bluuebunny/crossref_metadata_2025 huggingface dataset:
528-P: Provider Perspectives: Digital Apps in Delivering Diabetes Self-Management Education and Support (DSMES)
Authors: MEHROTRA NEHA , KRALL JODI S. , NG JASON , SIMINERIO LINDA M.
Published: May 2022

Introduction: DSMES is a critical component of diabetes (DM) care. Providers are expected to perform this service, but time for it is limited, especially for ongoing support. Digital tools, like mobile applications (apps) , show promise in extending efforts and supporting self-management, but have yet to be fully utilized. The purpose of this study was to examine provider insights on the role of mobile apps in DSMES delivery.

Methods: DM providers representing inpatient, outpatient, and community settings were invited to complete a validated survey about experiences with and perspectives on app use for DSMES. Survey results were recorded and summarized to capture dominant themes.

Results: Sixty providers (33% diabetes care and education specialists, DCESs, 21% endocrine clinicians) completed the survey. Of those, 17% (10/59) reported being very familiar with apps; 33% (20/59) had used an app to provide DM education while 25% (15/59) used an app for support. Respondents (77%, 46/60) primarily viewed apps as adjunct to DCES education, particularly for reinforcement. In terms of recommending apps, 90% of providers (54/60) rated patient app interest and access as most important factors to consider. In addition, 70% (42/60) agreed apps may be particularly useful to patients who use telehealth or live far from clinics. Specific to insulin, 70% agreed apps could serve as a helpful tool to prepare those new to insulin and aid with injection skills, dosing decisions and titration. Features they viewed as useful include clear set-up instructions, goal setting and digital coaching. Interestingly, outpatient DCESs reported willingness to use 15 or more minutes of visit on setting up/teaching app use, while hospital-based providers were willing to spend 5 minutes.

Conclusion: National standards recommend digital coaching as an effective method to deliver DSMES. These findings offer important feedback for introducing digital tools into clinical practice.

Disclosure

N.Mehrotra: None. J.S.Krall: Research Support; Becton, Dickinson and Company, Sanofi. J.Ng: Research Support; Sanofi. L.M.Siminerio: Advisory Panel; Abbott, Bayer AG, Research Support; Becton, Dickinson and Company, Sanofi.

Funding

Becton, Dickinson and Company
532-P: Voluntary Exercise during Food Restriction Promotes a Sustained Increase in Hepatic Oxidative Metabolism
Authors: DEJA STANISLAW , KUCEJOVA BLANKA , MAURER ADRIANNA , MIZERSKA MONIKA N. , FU XIAORONG , THYFAULT JOHN P. , BURGESS SHAWN C.
Published: May 2022

Exercise is an important lifestyle intervention for the prevention and treatment of NAFLD. Importantly, exercise can reduce hepatic steatosis independent of changes in body mass, which may stem from increased oxidative demand in liver during exercise. Increased hepatic gluconeogenesis (GNG) and tricarboxylic acid (TCA) cycle flux have been observed during exercise in rodents, but it is unclear whether this adaptation is chronically maintained outside of the exercise window. Liver metabolism is also altered by nutritional status. Fasting promotes hepatic fat oxidation, ketogenesis and GNG, while feeding promotes glycogen storage and fat synthesis. Hence, fasting and exercise may have a positive interaction, whereas exogenous nutrient intake or glucose infusion is known to reduce the induction of GNG during exercise. Here, we tested whether nutritional status impacts exercise induced hepatic metabolic adaptations. Sprague-Dawley rats were kept sedentary or provided voluntary wheel running (VWR) for 4 weeks in the presence or absence of food restriction during the dark phase when rats spontaneously run. Experiments were conducted one day following the last exercise bout. Hepatic metabolic flux was examined by in vivo stable isotope infusions of [U-13C3]propionate, [3,4-13C2]glucose and 2H2O in rats using mass spectrometry and computational analysis. Chronic VWR in the fed state had no effect on basal hepatic fluxes outside of the exercise window. However, exercise during food restriction chronically induced a 2-fold induction of TCA cycle turnover, increase in GNG from glycerol and lowered ketogenesis outside of the exercise window. Thus, VWR during food restriction triggered an increase in hepatic energy demand that was sustained for at least 24 hours, while the effects of exercise in the fed state dissipated by 24 hours. These data suggest that acute nutritional state may be an important factor in the long-term programming of liver metabolism by exercise.

Disclosure

S.Deja: None. B.Kucejova: None. A.Maurer: None. M.N.Mizerska: None. X.Fu: None. J.P.Thyfault: None. S.C.Burgess: n/a.

Funding

National Institutes of Health (R01DK121497, R01DK078184, P41EB015908)
54-OR: Psychosocial Factors and Medication Adherence in Young Adults with Youth-Onset Type 2 Diabetes: Longitudinal Results from the iCount Study
Authors: TRIEF PAULA M. , KALICHMAN SETH , USCHNER DIANE , FETTE LIDA M. , WEN HUI , DREWS KIMBERLY , ANDERSON BARBARA , BULGER JANE D. , WEINSTOCK RUTH S.
Published: May 2022

Aim: To identify psychosocial factors in young adults (mean age 26 yrs) that predict medication adherence 1 year later in the Treatment Options for Type 2 Diabetes in Adolescents and Youth (TODAY2) observational study.

Methods: Validated psychosocial measures (attitudes, beliefs, self-efficacy, distress, depression, anxiety, self-management support, needs insecurities) were completed at baseline (T1) . Medication adherence was assessed at T1 and 1 year later (T2) . Adherence to oral hypoglycemia agents (OHA) was assessed with 3 monthly unannounced phone pill counts. Insulin adherence was self-report. Adherence was defined categorically (≥ 80% pills/insulin=high adherent; < 80% = low adherent) and continuously (% adherence) . Logistic and linear regressions assessed psychosocial measures as predictors of adherence group (high vs. low) and % adherence, controlling for potential confounders.

Results: OHA adherence: Mean scores declined from T1 to T2 (57.9% vs. 51.4%, p=0.004; N=171) . In adjusted multivariable analyses, more concerns about diabetes medications (e.g. long-term effects) (p=0.035) and lack of healthcare coverage (p=0.043) predicted higher odds of being low adherent. Beliefs that medications are harmful (p=0.004) or overused (p=0.002) , lack of healthcare coverage (p<0.0001) , reporting ≥1 (p=0.004) and ≥2 (p=0.017) need insecurities predicted lower % adherence.Insulin adherence: Mean scores were stable from T1 to T2 (70.8% vs. 69.3%, p=0.622; N=157) . Beliefs that medications are harmful (p=0.022) or overused (p=0.002) and lower self-management support (p=0.006) predicted being low adherent and lower % adherence. High diabetes distress predicted lower % adherence (p=0.044) .

Conclusions: Negative beliefs about medicines and unmet material needs predicted poorer OHA adherence. Negative beliefs, low support and distress predicted lower insulin adherence. These factors may be targets for future interventions.

Disclosure

P.M.Trief: None. S.Kalichman: None. D.Uschner: None. L.M.Fette: None. H.Wen: None. K.Drews: None. B.Anderson: None. J.D.Bulger: None. R.S.Weinstock: Research Support; Boehringer Ingelheim International GmbH, Dexcom, Inc., Diasome, Eli Lilly and Company, Insulet Corporation, Kowa Pharmaceuticals America, Inc., Medtronic, Novo Nordisk, Tandem Diabetes Care, Inc., Tolerion, Inc.

Funding

National Institute of Diabetes and Digestive and Kidney Diseases (RO1DK110456, U01-DK61212, U01-DK61230, U01-DK61239, U01-DK61242, and U01-DK61254)
540-P: Meta-analysis of Blood Glucose Response to High Intensity Exercise in Adults with Type 1 Diabetes
Authors: MCCLURE REID , WESEEN EMMA , ALCÁNTARA CORDERO FRANCISCO JAVIER , MALDANER MIRANDA , HART SARAH , BOULÉ NORMAND G. , YARDLEY JANE E.
Published: May 2022

Background: High intensity exercise-induced hyperglycemia is recognized in T1D clinical guidelines, but its occurrence after high intensity intermittent exercise (HIIE) in acute studies is inconsistent. This meta-analysis aimed to examine the available evidence of BG responses to HIIE in adults with T1D. The secondary aim was to assess the role of prandial status (fasted/fed) , sex (by percentage of female participants ≤ 50, or > 50) , mean age, fitness (VO2peak) , interval duration, and total exercise duration on BG outcomes. We hypothesized that there would be no consistent effect on BG from HIIE, unless examined in the context of participant prandial status.

Methods: We conducted a literature search using keywords related to T1D and HIIE. Studies were required to have a minimum of 6 participants with T1D aged ≥17 years, involving a HIIE intervention, and a pre- and post-exercise measure of BG to be included. Analyses were performed using a general inverse variance statistical method with a random effects model on RevMan5® statistical software and a weighted multiple regression on STATA17® statistical software.

Results: Seventeen interventions from 13 studies were included in the final analysis. A mean overall BG change of -1.4 mmol/L (-3.0, 0.2) was found during exercise albeit with high heterogeneity (I2= 92%) . Fasted exercise increased BG by +1.7 mmol/L (-0.2, 3.6) , while fed exercise decreased BG by -2.6 mmol/L (3.7, -1.5) , with a statistically significant difference between groups (p<0.001) . There were no significant effects from sex (p=0.74) , fitness (p=0.46) , age (p=0.89) , interval duration (p=0.25) or exercise duration (p=0.38) .

Conclusions: The effect of HIIE on BG is inconsistent, but partially explained by prandial status.

Disclosure

R.Mcclure: None. E.Weseen: None. F.Alcántara cordero: None. M.Maldaner: None. S.Hart: None. N.G.Boulé: None. J.E.Yardley: Research Support; Abbott, Dexcom, Inc., LifeScan, Speaker's Bureau; Abbott Diabetes.
552-P: Changes in Food and Nutrient Intake and Diet Quality on a Low-Fat Vegan Diet Are Associated with Changes in Body Weight and Body Composition in Overweight Adults: A Randomized Clinical Trial
Authors: KAHLEOVA HANA
Published: May 2022

Objective: The aim was to identify changes in food, nutrient intake, and diet quality on a low-fat vegan diet and associations with changes in body weight and body composition.

Methods: Overweight adults (n=244) were randomly assigned to follow a low-fat vegan diet (n=122) or make no diet changes (n=122) . Main outcome measures were changes in food intake, macro- and micronutrient intake, and dietary quality as measured by AHEI-2010, analyzed from 3-day diet records, and associations with changes in body weight and body composition. A repeated measure analysis of variance (ANOVA) model, Spearman correlations, and linear regression were used for statistical analysis.

Results: The intervention group’s AHEI-20increased by 6.0 points on average in contrast to no significant change in the control group (treatment effect +7.2 [95% CI +3.7 to +10.7]; p<0.001) . Increase in AHEI-20correlated with reduction in body weight (r=0.14; p=0.04) , fat mass (r=-0.14; p=0.03) , and HOMA-IR (r=-0.17; p=0.02) , after adjustment for changes in energy intake. Fruit, vegetable, legume, meat alternative, and whole grain intake significantly increased in the intervention group. Intake of meat, fish and poultry; dairy products; eggs; nuts and seeds; and added fats decreased. Decreased weight was most strongly associated with increased intake of legumes (r=‑0.38; p<.0001) and decreased intake of total meat, fish, and poultry (r=+0.43;p<.0001) . Reduced fat intake was associated with reduced body weight (r=+0.15; p=0.02) and, after adjustment for changes in BMI and energy intake, with reduced fat mass (r=+0.14; p=0.04) .

Conclusions: Diet quality as measured by AHEI-20improved on the low-fat vegan diet, which was associated with improvements in weight and metabolic outcomes. Increased legume intake was the strongest single food group predictor of weight loss.

Disclosure

H.Kahleova: None.
58-OR: Remission of Prediabetes upon Weight Loss Depends on Insulin Sensitivity
Authors: SANDFORTH ARVID , LANGE KARL D. , WAGNER ROBERT ,   GERMAN CENTER FOR DIABETES RESEARCH, PFEIFFER ANDREAS F. , RODEN MICHAEL , FRITSCHE ANDREAS , JUMPERTZ VON SCHWARTZENBERG REINER , BIRKENFELD ANDREAS L.
Published: May 2022

The Prediabetes Lifestyle Intervention Study (PLIS) - a multicenter study conducted by the German Center for Diabetes Research - showed that intensified compared to conventional lifestyle intervention led to higher probability to normalize glucose regulation. Here, we examined clinical traits determining remission of prediabetes in PLIS participants with a clinically relevant weight loss of ≥5% of their initial body weight after 12 months of lifestyle intervention. Of 11participants, 298 achieved a weight loss of ≥5 %. We classified individuals as responders, who returned to normal glucose regulation by fasting glucose, 2h OGTT plasma glucose and HbA1c (n=128) and compared them to non-responders (n =170) . There were no differences in BMI change (-3.43 ±2.02 kg/m2 in responders, -2.83 ±1.37 in non-responders, p = 0.68) , whole body fat mass loss (6.7 ± 4.9 l vs. 5.9 ±4.5, p = 0.25) or reduction in liver fat (6.1 ±6.3 percentage points vs. 6.6 ±6.4, p = 0.59) . Similarly, there was no difference in change of insulin secretion between responders and non-responders. In contrast, responders improved insulin sensitivity significantly more than non-responders (Insulin Sensitivity Index +4.5 ±4.7, vs. +2.3 ±3.1, p < 0.01) . We conclude that, in prediabetes, weight loss induced return to normal glucose regulation primarily depends on improvements in insulin sensitivity, contrasting recently reported mechanisms of diabetes remission.

Disclosure

A.Sandforth: None. K.D.Lange: None. R.Wagner: Advisory Panel; Akcea Therapeutics, Daiichi Sankyo, Sanofi-Aventis Deutschland GmbH, Speaker's Bureau; Lilly, Novo Nordisk, Sanofi-Aventis Deutschland GmbH. German center for diabetes research: n/a. A.F.Pfeiffer: None. M.Roden: Advisory Panel; Eli Lilly and Company, Research Support; Boehringer Ingelheim International GmbH, Nutricia, Speaker's Bureau; Novo Nordisk. A.Fritsche: Advisory Panel; Boehringer Ingelheim International GmbH, Novo Nordisk, Sanofi-Aventis Deutschland GmbH. R.Jumpertz von schwartzenberg: None. A.L.Birkenfeld: None.
593-P: Similar Rate of Positive Depression Screen in Youth with Diabetes Before and During the COVID-Pandemic: Still No Reason for Complacency
Authors: SRIRAM SWETHA , LEIKAM LINDSAY M. , MARCH CHRISTINE , SCHREIBER JUSTIN , MUZUMDAR RADHIKA , LIBMAN INGRID
Published: May 2022

Adolescents with diabetes mellitus (DM) experience depression 2-3 times higher than the general population. Little is known about the impact of the COVID pandemic. We aimed to identify the prevalence of depression among youth with DM before and during the pandemic and associated factors in a large academic children’s hospital. Patient health Questionnaire-9 (PHQ-9) screens completed in fall 20 and 2020 (n=216 vs. 194 respectively) were reviewed. 187 subjects (81%) completed the screen at both periods (54% female, 97% white, 97% with type 1 DM (T1D) , mean (SD) age 15.1 (2.7) years, duration of DM 7.2 (4.2) years) . Among youth with T1D, 55% used insulin pumps and 64% continuous glucose monitor (CGM) . When comparing 20to 2020, median [IQR] PHQ-9 score (1 [0-3] vs. 0 [0-3], p=0.76) or rates of depression (17 vs. 15%, p=0.65) were not different. In 2011%, 4% and 2% had mild (PHQ-9 score 5-9) , moderate (score 10-14) , and severe (score >14) depression respectively with similar rates in 2020 at 10%, 2% and 3% There was no difference in mean HbA1c between 20 and 2020 (8.2±1.7 vs. 8.2± 1.8% respectively, p=0.99) . Using 20data, PHQ-9 score was significantly positively correlated with HbA1c (rho=0.22, p=0.003) and BMI z-score (rho=0.22, p=0.003) , but not to age (rho-0.02, p=0.73) , or duration of diabetes (rho=0.04, p=0.55) . Depression was more prevalent in females (21% vs. 12%, p=0.09) and in youth with no CGM use (24 vs. 12%, p=0.047) . Suicidal ideation was reported in 4 (2%) of youth in 20 and 3 (1.5%) in 2020. Our results suggest that the prevalence/severity of depression during the first year of the pandemic did not change in youth with DM compared to the previous year, the reason perhaps being that ∼ 90% of patients in our institution continued to being followed up, albeit virtually, during the pandemic. Still, almost 1/5 of adolescents with DM scored positive for depression highlighting the need to support the behavioral needs of youth with T1D.

Disclosure

S.Sriram: None. L.M.Leikam: None. C.March: None. J.Schreiber: None. R.Muzumdar: None. I.Libman: Consultant; Novo Nordisk.
623-P: COVID-Impact on Type 2 Diabetes Self-Management during the Pandemic
Authors: KOONMEN LEIGH ANNE , LENNIE TERRY A. , ICKES MELINDA , HIERONYMUS LAURA B. , MILLER JENNIFER L. , MUDD-MARTIN GIA
Published: May 2022

Introduction: Persons with diabetes and COVID-have higher rates of morbidity and mortality than those without diabetes. Engagement in Diabetes Self-Management Education and Support (DSMES) services may improve diabetes self-management adherence. The purpose of this study was to determine whether COVID-impact and attendance of DSMES services were predictors of diabetes self-management among individuals with T2D during the pandemic.

Methods: Participants (N=86) of this cross-sectional survey study were adults with T2D who either had (n=29) or had not (n=57) previously attended at least one DSMES class. The Coronavirus Impact Scale (range 0-24) was used to measure impact of the pandemic on daily life. The Self-Management Profile for Type 2 Diabetes was used to measure overall self-management and subscales for adherence, ease, coping, and importance. Multiple linear regressions were conducted to determine whether COVID-impact and DSMES participation predicted self-management total scores or subscale scores, controlling for age, sex, marital status, financial status, and time since diabetes diagnosis, with separate models for each predictor.

Results: Participants were 57±12.3 years; 50% female, and 90% non-Hispanic White. DSMES attendance did not significantly predict subscale or overall scores for self-management. Higher COVID-impact predicted worse self-management adherence (F 3.71, p=0.002) , greater self-management ease (F 3.72, p=0.002) , decreased coping (F 4.65, p<0.001) , and worse overall self-management (F 4.93, p<0.001) . Neither COVID-impact nor DSMES attendance predicted self-management importance (p=0.79 and 0.99, respectively) .

Conclusions: Findings underscore the negative impact of the COVID-pandemic on diabetes self-management and highlight the need for interventions to improve self-management practices during times of crisis.

Disclosure

L.Koonmen: None. T.A.Lennie: None. M.Ickes: None. L.B.Hieronymus: None. J.L.Miller: None. G.Mudd-martin: None.

Funding

Jonas Nurse Scholars Program, University of Kentucky College of Nursing PhD Dissertation Research Award
64-LB: Long-Term Effectiveness of the My Dose Coach Application on the Maintenance of Glycemic Control in Patients with Type 2 Diabetes Mellitus in Uncontrolled
Authors: POLANCO MIGUEL A.
Published: May 2022

Introduction: My Dose Coach (MDC) is an app designed for basal insulin dose titration that has demonstrated its versatility in several clinical studies. We evaluated its effect on the maintenance of glycemic control for 28 weeks in patients with type 2 Diabetes.

Objective: Compare the efficacy of 2 basal insulin titration strategies: MDC vs. Conventional Titration (CT) to maintain glycemic control (HbA1c < 7% and fasting plasma glucose -FPG- between 90-130 mg/dL) . Research Design and Methods: We design controlled and randomized clinical trial lasting 28 weeks, we included 80 patients with uncontrolled type 2 Diabetes (HbA1c between 8-10%) and without previous treatment with insulin. They were randomized into 2 groups: online insulin dose titration using the MDC app vs. CT in person every 2 weeks. At week 25, all enrolled patients titrated their dose in a conventional manner to assess the effect of discontinuing use of the app.

Results: We included 40 patients per group, with a mean age of 52.7 years and a duration of type 2 Diabetes of 8.1 years. A total of 36 subjects (90%) vs. 33 (82.5%) completed the study, p 0.215. In the initial evaluation the following results were obtained: baseline FPG 172 vs. 167 mg/dL, p 0.98, HbA1c 9 vs. 8.9%, p 0.497, initial dose of insulin Glargine (U-100/U-300) 16.9 vs. 17.6 IU, p 0.122, MDC vs. CT respectively. Evaluation at 24 weeks, glucose 106 vs. 110 mg/dL, p 0.69, HbA1c 6.87 vs. 7.08 %, p 0.016, mean HbA1c reduction -2.10 vs. -1.83 %, p 0.015. Final insulin dose 29.9 vs. 34.1 IU, p 0.004, mean time to FPG goal 18 vs. 26 days, p 0.001. When suspending the titration by means of the application in the week 25 to 28 average glucose increased 138.5 vs. 142 mg/dL p 0.605, MDC vs. CT respectively.

Conclusions: My Dose Coach app is an effective digital insulin glargine titration tool in real-world patients with uncontrolled type 2 Diabetes, as the number of participants achieving established control goals was higher and lasted longer. Fulfilling the objective of the study with lower doses of insulin and achieving stability in FPG in a considerably shorter time.

Disclosure

M. A. Polanco: None.
64-OR: Reduction of HbA1c in Adults with Type 2 Diabetes through Sugarfit's Diabetes Reversal Program Using a Coach-Led, Technology-Enabled, and Habit-Based Approach: A Retrospective Analysis
Authors: MEHRA CHHAVI GOYAL , RAYMOND ANNIE M. , PRABHU REKHA , TATTI APOORVA , GOEL VASU , RAMESH YASAM V.
Published: May 2022

This study aimed to compare the changes in vital variables pertaining to type 2 diabetes (T2D) using Sugarfit’s Diabetes Reversal Program (SDRP) and a group with NO personal coach assistance. This is a retrospective analysis of people with T2D who participated in SDRP compared with those who were not in SDRP. Participants of SDRP were assigned a personal coach with unlimited access via chat messages, audio & video calls. Regular monitoring was done by coaches to swap foods causing sugar spikes to a customised diet based on diabetes plate method using data points from Continuous Glucose Monitor (CGM) . Personalized interventions were advised in view of positive habit formation with frequent reminders. A total of 150 clients self enrolled in SDRP and 1clients were recruited as controls. Weight, Fasting blood sugar (FBS) and Hba1c levels were analysed from baseline to 90 days. In the group of SDRP, the weight from baseline was decreased from 76.94±12.44 kg to 73.87±11.53 kg (mean weight loss of 2.63±2.58 kg) compared to control where the weight from baseline was increased from 73.28±15.28 kg to 73.88±15.20 kg (mean weight gain of 0.50±2.37 kg) . In SDRP, Hba1c levels dropped from 8.7±1.65% to 7±1.32% with a mean change of 1.7±1.56% while the control group showed gain from 7.13±0.5% to 7.18±0.57% with a mean of 0.04±0.29%. FBS levels also showed a significant decrease in SDRP from 172.3±58.mg/dL to 114.03±24.24 mg/dL with mean loss of 61.4±57.7 mg/dL whereas control group saw slight decrease from 142.57±48.mg/dL to 141.15±44.88 mg/dL with a mean of 1.42±25.40 mg/dL. Overall, outcomes from SDRP positively affirm and signify the positive effects of change in behaviour and sustained lifestyle practises in people with T2D using proprietary SDRP methodology. Reduction of Hba1c and FBS through these evidence-based holistic recommendations can be life-altering & highly beneficial for people with T2D.

Disclosure

C.Goyal mehra: None. A.M.Raymond: None. R.Prabhu: None. A.Tatti: None. V.Goel: None. Y.V.Ramesh: None.
655-P: Evaluation of Accuracy and Longevity of an Implantable CGM System through 365 Days
Authors: JACQUIN ARNAUD E. , AL-KHAWI LUJAIN , SANCHEZ PATRICIA , MOHANTY SANAT , TWEDEN KATHERINE S. , KAUFMAN FRANCINE R.
Published: May 2022

Background: The PROMISE Clinical Trial, conducted to assess safety and accuracy of a 180-day implantable CGM System, had 43 subjects implanted with a modified sensor containing sacrificial boronic acid (SBA) to reduce the degradation of the boronic acid glucose-binding moieties. In-home use to 365 days was monitored in a 30 subject SBA sub-study.

Methods: Accuracy of sensor glucose (SG) measurements produced by an algorithm emulator was compared to YSI model 2300 glucose obtained during in-clinic visits to 180 days. The sub-study compared SG to fingerstick blood glucose (BG, CONTOUR Next One BG meter) 4-7 times/day, from days 1-365 or until sensor retirement. SG values were paired within 5 mins after a BG values in the 30 sensors. MARD for 1-180 days was assessed with both YSI and BG reference methods. MARD by glucose ranges were compared for 1-180 days, 181-365 days and 1-365 days using BG as reference.

Results: The MARD for SBA sensors for days 1-180 from in-clinic visits was 8.1% with YSI and 9.5% with BG as reference. The Table shows a comparison of MARD values by glucose ranges for the 3 time periods.

Conclusions: There was ∼1.4 percentage point increase in overall MARD obtained when BG measurements were used as the reference value rather than YSI. The extension of the PROMISE Clinical Trial in a subset of subjects implanted with SBA sensors suggests accuracy can be maintained and extended to 365 days and across 40-400 mg/dl glucose ranges.

Disclosure

A.E.Jacquin: Employee; Senseonics, Other Relationship; BrainScope Company, Inc. L.Al-khawi: None. P.Sanchez: Employee; Senseonics. S.Mohanty: Employee; Senseonics. K.S.Tweden: Employee; Senseonics. F.R.Kaufman: Consultant; Twin Health, Employee; Senseonics.
656-P: Effect of Calibration Frequency on Accuracy of a 180-Day Implantable CGM System
Authors: JACQUIN ARNAUD E. , AL-KHAWI LUJAIN , GHOSH-DASTIDAR SAMANWOY , TWEDEN KATHERINE S. , KAUFMAN FRANCINE R.
Published: May 2022

Background: The PROMISE Clinical Study was conducted to determine the accuracy and safety of the next generation implantable CGM System. A subset of 43 subjects had a sensor implanted with modified chemistry referred to as sacrificial boronic acid (SBA) , to protect the boronic acid glucose-binding moieties from degradation. This post-hoc analysis investigated the effect of SBA on accuracy through 180 days using different calibration (cal) schemes.

Methods: Data from the PROMISE Clinical Study from participants with SBA sensors was run through an algorithm emulator with cals of 1/day, 2/day, or using a dynamic cal scheme switching between 1-2/day, all starting on day 22 (day 1-21 had fixed 2 cals/day) . MARD was analyzed by glucose ranges and days of sensor wear through 180 days.

Results: The Table shows the MARD by glucose ranges and cal frequency. MARD (%) by days of sensor wear demonstrated: 9.6, 9.4, 9.2 on days 1-30; 9.5, 8.6, 8.3 on days 31-60; 7.7, 7.4, 7.6 on days 61-90; 8.3, 8.0, 7.9 on days 91-120; 9.6, 8.8, 7.5 on days 121-150; and 7.0, 7.3, 6.9 on days 151-180, respectively, for 1 cal/day, dynamic cal, and 2 cals/day.

Conclusions: The SBA sensor maintains an overall MARD less than 9.0% by glucose range and 9.6% by days of sensor wear through 180 days, whether it has a cal scheme of 1, dynamic, or 2 cal per day. By reducing sensor degradation with the SBA chemistry modification, the sensor maintains long-term accuracy with 1 cal/day.

Disclosure

A.E.Jacquin: Employee; Senseonics, Other Relationship; BrainScope Company, Inc. L.Al-khawi: None. S.Ghosh-dastidar: Employee; Senseonics. K.S.Tweden: Employee; Senseonics. F.R.Kaufman: Consultant; Twin Health, Employee; Senseonics.
660-P: The Effect of Real-Time Continuous Glucose Monitors on Fear of Hypoglycemia in People with Type 1 Diabetes: A Systematic Review and Meta-analysis
Authors: TALBO MERYEM K. , KATZ ALEXANDRA , PETERS TRICIA , YALE JEAN-FRANÇOIS , WU ZEKAI , BRAZEAU ANNE-SOPHIE
Published: May 2022

Background: Real-time continuous glucose monitors (rtCGM) are associated with improved type 1 diabetes (T1D) management and quality of life but little is known on their impact on fear of hypoglycemia (FOH) . This review and meta-analysis assessed the impact of rtCGM on FOH in T1D.

Methods: Studies assessing FOH in non-pregnant adults with T1D using rtCGM compared to capillary blood glucose (CBG) or intermittently scanned CGM (isCGM) were included. Results from RCTs were pooled using a random-effects model to calculate the standardized mean difference (SMD) with 95% CI.

Results: We identified 14 original studies, with 2590 participants and lasting 8 to 26 weeks for RCTs and 16 to 52 weeks for observational studies. Ten RCTs were included in the meta-analysis. A clear trend was observed that rtCGM was associated with lower FOH (mean difference (MD) = -3.44, 95%CI [-4.02, -2.85]) with the effect size showing a significant moderate association between rtCGM and FOH reduction compared to controls (SMD= -0.52, 95%CI [-1.02, -0.02], I2= 92%) (Figure) . Observational studies (n= 4) showed a significant association between rtCGM use and lower FOH (MD = -4.10, 95%CI [-4.84, -3.36]) .

Conclusions: Compared to both isCGM and CBG; rtCGM use shows a moderate trend for lower FOH in medium-term RCTs, which was further supported by results from longer observational studies.

Disclosure

M.K.Talbo: None. A.Katz: None. T.Peters: None. J.Yale: Advisory Panel; Bayer AG, Boehringer Ingelheim International GmbH, Eli Lilly and Company, Novo Nordisk Canada Inc., Sanofi, Research Support; Bayer AG, Speaker's Bureau; Abbott Diabetes, AstraZeneca, Bayer AG, Dexcom, Inc., Eli Lilly and Company, Janssen Pharmaceuticals, Inc., Merck & Co., Inc., Novo Nordisk Canada Inc., Sanofi. Z.Wu: Other Relationship; Eli Lilly and Company. A.Brazeau: Research Support; Eli Lilly and Company, Novo Nordisk, Sanofi.
669-P: Lower Peak Glucose and Increased Time in Range (TIR) in a CGM-Wearing T2D Population Not Taking Fast-Acting Insulin Shows Value of Real Time–CGM (rtCGM) as a Behavior Change Tool
Authors: CRAWFORD MARGARET A. , CHERÑAVVSKY DANIEL R. , BARNARD KATHARINE , WANG XIAOHAN (ARIA) , GENGE PAUL , GREENAWALD KENNETH , TRESSLER MICHELLE
Published: May 2022

Background: Lifestyle modification is advised for individuals with T2D to improve physical and mental health outcomes.

Methods: Glucose data were collected with rtCGMs in an observational 12-week clinical trial in US adults with T2D not taking fast-acting insulin (NIIT) . Participants did not receive education beyond standard of care. Paired T-tests were used to evaluate changes in % TIR 70-180 mg/dL, peak glucose, and hyper- and hypoglycemic events during meal-related time periods (morning, afternoon, evening) between the first and last weeks of CGM wear. Results are presented for the full T2D NIIT population and a subgroup of participants whose TIR increased by ≥ 5% over the study period.

Results: Fifty-three (35%) participants improved their TIR by ≥ 5%, in whom TIR and peak glucose were significantly improved and events of severe hyperglycemia were eliminated in meal-related time periods (Table 1) .

Conclusion: Lower peak glucose, TIR increasing to target, and elimination of severe hyperglycemic events suggest that participants optimized their glucose during the rtCGM wear period through behavior modification. Longitudinal research that collects contextual behavioral and self-learning information alongside CGM data can provide further insight into how rtCGM operates as a behavior change tool.

Disclosure

M.A.Crawford: Employee; Dexcom, Inc. D.R.Cherñavvsky: Employee; Dexcom, Inc. K.Barnard: Advisory Panel; Roche Diabetes Care, Sanofi, Research Support; Dexcom, Inc., Novo Nordisk. X.Wang: None. P.Genge: Employee; Dexcom, Inc. K.Greenawald: None. M.Tressler: Employee; Dexcom, Inc.
670-P: Iron-Deficiency Anemia Case Report Showing the Clinical Relevance of RBC-Lifespan–Adjusted A1C
Authors: HIROTA YUSHI , XU YONGJIN , YAMAMOTO AKANE , MATSUOKA ATSUKO , DUNN TIMOTHY , OGAWA WATARU
Published: May 2022

Laboratory A1C does not precisely reflect glycemic control in those with altered RBC lifespan and our aim was to evaluate an adjusted A1C, a glycemic measure that adjusts A1C to a reference RBC lifespan. By removing the individual RBC lifespan variation, adjusted A1C better reflects intracellular glucose exposure in RBCs and perhaps other organs susceptible to complications. Iron-deficiency anemia and treatment is known to affect RBC lifespan and therefore provides opportunity to evaluate the model.

The patient was a 53-year-old woman with iron-deficiency anemia and type 1 diabetes utilizing sensor-augmented pump therapy. Longitudinal A1C and CGM were evaluated with a novel kinetic model to estimate RBC lifespan and glucose uptake rate. During the six months before iron therapy, the RBC lifespan was estimated at 151 days and 93% of a reference glucose uptake. During six months of iron therapy, the RBC lifespan decreased to 122 days, while the RBC glucose uptake increased slightly to 101% of reference value. The RBC lifespan change explains the observed laboratory A1C change (Figure) and can be attribute to the iron therapy and supported by Hb, RDW and Ferritin data. The adjusted A1C based on these two different RBC lifespans agree with the stable CGM mean glucose of this patient. In this case study, we confirmed the clinical relevance of adjusted A1C to account for variations in RBC lifespan.

Disclosure

Y.Hirota: Speaker's Bureau; Abbott Japan Co., Ltd., Astellas Pharma Inc., AstraZeneca, Boehringer Ingelheim International GmbH, Daiichi Sankyo, Kissei Pharmaceutical Co., Ltd., Kowa Company, Ltd., Kyowa Kirin Co., Ltd., Lilly, Medtronic, Mochida Pharmaceutical Co., Ltd., Novo Nordisk, Ono Pharmaceutical Co., Ltd., Pfizer Japan Inc., Sanofi, Sanwa Kagaku Kenkyusho, Sumitomo Dainippon Pharma Co., Ltd., Takeda Pharmaceutical Company Limited, Teijin Pharma Limited, Terumo Corporation. Y.Xu: Employee; Abbott Diabetes. A.Yamamoto: None. A.Matsuoka: None. T.Dunn: Employee; Abbott. W.Ogawa: Advisory Panel; Abbott Japan Co., Ltd., Nippon Boehringer Ingelheim Co. Ltd., Novo Nordisk, Other Relationship; Abbott Japan Co., Ltd., Mitsubishi Tanabe Pharma Corporation, Nippon Boehringer Ingelheim Co. Ltd., Sumitomo Dainippon Pharma Co., Ltd., Takeda Pharmaceutical Company Limited, Research Support; Abbott, Astellas Pharma Inc., Eli Lilly and Company, Kowa Company, Ltd., Nippon Boehringer Ingelheim Co. Ltd., Novo Nordisk, Ono Pharmaceutical Co., Ltd., Sumitomo Dainippon Pharma Co., Ltd.

Funding

Abbott Diabetes Care
701-P: Time Features Improve Glucose Prediction
Authors: LOUIS MAXIME , ROMERO-UGALDE HECTOR M. , ADENIS ALICE , DAUDET LAURENT , TOURKI YOUSRA , HUNEKER ERIK
Published: May 2022

Objective: We show how the use of time features in a deep learning model improves glucose prediction on T1D patients.

Method: Data of 139 adult T1D patients wearing DBLG1 System, from clinical trials NCT02987556 and NCT04190277, were used in this study. 70% of patients were used as a train set and 30% as a test set. The OHIO test database was used as an extra test set. In all cases, we only kept the data far from meals and physical activities.

The hour of the day may reflect the meal pattern and night/day differences. To consider this, we added (cos ((time in hour) / 24 * 2 pi) , (sin ((time in hour) / 24 * 2 pi) as input to the perceptron.

The day of the week may also reflect different behaviors. To consider this, we input a label for weekday vs. week-end.

We trained 2-layer perceptrons using past glucose levels (13 values with 5 minutes interval) and combinations of these time features to predict the glycemia at 45 minutes.

Results: On the clinical trials data, the baseline model achieved a 13.35% MARD and a 26.56 RMSE. When using the hour, we got a 13.2% MARD and 26.35 RMSE. When using the weekday label, we got a 13.32% MARD and an RMSE of 26.56. When using the hour and the weekday label, we obtained a 13.17% MARD and a 26.39 RMSE. We observe similar results on the Ohio data: the figure shows the clark grids for the baseline (left) and when using hour and weekday label (right) .

Conclusion: The use of the time of the day leads to great improvements on MARD and RMSE, as does, to a lesser extent, the use of the day of the week.

Disclosure

M.Louis: Employee; Diabeloop SA. H.M.Romero-ugalde: Employee; Diabeloop SA. A.Adenis: Employee; Diabeloop SA. L.Daudet: Employee; Diabeloop SA. Y.Tourki: Employee; Diabeloop SA. E.Huneker: Board Member; Diabeloop SA.
709-P: Persons with High-Risk Diabetes, Depression, and Stress Using a Digital Health Platform Experience an Improvement in Glycemic Management
Authors: HERSHCOVITZ YIFAT , TAMIR MICHAL , RITHOLZ MARILYN D. , MANEJWALA OMAR
Published: May 2022

Introduction: As the prevalence of type 2 diabetes (T2D) continues to grow worldwide, individuals struggle with how to integrate diabetes self-management into their lives. This is complicated by the high rate of depression and stress among persons with T2D. A multicondition behavior change-oriented digital therapeutic platform may alleviate the burdens faced by persons with comorbid diabetes and mental health conditions.

Objective: To investigate blood glucose levels outcomes in persons with T2D and comorbid depression and stress who used a multicondition digital therapeutic to manage their blood glucose levels.

Method: We performed a retrospective data analysis on the DarioTM database using users who activated the mobile app during 2019-2021 and who self-reported stress and depression in the App questionnaire. Participants who took at least 5 measurements at 1st and 12th month with Dario and who started with an average blood glucose >180 mg/dL were termed “high-risk.” The ratios assessed were average blood glucose and high blood glucose (>180 mg/dL) readings ratio over a year.

Results: The high-risk group of 491 users significantly reduced their average blood glucose by 13% (204±60 vs. 234±55) (P<0.001) . A subset of high-risk users with type 2 (N=379) was also evaluated and significantly reduced their average blood glucose by 14% (P<0.001) (201±66 vs. 233±53) . Moreover, their high glucose events ratio (>180 mg/dL) was significantly reduced from 69.4% to 46.9% over a full year usage (P<0.001) .

Conclusion: The use of a multicondition digital therapeutic platform may be associated with improved glucose management for persons with “high risk” glycemia who cope with depression and stress. The present study revealed that the digital multicondition platform has the potential to enhance self-care behaviors among people with diabetes that suffer from stress and depression.

Disclosure

Y.Hershcovitz: None. M.Tamir: None. M.D.Ritholz: Advisory Panel; DarioHealth Corp. O.Manejwala: Employee; DarioHealth Corp., Stock/Shareholder; DarioHealth Corp.
71-LB: Real-World Evidence of Arabic Digital Therapeutics for People Living with Type 2 Diabetes in Qatar
Authors: JANDALI NOOR , SAAD RAHMA
Published: May 2022

Background: Around 17% of people in Qatar live with diabetes. This study reports on the impact of an Arabic digital therapeutics product, named Droobi Health™ (DH) on glycemic control in patients with T2DM.

Methods: DH provides participant with a 16-week digital behavior change program tailored for people with T2DM. The programs are based on DSME content and AADE7 guidelines for T2DM, with the content localized to be culturally relevant. The DH app gives participants access to chat with a real-human CDE, tracking tools for blood glucose, weight, food intake, and physical activity, and weekly lessons. Participants at primary healthcare centers with T2DM and a starting A1c equal to or greater than 8% were provided the DH intervention. A post-intervention A1C was measured after three months. This study presents results from 633 participants who completed follow-up A1c.

Results: The mean pre and post-intervention A1c for 633 participants was 9.67% and 8.76% respectively, showing a mean reduction of 0.91% (95% CI 0.73%-1.09%, P≤0.001) . For women, the use of DH was associated with a statistically significant A1c reduction of 0.73% (95% CI 0.42%-1.04%, P≤0.001) . For men, the use of DH was associated with a statistically significant A1c reduction of 0.99% (95% CI 0.75%-1.21%, P≤0.001) .

Conclusion: Based on the results, participants have improved glycemic control outcomes, particularly male participants, underscoring DH’s potential to deliver a clinically effective intervention for people with T2DM in Qatar and across the Middle East.

Disclosure

N. Jandali: Stock/Shareholder; Droobi LLC. R. Saad: Employee; Droobi LLC.
710-P: In Patients with Type 2 Diabetes Mellitus (T2DM) , Continuous Glucose Monitoring System (CGMS) Usage Does Not Alter Multiple Measures of Glycemic Variability (GV)
Authors: LEE YEE LIONG , MEHFOOZ AYESHA , WANG QI , CHOW LISA S.
Published: May 2022

Background: The RCT data on CGMS and GV in patients with T2DM have used limited measure of GV metrics. In patients with T2DM on CGMS, we examined whether the use of blinded or unblinded CGMS will affect their GV across a broad swatch of metrics.

Methods: A randomized control study involving 40 subjects with T2DM was done [50% females, mean (SD) age 59 years (12.5) , BMI 34.kg/m2 (8.1) , mean (SD) screening HbA1c 7.59% (1.2) ]. Patients were randomized (1:1) to either 1 unblinded (Freestyle Libre) +1 blinded (Freestyle Libre Pro) CGMs or 2 blinded CGMS (Freestyle Libre Pro) for 16 weeks. Sensors were replaced every 2 weeks with an in-person visit. Multiple GV metrics were calculated from the blinded CGM at baseline (Week 0-Week2) and end-intervention (Week 14-16) . Participants randomized to the Unblinded/Blinded CGM group were instructed to use the CGM as they wished. Participants randomized to the Blinded CGM group were instructed to continue checking their fingerstick glucose as usual.

Measured GV metrics included the following: mean glucose, standard deviation (SD) , and coefficient of variation (CV) , continuous overlapping net glycemic action (CONGA) , liability Index, J-index, low and high blood glucose index (LBGI/HBGI) , glycemic risk assessment diabetes equation (GRADE) , mean of daily differences (MODD) , average daily risk range (ADRR) , mean amplitude of glycemic excursions (MAGE) , mean of daily differences (MODD) , Area Under Curve (AUC) , time spent in range (TIR) , Glucose Management Indicator (GMI) , number of episodes below 55 and glycemic variability percentage (GVP) .

Results: In this study, we found that was no significant difference in all GV metrics between the blinded/ blinded CGMS group and unblinded/blinded CGMS group at baseline and end intervention.

Conclusion: The novelty of this study is the extensive analysis of GV across multiple metrics in patients with T2DM on CGMS and CGMS usage did not significantly alter GV.

Disclosure

Y.Lee: None. A.Mehfooz: None. Q.Wang: None. L.S.Chow: Other Relationship; Dexcom, Inc.
72-LB: Blood Glucose Levels in High-Risk Type 2 Diabetes Users of a Digital Therapeutic Platform by Race/Ethnicity
Authors: HERSHCOVITZ YIFAT , GERSHONI TAMAR , MANEJWALA OMAR
Published: May 2022

Introduction: Significant racial and ethnic disparities in care have been observed in type 2 diabetes, including impairments in diagnosis, access to care and outcomes. Complex social and cultural factors drive these disparities, some of which might be mitigated through digital approaches. Digital therapeutic platforms assist users in achieving and maintaining target blood glucose levels. This study examines by race/ethnicity the differences in blood glucose levels among users of a digital health platform over a year based on real-world data.

Method: A retrospective data study was performed on the Dario™ database. A group of Dario digital therapeutic users with type 2 diabetes started with average blood glucose above 180 mg/dL (“high-risk users”) and reported in the app ethnicity as one of the following: White, Latino, Black or Asian. This population was active during 2019-2021 and took >3 blood glucose measurements in the first and 12th months. A Statistical analysis (ANOVA) was used to evaluate the difference in average blood glucose level over a year.

Results: A group of 1000 users was analyzed, 736 (74%) White; 122 (12%) Latino; 103 (10%) Black, and 39 (4%) Asian. The average glucose level significantly reduced in all users and per ethnic group over a year: All users by 14% (230±58 vs. 197±47) (p<0.001) ; respondents identifying as White reduced by 14% (229±58 vs. 197±47) ; Latino by 15% 237±59 vs. 202±48) (p<0.001) ; Black by 15% (230±63 vs. 196±48) (p<0.001) and Asian by 15% (229±55 vs.195±43) (p<0.001) . Finally, no significant differences in average blood glucose reductions between the races/ethnicities in the first month and in 12th month were observed (p=0.384) .

Conclusion: Digital therapeutic platforms may promote behavior modification in high-risk patients with type 2 diabetes to create sustainable outcomes. While treatment, as usual, is generally associated with disparate outcomes by race/ethnicity, the present study suggests that digital therapeutics may improve compliance and diabetes management and therefore address some of the disparities seen in diabetes care.

Disclosure

Y. Hershcovitz: None. T. Gershoni: None. O. Manejwala: Employee; DarioHealth Corp., Stock/Shareholder; DarioHealth Corp.
729-P: Relationship between Body Weight Change and Glycemic Control with Tirzepatide Treatment in People with Type 2 Diabetes
Authors: PEDERSEN SUE , UMPIERREZ GUILLERMO E. , GIORGINO FRANCESCO , RODRÍGUEZ ÁNGEL , THIEU VIVIAN , SAPIN HELENE , LANDO LAURA FERNANDEZ , KARANIKAS CHRISANTHI A. , KILJANSKI JACEK I.
Published: May 2022

Tirzepatide (TZP) , a novel, once weekly, dual GIP/GLP-1 receptor agonist, is being developed as a glucose lowering agent in type 2 diabetes (T2D) . In the SURPASS clinical trial program, TZP demonstrated significant HbA1c and body weight reductions vs. placebo and active comparators. This post-hoc analysis assessed the relationship between HbA1c and body weight reductions with TZP treatment (5, or 15 mg) . HbA1c and body weight data at 40 weeks (SURPASS-1, -2 and -5) and 52 weeks (SURPASS-3 and -4) were analyzed by trial, due to differences in design, background therapy, and baseline characteristics of participants. Across the trials, HbA1c reductions from baseline were observed in 96-99%, 98-99% and 94-99% of participants treated with TZP 5, and 15 mg, respectively. Moreover, 87-94%, 88-95% and 88-97%, respectively, also experienced weight loss. Significant correlations between HbA1c and body weight changes were observed with TZP in SURPASS-2, -3, -4 (all doses) and -5 (TZP 5 mg only) (statistically significant correlation coefficients ranged from 0.1438 to 0.3130 across studies; p≤0.038, for all doses) . Consistent reductions in HbA1c and body weight, even when used with medications associated with weight gain, were observed in the vast majority of participants treated with TZP at doses of 5, 10, or 15 mg.

Disclosure

S.Pedersen: Advisory Panel; Abbott Diabetes, AstraZeneca, Bausch + Lomb, Bayer AG, Boehringer Ingelheim International GmbH, Eli Lilly and Company, HLS Therapeutics Inc., Janssen Global Services, LLC, Novo Nordisk, Consultant; AstraZeneca, Bausch + Lomb, Bayer AG, Boehringer Ingelheim International GmbH, Eli Lilly and Company, HLS Therapeutics Inc., Janssen Global Services, LLC, Novo Nordisk, Research Support; AstraZeneca, Eli Lilly and Company, Novo Nordisk, Pfizer Inc., Prometric, Speaker's Bureau; Abbott Diabetes, AstraZeneca, Bausch + Lomb, Bayer AG, Boehringer Ingelheim International GmbH, Dexcom, Inc., Eli Lilly and Company, HLS Therapeutics Inc., Janssen Global Services, LLC, Novo Nordisk. G.E.Umpierrez: Research Support; AstraZeneca, Dexcom, Inc., Novo Nordisk. F.Giorgino: Advisory Panel; AstraZeneca, Boehringer Ingelheim International GmbH, Novo Nordisk, Consultant; Lilly Diabetes, Sanofi, Research Support; Lilly Diabetes, Roche Diabetes Care, Takeda Pharmaceutical Company Limited. Á.Rodríguez: Employee; Eli Lilly and Company, Stock/Shareholder; Eli Lilly and Company. V.Thieu: None. H.Sapin: Employee; Eli Lilly and Company. L.Fernandez lando: Employee; Eli Lilly and Company, Stock/Shareholder; Eli Lilly and Company. C.A.Karanikas: Employee; Eli Lilly and Company, Stock/Shareholder; Eli Lilly and Company. J.I.Kiljanski: Employee; Eli Lilly and Company, Stock/Shareholder; Eli Lilly and Company.

Funding

Eli Lilly and Company