bluuebunny/crossref_metadata_2025_split huggingface dataset:
558-P: Effect of Vitamin D Supplementation on Regression to Normal Glucose Regulation from Prediabetes in the D2d Study
Authors: HSIA DANIEL S. , NELSON JASON P. , VICKERY ELLEN , RASOULI NEDA , LEBLANC ERIN S. , KIM SUN H. , BRODSKY IRWIN , PRATLEY RICHARD E. , DAWSON-HUGHES BESS , PITTAS ANASTASSIOS G. ,   D2D RESEARCH GROUP
Published: May 2022

Regression to normal glucose regulation (NGR) has been reported in response to lifestyle modification and medications. In this secondary analysis of the D2d study, a randomized trial of 4,000 IU/d of vitamin D3 vs. placebo, we determined whether vitamin D increased regression to NGR in people with prediabetes. Eligible participants met at least 2-of-3 ADA glycemic criteria for prediabetes (n=2423) and the two groups were similar at baseline. During follow-up, glycemic status was assessed semi-annually with FG and HbA1c and annually with 2-hour glucose after 75-g glucose load (2hPG) . In exploratory analyses that censored follow up at initiation of diabetes/weight-loss medication, stopping trial pills, taking vitamin D above the trial limit, death or withdrawal, we tested for an effect of vitamin D on new-onset NGR, which was defined as the first occurrence of 2 or 3 glycemic criteria in the normal range and none in the diabetes range. Over a median follow-up of 2.5 years, the NGR outcome occurred in 343/12 participants in the vitamin D group and 295/1212 in the placebo group; hazard ratio (95%CI) for time-to-NGR for vitamin D was 1.16 (0.99-1.36) . Among those who never met NGR during follow-up (n=1785) , 29% developed diabetes compared to 8.2% among those who met NGR at some point during the study (p&lt;0.01) . At the last encounter, the NGR outcome was observed in 133/1069 participants in the vitamin D group and 102/1050 in the placebo group; incidence rate ratio (95%CI) for vitamin D was 1.26 (0.97-1.63) . When we used the NGR definition from other studies to include only those with normal FG and 2hPG regardless of HbA1c, 90/1037 participants in the vitamin D group and 63/1050 in the placebo group at the last encounter had NGR; incidence rate ratio (95%CI) for vitamin D 1.39 (1.01-1.91) .
In conclusion, vitamin D supplementation increased the likelihood of regression to NGR at the last visit, and those who met NGR during the study were less likely to subsequently develop diabetes.

Disclosure
D.S.Hsia: None. A.G.Pittas: None. D2d research group: n/a. J.P.Nelson: None. E.Vickery: None. N.Rasouli: Advisory Panel; Eli Lilly and Company, Novo Nordisk, Sanofi, Research Support; Allergan, Eli Lilly and Company, Novo Nordisk. E.S.Leblanc: n/a. S.H.Kim: Advisory Panel; GI Dynamics, Consultant; Aligos, Research Support; Fractyl Health, Inc. I.Brodsky: None. R.E.Pratley: Other Relationship; Bayer AG, Corcept Therapeutics, Dexcom, Inc., Hanmi Pharm. Co., Ltd., Merck & Co., Inc., Metavention, Novo Nordisk, Pfizer Inc., Poxel SA, Sanofi, Scohia Pharma Inc., Sun Pharmaceutical Industries Ltd. B.Dawson-hughes: None.

Funding
American Diabetes Association (1-14-D2d-01) ; National Institutes of Health National Institute of Diabetes and Digestive and Kidney Diseases and Office of Dietary Supplements (U01DK098245)
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 &lt; 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 &gt;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&lt;0.001) , and worse overall self-management (F 4.93, p&lt;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 &lt; 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.