with type-2 diabetes (T2D) receiving hemodialysis. Subjects were instructed to wear a Dexcom G6-Pro and perform Nova StatStrip CBG at least 2-4/d for 10-days. We compared mean glucose, hypoglycaemia, and hyperglycaemia rates, time-in-target range (TIR), time above range (TAR), and time below range (TBR) between testing methods.

Results: Glucose metrics are shown in Table 1.

Conclusion: Compared to CBG, CGM provides a comprehensive glycemic evaluation in insulin-treated subjects with T2D on hemodialysis. CGM was superior in assessing glycemic control (TIR), detection of severe hyperglycemia and hypoglycemic excursions, particularly nocturnal and prolonged events. Safer treatment options assessed by CGM metrics are needed for this high-risk population.

Disclosure

R.J.Galindo: Consultant; Novo Nordisk, Eli Lilly and Company, Sanofi, Pfizer Inc., Bayer Inc., WW (Weight Watchers), Research Support; Novo Nordisk, Eli Lilly and Company, Dexcom, Inc. A.Y.G.Gerges: None. B.Moazzami: None. L.Peng: None. K.R.Tuttle: Consultant; Lilly, AstraZeneca, Gilead Sciences, Inc., Research Support; Bayer Inc., Boehringer Ingelheim (Canada) Ltd., Novo Nordisk, Goldfinch Bio, Inc., Traveere Pharmaceuticals. G.Umpierrez: Research Support; Abbott, Dexcom, Inc., Baxter.
968-P: Real-World Comparison of Younger and Older Cohorts Using the Bigfoot Unity System for Six Months
Authors: VAUGHAN SARAH , TILLMAN JOHN , OLSON BYRON P. , NAUREEN SHEIKH F. , MALONE JAMES K.
Published: June 2023

Background: The Bigfoot Unity® System is an FDA-cleared smart pen cap system incorporating CGM data, real-time alerts, and clinician-directed dose recommendations. The objective was to analyze real world data from younger and older subgroups using the System for MDI.

Methods: We conducted a 6-month retrospective analysis using deidentified data and a prespecified analysis plan for commercial users with ≥50% CGM data in the 6th month (N=127, 24 clinics). A baseline A1C was obtained from clinic medical records (N=118). Outcomes for those <65 (N=58) and ≥65 (N=69) years old were compared.

Results: Most (83%) in each group had T2D; mean age in <65 and ≥65 groups was 54 and 73 years. Mean baseline A1C was 8.6±1.7% and 8.2±1.6% in the <65 and ≥65 groups; mean 6 month GMI was 7.5±0.9% and 7.3±0.8%, respectively. Glycemic outcomes and System use data are shown for age subgroups (Table). Using GMI as an A1C proxy, pairwise comparisons of GMI at 6 months to baseline A1C (N=118) show a 1.1±1.4% improvement overall (P<0.05).

Discussion: The overall cohort consisted mostly of older T2D adults using MDI with suboptimal glycemic control. Given there may be concerns with older people adequately adopting and using new technology to manage diabetes, comparison with those younger highlights similar glycemic control and System engagement with Bigfoot Unity. Both groups demonstrate close adherence to established glycemic targets at 6 months.

Disclosure

S.Vaughan: Employee; Bigfoot Biomedical, Inc. J.Tillman: Employee; Bigfoot Biomedical, Inc. B.P.Olson: Employee; Bigfoot Biomedical, Inc. F.Sheikh: Employee; Bigfoot Biomedical, Inc. J.K.Malone: Employee; Bigfoot Biomedical, Inc.

Funding

Bigfoot Biomedical, Inc.
97-LB: Empagliflozin Improves Cardiopulmonary Function and VE/VCO2 in Patients with T2D and HFrEF
Authors: QIN YUEJUAN , ACOSTA FRANCISCA M. , NEPPALA SIVARAM , CORTES TIFFANY M. , STEPANENKO ALLISON , MOODY ALEXANDER , SANCHEZ NOAH D. , BROWN MARISSA , CRUZ MORENO LUIS A. , TRIPLITT CURTIS L. , CLARKE GEOFFREY D. , CERSOSIMO EUGENIO , ESPINOZA SARA E. , DEFRONZO RALPH A. , SOLIS-HERRERA CAROLINA
Published: June 2023

Background: Cardioprotective benefits of SGLT2 inhibitors (SGLT2i) are well established. However, their effects on cardiopulmonary function measured by CPET in patients with T2D and HFrEF continue to be largely unknown.

Objective: Examine the effects of SGLT2i on cardiopulmonary function measured by cardiopulmonary exercise test (CPET) & 6MWT in patients with T2D & HFrEF.

Methods: Six subjects with T2D with HFrEF (<40%) (Age=59±2.6, BMI=33.3±1.1, A1c=7.1±0.3, EF 28±4%) were randomized to empagliflozin 25mg (SGLT2i) vs. placebo in a 2:1 fashion for 12 weeks. Cardiac MRI, 6MWT, and CPET were performed pre- and post-intervention.

Results: SGLT2i group showed an increase in EF. All subjects reached submaximal cardiovascular effort (RER≤1.10). The Ventilatory Anaerobic Threshold (VT, submaximal index of exercise capacity) showed a significant increase in VT time with SGLT2i (p=0.05). The rest of the parameters trended toward improvement including Ve/VCO2 slope and 6MWT.

Conclusion: Subjects with T2D and HFrEF, treated with an SGLT2i had improved EF, a decrease in the worsening of the Ve/VCO2 slope (a predictor of mortality in HF patients), an increase in 6MWT, and significantly improved VT time (aerobic metabolism) compared to placebo. These findings may represent a novel mechanism of CV protection and warrants further investigation.

Disclosure

Y. Qin: None. C. L. Triplitt: Speaker's Bureau; Novo Nordisk. G. D. Clarke: None. E. Cersosimo: None. S. E. Espinoza: None. R. A. Defronzo: Advisory Panel; AstraZeneca, Bayer Inc., Boehringer-Ingelheim, Novo Nordisk, Research Support; AstraZeneca, Boehringer-Ingelheim, Merck & Co., Inc., Speaker's Bureau; AstraZeneca. C. Solis-herrera: None. F. M. Acosta: None. S. Neppala: None. T. M. Cortes: None. A. Stepanenko: None. A. Moody: None. N. D. Sanchez: None. M. Brown: None. L. A. Cruz moreno: None.

Funding

Doris Duke Charitable Foundation; Voelcker Foundation; National Institutes of Health
971-P: Targeting Personalized Glycemic Response Led to Reduction in Glycemic Variability in Fitterfly CGM Diabetes Digital Therapeutics Program
Authors: VERMA RITIKA , KHADER MOHAMMED A. , LATHIA TEJAL , TANNA SNEHAL R. , PATANGE SONALI A. , SAMUDRA KIRTI , ROHATGI RAGINI M. , CHITALE MANOJ S. , RANADIVE RUCHIRA M. , GUNTUR SAIMALA , SINGAL ARBINDER K.
Published: June 2023

Background and Aim: Glycemic variability (GV) has shown association with higher risk of diabetes-related complications and increased cardiovascular events in people with T2DM. Personalized glycemic response (PGR) refers to differences in postprandial glycemic response between two people after consumption of the same food. Understanding of PGR after meals can help in improving glycemic control. The study aims at assessing the real-world effectiveness of the PGR based Fitterfly Diabetes CGM program to reduce GV among people with T2DM.

Methods: De-identified data of 220 participants (mean age: 48.8 ± 12.8 years, female: 35.9 % (79/220)), enrolled in the Fitterfly Diabetes CGM program was analyzed. CGM access was provided in the first 14 days of the program. In week-1, the users followed their usual lifestyle where blood sugar readings were correlated with meals and other lifestyle data to understand the PGR of each user. A modified lifestyle plan was introduced in week-2 and was followed till the end of the program. Mean blood glucose (mg/dL), TIR, TAR, TBR, glucose management indicator (GMI), and the percentage coefficient of variation for glucose (CV) were analyzed in week-1 and week-2. All data has been represented as median (IQR).

Results: After 7 days, the median mean blood glucose and TAR significantly reduced by -4.3 (-14.8, 3.3) mg/dL (P<.001) and -2.5 (-11.6, 5.2) % (P<.001) from week-1 baseline of 130.4 (104.4, 169.7) mg/dl and 15.1 (2.8, 36.8) % respectively. The median TIR significantly increased by 1.7 (-2.8, 7.0) % from a baseline of 77.7 (57.2, 89.9) % (P=.001). The median GMI and CV was significantly reduced by -0.1 (-0.3, 0.1) % (P<.001) and -0.7 (-3.4, 1.8) % (P=.005) from baseline of 6.4 (5.8, 7.4) % and 26.9 (22.9, 31.9) % respectively. No significant change was observed in median TBR (P=.40).

Conclusion: The study showed significant improvement in glycemic control and GV after 7 days of PGR-based guidance on the Fitterfly Diabetes CGM program.

Disclosure

R.Verma: Employee; Fitterfly Healthtech Pvt Ltd. S.Guntur: Employee; Fitterfly Health Tech Pvt. Ltd. A.K.Singal: Employee; Fitterfly Healthtech Pvt Ltd. M.A.Khader: Employee; Fitterfly Health Tech Pvt. Ltd. T.Lathia: None. S.R.Tanna: None. S.A.Patange: None. K.Samudra: None. R.M.Rohatgi: None. M.S.Chitale: None. R.M.Ranadive: Employee; Fitterfly Health Tech Pvt. Ltd.

Funding

Fitterfly Healthtech Pvt. Ltd.
974-P: BGM Readings in Range as a Marker of Glycemic Variability in People with Type 2 Diabetes—Interim Analysis from an Ongoing Prospective Study
Authors: MAKKAR BRIJ M. , SOOTA KIRTI , GUPTA VIPUL , SHARMA JUGAL K. , KHURANA GIRISH , CHAWLA RAJEEV
Published: June 2023

Background: Glycemic variability (GV) is emerging as an independent risk factor for long-term complications. However, measuring GV using CGM is expensive and used sparingly in India. We evaluated BGM readings in-range, above range, and below range (RIR, RAR, RBR) using the OneTouch Verio Flex® (OTVF) BGM with the OneTouch Reveal® (OTR) application to assess GV and its correlation with TIR, TAR and TBR measured using CGM.

Aims and Objectives:1. To evaluate structured BGM as a tool for estimating GV 2. To assess the correlation between BGM-measured RIR, RAR, RBR and the GV parameters reported on AGP using Libre Pro CGM

Materials and Methods: We performed data analysis of 76 completed patients from an ongoing, prospective, multicentre, investigator-initiated study being conducted in New Delhi, India. Persons with T2D on stable treatment (OADs, OADs + Insulin, or Insulin) for ≥ 4 weeks were randomized 1:1 to perform daily 4-point profiles or 7-point profiles using structured BGM readings for 14 days while also wearing blinded CGM using the Libre Pro system. CGM parameters were compared with BGM readings in different ranges measured on the OTR platform.

Results: Most of the PwD performed fewer BGM readings than advised (average readings/day 3.62±1.4). There were strong correlations between daily average glucose, TIR and RIR, TAR and RAR, TBR and RBR (r 0.926, p<0.0001; r 0.805, p<0.00001; r 0.826, p<0.00001; r 0.348, p=0.0092, respectively). Further, there was a significant correlation between 14 days average glucose (158.3mg/dl±56.85 vs 186.13mg/dl±58.9, p=0.0139), TIR vs RIR (66.09%±27.59 vs 52.477%±28.65), TAR vs RAR (30%±29.45 vs 46.95%±28.78, p=0.0029), and TBR vs RBR (3.91%±6.27 vs 0.58%±1.54, p=0.0002).

Conclusion: Structured BGM using OneTouch Verio Flex® paired with the OneTouch Reveal application may be used to assess glycemic variability.

Disclosure

B.M.Makkar: Advisory Panel; AstraZeneca, Boehringer Ingelheim (Canada) Ltd., Novartis, Novo Nordisk, Sanofi, Research Support; Lifescan. K.Soota: Research Support; LIFESCAN. V.Gupta: None. J.K.Sharma: None. G.Khurana: None. R.Chawla: None.

Funding

LifeScan
975-P: Clinical and Lifestyle Determinants of Continuous Glucose Monitoring Metrics in Insulin-Treated Patients with Type 2 Diabetes
Authors: YOUNG LEE DA , KIM NAMHO , JUNG INHA , YOUNG PARK SO , HEE YU JI , A SEO JI , PARK SUNG-MIN , HEE KIM NAN
Published: June 2023

Objective: There was limited evidence to evaluate the association between lifestyle habits and continuous glucose monitoring (CGM) metrics. Thus, we aimed to depict the behavioral and metabolic determinants of CGM metrics in insulin-treated patients with type 2 diabetes (T2DM).

Methods: This is a prospective observational study. We analyzed data from 122 insulin-treated patients with T2DM. Participants wore Dexcom G6 and Fitbit, and diet information was identified for 10 days. Multivariate-adjusted logistic regression analysis was performed for the simultaneous achievement of CGM-based targets, defined by the percentage of time in terms of hyper, hypoglycemia and glycemic variability (GV). Intake of macronutrients and fiber, step counts, sleep, postprandial C-peptide to glucose ratio (PCGR), information about glucose-lowering medications and metabolic factors were added to the analyses. Additionally, we evaluated the impact of the distribution of energy and macronutrient during a day, and snack consumption on CGM metrics.

Results: Logistic regression analysis revealed that female, participants with high PCGR, low HbA1c and daytime step count had a higher probability of achieving all targets based on CGM (odds ratios [95% confidence intervals] which were 0.24 [0.09–0.65], 0.95 [0.9–0.99], 1.34 [1.03–1.25], and 1.15 [1.03–1.29], respectively). And participants who ate snacks showed a shorter period of hyperglycemia and less GV compared to those without.

Conclusions: We confirmed that residual insulin secretion, daytime step count, HbA1c, and women were the most relevant determinants of adequate glycemic control in insulin-treated patients with T2DM. In addition, individuals with snack consumption were exposed to lower times of hyperglycemia and GV.

Disclosure

D.Lee: None. N.Kim: None. I.Jung: None. S.Park: None. J.Yu: None. J.Seo: None. S.Park: None. N.Kim: None.

Funding

National Research Foundation of Korea (2019M3E5D3073102, 2019R1H1A2039682, 2020R1I1A1A01071665); National IT Industry Promotion Agency (S0252-21-1001)
977-P: Continuous Glucose Monitoring in the Early Post–Lung Transplantation Period
Authors: MUNOZ PENA JUAN M. , RASMUSSEN HANNAH , SALLOUM RAMZI G. , CHONG LEONG MAN , ALGARRA KIMBERLY A.
Published: June 2023

Objective: Post-Transplant Diabetes Mellitus (PTDM) occurs in an estimated 20-40% of lung transplantation within five years, and hyperglycemia adversely affects outcomes, including rejection, infection, cardiovascular events, and mortality. Whereas continuous glucose monitoring (CGM) is common in patients with type 1 and type 2 diabetes mellitus, there is a significant knowledge gap in its application to PTDM. The objective of this study was to evaluate the performance of CGM in detecting hypoglycemia and hyperglycemia in the early post-lung transplantation period, compared with self-monitoring blood glucose.

Research and Design Methods: We conducted a prospective pilot study with patients aged 18-75 who underwent lung transplantation and had hyperglycemia managed with insulin. Enrolled patients wore a blinded CGM at discharge and self-monitored glucose levels at home for 10 days. Data were summarized according to the following categories and compared across both tests using the paired t-test: % time in range (70-180 mg/dl); % high (181-250 mg/dl); % very high (>250 mg/dl); % low (50-69 mg/dl); % very low (<50 mg/dl).

Results: The sample included 15 patients (mean age 58.6 years; 53.3% men; 73.3% with pre-transplantation diabetes). There was a significantly higher rate of detection for hyperglycemia with CGM use vs. self-monitored blood glucose. For the “% very high” group, the mean difference was 7.12, (95% confidence interval [CI], 1.8-12.4), and for the “% high” group, the mean difference was 11.1, (95% CI, 3.5-18.8), and for the combined group, “% high and % very high”, the mean difference was 18.3, (95% CI: 7.37-29.24). There was no statistically significant difference for the “% low and % very low” groups.

Conclusions: CGM demonstrated a higher rate of detection for hyperglycemia compared to self-monitoring blood glucose. The mean difference for hypoglycemia detection was not significant. Larger studies are required to provide statistically meaningful conclusions about CGM in PTDM.

Disclosure

J.M.Munoz pena: None. H.Rasmussen: None. R.G.Salloum: None. M.Leong: None. K.A.Algarra: None.

Funding

Dexcom, Inc. (MM130159)
98-LB: Effects of SGLT2 Inhibition on Skeletal Muscle Bioenergetics and Myocellular Lipids in Patients with T2D and HFrEF
Authors: QIN YUEJUAN , SANCHEZ NOAH D. , MOODY ALEXANDER , ACOSTA FRANCISCA M. , NEPPALA SIVARAM , BROWN MARISSA , HONKA HENRI , CRUZ MORENO LUIS A. , TRIPLITT CURTIS L. , CLARKE GEOFFREY D. , CERSOSIMO EUGENIO , DEFRONZO RALPH A. , SOLIS-HERRERA CAROLINA
Published: June 2023

Background: The CV benefits of SGLT2i are well established. However, how skeletal muscle (SkM) bioenergetics respond to SGLT2i in T2D and HFrEF remains largely unknown.

Objective: To explore the effects of empagliflozin on SkM bioenergetics (phosphorus metabolites & myocellular lipid content) at rest and post-exercise (31P & 1H MRS) and cardiac function (MRI). Methods: Subjects with T2D & HFrEF (<40%) (n=6) were randomized 2:1 to empagliflozin 25mg (SGLT2i) or placebo for 12 wks (Age=59±2.6, BMI=33.3±1.1, A1c=7.1±0.3, EF 28±4%). A cardiac MRI, & static/dynamic 31P & 1H SkM by MRS, were performed before & after treatment.

Results: In the empagliflozin group, SkM 31P MRS at rest, showed decrease in phosphodiesterase [PDE]. 31P MRS post-exercise, showed significant improvement in Phosphocreatinine (PCr) recovery, expressed by the K value. 1H MRS showed a reduction of saturated intramyocellular lipids (IMCL-CH2:CH3 ratio).

Conclusion: Empagliflozin in subjects with T2D and HFrEF had beneficial effects in SkM energy utilization and muscle recovery post-exercise as determined by a decrease in PDE and increase in K value. Additionally, empagliflozin decreased saturated IMCL, which could be expected to improve mitochondrial function and energy utilization. If similar findings were to occur in cardiac muscle, this could provide a novel mechanism for the beneficial CV effects of SGLT2i.

Disclosure

Y. Qin: None. N. D. Sanchez: None. A. Moody: None. F. M. Acosta: None. S. Neppala: None. M. Brown: None. H. Honka: None. L. A. Cruz Moreno: None. C. L. Triplitt: Speaker's Bureau; Novo Nordisk. G. D. Clarke: None. E. Cersosimo: None. R. A. DeFronzo: Speaker's Bureau; AstraZeneca. Advisory Panel; AstraZeneca, Bayer Inc., Boehringer-Ingelheim, Novo Nordisk. Research Support; AstraZeneca, Boehringer-Ingelheim, Merck & Co., Inc. C. Solis-Herrera: None.

Funding

Doris Duke Charitable Foundation; Voelcker Foundation; National Institutes of Health
98-OR: Oral Insulin Alleviates Liver Fibrosis and Reduces Fat in Patients with NASH and Type 2 Diabetes—Results of Phase II Clinical Trial
Authors: ISHAY YUVAL , NEUTEL JOEL M. , KOLBEN YOTAM , GELMAN RAM , SNEH ARBIB ORLY , LOPEZ OLIVER , SOTOLONGO ROBERTO , ILAN YARON , KIDRON MIRIAM
Published: June 2023

NAFLD is the most common liver disorder in the USA. NASH is an advanced form of NAFLD and a leading cause of end-stage liver disease and indication for liver transplantation. Insulin resistance and inflammation underlie the pathogenesis of the disease. This double-blind, randomized, placebo-controlled, multicenter study aimed to determine the effect of oral insulin in patients with NASH and T2DM. Patients were treated twice daily for 12 weeks with an 8 mg insulin (n=21) or placebo (n=11) capsule. Safety was monitored throughout the study. At screening and after 12 weeks of treatment, liver fat content was measured by MRI-PDFF and liver fibrosis and steatosis levels by FibroScan®. No severe drug-related adverse events were reported during the study. After 12 weeks of treatment, mean percent reductions in whole-liver (-11.2±22.8% vs. -6.5±15.3%, respectively) and liver segment 3 (-11.7±21.1% vs. +0.1±17.3%, respectively) fat content were higher in the insulin as compared to the placebo arm. Patients receiving insulin showed a median -1.1 kPa and -21.0 dB/m reduction from baseline fibrosis and steatosis levels, respectively. In comparison, placebo-treated patients showed median increases of 0.3 kPa and 13.0 dB/m, respectively. At Week 12, HbA1c levels decreased by a mean -0.27±1.3% in the oral insulin cohort and increased by a mean 0.23±0.73% in the placebo cohort. Mean percent changes from baseline ALT and AST levels were -0.1±30.4% and -0.8±28.6%, respectively, in the oral insulin arm and 3.0±26.7% and 13.4±46.6%, respectively, in the placebo arm. Over the treatment period, mean total cholesterol, HDL, LDL, and triglycerides levels were consistently lower than baseline in the active arm and higher than baseline in the placebo arm. The results of this feasibility study support the safety and potential therapeutic effect of orally delivered insulin on liver fibrosis, fat accumulation, and inflammatory processes.

Disclosure

Y.Ishay: None. J.M.Neutel: None. Y.Kolben: None. R.Gelman: None. O.Sneh arbib: None. O.Lopez: None. R.Sotolongo: None. Y.Ilan: None. M.Kidron: Employee; Oramed Pharmaceuticals.
986-P: Near-Infrared Device for Screening of Diabetes—ANODE02 Study
Authors: XAVIER COS FRANCESC , LAZARO-PACHECO DANIELA , SALTER JOHN E. , PALDANIUS PAIVI M.
Published: June 2023

Background: Currently, screening for diabetes mellitus (DM) can be complex, inefficient and often resource-intensive with invasive sampling. Affordable screening tools with high specificity will be essential for smart allocation of limited healthcare resources for those in need of further diagnostics.

Materials and methods: We explored the accuracy and safety of a novel compact miniaturized near-infrared (NIR) full-spectrum spectroscopy device intended for DM screening. Assessments of up to 30 NIR spectra per each middle fingernail and hand, in a cohort of people living with (n=50) or without (n=50) DM focused on detection of dichotomised DM status (< HbA1c 48 mmol/mol or 6.5% ≥) and specificity (%) based chemometrics outcomes, in assessment of glycated nail keratin versus an HbA1c point-of-care assay as control.

Results: Demographics of a community primary care centre-based cohort (n=100) are presented in Table. Overall, no adverse NIR-device-related events were being reported for any of the over 6000 spectral measurements. Based on the best chemometrics model, the NIR-device demonstrated a specificity of 98.5% (95%CI 95.5 - 100.0) and 88.9% (80.5 - 97.3) at 48 and 42 mmol/mol cut-off levels, respectively, in detection of those without DM.

Conclusions: Our preliminary results are indicative of high specificity and safe implementation of non-invasive NIR technology with potential for early detection and management of increasing DM risk.

Disclosure

F.Cos: Advisory Panel; AstraZeneca, Boehringer Ingelheim International GmbH, Abbott Diagnostics, Lilly, Novo Nordisk, Consultant; Glyconics Ltd, Menarini Group, Speaker's Bureau; AstraZeneca, Boehringer Ingelheim International GmbH, Lilly. D.Lazaro-pacheco: Consultant; Glyconics Ltd. J.E.Salter: None. P.M.Paldanius: Consultant; Glyconics Ltd, Speaker's Bureau; Novartis.

Funding

Glyconics
99-LB: Myocardial Blood Flow in Association with Baseline Ejection Fraction after Elevation in Plasma Ketones in Patients with T2DM and Heart Failure
Authors: SOLIS-HERRERA CAROLINA , QIN YUEJUAN , HONKA HENRI , ACOSTA FRANCISCA M. , MOODY ALEXANDER , CHAVEZ ALBERTO , TRIPLITT CURTIS L. , CLARKE GEOFFREY D. , CERSOSIMO EUGENIO , DEFRONZO RALPH A.
Published: June 2023

Background: SGLT2 inhibitors have been shown to provide CV benefits in HFpEF and HFrEF patients with and without diabetes. The underlying mechanisms continue being explored.

Objective: To examine the effect of hyperketonemia on myocardial blood flow (MBF) in patients with HF and T2DM.

Methods: Subjects with T2DM and HF (EF <50%) received a 6-hr BOHB infusion or a HCO3 infusion (control). A cardiac MRI and a PET study with 18FDG and 15O water were performed before and after the infusion.

Results: Twelve Subjects were studied (Age=60; BMI=32 kg/m2; A1c = 7.7%). Plasma ketone levels reached 1.6±0.2mmol/L. MBF significantly increased in six subjects (“responders” 1.05±0.13 to 1.38±0.17, p = 0.003) and decrease in six subjects (“non-responders” 1.44±0.07 to 0.95±0.08, p = 0.007). With multivariable analysis, only baseline EF was shown to significantly correlate with the increase in MBF.

Conclusion: These findings suggest that patients with a higher baseline EF might be more responsive to ketones and be able to increase MBF as an additional mechanism of CV improvement. These novel results shed new light on the potential effect of ketones in different populations of patients with HF and needs to be further explored.

Disclosure

C. Solis-Herrera: None. Y. Qin: None. H. Honka: None. F. M. Acosta: None. A. Moody: None. A. Chavez: None. C. L. Triplitt: Speaker's Bureau; Novo Nordisk. G. D. Clarke: None. E. Cersosimo: None. R. A. DeFronzo: Speaker's Bureau; AstraZeneca. Advisory Panel; AstraZeneca, Bayer Inc., Boehringer-Ingelheim, Novo Nordisk. Research Support; AstraZeneca, Boehringer-Ingelheim, Merck & Co., Inc.

Funding

Max and Minnie Tomerlin Voelcker Fund; Merck & Co., Inc.