bluuebunny/crossref_metadata_2025 huggingface dataset:
56-OR: Relationship between Delay Discounting and Psychological Health in Adults with Type 2 Diabetes
Authors: CAMPBELL JENNIFER A. , EGEDE LEONARD E.
Published: May 2022

Background: Delay discounting is the process of making choices that provide small immediate rewards versus choosing to wait for a greater more meaningful reward. Measured by two constructs, delay discounting measures the gain or loss of value on an outcome when delay is present, and delay aversion, measures the emotional response when a delay is present. Emerging evidence shows delay discounting is associated with poor self-care behavior, glycemic control, and quality of life. There is limited data on the impact of delay discounting on psychological health (depression, anxiety, perceived stress) and social support.

Methods: This study used data from 365 adults with T2DM to evaluate relationships between delay discounting and psychological health and social support. Delay discounting was measured with the validated QDQ scale with 2 subscales for delay discounting and delay aversion. Depression was measured by the PHQ-9, anxiety by the GAD-8, perceived stress by the PSS-4, and social support by the DUSOC. Adjusted linear regression was used to assess the relationship between delay discounting and delay aversion on psychological health (depression, anxiety, perceived stress) and social support controlling for relevant covariates.

Results: Mean age of the sample was 61.8 years, 54.5% were African American, 41.8% were White, and 3.7% were Hispanic/Other. After adjusting for sociodemographic factors, delay aversion was significantly associated with depression (B=.35; p<0.001) , anxiety (B=.52; p<0.001) , stress (B=.22; p<0.001) , and lower family support (B=-.62; p<0.05) . Delay discounting was significantly associated with depression (B=.32; p<0.001) , anxiety (B=.46; p<0.001) , and stress (B=.26; p<0.001) .

Conclusion: Both constructs of delay discounting (delay discounting and aversion) are significantly associated with poor psychological health and poor social support. Future studies need to examine mechanisms and pathways for potential interventions.

Disclosure

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

Funding

National Institute of Diabetes and Digestive Kidney Disease (K24DK093699, R01DK118038, R01DK120861, PI: Egede) National Institute for Minority Health and Health Disparities (R01MD013826, PI: Egede/Walker) .
565-P: Vitamin D Supplementation Improves Anxiety and Depression Status in Elderly People with Prediabetes: An Open-Label 12-Month Randomized Controlled Study
Authors: ZAROMYTIDOU EVANGELIA , KOUFAKIS THEOCHARIS , DIMAKOPOULOS GEORGIOS , DRIVAKOU DESPOINA , MERISTOUDIS GEORGIOS , KONSTANTINIDOU STAVROULA , KARALIOLIOS GEORGIOS , MELIDOU EIRINI , RAKITZI PANTELITSA , GRAMMATIKI MARIA , MANTHOU ELENI , PSARRAKOU IOANNA S. , IAKOVOU IOANNIS , GOTZAMANI ANNA , KOTSA KALLIOPI
Published: May 2022

Background: The combination of prediabetes and depressive or anxiety symptoms is known to increase the risk of progression to diabetes. We aimed to assess the effects of vitamin D supplementation on anxiety and depression status among elderly people with prediabetes.

Methods: Participants were randomly assigned to a weekly dose of vitamin D3 of 25,000 IU (n=45) or nothing (n = 45) , in addition to lifestyle measures. The State Trait Anxiety Inventory and the Patient Health Questionnaire-9 (PHQ-9) tools were used to evaluate anxiety and depression levels, respectively, at baseline, 6 and 12 months.

Results: Participants in the intervention and control group presented comparable baseline characteristics in terms of age (73.± 7.16 vs. 74.03 ± 7.64 years, respectively) , fasting glucose (103.4 ± 12.vs. 102.29 ± 12.82 mg/dl, respectively) and HbA1c values (5.87 ± 0.21 vs. 5.87 ± 0.22 %, respectively) . In the supplemented group, 25-hydroxyvitamin D concentrations increased significantly at 6 (26.56 ± 8.64 ng/ml) and 12 months (28.71 ± 9.03 ng/ml) compared to baseline (19.98 ± 6.73 ng/ml, p<0.0 for both comparisons) . The mean trait anxiety scores were lower in supplemented individuals than the control group at 6 (38.02 ± 9.03 vs. 43.91 ± 7.18, respectively, p=0.003) and 12 months (32.35 ± 7.77 vs. 44.97 ± 7.78, respectively, p<0.001) . The same pattern was evident for state anxiety scores at 6 (37.± 7.88 vs. 43.20 ± 9.33, p=0.003) and 12 months (32.59 ± 6.45 vs. 44.60 ± 9.53, p<0.001) . Supplemented participants demonstrated lower mean PHQ-9 scores compared with controls at 6 (15.69 ± 6.15 vs. 19.77 ± 8.96, respectively, p=0.021) and 12 months (13.52 ± 5.vs. 20.20 ± 8.67, respectively, p<0.001) .

Conclusion: In a high-risk population, a weekly vitamin D supplementation scheme was effective in reducing anxiety and depression levels. Further studies are needed to elucidate the relevant mechanisms.

Disclosure

E.Zaromytidou: None. M.Grammatiki: Research Support; Lilly. E.Manthou: None. I.S.Psarrakou: None. I.Iakovou: None. A.Gotzamani: None. K.Kotsa: Advisory Panel; Abbott, Novo Nordisk, Research Support; Boehringer Ingelheim International GmbH, Eli Lilly and Company, Speaker's Bureau; AstraZeneca, Merck Sharp & Dohme Corp., Novartis AG, Sanofi. T.Koufakis: Advisory Panel; Novo Nordisk, Speaker's Bureau; AstraZeneca, Boehringer Ingelheim International GmbH, Lilly, Novo Nordisk. G.Dimakopoulos: None. D.Drivakou: None. G.Meristoudis: None. S.Konstantinidou: None. G.Karaliolios: None. E.Melidou: None. P.Rakitzi: None.
57-OR: Responses to Lifestyle Intervention (LI) Are Associated to the Inter-Individual Variability in Glucose Metabolism at Baseline for Individuals at High Risk of Type 2 Diabetes (T2D)
Authors: SABATINI SILVIA , NOLAN JOHN J. , O'GORMAN DONAL , GASTALDELLI AMALIA
Published: May 2022

LI can delay the onset of T2D. How inter-individual variability in response to LI relates to baseline phenotypic characteristics would help clinicians to advise on risk reduction. 328 subjects at high risk of T2D underwent a 12-weeks LI. Before and after LI, subjects were profiled for glucose and insulin measured through 75g-OGTT, peripheral (Matsuda (ISI) and HOMA) and hepatic (Hep-IR) insulin resistance indexes, insulinogenic index (IGI) , disposition index (DI=MI x dAUC0-180-Ins/glu) and target metabolomics. Hierarchical cluster analysis, based on indexes of insulin resistance (HOMA and ISI) and secretion (AUCins and IGI) , was performed to stratify the subjects at baseline. Pre vs. post values were compared in each cluster. Cluster analysis identified 4 groups with different degrees of glucose tolerance, insulin sensitivity and secretion (Figure A-D) , CL1 being the best. The 4 clusters showed different responses to LI: CL2-4 significantly improved insulin and reduced AUCins and α-ketoglutarate (p<0.05) , while no significant changes in CL1 (Figure E) .

Conclusions: Hierarchical clustering identified phenotypes that might predict metabolic responses to LI.

Disclosure

S.Sabatini: None. J.J.Nolan: Consultant; My Way Digital Health, Speaker's Bureau; Novo Nordisk A/S. D.O'gorman: None. A.Gastaldelli: Advisory Panel; Boehringer Ingelheim International GmbH, Novo Nordisk Global Business Services, Consultant; Boehringer Ingelheim International GmbH, Inventiva Pharma, Other Relationship; Eli Lilly and Company, Gilead Sciences, Inc., Pfizer Inc., Speaker's Bureau; Novo Nordisk.
584-P: Who’s the Boss of Me? Autonomous vs. Controlled Motivation among Young Adults with T1D
Authors: PYATAK ELIZABETH , VIGEN CHERYL , SIDERIS JOHN , FOX D. STEVEN , DIAZ JESUS , ALI AINA , BLANCHARD JEANINE , GRANADOS GABRIELLE , SALAZAR ELIA , TAYLOR ELINOR , RAYMOND JENNIFER
Published: May 2022

Introduction: Young adults (YAs) with T1D experience poorer self-care, psychosocial well-being and clinical outcomes relative to other age groups. A better understanding of factors that drive these challenges is needed to better support this age group. Behavioral science theory suggests that greater autonomous (vs. controlled) motivation (the degree to which behaviors are motivated by internal vs. external drivers) may enable YA to more effectively navigate the challenges of living with T1D.

Methods: Baseline surveys and clinical data from an ongoing self-management RCT were analyzed to examine associations between autonomous motivation (modified TSRQ) , glycemic control (HbA1c) , diabetes distress (DDS) , diabetes self-management (DSMQ) , self-efficacy (DES-SF) , and quality of life (ADD-QoL) . All analyses were adjusted for treatment regimen (injections/pump/CGM) .

Results: Among 133 YA with T1D (24.2±3.7 yrs, 53% female, 53% Latinx, 36% White, 11% multiethnic/other) , more autonomous motivation was associated with lower diabetes distress (standardized b= -0.19, p=0.04) and better self-management (b=0.18, p=0.04) . Analyses revealed that the association of autonomous motivation with lower diabetes distress scores was attributable to its associations with the emotional burden (b=-0.17, p=0.05) and regimen distress (b=-0.24, p=0.01) subscales, and its association with higher self management scores was driven by its association with the glucose monitoring subscale (b=0.32, p=0.0005) . Relationships between motivation and other measures were not significant.

Conclusion: Among YA with T1D, those with greater autonomous motivation for diabetes care had lower regimen distress and emotional burden, and greater glucose monitoring. While the causal direction of these relationships is unclear, it is plausible that interventions to enhance autonomous motivation may enhance self-management and well-being in this population.

Disclosure

E.Pyatak: Research Support; Abbott Diabetes. E.Taylor: None. J.Raymond: None. C.Vigen: n/a. J.Sideris: None. D.Fox: None. J.Diaz: None. A.Ali: None. J.Blanchard: None. G.Granados: None. E.Salazar: None.

Funding

National Institutes of Health (R01DK116719)
585-P: African-American Youth and Parent Perspectives on Advanced Technologies in Diabetes Management: Closing the Loop on Health Disparities
Authors: DELAMATER ALAN M. , PULGARON ELIZABETH R. , GUEVARA GABRIELA , WASHINGTON SONJA A. , FRANZ DIANE Z. , GOMEZ RICARDO , FELIPE DANIA , BHAT JAYALAKSHMI NARAYAN , CHALEW STUART
Published: May 2022

Background: Research has shown that African American (AA) youth with type 1 diabetes (T1D) are at increased risk for suboptimal glycemic control, and less often utilize advanced technologies for diabetes management (DM) .

Objective: To better understand challenges to optimal DM for AA youth and willingness to use advanced technologies. Methods: Twenty-one AA youth with T1D and their parents participated in multi-family focus groups or individual family semi-structured interviews addressing barriers to DM and attitudes about new technologies such as the advanced hybrid closed loop (AHCL) insulin pump. Groups and interviews were recorded and conducted either in-person or using telehealth methods. Based on verbatim transcripts, content analysis was conducted using NVivo to develop a code book; two independent raters coded responses into themes and a third rater resolved discrepancies.

Results: The 21 youth participants (8 girls and 13 boys) had a mean age of 14.0 years and mean HbA1c of 9.6%; 16 (76%) had Medicaid; (47.6%) were using CGM and six (28.5%) had insulin pumps. Qualitative analyses revealed six main themes encompassing current regimens, life with diabetes, parenting, ethnicity, willingness to try new DM technologies, and hesitancy to utilize an AHCL system. Thirteen (62%) youth-parent dyads reported being very willing to try the AHCL system while just two (9.5%) reported they preferred to stay with their current regimen of injections and blood glucose checks; six dyads (28.5%) were open but not ready to commit, citing concerns about reliance on technology, potential side effects, and need for more information.

Conclusions: Innovative technology such as the AHCL insulin pump system may help to improve glycemic outcomes and reduce health disparities for AA youth. Many AA youth with T1D and their parents are ready to try advanced technologies but may require individualized support from the health care team to achieve optimal outcomes.

Disclosure

A.M.Delamater: None. E.R.Pulgaron: None. G.Guevara: None. S.A.Washington: None. D.Z.Franz: None. R.Gomez: None. D.Felipe: None. J.Bhat: None. S.Chalew: Advisory Panel; Medtronic.

Funding

National Institutes of Health (1R21DK118643)
596-P: Diabetes Responsibility Moderates Relationship between Fear of Hypoglycemia and A1C in Adolescents with Type 1 Diabetes
Authors: SHAFFER EMILY R. , O'DONNELL HOLLY K. , ALONSO GUY T. , MAJIDI SHIDEH , SNELL-BERGEON JANET K. , WADWA R. PAUL , DRISCOLL KIMBERLY A.
Published: May 2022

Fear of hypoglycemia (FOH) is not consistently correlated with A1C in youth with T1D, but few studies have taken other psychosocial variables into account. This study examined T1D responsibility as a moderator of the relationship between FOH and A1C.

N=1youth ages 10-18 yrs (45.5% male; age=14.7±1.9 yrs; A1C=9.9±1.6%; T1D duration=6.5+3.4 yrs) completed the Maintain High Blood Glucose subscale of the Children’s Hypoglycemia Fear Survey (assesses behavioral manifestations of FOH) and Diabetes Family Responsibility Questionnaire (assesses distribution of T1D responsibility between child and caregiver) . Higher scores indicate greater FOH and caregiver responsibility, respectively.

The main effect of T1D responsibility on A1C was not significant (p>0.05) , whereas the main effect of Maintain High Blood Glucose was (p=0.03) . Responsibility moderated the relationship between Maintain High Blood Glucose and A1C; child’s FOH had less of an effect on A1C if the caregiver had higher responsibility (B=-0.41, p=0.04; R2 =0.038, p<0.04) .

Children who maintain their blood glucoses higher than recommended due to high FOH should have more parent involvement in their T1D care to minimize the deleterious impact of their fears on A1C. Future research should examine the Maintain High Blood Glucose subscale and other psychosocial moderators specifically in relation to glycemic outcomes.

Disclosure

E.R.Shaffer: None. H.K.O'donnell: None. G.T.Alonso: None. S.Majidi: None. J.K.Snell-bergeon: Stock/Shareholder; GlaxoSmithKline plc. R.Wadwa: Advisory Panel; Dompé, Consultant; Beta Bionics, Inc., Other Relationship; Tandem Diabetes Care, Inc., Research Support; Dexcom, Inc., Eli Lilly and Company, Tandem Diabetes Care, Inc. K.A.Driscoll: None.

Funding

National Institute of Diabetes and Digestive and Kidney Diseases (DP3DK113363)
604-P: Self-Efficacy: Relationships with Diabetes Self-Care, Medication Adherence, and Diabetes Distress among Diverse Adults with Suboptimally Controlled Type 2 Diabetes (T2D)
Authors: FANG RAN , HOOGENDOORN CLAIRE J. , PAPPALARDO LINDSEY D. , MENDEZ-RODRIGUEZ HEIDY , WALKER ELIZABETH A. , GONZALEZ JEFFREY S.
Published: May 2022

Background: Self-efficacy has been inconsistently operationalized in diabetes, with measures often failing to focus on confidence in one’s capacity to perform self-care. Measures that focus on confidence have been shown to be closely associated with self-care behaviors, but received limited psychometric evaluation and have not been examined in relation to diabetes distress.

Methods: We examined the reliability and factor structure of a previously published 8-item scale evaluating self-efficacy for diabetes self-care activities adapted by Sarkar and colleagues in 2006. We assessed cross-sectional relationships in baseline data with overall diabetes self-care, medication adherence, and diabetes distress among 812 predominantly Latino adults with T2D. They participated in a self-management support trial (Female = 56.9%; Latino = 86.5%) ; Mean (SD) Age and A1C = 59.2 (10.8) , 9.3 (1.8) , respectively.

Results: The scale demonstrated good internal reliability in the overall sample (α = .80) and among English (n = 179, α = .77) and Spanish (n = 633, α = .80) speakers. Exploratory factor analysis yielded a single factor, explaining 42% of the variance in self-efficacy scores. After adjusting for covariates, higher self-efficacy was independently associated with better diabetes self-care (β = .56, p < .001) , better medication adherence (β = .30, p < .001) , and lower diabetes distress (β = -.42, p < .001) . Moderation analyses suggested consistency in these relationships across age, gender, SES, language, health literacy and numeracy.

Conclusions: To our knowledge, the factor structure of this diabetes self-efficacy scale has not been previously evaluated. Findings suggest self-efficacy is a robust correlate of T2D self-care, medication adherence, and distress. The scale is appropriate for predominantly disadvantaged English and Spanish speakers with varying health literacy and numeracy levels.

Disclosure

R.Fang: None. C.J.Hoogendoorn: None. L.D.Pappalardo: None. H.Mendez-rodriguez: None. E.A.Walker: None. J.S.Gonzalez: Consultant; Virta Health Corp.

Funding

National Institutes of Health (R18 DK098742) National Institutes of Health (RDK104845) National Institutes of Health (RDK121298) National Institutes of Health (RDK121896) Einstein-Mount Sinai Diabetes Research Center (P30 DK020541) New York Regional Center for Diabetes Translation Research (P30 DK111022)
606-P: What Do People with Type 1 Diabetes Think of a Fully Implantable Bionic Invisible Pancreas? A Qualitative Study
Authors: EHRMANN DOMINIC , FINKE-GROENE KATHARINA , KULZER BERNHARD , HERMANNS NORBERT
Published: May 2022

The EU project “FORGETDIABETES” will develop a fully implantable automated insulin delivery (AID) system. It will consist of an intraperitoneal pump and an implantable CGM sensor. It aims at providing fully automated diabetes management with minimal user interaction. Semi-structured interviews to explore human factors of the bionic invisible pancreas (BIP) were conducted with people with type 1 diabetes. All participants provided written informed consent and were shown a video illustrating the components and functionality of the BIP. Participants were asked about aspects of life that could benefit from the BIP and aspects of life that could become more complicated. Interviews from 38 people were analysed. The most frequently mentioned aspect that could benefit was psychological with expected positive effects on quality of life, reduced diabetes distress, and less thinking about diabetes. Also, better glycaemic control and improvements regarding long-term complications were also frequently mentioned as aspects that could benefit. Aspects that might become more complicated related mostly to technical aspects (implantation procedure, taking an insulin pill, being dependent on the technology) . Loss of control was also a frequently named issue. Psychological aspects such as improvements in quality of life but also loss of control are important human factors for future AID systems.

Disclosure

D.Ehrmann: Advisory Panel; Dexcom, Inc., Consultant; mySugr, Roche Diabetes Care, Speaker's Bureau; Berlin-Chemie AG, Dexcom, Inc. K.Finke-groene: Speaker's Bureau; Berlin-Chemie AG. B.Kulzer: Advisory Panel; Bayer AG, Bayer AG, Becton, Dickinson and Company, Becton, Dickinson and Company, Berlin-Chemie AG, Berlin-Chemie AG, Dexcom, Inc., Dexcom, Inc., Insulet Corporation, Novo Nordisk, Roche Diabetes Care, Sanofi, Sanofi-Aventis Deutschland GmbH, Research Support; Novo Nordisk, Roche Diabetes Care. N.Hermanns: Advisory Panel; Abbott Diabetes, Research Support; Becton, Dickinson and Company, Roche Diagnostics, Speaker's Bureau; Berlin-Chemie AG, Novo Nordisk, Sanofi.

Funding

The present work was supported by H2020-FETPROACT Project FORGETDIABETS, n. 951933
636-P: The Effect of Cognitive Behavioral Therapy for Insomnia on Cardiometabolic Health: A Systematic Review of Randomized Controlled Trials
Authors: SAVIN KIMBERLY L. , CLARK TAYLOR , PEREZ-RAMIREZ PERLA , PARRA MAÍRA TRISTăO , GALLO LINDA
Published: May 2022

Observational studies link poor sleep and insomnia with worse cardiometabolic health. Few studies have examined the effect of insomnia treatment on cardiometabolic health. This systematic review of randomized controlled trials (RCTs) aims to assess the effectiveness of Cognitive Behavioral Therapy for Insomnia (CBT-I) on cardiometabolic health. Medline, EMBASE, PsycINFO, and Cochrane CENTRAL databases were searched using relevant terms and articles were screened by two independent reviewers. Eligibility criteria were adult population, the delivery of CBT-I, reporting of ≥1 cardiometabolic health marker, and peer-review. Standardized mean differences (Cohen’s d) in outcomes between groups post-intervention were calculated. Studies were appraised for quality by two independent raters using the Cochrane Risk of Bias 2.0 tool. After screening 1290 articles, 13 unique studies (15 publications) met inclusion criteria. Markers of inflammation (CRP, IL-6, TNF-α) , systolic and diastolic blood pressure (SBP, DBP) , and glycemic regulation (HbA1c) were reported most frequently, in ≥3 studies each. Most studies that examined HbA1c and CRP found reductions in the CBT-I group compared to the control group and effect sizes ranged from small (d = -0.27) to medium (d = -0.66) . Effects varied widely for IL-6, TNF-α, SBP, and DBP, with most studies finding null results. Two studies were judged as having low risk of bias and the remaining as moderate to high risk of bias. CBT-I was most consistently associated with improvements in HbA1c and CRP, which are relatively temporally stable, suggesting that CBT-I may influence enduring habits rather than short term behavior changes. Interpretation of studies is limited by high risk of bias (e.g., baseline differences between groups despite randomization, lack of prespecified analytic plan) . High quality studies are needed to better understand and quantitatively synthesize effects.

Disclosure

K.L.Savin: None. T.Clark: None. P.Perez-ramirez: None. M.Tristăo parra: None. L.Gallo: None.
682-P: Feasibility of CGM Use in Basal-Bolus Insulin Therapy with an Electronic Decision Support System in Hospitalized Patients
Authors: BYTYQI KUJTIM , BAUMANN PETRA M. , HOCHFELLNER DANIEL A. , POETTLER TINA , SIMIC AMRA , BECK PETER , MADER JULIA K.
Published: May 2022

Continuous glucose monitoring (CGM) provides a more holistic picture of glycemic control than capillary blood glucose (BG) measurements. We simulated CGM use with a clinical decision support system (cDSS) with a basal-bolus insulin algorithm using CGM values recorded at the same time (CGM0) vs. 15 minutes after the BG measurement (CGM+15) to simulate typical CGM trend information.

Data of 30 inpatients with T2D (age: 74.1±10.9 years, female: 60 %, Caucasian: 100 %, BMI: 28.6±5.6 kg/m2, diabetes duration: 13.2±11.6 years, HbA1c: 72±22 mmol/mol, stay duration: 8.2±3.7 days) were used. Simulation results were analysed for insulin doses, overall glycemic control, and potentially avoidable hypoglycemic events (PAHE) : those occurring within 3 hours of a bolus insulin injection when the suggested dose based on CGM was lower.

Glucose levels and insulin doses were lower when using CGM. Glucose differences were mainly due to nocturnal hypoglycemia undetected by BG (Table 1) . 36 PAHEs occurred in 17 patients with CGM0 vs. 38 PAHEs in patients with CGM+15. In the simulation, lower CGM readings and undetected nocturnal hypoglycemia resulted in lower insulin doses (single and total daily doses) . Consequently, there were hypoglycemic events that could have been avoided had CGM been used. Combining cDSS and CGM is feasible and can facilitate glycemic control whilst avoiding hypoglycemia.

Disclosure

K.Bytyqi: None. P.M.Baumann: None. D.A.Hochfellner: None. T.Poettler: None. A.Simic: None. P.Beck: Employee; decide Clinical Software GmbH, Stock/Shareholder; decide Clinical Software GmbH. J.K.Mader: Advisory Panel; Abbott Diabetes, Boehringer Ingelheim International GmbH, Eli Lilly and Company, Medtronic, Merck Sharp & Dohme Corp., Novo Nordisk A/S, Roche Diabetes Care, Sanofi-Aventis Deutschland GmbH, Speaker’s Bureau; Abbott Diabetes, Eli Lilly and Company, Medtronic, Merck Sharp & Dohme Corp., Novo Nordisk A/S, Roche Diabetes Care, Sanofi-Aventis Deutschland GmbH, Servier Laboratories, Stock/Shareholder; decide Clinical Software GmbH.
691-P: Evaluation of an Implantable CGM System Using a Multiple-Analyte Indicator Hydrogel for Calibration Reduction
Authors: VELVADAPU VENKATA N. , MASCIOTTI JAMES M. , DEHENNIS ANDREW D. , SANCHEZ PATRICIA , TWEDEN KATHERINE S. , KAUFMAN FRANCINE R. , IOACARA SORIN
Published: May 2022

Background: The Eversense CGM System sensor is implanted in the upper arm. It uses a fluorescent, boronic acid glucose-binding moiety to measure glucose. The glucose indicator is susceptible to oxidative de-boronation from reactive oxygen species (ROS) in the interstitial fluid, necessitating daily calibrations. To reduce calibration frequency, a ROS indicator was added to measure oxidative de-boronation. Figure 1 (a) shows the copolymerization of glucose and ROS indicators into a single hydrogel matrix with orthogonal excitation emission properties. The sensor uses a 380 nm LED for excitation of the glucose indicator and a 470 nm LED for excitation of the ROS indicator.

Methods: The fluorescence of the indicators was characterized in vitro. In addition, sensors were implanted in subjects with type 1 diabetes in a 365-day clinical feasibility study to assess accuracy against fingerstick measurements.

Results: Figure 1 (b) illustrates the relationship whereby ROS exposure increases the fluorescence of the ROS indicator and decreases the fluorescence of the glucose indicator. A MARD of 9.9% against fingerstick with one calibration per week was observed through 90 days.

Conclusions: Early data suggests the multiple-analyte system should allow the next generation of long-term, implanted CGM systems to maintain accuracy with significantly reduced calibration requirements.

Disclosure

V.N.Velvadapu: None. J.M.Masciotti: Employee; Senseonics. A.D.Dehennis: Employee; Senseonics. P.Sanchez: Employee; Senseonics. K.S.Tweden: Employee; Senseonics. F.R.Kaufman: Consultant; Twin Health, Employee; Senseonics. S.Ioacara: Research Support; Senseonics.
695-P: Engagement and Glycemic Outcomes over 24 Weeks among New Level2 Members
Authors: KAMRUDIN SAMIRA , CLARK CALLAHAN , MONDEJAR JOYVALERIE P. , VARGAS MAYNARD F. , THOMPSON NELS , MACFARLANE ELIZABETH , DEFAIL ANTHONY , OECHLER AMANDA L. , COOK DAVID J.
Published: May 2022

Level2’s virtual specialty clinic, offered across the United States to people with type 2 diabetes on participating insurance plans, includes continuous glucose monitors (CGM) , fitness trackers, lifestyle recommendations, and/or coach/clinician interactions. We retrospectively assessed differences in engagement and glycemic measures over 24 weeks following Level2 enrollment. From 01/01/21 to 07/31/21, 9,137 individuals newly joining Level2 had at least 12 prior months of continuous enrollment in a participating commercial health plan to assess demographics using medical and pharmacy claims. This group was 47% female, averaged 55 years of age (SD 9) , and averaged 0.7 (SD 1.1) Diabetes Complications and Severity Index conditions. Most (60%) had fill histories for 1 or 2 diabetes drug classes; 7% had four or more.Over 24 weeks, participants averaged 175 days of enrollment and coaching interactions; two in three (N = 5,760) wore a CGM at least once. We used least absolute shrinkage and election operator regression analysis, multivariable logistic regression analysis, and zero inflated negative binomial to find features associated with coaching visit frequency and CGM wear; associations included younger age and nephropathy-related claim history. For a subset with available A1c values in the 3 months before starting Level2 and sufficient CGM data at week 12 (N = 458) or week 24 (N = 512) , GMI-based glycemic improvement of 0.5% or greater was evident for 63 - 67% of those with initial A1c between 7 - 9% and 94 - 97% of those with an initial A1c above 9%. Over 24 weeks, Level2 engagement outcomes were associated with younger age and nephropathy-related claim history; improvements in glycemic control were evident at weeks 12 and 24, particularly for those entering Level2 with A1c above 9%. Additional research is needed to characterize longitudinal clinical and engagement outcomes, including features associated with achieving and sustaining type 2 diabetes remission.

Disclosure

S.Kamrudin: Employee; UnitedHealth Group. C.Clark: Employee; UnitedHealth Group, Stock/Shareholder; UnitedHealth Group. J.P.Mondejar: None. M.F.Vargas: None. N.Thompson: Employee; Level2. E.Macfarlane: Employee; Level2. A.Defail: Employee; Level2. A.L.Oechler: Employee; Level2. D.J.Cook: None.
763-P: Real-World Use of the MiniMed 780G Advanced Hybrid Closed-Loop (AHCL) System with the Guardian 4 Sensor and the Guardian Sensor 3
Authors: VIGERSKY ROBERT A. , CASTAÑEDA JAVIER , ARRIETA ARCELIA , CORDERO TONI L. , RHINEHART ANDREW S. , SHIN JOHN
Published: May 2022

Objective: The MiniMed™ 780G system with the adjunctive Guardian™ sensor 3 that requires calibration has been commercially available in Europe, since October 2020. Since October 2021, the system has been available with the non-adjunctive Guardian™ 4 sensor, which does not require calibration. In this study, glycemic outcomes during real-world MiniMed™ 780G system use with both sensors were evaluated.

Methods: Analyses were based on data collected on Dec 10, 2021, from consenting system users (N=674) residing in Europe with ≥days of sensor glucose (SG) data from both sensors. Glycemic outcomes including mean±SD of the glucose management indicator (GMI) and percentage of time spent in target range of 70-180mg/dL (TIR) , at <54mg/dL and <70mg/dL (TBR) and at >180mg/dL (TAR) were assessed. The time spent in AHCL, number of AHCL exits/week and self-monitoring of blood glucose (SMBG) measurements/day were also determined. Results:

System use with the Guardian™ 4 sensor versus Guardian™ sensor 3 demonstrated 94±9% vs 93±11% of time in AHCL, 73.1±11.4% vs 74.6±9.8% TIR, 0.11±0.16% vs 0.51±0.58% TBR<54, 1.6±1.4% vs 2.4±1.8% TBR<70, and 25.3±11.7% vs 23.1±10.0% TAR<180. During the night (12AM-6AM) , greater glycemic control was observed: with 81.6±13.3% vs 82.8±11.0% TIR, 0.09±0.22% vs 0.42±0.69% TBR<54, 1.1±1.5% vs 1.8±1.9% TBR<70 and 17.3±13.3% vs 15.4±11.0% TAR>180. The GMI was 6.98±0.43% vs 6.84±0.38%. Closed-loop exits were 0.83±1.02 vs 1.1±1.06/week and SMBG measurements were 0.9±0.9 vs 3.3±0.9/day. Conclusion: Real-world MiniMed™ 780G system use findings indicate reduced burden related to SMBG measurements and closed-loop exits, with the Guardian™ 4 sensor, while maintaining favorable glycemic outcomes of the MiniMed™ 780G + Guardian™ sensor 3 system.

Disclosure

R.A. Vigersky: Employee; Medtronic. J. Castañeda: Employee; Medtronic. A. Arrieta: Employee; Medtronic. T.L. Cordero: Employee; Medtronic, Medtronic. A.S. Rhinehart: Employee; Medtronic. Stock/Shareholder; Medtronic. J. Shin: Employee; Medtronic.
776-P: Glycemic Outcomes after Six Months of Real-World MiniMed 780G Advanced Hybrid Closed-Loop (AHCL) Therapy Use in Chile
Authors: CASTRO MATIAS , CARRASCO BONILLA CAMILA NICOLE , LEON MACEDO JOANA C. , GUTIERREZ MARIA FERNANDA , VALERA LOPEZ ZEUDI C. , DAGHERO ANDREA
Published: May 2022

Objective: MiniMed™ 780G system use has improved glycemic control in clinical trials1,2 and real-world data analyses3. This study evaluated real-word glycemic outcomes before and 6 months after AHCL initiation by individuals with T1D living in Chile.

Methods: Data from 37 MiniMed™ 780G users (aged 5-76 years, mean±SD of 29.3±19.3 years) at 12 centers throughout Chile were prospectively collected and analyzed. Mean glucose management indicator (GMI) , sensor and system use, and time spent at SG ranges including target SG range (TIR, 70-180mg/dL) were determined using 14 days of SG data at baseline and 2, 14, 28, 90 and 180 days post-AHCL initiation.

Results: Overall, ≥95% of time was spent in AHCL (Figure 1) and GMI was <7% throughout the study. TIR increased from 68.9% to 79.5% in 7 former MiniMed™ 640G users and from 75.3% to 78.1% in 30 former MiniMed™ 670G users. The percentage of users achieving TIR >70% and GMI <7.0% increased from 63.6% to 86.5% and from 70.3% to 82.4% by 180 days post-AHCL initiation, respectively.

Conclusion: MiniMed™ 780G use in Chile allowed most to increase TIR within 2 weeks, an important outcome that was sustained over 6 months.

Disclosure

M.Castro: Employee; Medtronic. C.Carrasco bonilla: Employee; Medtronic. J.C.Leon macedo: Employee; Medtronic. M.Gutierrez: Employee; Medtronic. Z.C.Valera lopez: Employee; Medtronic. A.Daghero: Employee; Medtronic.
798-P: A Real-Life Experience with Hybrid Closed-Loop Insulin Delivery Systems in People with Type 1 Diabetes: One Year After
Authors: CONVERTINO ALESSIO , GIULIANI CHIARA , BITTERMAN OLIMPIA , NAPOLI ANGELA
Published: May 2022

Objective: evaluate the metabolic impact and metrics of the new hybrid closed loop insulin delivery system on the quality of life in patients with type 1 diabetes.

Methods: Metrics obtained with CGM with >80% of CGM readings over a 4-week period in real life: Time in Range (TIR%) [target 70-180 mg/Dl (3.9-10mmol/L) ], Time Above Range (TAR%) [ (>180mg/dl (>10mmol/L) ], Time Below Range (TBR%) [<70mg/dl (3.9mmol/L) ], CV (<36%) referred to 30 consecutive days. Statistics ANOVA post-hoc Bonferroni/Tukey tests were used as appropriate.

Results: Fifty-two type 1 diabetic patients (38F; 14M) on SAP therapy aged 45.5±12.0 yrs, BMI 27.7±15.5 kg/m2, duration of diabetes 24.6±13.4 yrs, were studied. In these patients, who were treated with total daily insulin (TDI) 0.55±0.16 UI/kg/day, basal 0.27±0.UI/kg/day, bolus 0.28±0.UI/kg/day, mean glucose was 158.6 mg/dl (8.8 mmol/L) (121-250) , TIR% 62.4±13.5%, TBR% 4.6±4.5%, TAR% 33.0±15.1%, CV% 36.1±5.2%. Only 19 of 52 patients reached TIR≥70%. A subgroup of 30 patients (21F; 9M) , mean age 44.2±12.2 yrs, BMI 29.2±19.7 kg/m2, duration of diabetes 24.2±13.6 yrs, HbA1c 7.7±1.4%, TDI 0.59±0.14 UI/kg/day, basal 0.30 UI/kg/day, bolus 0.29 UI/kg/die, shifted from SAP to HCL. CGM Metrics regarding our patient's glucose status at baseline and 1, 2, 3, 6 and 12 months after, showed that: mean sensor BG decreased from 158.6 mg/dl (8.8 mmol/L) at baseline to 144.3 mg/dl (8.2mmol/L, p<0.05) at the 2nd month, p<0.05. TIR% significantly increased from 62.4% (TBR 4.6%, TAR 33.0%, CV 36.1%) to 76% at the first month, to 76.5% (TBR 2.6%, TAR 20.9%, CV 33%) at the 3rd month, p<0.05. After 12 months (n=10) TIR% was 73.4±8.8%, TBR% 2.7±3.1%, TAR% 23.9±7.2%, CV% 35.5±5.2%, p<0.05.

Conclusions: HCL improves glucose status increasing TIR% and reducing TAR%, TBR% and glycemic variability, improving the quality of life.

Disclosure

A.Convertino: None. C.Giuliani: None. O.Bitterman: None. A.Napoli: None.
80-LB: At Home, Monitoring Device for Prevention and Interception of Diabetic Ketoacidosis Events in Children
Authors: EDGAR SOPHIE L. , PAUNESCU ALEX , DONG MING
Published: May 2022

Diabetic ketoacidosis (DKA) is often the first sign of type 1 diabetes (T1D) , especially in those children under the age of 3, with 55-100% of those in this age range diagnosed in DKA. Furthermore, 10-12% of children diagnosed with Stage 3 T1D are 3 or less, highlighting a critical need to identify those children at highest risk of a potentially life threatening DKA event at diagnosis. Commercially available urine analysis strips are not easily used with young children, so a simpler solution is urgently needed for early detection of DKA. In order to change the T1D diagnosis and treatment paradigm, we have developed a non-invasive monitoring solution that integrates into a child’s everyday routine and can alert caretakers real time when some of the early indicators of diabetes and DKA arise. The solution comprises of a single use sensing pad and a reusable Bluetooth® connected device which together fit into standard diapers. The pad collects urine and saturates two specialized colorimetric biosensor membranes which react with glucose and ketones. The device detects sufficient saturation of the biosensors and at a prescribed optimal time point, takes a reading via a photodetector to quantify the color change. Data is then sent to a mobile app which converts the readings to glucose & ketone levels using an algorithm. It sends alerts to the child’s caregiver if values indicate a threshold limit of ketones have been met, which can be early signs of diabetes or DKA. The data captured by the device can be stored and analyzed over time, so caregivers and healthcare providers may know days or weeks in advance if their child is headed toward diabetes, hoping to fend off a DKA event. This feature may provide an earlier and less precipitous diagnosis and treatment, rather than experiencing a life-threatening emergency. This at home, mobile smart monitoring solution provides a practical solution for at-home, real-time monitoring of urine glucose and ketones in young children at risk of developing T1D.

Disclosure

S. L. Edgar: None. A. Paunescu: None. M. Dong: Employee; Johnson & Johnson.
80-OR: Proinflammatory Macrophage Impairs Retrograde Axonal Transport via Inflammation and Insulin Resistance in Sensory Neurons
Authors: OSONOI SHO , MIZUKAMI HIROKI , OGASAWARA SAORI , KUDOH KAZUHIRO , DAIMON MAKOTO , YAGIHASHI SOROKU
Published: May 2022

Inflammation, insulin resistance (IR) , and deficit of retrograde axonal transport (RAT) are implicated in the pathogenesis of diabetic polyneuropathy (DPN) . Pro-inflammatory macrophage (M1) skewed by diabetic insults causes IR in adipose tissue. The activation of Advanced Glycation End products (AGEs) - Receptor for AGEs (RAGE) signaling is involved in the macrophage polarization into M1, while its contribution to the deficit of RAT in DPN is still unclear. In this study, we investigated the implication of M1-related inflammation to RAT deficit in sensory neurons. We evaluated the activation of macrophage cell line RAW 264.7 (RAW) and neurons isolated from dorsal root ganglia (DRG) of C57BL/6 mice stimulated by 200 μg/ml of AGE. A DRG neurons-RAW co-culture system was established by seeding RAW onto DRG neurons. After 12h co-culturing, we added AGE to the co-culture and stimulated RAW. A DRG neuronal mono-culture was treated with 500 nM of insulin receptor antagonist (BMS-754807) , and 20 ng/ml of TNF-α with/without 50 nM JNK inhibitor (SP600125) . Axonal transport was visualized by Lysotracker and captured by time-lapse microscopy. The movements were quantified on kymographs generated from 100 μm axonal segments. AGE induced the M1 phenotype in RAW with elevated expressions of iNOS and TNF-α mRNA, while no effects on DRG neuron were identified. In the co-culture, the frequency of RAT (RAT%) was significantly reduced when RAW was stimulated by AGE compared to naive RAW (p < 0.001) . In the mono-culture, RAT% was significantly reduced when neurons were treated with BMS-7548 and TNFα (vs. control, both p < 0.001) . TNFα stimulation also increased the phosphorylation of JNK in the axons, a major target of TNFα, which was confirmed by immunofluorescence. The reduction of RAT% by TNFα was rescued by SP600125.

In summary, RAT could be impaired by TNF-α and IR, which suggests inflammation induced by M1 in SN can attenuate RAT, which contributes to the DPN pathology.

Disclosure

S.Osonoi: None. H.Mizukami: None. S.Ogasawara: None. K.Kudoh: None. M.Daimon: None. S.Yagihashi: None.

Funding

Japan Society for the Promotion of Science (18K16220)
809-P: Digital-Tool-Supported Basal Insulin (BI) Titration: Real-World Effectiveness of My Dose Coach (MDC) in People with Type 2 Diabetes (T2D) in Colombia
Authors: GOMEZ ANA MARIA , RINCON ALEX RAMIREZ , FERIZ KAREN , SALAMANCA CARLOS F. , SILVA LILIANA P.
Published: May 2022

BI therapy is recommended in people with T2D uncontrolled on oral antidiabetic agents. However, due to delay in BI initiation and titration, many people with T2D fail to achieve recommended glycemic targets. MDC, an FDA-approved digital app, helps people with T2D to adjust their BI doses based on their fasting blood glucose (FBG) readings and hypoglycemic event data. We evaluated real-world outcomes from people with T2D on BI therapy, who registered on MDC app from 08/01/2018 to 09/30/2021 and received insulin glargine 100 U/mL or 300 U/mL. FBG target achievement (≥3 consecutive measurements within the target range) , change in FBG, and hypoglycemia events were assessed. A total of 5MDC users from Colombia with mean (SD) age 56.6 (15.1) years (55.8% female) were included (Table) . Overall, 4 (80.9%) users achieved individualized FBG target, 44 (8.7%) were still titrating and 52 (10.3%) stopped using MDC. The mean (SD) time to reach FBG target was 10.3 (15.8) days. Mean (SD) FBG at baseline was 141.7 (55.0) mg/dL, which decreased to 117.3 (31.7) mg/dL and mean (SD) BI dose increased from 22.2 (11.3) U to 24.2 (12.4) U. Hypoglycemia events were reported in 72 (14%) participants overall. These results show that people with T2D from Colombia using MDC were able to successfully titrate their BI doses and achieve FBG target with low risk of hypoglycemia.

Disclosure

A.Gomez: Advisory Panel; AstraZeneca, Research Support; Abbott Diabetes, Speaker's Bureau; Eli Lilly and Company, Medtronic, Novo Nordisk, Sanofi. A.Rincon: Advisory Panel; AstraZeneca, Medtronic, Sanofi, Consultant; Abbott, Medtronic, Novo Nordisk, Novo Nordisk, Sanofi, Other Relationship; Boehringer Ingelheim International GmbH, Novo Nordisk, Sanofi. K.Feriz: Other Relationship; Abbott, Boehringer Ingelheim International GmbH, Novo Nordisk, Sanofi, Speaker's Bureau; AstraZeneca, Lilly Diabetes, Medtronic, Merck Sharp & Dohme Corp. C.F.Salamanca: Employee; Sanofi. L.P.Silva: Employee; Merck KGaA, Sanofi.

Funding

Sanofi
81-LB: Continuous Glucose Monitoring Strategies and Devices at a Diabetes Camp
Authors: GLEICH SARAH E. , TECCA HEATHER R. , GIBSON-NORTH NATHANIEL D. , SCHUSTER ERIKA , GREEN COURTNEY R. , WALKER TOMAS C.
Published: May 2022

Background: Safe management of T1D in congregate settings such as diabetes camps may involve continuous glucose monitoring (CGM) devices, and managers of these facilities face choices regarding systems and deployment strategies. We aimed to compare individual versus multiplex monitoring strategies and to separately compare CGM systems from Dexcom (G6) and Abbott (Libre Pro) .

Methods: G6 users included 45 campers ages 8-17 years. Four used individual SMBG with G6 Pro systems in blinded mode; 41 used unblinded G6 systems whose data were available for remote review on an investigational multiplex display. Separately, data from 17 campers using G6 systems were compared to data from 17 campers using Libre Pro systems.

Results: As shown in the Table, most metrics of glycemic control favored the multiplex-monitored group over the individually SMBG-monitored group; the between-groups difference reached statistical significance with respect to nocturnal percent of time <54 mg/dL (%<54) . Analysis of data from G6 and Libre Pro systems revealed significantly lower mean glucose levels and more hypoglycemia among Libre Pro users, especially at night.

Conclusion: Meaningful differences in CGM-measured overall and nocturnal hypoglycemia may result from choices in monitoring strategies and device manufacturers.

Disclosure

S. E. Gleich: Research Support; Dexcom, Inc. H. R. Tecca: Employee; Dexcom, Inc. N. D. Gibson-north: n/a. E. Schuster: Employee; Dexcom, Inc. C. R. Green: Employee; Dexcom, Inc. T. C. Walker: Employee; Dexcom, Inc., Stock/Shareholder; Dexcom, Inc.

Funding

Dexcom, Inc.
870-P: Newer Glucose-Lowering Drugs and Risk of Dementia: A Meta-analysis of Cardiovascular Outcome Trials
Authors: TANG HUILIN , NIU SHU , BROWN JOSHUA D. , WEI JINGKAI , WINTERSTEIN ALMUT G. , BIAN JIANG , GUO JINGCHUAN
Published: May 2022

Background: Existing observational studies yielded mixed results between cognitive and dementia outcomes and newer glucose-lowering drugs (GLDs) , i.e., dipeptidyl peptidase-4 (DPP-4) inhibitors, glucagon-like peptide-1 receptor agonists (GLP-1RAs) , and sodium-glucose co-transporter-2 (SGLT2) inhibitors, while individual randomized trials have inadequate power to examine such an effect. Thus, we aimed to evaluate the effect of these newer GLDs on the risk of dementia by performing a meta-analysis of randomized outcome trials.

Methods: We included published randomized placebo-controlled cardiovascular and renal outcome trials that evaluated DPP-4 inhibitors, GLP-1RAs, and SGLT2 inhibitors and reported dementia events. The study outcomes were all-cause dementia and vascular dementia, extracted from clinicaltrials.gov. We calculated pooled odds ratios (OR) and 95% CIs using the Peto method.

Results: We included 21 trials involving 1all-cause dementia cases (including 22 vascular dementia cases) among 167,5patients with or without type 2 diabetes over a median follow-up of 2.2 years. Neither DPP-4 inhibitors (OR, 0.65 [0.33-1.29]) , GLP-1RAs (OR, 0.88 [0.51-1.52]) , or SGLT2 inhibitors (OR, 1.22 [0.54-2.74]) were significantly associated with all-cause dementia incidence. For vascular dementia, compared with placebo, SGLT2 inhibitors were significantly associated with a decreased risk (OR, 0.[0.02-0.66]) , while DPP-4 inhibitors (OR, 0.67 [0.12-3.85]) and GLP-1RAs (OR, 0.37 [0.12-1.14]) did not significantly decrease the risk. No evidence of statistical heterogeneity or publication bias was detected in the meta-analysis (p >0.05) .

Conclusion: SGLT2 inhibitors may have a beneficial effect on lowering the vascular dementia risk, thus may be a drug repurposing signal. Nevertheless, future randomized controlled trials and/or comparative effectiveness studies using real-world data are warranted to further confirm our conclusion.

Disclosure

H.Tang: None. S.Niu: None. J.D.Brown: None. J.Wei: None. A.G.Winterstein: Consultant; Genentech, Inc., Research Support; Merck & Co., Inc. J.Bian: None. J.Guo: None.