bluuebunny/crossref_metadata_2025 huggingface dataset:
Expansionary monetary policy vs. bank concentration: The Eurozone & other European countries
Authors: Jovic Zeljko
Published: June 2023

Expansionary monetary policy, combined with unconventional measures, led to a decline in the profitability of U.S. and European banks. In this paper, we study whether such measures also affected the asset concentration in the European banking sector. The findings of this research add value to previous research, taking a step deeper into examining the consequences of expansionary monetary policy. We find that reductions in the ECB?s key policy rate can predominantly explain the concentration growth in the Eurozone countries. The ECB?s monetary policy had a more substantial influence on the growth of the concentration of banks outside the Eurozone than the own monetary policies of those countries. In this way, expansionary monetary policy poses specific challenges to financial stability in Europe.
1787-PUB: An Increased Risk of Metabolic Syndrome in Type 2 Diabetes Mellitus Patients Is Suggested by a High TG/HDL Ratio—A Retrospective Study
Authors: SAXENA ASHISH K. , GUPTA MUKULESH , LAKSHMANAN MEENAKSHISUNDARAM , SHEOHARE RAKA , PATNI BIJAY , ASLAM MOHSIN , MAHESHWARI ANUJ , SINGH NAGENDRA K. , HIREMATH VINAYAK S. , S. DARIYA S. , PATIL AASHNA , PATRA SURAJEET K. , KUMAR DINESH , REGULLA RAMA
Published: June 2023

Background: The prevalence of cardiovascular events and the risk of mortality are higher among patients with Metabolic syndrome (MetS), and the risk factors include central obesity, increased blood pressure, increased fasting blood glucose (FBG) levels and abnormal blood lipids. Early diagnosis of MetS and timely intervention can prevent unnecessary complications related to its progression and help reduce the risk of Cardiovascular disorders (CVD).

Purpose: The purpose of this EHR-based real-world study was to identify the relationship between Triglyceride/High-density lipoprotein cholesterol (TG/HDL-C) ratio and metabolic syndrome.

Methods: Participants in the trial must have had type 2 diabetes mellitus for at least six months and must be presenting for routine treatment in one of 14 centres around the nation. Data on medical history, diabetes complications, medications, and laboratory values were gathered using an EMR (MEDEVA) integrated research proforma, and the study period was for six months (March-August 2022). Clinical and statistical professionals at MEDEVA combined anonymized data and conducted analyses using Python 3.6 (pandas, scikit-learn, SciPy for exploratory data analysis, and Matplotlib for exploratory visualisation), SPSS version 26 (statistical analysis).

Results: Of the 372 patients with Type 2 Diabetes Mellitus, 278 had Metabolic Syndrome (MetS), and 94 did not have MetS. The TG/HDL ratio was significantly higher for the group with MetS (5.1) than the group without MetS (2.7). As a next step, to avoid potential confounding, the sample was adjusted for BMI and age, i.e., covariate matching was done. The TG/HDL ratio continued to be higher for the group with MetS (5.4) than the group without MetS (2.7).

Conclusion: We discovered a strong link between metabolic syndrome and the TG/HDL-C ratio. A high TG/HDL ratio indicates an increased risk of developing metabolic syndrome.

Disclosure

A.K.Saxena: None. S.S.Dariya: None. A.Patil: None. S.K.Patra: None. D.Kumar: None. R.Regulla: None. M.Gupta: None. M.Lakshmanan: None. R.Sheohare: None. B.Patni: None. M.Aslam: None. A.Maheshwari: None. N.K.Singh: None. V.S.Hiremath: None.
1790-PUB: Effectiveness of an Intensive Lifestyle Modification Program on Type 2 Diabetes Remission in Indian Population
Authors: TRIPATHI PRAMOD , KADAM NIDHI S. , SHARMA BABY , VYAWAHARE ANAGHA R. , GANLA MALHAR H. , DAS BISWAS MAYURIKA , SABOO BANSHI D.
Published: June 2023

Background and Aim: Type 2 diabetes (T2D) remission is widely reported across the world. However, there are no large-scale cohort studies that report the effectiveness of lifestyle intervention on T2D remission, especially in Indian population. The study aimed to evaluate the effectiveness of a one-year lifestyle modification program-Holistic Transformation Program (HTP) on T2D remission in Indian population.

Materials and methods: Patients with diagnosed T2D (>18 years of age) were recruited in a one-year intensive lifestyle modification program at the Freedom from Diabetes Clinic, Pune (India) between April and December 2021. The intervention included a customized vegan diet, exercises, stress management support, and medical management. Anthropometric and biochemical parameters were assessed with scheduled consults every 3 months. Remission was defined as HbA1c<48 mmol/mol for a minimum of 3 months without the use of antidiabetic medication.

Results: The mean age and duration of diabetes were 52.0±10.6 years and 10.3±7.9 years, respectively (n=2764). Post-intervention, median weight, and HbA1c decreased significantly (weight-71 kgs to 67 kgs, p<0.01; HbA1c-7.5% to 6.6%) (p<0.05). Remission was seen in 837 (30.3%) patients. Significantly higher remission was seen in those with >15 kg weight loss and with diabetes duration of <10 years (p<0.05). Remission was highest in those who never started medication (with HbA1c>48 mmol/mol at baseline) (79%) followed by those only on oral hypoglycemic agents (31.7%). Improvement in HbA1c and weight loss were similar between patients on external insulin and/or OHA (p>0.1) indicating efficacy of the intervention irrespective of the medicine status at baseline.

Conclusion: Our findings suggest that customized lifestyle intervention is beneficial in achieving T2D remission in Indian population. A one-year post-intervention follow-up is underway to understand the long-term effects of the intervention.

Disclosure

P. Tripathi: Board Member; Freedom from Diabetes Clinic. N.S. Kadam: Research Support; Freedom from Diabetes Clinic. B. Sharma: Research Support; Freedom From Diabetes clinic. A.R. Vyawahare: Research Support; Freedom From Diabetes. M.H. Ganla: Employee; Freedom from Diabetes Clinic. M. Das Biswas: Employee; Freedom from Diabetes Clinic. B.D. Saboo: None.
1791-PUB: Implementation of a Food Pharmacy into a Pediatric Diabetes Clinic
Authors: FRYMARK EMILY , RICHARDSON ALEXIS M. , KESSENICH HADLEY , HOLLY SARAH L. , ODIMAYOMI OMOTOKE , TOPPING SUSAN , LEON JACQUELINE , MAJIDI SHIDEH
Published: June 2023

Introduction: Social Determinants of Health (SDOH) is an essential focus in providing equitable diabetes care. Food and nutrition are integral parts of T1D and T2D management. Food insecurity (FI) increases the risk for T2D and is associated with higher A1C levels and hospitalization in those with diabetes. Children’s National Hospital and Capital Area Food Bank (CAFB) collaborated to create a Food Pharmacy within the diabetes clinic.

Methods: The Food Pharmacy Program was implemented October 2021. Groceries, including grains, vegetables, fruit, dairy, and protein, are provided by the CAFB and stored in clinic. Each set of bags weighs about 50 lbs and serves a family of 4 for 3 days. A FI questionnaire is provided to diabetes patient families during their clinic visit. If positive, families qualify to receive supplemental groceries from the clinic, which are provided to families before they leave. Menus change on a quarterly basis based on feedback from patients and the dietetic team.

Results: To date, 62% screened positive for FI. Approximately 20% of our diabetes patient population (496 families) have received groceries (46% male; mean age 14.4±3.9 years; 46% T1D; 51% prediabetes or T2D; mean diabetes duration 3.4 years; Ethnicity: 32% Hispanic; Race: 55% Black; 5% Caucasian). Over the initial 6 months of the program, an average of 49 families per month were receiving groceries. Since then, an average of 117 families per month are receiving groceries. A total of 24,800 pounds of food have been provided through the Food Pharmacy.

Conclusions: A Food Pharmacy was successfully implemented within a diabetes clinic, showing the benefits of a partnership between a hospital and local food bank focusing on SDOH to improve patient care. A research project is being developed to study diabetes, psychosocial, cost analysis, and health utilization outcomes with a more intensive food intervention in youth with prediabetes or T2D.

Disclosure

E. Frymark: None. A.M. Richardson: None. H. Kessenich: None. S.L. Holly: None. O. Odimayomi: None. S. Topping: None. J. Leon: None. S. Majidi: None.
1792-PUB: Predictors of Weight Loss Variability in the COVID-19 Disrupted ACT1ON Diet Pilot in Young Adults with T1D
Authors: IGUDESMAN DARIA , ADDALA ANANTA , CRANDELL JAMIE , MUNTIS FRANKLIN R. , ZAHARIEVA DESSI P. , THOMAS JOAN , CORBIN KAREN , CASU ANNA , SUE KIRKMAN M. , KOSOROK MICHAEL R. , PRATLEY RICHARD E. , MAAHS DAVID M. , MAYER-DAVIS ELIZABETH J.
Published: June 2023

We reported that young adults with T1D and overweight or obesity lost equivalent weight when randomized to 3 months of a hypocaloric low carb or moderate low fat diet or an ad libitum Mediterranean diet. The remainder of the 9 month study was disrupted by COVID-19. We identified predictors of weight loss variability between study enrollment and completion/dropout, accounting for % of participant study time during COVID-19.

Potential predictors of % weight loss were identified a priori and included in multivariate models when univariate correlations had a p-value <0.2. General linear models used backward elimination. We introduced variables in groups (order: demographic and design, clinical, behavioral); the variable with the highest p-value was sequentially removed until those with p<0.2 remained.

Crude weight changed by -0.87% (95%CI -2.6, 0.85, p=0.31, n=48) over 12 months (IQR 10.8, 12.9). Accounting for % COVID-19 time and study duration, 26.3% (model p=0.07) of weight loss variability was collectively explained by employment status (full-time lost less weight than unemployed), age at highest weight (weight loss decreased with younger age), education level (more weight loss with bachelor degree or higher than less education), and HbA1c (weight loss decreased with higher HbA1c, Table). Larger studies should confirm these findings and uncover additional predictors of weight loss success in T1D.

Disclosure

D.Igudesman: None. M.R.Kosorok: None. R.E.Pratley: Other Relationship; Bayer Inc., Corcept Therapeutics, Dexcom, Inc., Gasherbrum Bio, Inc., Hanmi Pharm. Co., Ltd., Hengrui (USA) Ltd., Merck Sharp & Dohme Corp., Novo Nordisk, Pfizer Inc., Rivus Pharmaceuticals Inc., Sanofi, Scohia Pharma Inc., Sun Pharmaceutical Industries Ltd. D.M.Maahs: Advisory Panel; Medtronic, LifeScan Diabetes Institute, MannKind Corporation, Consultant; Abbott, Research Support; Dexcom, Inc. E.J.Mayer-davis: None. A.Addala: None. J.Crandell: None. F.R.Muntis: None. D.P.Zaharieva: Advisory Panel; Dexcom, Inc., Research Support; Hemsley Charitable Trust, International Society for Pediatric and Adolescent Diabetes, Insulet Corporation, Speaker's Bureau; American Diabetes Association, Ascensia Diabetes Care, Medtronic. J.Thomas: None. K.Corbin: None. A.Casu: None. M.Kirkman: None.

Funding

National Institute of Diabetes and Digestive and Kidney Diseases (1DP3DK113358-01)
1793-PUB: Effects of Nonnutritive Sweeteners on Glycemic Indices in Healthy Persons, with Overweight or Obesity, or Diabetes—A Systematic Review and Meta-analysis of Randomized Controlled Trials
Authors: AMIRHOSSEIN GOLZAN S. , ESPINOSA ALAN , ABBASI MOHAMMADMAHDI , MOVAHEDIAN MINA , FATHI MOBINA , HEKMATDOOST AZITA
Published: June 2023

Evidence on nonnutritive sweeteners (NNS) and glycemia is controversial due to possible mechanisms promoting glucose intolerance. No study had systematically assessed variations in glycemic outcomes based on NNS type and dose, length of exposure, and nature of the comparator in trials evaluating subjects undergoing different clinical conditions. We conducted a systematic review and meta-analysis summarizing trials contrasting NNS consumers vs. non-consumers to assess the effect on eight glycemic indices. In participants without any major disease at baseline, NNS intake significantly increased fasting blood glucose (FBG). FBG and fasting insulin (FI) were higher among NNS consumers with hyperglycemia, those who followed for > 8wk, consumers of ≤ 350 mg/d, and participants receiving sucralose. Sucralose also increased 2h-glucose and 2h-insulin but reduced HbA1c. Aspartame increased HbA1c. Participants with obesity consuming NNS displayed significantly less FBG, FI, and HOMA. Results were consistent when clustering those with controlled baseline glycemia, subjects followed for ≤ 8wk, consumers of > 350 mg/d, and those replacing sugar with NNS. NNS consumers with baseline hyperglycemia exhibited less FI and HOMA. Participants consuming ≤ 350 mg/d displayed reductions in FBG and HOMA. Trials evaluating stevia consumers reported less FBG and FI levels. We found no overall effect on persons with diabetes. Subgroup assessments revealed that persons with diabetes with uncontrolled glycemia at baseline or who were followed for > 10wk displayed higher FI. In summary, the effect of NNS in glycemia varies across indices and between persons with inequivalent clinical conditions. Higher doses of NNS or longer interventions do not necessarily improve glycemic indices. Better-designed trials evaluating glycemic metabolism are needed to elucidate if NNS can be used as an alternative to sugar.

Disclosure

S.Golzan: None. A.Espinosa: None. M.Abbasi: None. M.Movahedian: None. M.Fathi: None. A.Hekmatdoost: None.
1795-PUB: Teaming Up for T1D with Telehealth—An Initial Look at Youth and Family Coping following a New T1D Diagnosis
Authors: HOWARD KELSEY R. , SMITH NICHOLAS DAVID W. , GARZA KIMBERLY P. , WEISSBERG-BENCHELL JILL , FELDMAN MARISSA
Published: June 2023

Purpose: A diagnosis of T1D is often associated with increased youth and parental distress as families learn to manage complex daily diabetes tasks and navigate glycemic fluctuations. This study sought to capture the early experiences of families following initial diagnosis, specifically focusing on its psychosocial impact.

Method: Eight children (8-12; M=9.0; SD=1.3), 12 teenagers (13-17; M=14.7; SD=1.9) with T1D and 31 parents of youth ages 3-17 diagnosed with T1D were surveyed two weeks following diagnosis as part of a larger pilot of a prevention intervention to support families during the first-year post diagnosis. Additionally, electronic medical records were reviewed 3 months post diagnosis to evaluate health care utilization and medical outcomes.

Results: Two weeks post T1D diagnosis, some parents (38.7%) and youth (18.8%) reported elevated symptoms of depression. Similarly, 36.7% of parents and 12.5% of youth reported elevated symptoms of anxiety. Fewer youth (11.8%) and parents (11.1%) endorsed elevated diabetes distress at two weeks post-diagnosis. At 3 months, mean A1c was 7.5% (SD = 1.4) and mean time in range was 67% (SD = 21.8). No baseline variables were correlated with A1c at 3 months post-diagnosis; however, youth report of family conflict was negatively correlated with time in range (r = -.761; p <.01). At 3 months following diagnosis, nearly all (92.6%) youth were using CGM, while few (7.7%) were using insulin pumps.

Discussion: This study examined the experiences of youth and their parents following a T1D diagnosis, along with 3-month post diagnosis clinical outcomes. Many parents experience elevated symptoms of depression and anxiety two weeks following diagnosis. Few baseline variables correlated with clinical outcomes at three months following diagnosis. Future studies should examine family experiences in the first year following diagnosis, as well as interventions that promote positive coping among youth and their parents.

Disclosure

K.R.Howard: Stock/Shareholder; Abbott, AbbVie Inc. N.W.Smith: None. K.P.Garza: None. J.Weissberg-benchell: Advisory Panel; Beta Bionics, Inc., Research Support; Beta Bionics, Inc. M.Feldman: None.

Funding

JDRF (2-SRA-2020-985-S-B)
1798-PUB: Clinical Factors Associated with Positive Depression Screen in Youth with Type 1 Diabetes Before and During the COVID 19 Pandemic
Authors: SRIRAM SWETHA , MARCH CHRISTINE , LEIKAM LINDSAY M. , SCHREIBER JUSTIN , MUZUMDAR RADHIKA , LIBMAN INGRID
Published: June 2023

We have previously shown that 1 out of 5 adolescents with type 1 diabetes (T1D) scored positive for depression with no differences between 2019 (pre pandemic) vs 2020 (pandemic). We aimed to identify clinical factors associated with a positive screen and if these differ pre (2019) and during (2020) the pandemic in a large academic children’s hospital. We included 239 adolescents with T1D who completed a PHQ-9 screen in both years (52% female, 97 % non-Hispanic white, mean (SD) age 15.1 ± 1.7 years, T1D duration 7.0 ± 4.0 years, 54% and 63% were on insulin pumps, 68% and 62% were on continuous glucose monitors in 2019 and 2020 respectively. In 2019 12%, 4% and 3% had mild (PHQ-9 score 5-9), moderate (score 10-14), and severe (score >15) depression respectively with similar rates in 2020 at 9%, 3% and 3%. In univariable logistic regression, elevated HbA1c (OR 1.59, p<0.001) and prior mental health history (OR 15.5, p<0.001) increased the odds of a positive screen in 2019, but not age (p=0.94), diabetes duration (p=0.64) or pump/CGM use (p=0.33/p=0.16). Similar findings were seen in 2020. Proportion of adolescents with a positive 2019 screen who were not in counseling (n=6, 14%) doubled in 2020 (n=10, 29%), possibly reflecting inadequate access to services during the pandemic, albeit small numbers. There was no association between a positive depression screen and screening for comorbidities (thyroid, celiac disease, and dyslipidemia) or complications (nephropathy and retinopathy) in 2019 or 2020. Though the prevalence of depression did not change during the pandemic, the most vulnerable groups were those with pre-existing mental health diagnoses and uncontrolled diabetes. This highlights the need for continued mental health therapy services in this group. Screening for comorbidities or complications was not associated with a positive depression screen which is reassuring and may relate to these screens being done in clinic, including screening for retinopathy.

Disclosure

S.Sriram: None. C.March: None. L.M.Leikam: None. J.Schreiber: None. R.Muzumdar: None. I.Libman: Advisory Panel; Novo Nordisk.
1801-PUB: Efficacy and Safety of Once-Weekly Semaglutide in People with Type 1 Diabetes in Real-World Practice
Authors: BELLIDO VIRGINIA , GROS HERGUIDO NOELIA , AMUEDO SANDRA , BAENA ARIZA LUIS , ALFONSO SOTO M.
Published: June 2023

Introduction: Semaglutide has shown significant improvements in weight and HbA1c in T2D, but the data about the efficacy and safety in people with T1D (PWT1D) are scarce.

Aims & Methods: We conducted a retrospective study including adults with T1D and obesity who had initiated once weekly (OW) semaglutide adjunct to insulin, to evaluate its efficacy and safety.

Results: Twenty-one subjects were included (52.4% female, mean age 44.2 ± 12.9 years, diabetes duration 19.1 ± 10.8 years, HbA1c 7.7 ± 0.8%, BMI 38.3 ± 5.9 kg/m2). Of them, 47.6% had hypertension, 52.4% dyslipidaemia, 23.8% cardiovascular disease, and 19% renal disease. Mean treatment duration was 30.4 weeks. Mean OW semaglutide dose was 0.8 ± 0.2 mg. Significant reductions in HbA1c (-0,6 ± 0.7%), weight (-8.1 ± 6.1 kg; -7.5 ± 5.8%) and daily insulin dose (-20.7 ± 18.9 U/day) were achieved. An HbA1c reduction of ≥ 0.4% was seen in 61.9% of subjects. Weight loss ≥ 5% and ≥ 10% were achieved in 57.1% and 33.3% of cases, respectively. Significant improvements in time in range (+8.8 ± 13.4%) and time in hyperglycemia >250 mg/dL (-5.3 ± 5.1%) were attained. Four subjects experienced gastrointestinal adverse events, and two of them discontinued treatment.

Conclusions: Adjunct treatment with OW semaglutide in PWT1D in a real-life setting resulted in promising results in glycemic control, weight, and insulin requirements, in a safe and well-tolerated manner.

Disclosure

V.Bellido: None. N.Gros herguido: None. S.Amuedo: None. L.Baena ariza: None. S.M.Alfonso: None.
1802-PUB: Liraglutide as a Potential Drug Repurposing Candidate for Alzheimer’s Disease and Related Dementia—Real-World Evidence
Authors: WANG TIANSHENG , BUSE JOHN B. , PATE VIRGINIA , STÜRMER TIL
Published: June 2023

Previous studies suggested GLP-1 receptor agonists (GLP1RA) may improve cognitive function and liraglutide’s effect on Alzheimer’s disease is being evaluated by the ELAD (Evaluating Liraglutide in Alzheimer's Disease) clinical trial. To examine whether liraglutide decrease Alzheimer’s disease and related dementia (ADRD) risk compared with other antidiabetics, we implemented an active comparator, new user cohort design identifying initiators of liraglutide, DPP-4 inhibitors (DPP4i), respectively, using a US nationwide 20% random sample of fee-for-service Medicare beneficiaries aged 70+ with parts A, B, and D coverage from 2007-2019. We required patients to have 2nd prescription of the same drug class and be free of ADRD in the 3-year window (during which requiring 3-year continuous enrollment of parts A, B) prior to drug initiation. The ADRD outcome was defined as 1) ≥1 ADRD claims in 1 year AND 2) ≥1 ADRD claims in another year or nursing home stay ≥ 6 months in the 3-year follow-up period. We estimated propensity scores (PS) to balance confounders across cohorts and estimated adjusted risk difference (RD) and 95% CI using inverse probability treatment and censoring weight. The initiators of liraglutide (n=1260) and DPP4i (n=15952) were followed for a median (IQR) duration of 3.0 (2.0 to 3.0) and 3.0 (1.7 to 3.0) years, respectively. During follow-up, incident cases of ADRD was 196 and 3215 in liraglutide and DPP4i, respectively; and incident rate was 63 and 85 per 1000 person-years, respectively. Adjusted RD (%) was -4.4 (95%CI -6.6 to -2.39) comparing liraglutide to DPP4i. Results were consistent across sensitivity analyses with varying exclusion criteria, baseline period, and outcome definitions. Our active comparator, new user cohort study of older patients showed liraglutide is associated with a decreased ADRD risk compared with alternatives. This study is limited by the relatively short duration of treatments.

Disclosure

T.Wang: None. J.B.Buse: Consultant; Alkahest, Anji Pharmaceuticals, AstraZeneca, Bayer Inc., Biomea Fusion, Inc., Boehringer Ingelheim International GmbH, CeQur SA, Cirius Therapeutics, Inc., Corcept Therapeutics, Eli Lilly and Company, GentiBio, Glycadia, Glyscend Inc., Janssen Pharmaceuticals, Inc., Mellitus Health, Pendulum Therapeutics, Praetego, LLC, Stability Health, Terns, Inc, Valo, Other Relationship; Novo Nordisk, Research Support; Dexcom, Inc., Novo Nordisk, vTv Therapeutics, Stock/Shareholder; Glyscend Inc., Mellitus Health, Pendulum Therapeutics, PhaseBio Pharmaceuticals, Inc., Praetego, LLC, Stability Health. V.Pate: None. T.Stürmer: Stock/Shareholder; Novartis, Novo Nordisk, Roche Pharmaceuticals.

Funding

American Diabetes Association (4-22-PDFPM-06 to T.W.)
1804-PUB: Switching from Glucagon-Like Peptide-1 Receptor Agonists Therapy to Second Generation Basal Insulins—Comparative Effectiveness Analysis of Glargine 300 U/mL vs. Degludec 100 U/mL—The RESTORE-G Real-World Study
Authors: CANDIDO RICCARDO , NICOLUCCI ANTONIO , LAROSA MONICA , CHIARA ROSSI MARIA , NAPOLI RAFFAELE ,   RESTORE-G STUDY GROUP
Published: June 2023

ADA recommends early use of GLP1-RA in T2DM. In patients treated with GLP1-RA and needing therapy intensification, the switch to insulin therapy is still a common approach. Compared to first generation basal insulins, second generation ones (2BI) provide similar or improved efficacy with better safety profile. Aim of this RESTORE-G sub-study was to perform a comparative effectiveness analysis of switching to Glargine 300 U/mL (Gla-300) vs. Degludec 100 U/mL (Deg-100) in patients on GLP1-RA therapy (±oral hypoglycemic agents) needing intensification. Table shows sample sizes, patients characteristics and propensity score (PS) adjusted effectiveness results.

Statistically significant larger reductions of HbA1c and FBG were obtained with Gla-300 vs. Deg-100 after 6 months. No statistically significant between-group differences were documented in weight and 2BI dose changes. PS matching (sensitivity analysis) confirmed the larger effect of Gla-300 vs. Deg-100 on HbA1c reduction [estimated mean difference -0.55% (95%CI -1.02;-0.08); p=0.02]. Switch from GLP1-RA to 2BI is a valuable option and Gla-300 vs. Deg-100 is associated with larger HbA1c decrease. There is urgent need to reduce clinical inertia, witnessed by very high HbA1c levels at switch and suboptimal titration of 2BI.

Disclosure

R.Candido: None. A.Nicolucci: Board Member; AstraZeneca, Research Support; Novo Nordisk, Sanofi, Sobi, Shionogi & Co., Ltd., AlfaSigma, Speaker's Bureau; Boehringer Ingelheim and Eli Lilly Alliance. M.Larosa: None. M.Rossi: Research Support; Sanofi, Novo Nordisk, Shionogi & Co., Ltd., AlfaSigma. R.Napoli: Advisory Panel; Sanofi, Eli Lilly and Company, Novo Nordisk, Research Support; Novo Nordisk, AstraZeneca, Speaker's Bureau; Sanofi, Eli Lilly and Company, Novo Nordisk, AstraZeneca, MSD Life Science Foundation. Restore-g study group: n/a.

Funding

Sanofi
1808-PUB: Effective and Durable Stem-Cell-Enabled Therapy of Autoimmune T1DM in Rodents and Dogs Provides the Scientific Basis for the First-in-Human Trial Using I.P. Administered “Neo-Islets,” 3-D Organoids of Allogeneic Islet, and Mesenchymal Stromal Cells—The Omentum Becomes the New Endocrine Pancreas without the Need for Antirejection Drugs
Authors: GOOCH ANNA , WESTENFELDER CHRISTOF
Published: June 2023

Two initial reports from Clinical Trials with cell-based interventions for the urgently needed therapy of T1DM show: (a) Open, s.c.-placed encapsulation devices containing insulin-producing progenitor cells that require anti-rejection drugs have failed to adequately improve glycemic control. (b) The intraportal administration of stem cell-derived insulin-producing cells, requiring anti-rejection drugs, has shown promising results in 2 or 3 subjects. However, the inability to retrieve these cells and the need for anti-rejection drugs remain a concern. Our approach harnesses the immune-modulating and -isolating, anti-inflammatory, angiogenic, anti-apoptotic and other trophic actions of Mesenchymal Stromal Cells (MSCs). First, we demonstrated that allogeneic Neo-islets (NIs), islet-sized organoids composed of equal numbers of MSCs and culture expanded Islet Cells do, when given i.p., omentally engraft, redifferentiate, re-express all islet hormones and permanently restore euglycemia in auto-immune diabetic NOD mice, i.e., without encapsulation devices or antirejection drugs. The omentum becomes the new endocrine pancreas. Second, i.p. therapy of spontaneously diabetic pet dogs with allogeneic canine NIs significantly improved glycemia and insulin needs (> 3 years), and this without immune response (abstract this meeting). Third, human NIs permanently correct streptozotocin-induced diabetes in NOD/SCID mice. Removal of the omentally-engrafted NIs promptly restores the diabetic state. No long-term complications of the NI therapy have been observed. Based on this body of evidence, a successful Pre-IND meeting with the FDA was held and final Proof-of-Concept studies that are expected to lead IND approval are ongoing.

Disclosure

A.Gooch: Board Member; SymbioCellTech, LLC, Employee; SymbioCellTech, LLC, Stock/Shareholder; SymbioCellTech, LLC. C.Westenfelder: Board Member; SymbioCellTech, LLC., Employee; SymbioCellTech, LLC., Research Support; SymbioCellTech, LLC., Stock/Shareholder; SymbioCellTech, LLC.
1813-PUB: Cardiorenal Effect of Dapagliflozin and Dapagliflozin-Saxagliptin Combination on CD34+ve Hematopoietic Stem Cells (HSCs) and Podocyte Specific Markers in Type 2 Diabetes Subjects
Authors: RAO NANDULA SESHAGIRI , SEN SABYASACHI
Published: June 2023

Introduction: Effect of Dapagliflozin (Dapa) and Dapagliflozin-Saxagliptin combination (Combo) was examined on peripheral blood derived CD34+ HSCs as a cellular CVD biomarker. Both Dapa (a SGLT2 receptor inhibitor) and Saxagliptin (a DPP4 enzyme inhibitor) are T2DM meds, but the combo has not been evaluated for cardio-renal risk.

Hypothesis: We hypothesized that Dapa will improve the outcomes when compared to placebo and the Combo maybe even more beneficial.

Methods: 15 subjects were enrolled in 16 weeks, double-blind, three-arm, randomized placebo matched trial, with 10mg Dapa + Saxa placebo (n=4), 10 mg Dapa + 5 mg Saxa (n=5) Combo, And Dapa placebo + Saxa placebo (n=6), Placebo groups. T2DM (30-70 yrs) with HbA1c of 7-10%, were included. CD34+ HSC number, migration, mRNA expression along with biochemistry and urine exosomes were measured. Data were collected at wks 0, 8, and 16. For stats, a mixed model regression analysis was used.

Results: Significant HbA1c (p=0.0357) reduction was noted in Combo group vs Dapa alone and Placebo. hsCRP levels (P=0.0317) and IL-6, two important inflammatory molecules, were significantly reduced in both Dapa and Combo vs Placebo. Leptin levels decreased significantly in both Dapa alone (p=0.035) and Combo group (p=0.015), vs Placebo, however the Adiponectin levels were higher in Dapa alone group. EPC migration improved significantly in both Dapa alone (p=0.05) and Combo group (p=0.05) vs Placebo. Interestingly, urine exosome-based podocyte specific protein such as podocalyxin was actually higher in Combo vs Control.

Conclusions: Several parameters showed significant improvement with both Dapa and Combo vs placebo. However, other than glycemic control Combo didn’t offer any further benefit over Dapa alone in terms of HSC and biochemistry. Moreover, the Combo may have deleterious effect on renal podocyte inflammation which needs to be examined in a larger study.

Disclosure

S.Nandula: None. S.Sen: None.
1817-PUB: CGM-Derived Metrics and HbA1c in Adults with Type 2 Diabetes (T2D) on Different Insulin Treatment Regimens Not Meeting Glycemic Targets
Authors: LIND NANNA , CHRISTENSEN MERETE B. , NØRGAARD KIRSTEN
Published: June 2023

Objective: Despite advances in treatment strategies, many individuals with T2D treated with insulin still struggle with inadequate glycemic control. The aim was to describe CGM-derived metrics and HbA1c for adults with T2D and HbA1c ≥7.5% (≥58 mmol/l) using different insulin treatment regimens; basal insulin only or multiple daily injections (MDI).

Methods: Baseline characteristics of participants with T2D entering a randomized controlled trial on the efficacy of using CGM were analyzed including CGM-derived metrics from 10 days blinded CGM (Dexcom G6).

Results: Included were 96 adults (men 61.5%, age 61 (54-67) years and BMI 30.7 (26.7-35.7) kg/m2, all median (+IQR)). Compared to adults on basal insulin only, the MDI treated had a longer diabetes duration of 22 (19-25) vs 18 (14-22) years, a higher HbA1c 9.2 (8.6-9.7) vs 8.3 (7.8-9.1) % and a lower C-peptide 396 (217-630) vs 745 (504-1178) pmol/l. There were no differences in time in range or mean sensor glucose. In contrast, the MDI treated had less time above range (28 (21-32) vs 33 (25-42) %) but a higher coefficient of variation (32 (26-36) vs 26 (23-31)%) and a higher time below range (<3.0 mmol/l).

Conclusion: These results suggest that while MDI treatment may be associated with higher HbA1c levels and greater glycemic variability, this is not consistently reflected in all CGM-derived metrics.

Disclosure

N.Lind: None. M.B.Christensen: Speaker's Bureau; Novo Nordisk A/S, Sanofi. K.Nørgaard: Advisory Panel; Medtronic, Novo Nordisk, Research Support; Medtronic, Dexcom, Inc., Novo Nordisk, Zealand Pharma A/S, Speaker's Bureau; Medtronic, Novo Nordisk, Stock/Shareholder; Novo Nordisk.
1820-PUB: To Compare the Average TIR Metric in Type 2 DM Population across Two Specialty Centers in Urban India Using Different Strategies for CGM Guided Management
Authors: SOWANI ALPANA , CHAWLA PURVI M. , CHAWLA MANOJ S.
Published: June 2023

Methodology: We analyzed FGM Libre pro data of 394 patients from Centre - 1 and 200 patients from Centre - 2 over last 1 year for Type 2 DM patients visiting 2 different specialty clinics. Centre - 1 was analyzing the data for the blinded CGM at the end of 14 days and capturing the TIR data and making management decisions. Centre - 2 was calling the patient on day 7, analyzing the data, making therapeutic changes and capturing the TIR data at end of 14 days period and making further therapeutic changes.

Discussion/Conclusion: Use of CGM in type 2 DM patients in routine clinic practice is used at very few centers across India due to various challenges including cost of monitoring in a self-pay market. There is a constant search for innovating means to economize cost of treatment and optimize the use of resources. Hence, the practice of calling patients at least once in the intermittent period back to the clinic, while on the blinded CGM to analyze the data and make lifestyle and therapeutic changes, the benefits of which may be seen at the end of 14 days period may seem feasible in Indian settings. This strategy often results in improving TIR metrics at the end of 14 day period as most type 2 patients doing CGM in India may not repeat the same more than 1-2 times per year.

Disclosure

A.Sowani: None. P.M.Chawla: None. M.S.Chawla: None.
1822-PUB: Identifying the Link between In-Hospital Hyperglycemia and Outcomes among Persons Admitted with a Severe Infection
Authors: BAKKER JULIA J. , VAN DER VAART AMARENS , BOUMA HJALMAR , CHOUDHARY PRATIK , VAN DIJK PR
Published: June 2023

Background: Hyperglycemia is common among hospitalized patients and is associated with suboptimal outcomes. We investigated the impact of hyperglycemia in persons admitted with severe infection (diagnosis of infection according to the treating physician combined with either ≥2 qSOFA-criteria or ≥2 SIRS-criteria) with and without diabetes.

Methods: We prospectively recruited people with a severe infection into this observational study and applied a blinded glucose sensor. No changes were made to usual care.

Results: Here, we present preliminary data from 48 persons (expected recruitment n=200) : 67% male, age 63±17 y). 29% had known diabetes. Urinary (20%), airway (8%), and skin (8%) were the most common infection foci; three persons died during admission. Among all, the mean glucose was 140±64 mg/dL, with hyperglycemia present in 36 (75%) persons (Figure 1). Figure 1 shows the 24h sensor profiles for all (panel A), persons with (panel B) and without diabetes (panel C). Mean glucose was 205 (±75) vs 113 (±33) in people with and without known diabetes. Similarly time in range (70-180 mg/dl) was 11 vs 77% in people with and without diabetes. 18% of those with no known diabetes had >10% time above range (>180 mg/dl)

Conclusion: Hyperglycemia was a frequent finding. We will evaluate the link between sensor-measured glycemic parameters, blood values and detailed outcome data using the Acutelines biobank.

Disclosure

J.J.Bakker: None. A.Van der vaart: None. H.Bouma: None. P.Choudhary: Advisory Panel; Medtronic, Novo Nordisk, Dexcom, Inc., MannKind Corporation, Insulet Corporation, Research Support; Abbott Diabetes, Speaker's Bureau; Sanofi, Lilly. P.Van dijk: None.
1824-PUB: Implementation of an Integrated Care Management Pilot Program Improves Diabetes Quality Outcomes after 12 Months
Authors: TINSLEY LIANE J. , ARIYABUDDHIPHONGS KIM D. , HALPRIN ELIZABETH , BEAULIEU JEREMY , MOREAU MERREDITH , MILLAN-FERRO ANDREINA , RIZZOTTO JO-ANNE , CRONIN BRIAN , MEHTA SANJEEV N.
Published: June 2023

Care management efforts focused on patients not achieving quality goals can improve performance in value-based care quality programs, but may pose challenges for integration into routine clinical care. We evaluated a 12-month NP-led care management pilot program (CMPP) to improve outcomes for adults with T2DM and A1c>9% (N=62, 40% male) covered under a value-based care quality program and receiving care at a diabetes center. Visits were scheduled as billable encounters between routine clinical visits. Diabetes quality outcomes (A1c≤9%, BP<140/90, and annual retinal screening) were assessed by CMPP participation. For this pilot program, p<0.05 and p<0.10 defined significance and trend, respectively. The CMPP began in November 2020 with 43% (n=27) participation; participants and non-participants had no baseline differences in age, diabetes duration, or baseline attainment of diabetes quality metrics. CMPP participants had more visits compared to non-participants over the 12 month pilot period (10.4 vs. 4.0, p<.001); 62% of participant visits were virtual vs 47% among non-participants (p=.01). At 12 months, CMPP participants had a significant improvement in % A1c≤9% and trended towards improved annual retinal screening. This integrated NP-led CMPP leveraging virtual care may improve diabetes quality outcomes. Future efforts will focus on scaling and implementation in primary care.

Disclosure

L.J.Tinsley: None. K.D.Ariyabuddhiphongs: None. E.Halprin: None. J.Beaulieu: None. M.Moreau: None. A.Millan-ferro: None. J.Rizzotto: None. B.Cronin: None. S.N.Mehta: None.
1825-PUB: Factors Associated with Completion of a Diabetes Transition Program (DTP) in Youth with Diabetes Mellitus
Authors: ALNAYEM WEAM , KRALL JODI S. , SIMINERIO LINDA M. , LIBMAN INGRID
Published: June 2023

Adolescence and young adulthood are periods of transition when youth with DM typically experience poor outcomes. Programs that equip youth with confidence, support, and knowledge to foster successful lifelong DM management are needed. The DTP was developed to provide care and guided peer-discussions on pertinent topics with a multidisciplinary team over 4 clinic visits annually. To identify predictors for program completion, characteristics of patients who completed the program versus those who did not were examined. A total of 152 subjects were referred (prior to Covid) (53% male, 91% white, mean age at 1st visit 18.8±1.4 years, age at diagnosis 9.8±4.8 years, body mass index (BMI) %ile 74.6±20.6, HbA1c 8.9±2%, 54% on insulin pumps, 17% on continuous glucose monitors (CGM). Half (n=76) completed the program. Characteristics are presented below.

There were no differences between those that completed the program vs those that did not in depression score (measured by (PHQ-9)) (8.8±0.5 vs 8.8±0.4, p=0.87), history of visits to ED (3 vs 7%, p=0.44) or admissions (4.5 vs 7%, p=0.72) in the year prior to referral. Patients referred to the DTP appear to be a high-risk population which may explain why completion of the program was 50%. Moreover, identifying as non-white appears to be associated with non-completion of the program, emphasizing the need for different approaches to reach emerging adults.

Disclosure

W.Alnayem: None. J.S.Krall: Research Support; Sanofi, Becton, Dickinson and Company. L.M.Siminerio: Advisory Panel; Abbott, Research Support; Becton, Dickinson and Company, Sanofi. I.Libman: Advisory Panel; Novo Nordisk.
1826-PUB: Efficacy of Digital Diabetes Care Program in India—Retrospective Analysis
Authors: AGRAWAL NAVNEET , PANJABI ADITYA , DIXIT PRASHANT K. , D BHEEMARAYA
Published: June 2023

Background: Lack of knowledge in self-management and limited access to specialized healthcare services leads to uncontrolled diabetes. Continuous digital care delivered through a mobile healthcare app aid in metabolic control.

Aims: To analyze the efficacy of BeatO’s digital diabetes care management program among people with diabetes

Methods: A retrospective analysis of 721 participants enrolled in BeatO’s mobile app-based diabetes care program for 3 months, the period of enrollment was between 28th February to 31st August 2022. Participants received remote access to health professionals for diabetes education, nutritional guidance and doctor consultation through the BeatO app. Throughout the care program, they were connected with a dedicated health coach. The medication prescribed by the doctor was delivered to the participant’s home. Regular blood glucose monitoring was done using BeatO’s smartphone-connected glucometer that works in accordance with the BeatO app. The parameters like FBG, PPBG, HbA1c, lipid profile and weight was recorded at baseline and after 3 months.

Results: Of the 721 participants, 96.5 % had Type 2 diabetes. The mean age of the participants was 47.5 years, and the majority (80.8%) were males. T2DM was present in 696, T1DM (11), LADA (9), Prediabetes (3) and GDM (2). Out of these, 704 participants completed the program. A significant improvement in blood glucose control was observed, as reflected by a mean decrease in FBG by 38 mg/dL (p <0.0001), PPBG by 37 mg/dL (p <0.0001) and HbA1c reduced by 2.16% (p < 0.0001) at the end of 3 months. There was a significant weight loss of about 1.8 kg (p = 0.01) and a reduction in total cholesterol by 15 mg/dl through this remote personalized care.

Conclusions: BeatO's digital diabetes care management program among people with diabetes showed good efficacy in terms of glycemic control and weight loss. Hence, the implementation of digital technology in diabetes care can help in increasing access and awareness of diabetes care and achieving glycemic targets.

Disclosure

N.Agrawal: Advisory Panel; Biocon, Eris Lifesciences Ltd., Lupin Pharmaceuticals, Inc., Sanofi, USV Private Limited, Other Relationship; BeatO, Health Arx Technologies Pvt LTD. A.Panjabi: Advisory Panel; Torrent Pharmaceuticals Ltd, USV Private Limited, Consultant; BeatO, Health Arx Technologies. P.K.Dixit: Advisory Panel; USV Private Limited, Intas Pharmaceuticals Ltd., Consultant; Beato, Health Arx Technologies. B.D: Consultant; BEAT-O, HEALTH ARX TECHNOLOGIES.
1834-PUB: Gestational Diabetes Mellitus in Nonobese Women Is Associated with Adipose Tissue Health
Authors: SINHA AJAY K. , BHARTI BISHWA B. , CHOUDHARY BINOD K. , HANS PANKAJ
Published: June 2023

Background: Health issues are linked to gestational diabetes mellitus (GDM) in both the mother and the foetus. Adipose tissue (AT) health issues and obesity are linked to the emergence of GDM. Recent research has nevertheless demonstrated that decreased AT health can exist even in the absence of fat. In this study, we investigated whether AT health influences the onset of GDM in non-obese women.

Method: GDM-diagnosed expectant mothers were examined. Non-GDM women with matching BMI and age served as the Controls (n=6 per group). Before and during cesarian sections, samples of AT and fasting blood were taken, respectively. Using the Bioplex assay, the serum levels of adiponectin were determined. Western blotting was used to quantify the expression of phosphorylated p38 (p-p38) in AT, and average adipocyte size values were calculated. Two-tailed unequal variance was used to determine the differences in the variables between the groups. P < .0 was regarded as statistically significant for the Student t test.

Results: The pre-pregnancy BMI and age did not differ. The serum level of adiponectin was considerably lower in the GDM group. p-AT p38's expression, however, was noticeably higher. In the GDM group, the adipocyte size was 11% smaller, but the difference did not statistically vary from zero.

Conclusion: Our findings show that among non-obese women, the development of GDM may be significantly influenced by AT health. Future research is necessary to identify the pathways via which AT health, in the absence of obesity, contributes to the development of GDM.

Disclosure

A.K.Sinha: None. B.B.Bharti: None. B.K.Choudhary: None. P.Hans: None.
1843-PUB: Epidemiological Investigation on Diet and Drugs of Adult Diabetes Mellitus in Guangdong Province
Authors: CHEN XUANRONG , JIANG WEI , XIONG FEI , YANG LI , XU WEN , ZENG LONGYI ,   STUDY GROUP THE CHINA NATIONAL DIABETIC CHRONIC COMPLICATIONS
Published: June 2023

Objective: To study the epidemiological characteristics of adult diabetes, and effect of food composition on blood glucose in Guangdong Province.

Methods: The data of this study were from the China DiaChronic Study. This study investigated diabetic patients in eight urban and rural centers in Guangdong Province. Questionnaire survey, physical examination and fundus photography were carried out, and blood and urine indexes were measured. All 1621 subjects were finally included.

Results: (1) The prevalence rates of obesity, hypertension, hypertriglyceridemia, hyper LDL-C, were 15.8%, 37.9%, 50.5% and 79.3% respectively. The prevalence rates of diabetic nephropathy and retinopathy were 33.6% and 16.7% respectively. The treatment rate of subjects was 93.6%, and the compliance rate of HbA1c of them was 49%. (2) In all subjects, the median of total caloric intake of food was 1660 kcal/d, of which grains account for the most with 810 kcal, and milk were the least with 0 kcal. Men's caloric intake in grains, livestock meat, poultry meat and aquatic products were significantly higher than that of women, while women's caloric intake in potatoes and milk were significantly higher than that of men (P<0.05). The caloric intake of grains, vegetables and livestock meat in rural were significantly higher than that in urban, while the caloric intake of miscellaneous grains, potatoes, beans, fruits, milk, poultry meat, aquatic products, eggs and nuts in urban areas were higher than that in rural areas (P<0.05). For subjects with HbAIc<6.5%, the energy intake of vegetables, fruits, poultry meat and eggs was significantly higher than that of them with HbA1c>6.5% (P<0.05).

Conclusion: Despite patients try to control blood glucose, half of them have poor blood glucose control. At present, the diet of rural residents mainly include grains, vegetables and livestock meat. Vegetables, fruits, poultry and eggs may be beneficial to blood glucose control, which needs further research to confirmation.

Disclosure

X.Chen: None. W.Jiang: None. F.Xiong: None. L.Yang: None. W.Xu: None. L.Zeng: None. S.Te china national diabetic chronic complications : n/a.
1849-PUB: RNA Sequencing Analysis Related to Immune Homeostasis in the Skin of a Corticotropin-Releasing Hormone (CRH) Transgenic Mouse Model
Authors: HAK JEONG HYEON , LEE BONGGI
Published: June 2023

Chronic glucocorticoid exposure in humans is well-known to induce diabetes-like phenotypes associated with Cushing's syndrome. Diabetes mellitus is also closely related to skin abnormalities. To elucidate changes in the transcriptome of the skin in corticotrophin-releasing hormone transgenic (CRH-TG) mice with skin abnormalities and diabetes-like phenotypes, we performed RNA-Seq analysis with a focus on immune homeostasis. Compared to WT-skin, DEG analysis revealed that the levels of 2854 genes were significantly altered in CRH-TG mice (Up-1134 genes, Down-1720 genes). The KEGG analysis further showed that various signaling pathways associated with immune functions were significantly altered, which include signaling pathways related to hematopoietic cells, complement cascade, and major histocompatibility complex class II (MHC class II) molecules. Additionally, qPCR analysis confirmed that the mRNA level of MHC class II molecules, which play an antigen-presenting function, was downregulated in CRH-TG skin. Although further studies are needed, chronic glucocorticoid exposure may lead to immune imbalance, making the skin vulnerable to external and intrinsic stimulations.

Disclosure

H.Jeong: None. B.Lee: None.

Funding

Korean Ministry of Agriculture, Food and Rural Affairs (821030-3)2); Korea Ministry of Oceans and Fisheries (20220252)