bluuebunny/crossref_metadata_2025_split huggingface dataset:
738-P: Social Support Moderates the Association between Diabetes Distress and Diabetes Self-Care in Adults with Diabetes in Appalachian Ohio
Authors: BEVERLY ELIZABETH A. , RITHOLZ MARILYN D. 
Published: June 2020

Background: Social support is associated with better physical and mental health in people with diabetes. Social support may buffer the negative effects of diabetes distress on health outcomes. The purpose of this study was to assess the moderating role of social support in the relationship between diabetes distress and self-care in adults with type 1 (T1D) and type 2 (T2D) diabetes in Appalachian Ohio.
Methods: Participants completed the Diabetes Distress Scale for T2D or T1D, the Medical Outcomes Study Social Support Survey, and the Self-Care Inventory Revised. We conducted hierarchical multiple regression models using SPSS version 26.0. To avoid multicollinearity with the interaction terms, variables were centered.
Results: A total of 325 adults (age=41.6±19.2 years, 62.2% female, 86.5% white; A1C=7.5±1.6%; duration=12.4±9.6 years) participated. Of the 131 participants with T1D, 30.5% reported high diabetes distress. For the 194 T2D participants, 27.7% reported high diabetes distress. In the T1D model, diabetes distress and social support were significantly associated with diabetes self-care: R2 .15, F(2, 103)=8.81, p&lt;.001. However, the interaction term did not account for the variance in T1D self-care (b= -.032, t= -.349, p=.728). In the T2D model, diabetes distress and social support were significantly associated with diabetes self-care: R2 .17, F(2, 182)=18.58, p&lt;.001. The interaction term between diabetes distress and social support accounted for a significant proportion of the variance in T2D self-care: ΔR2=.03, ΔF(1, 296)=6.82, p=.01, b= -.185, t= -2.61, p=.01.
Conclusions: Social support moderated the relationship between diabetes distress and self-care in adults with T2D but not T1D. Further explorations of social support in adults with T1D is warranted. Given the importance of kinship in Appalachian culture, engaging family members and the community in diabetes management may buffer the negative effect of diabetes distress.

Disclosure
E.A. Beverly: None. M.D. Ritholz: None.

Funding
American Osteopathic Association (1291708718)
77-LB: Improved A1C and TIR in Adults with T2D Participating in a CGM-Driven Virtual Diabetes Clinic
Authors: MAJITHIA AMIT R. , KUSIAK COCO , LEE AMY ARMENTO , COLANGELO FRANCIS R. , ROMANELLI ROBERT , ROBERTSON SCOTT , MILLER DAVID P. , ERANI DAVID M. , DIXON RONALD F. , ZISSER HOWARD 
Published: June 2020

The Onduo Virtual Diabetes Clinic (VDC) for people with T2D combines a mobile app, remote personalized lifestyle coaching, connected devices and live video consultations with board-certified endocrinologists for medication management and prescription of real-time CGM devices for intermittent use. This prospective single-arm study enrolled adults with a baseline A1c of ≥8.0% to ≤12.0% from 2 primary care centers to participate in the VDC program. The primary outcome was change in A1c from baseline at 4 mo. Secondary outcomes included change in CGM-based (Dexcom G6) glycemic parameters. Participants (n=55) were: 57.3±11.6 yr, 40.0% female and BMI 33.7±7.2. A1c decreased significantly by -1.6%±1.0 (p&lt;0.001) from 8.9%±1.0 to 7.3%±0.9 at 4 mo. Stratified by baseline A1c 8.0% to 9.0% (n=36) and &gt;9.0% (n=19), A1c decreased by -1.2%±0.6 and -2.4%±1.3 (both p&lt;0.001). CGM metrics (n=43) are presented in the Table. Percent time in range (TIR) increased significantly from below target to target levels at follow-up. The results indicate that participation in the VDC for 4 mo was associated with significant improvement in A1c, increased TIR, decreased time in hyperglycemia and no increase in hypoglycemia.
In conclusion, the VDC has potential to support people with T2D and their clinicians between office visits by increasing access to specialty care and advanced diabetes technology including CGM.

Disclosure
A.R. Majithia: Consultant; Self; Onduo. C. Kusiak: Employee; Self; Verily Life Sciences LLC. Stock/Shareholder; Self; Verily Life Sciences LLC. A. Armento Lee: None. F.R. Colangelo: None. R. Romanelli: Advisory Panel; Self; Novo Nordisk Inc. S. Robertson: Other Relationship; Self; Verily Life Sciences LLC. D.P. Miller: Employee; Self; Verily Life Sciences LLC. Stock/Shareholder; Self; Verily Life Sciences LLC. D.M. Erani: None. R.F. Dixon: Employee; Self; Onduo. H. Zisser: Employee; Self; Verily Life Sciences LLC. Stock/Shareholder; Self; Verily Life Sciences LLC.
789-P: Self-Care for Blood Glucose Monitoring (BGM) in Teens with Type 1 Diabetes (T1D): Impact of Real-Time Positive and Negative Affect
Authors: SHAPIRA AMIT , VOLKENING LISA K. , BORUS JOSHUA , LAFFEL LORI M. 
Published: June 2020

Aim: Teens with T1D often report negative emotions related to diabetes self-care. Affect tends to vary throughout the day and may provide an explanatory pathway to poor diabetes self-care and suboptimal glycemic control in teens. We used momentary sampling to examine associations between affect and BGM adherence in teens with T1D.
Methods: Over 2 weeks, 32 teens (ages 14-18 years) used handheld computers to self-report positive (POS) and negative (NEG) affect (Positive and Negative Affect Schedule) and BGM adherence 4 times daily. Teens selected the times to receive the messages based on their usual BGM times. There were 225 paired affect and BG adherence reports. Z-scores were calculated for the NEG and POS subscales to reflect deviations from each teen’s overall affect. Separate logistic generalized estimating equations, adjusted for age, sex, T1D duration, and pump therapy assessed associations between POS and NEG affect and BGM adherence.
Results: Teens (56% female) were (M±SD) 16.6±1.4 years old with T1D duration of 8.8±4.2 years; 63% were pump treated and A1c was 8.8±1.4%. Teens reported checking BG 59% of the time. In adjusted models, greater NEG affect was associated with lower odds of BGM (OR=0.5, 95% CI: 0.4-0.8, p=.001). POS affect was not significantly associated with BGM. Age, sex, T1D duration, and pump therapy were not significantly associated with BGM.
Conclusions: In a sample of teens with T1D receiving multiple daily prompts to check BG, positive affect did not relate to BGM frequency; however, negative affect was associated with being half as likely to check BG. These findings suggest a need to provide teens with strategies for maintaining diabetes self-care behaviors when they are experiencing negative emotions.

Disclosure
A. Shapira: None. L.K. Volkening: None. J. Borus: None. L.M. Laffel: Advisory Panel; Self; Roche Diabetes Care. Consultant; Self; Boehringer Ingelheim Pharmaceuticals, Inc., ConvaTec Inc., Dexcom, Inc., Insulet Corporation, Insulogic LLC, Janssen Pharmaceuticals, Inc., Lilly Diabetes, Novo Nordisk Inc., Sanofi US.

Funding
JDRF International; National Institutes of Health (P30DK036836, K12DK094721)
862-P: A Machine Learning Model Predicts Engagement with a Mobile Health (mHealth)-Based Remote Patient Monitoring (RPM) Program among Persons with Diabetes (PWDs)
Authors: BABIKIAN SARINE , SINGH VIKRAM , CLEMENTS MARK A. 
Published: June 2020

We developed a machine learning model that predicts risk of declining engagement (churn) with an mHealth app (Glooko) that supports diabetes self-management. The model uses self-monitored blood glucose (SMBG), demographic, and app engagement data.
We selected 7134 PWD using meter and/or insulin pump devices who used the Glooko diabetes management app in a remote (outside of the clinic) setting between 1/1/2019-7/1/2019 (40,349 total weekly predictions). We trained a gradient boosting algorithm to predict risk of churn in the next 28 days.
We built features using data from the prior 28 days; features included outcomes (counts of glucose checks, hypo/hyperglycemia occurrences, mean blood glucose), app engagement (counts of app clicks and meter and/or insulin pump uploads, duration of sessions), and demographics (diabetes type, gender, age).
The training cohort had median age=22 years (IQR:11-49), 52% female, 60% type 1 diabetes (T1D). We performed out-of-sample validation using 4647 individuals (8646 total weekly predictions). The validation cohort had median age=20 years (IQR:11-49), 52% female, 60.5% T1D. The algorithm predicted individuals at risk of churning with a precision of 0.67 and a recall of 0.8. This correlates to sensitivity=80%, specificity=58%, and positive predictive value=67%.
The present model indicates that it is feasible to predict declining engagement with an mHealth app to support diabetes self-management. The ability to predict churn may help clinics design effective mHealth-based RPM programs. These predictions can allow clinicians to proactively reach out to PWDs at risk of program dropout. Future research should examine whether dropout from RPM programs predicts worsening diabetes-related outcomes.

Disclosure
S. Babikian: Employee; Self; Glooko, Inc. V. Singh: Employee; Self; Glooko, Inc. M.A. Clements: Consultant; Self; Glooko, Inc. Other Relationship; Self; Glooko, Inc.
866-P: Estimated HbA1c Discordance: Should Estimated HbA1c Be Derived from Time-in-Range or Mean Glucose Levels?
Authors: TAKEISHI SOICHI , TSUBOI HIROKI 
Published: June 2020

In patients with hypoglycemia, estimated HbA1c (eA1c) derived from the percentage of time in range [TIR] (reference range, 70-180 mg/dL) using reported formulae may be overestimated. We examined eA1c derived from TIR (TIR-eA1c) and eA1c derived from mean glucose levels (mean-eA1c). In this cross-sectional study, we analyzed 24-h glucose levels measured from 00:00 to 24:00 during hospitalization using a continuous glucose monitor (iPro2) in 119 patients with type 2 diabetes. We calculated TIR-eA1c and mean-eA1c for these 119 patients using the reported following formulae: TIR-eA1c 1 = 10.31 - 0.048 × TIR; TIR-eA1c 2 = (TIR - 155.4) ÷ -12.762; mean-eA1c 1 = (mean glucose level + 46.7) ÷ 28.7; and mean-eA1c 2 (proposed as the glucose management indicator) = 3.31 + 0.02392 × mean glucose level. The values of TIR-eA1c 1 - mean-eA1c 1 [Δ1], TIR-eA1c 2 - mean-eA1c 1 [Δ2], TIR-eA1c 1 - mean-eA1c 2 [Δ3], and TIR-eA1c 2 - mean-eA1c 2 [Δ4] were also evaluated. An increase in the percentage of time below range (&lt; 70 mg/dL) [TBR &lt; 70] was significantly associated with increased Δ1, Δ2, Δ3, and Δ4. The presence of hypoglycemia was significantly associated with Δ1 &gt; 0.5%, Δ2 &gt; 0.5%, Δ3 &gt; 0.5%, and Δ4 &gt; 0.5% (Table). Overall, our results show that mean-eA1c should be used as the indicator of HbA1c in patients with hypoglycemia.

Disclosure
S. Takeishi: None. H. Tsuboi: None.
907-P: Impact of Using a Digital Therapeutic and Blood Glucose Meter on Glycemic Control and Variability
Authors: KRISHNAKUMAR ARJUN , KUMAR VASANTH , SABOO BANSHI D. , KHATRY VARSHA , JOSHI SHILPA , ADHIKARY RISHI R. , KOLWANKAR SIDDDHESH , MATTOO VINOD 
Published: June 2020

Background: High out of pocket expenses have led to poor diabetes self-management and glycemic control in India. This study evaluates the impact of an iPDM (integrated personalized diabetes management) on blood glucose (BG) control.
Methods: Study participants (n=286) used an iPDM consisting of the Accu-Chek® Active BG meter and the Wellthy Care™ digital therapeutic platform (WDTx), which allowed them to log BG values while receiving artificial intelligence-powered real-time feedback and self-management education. The BG values at baseline (M0), month 2 (M2), month 4 (M4), and month 6 (M6) were analyzed. Mean BG (MBG), Fasting BG (FBG), Post-meal BG (PBG), number of hypoglycemia logs (&lt;70 mg/dl), and in-range logs (FBG: 70-130 mg/dl; MBG/PBG: 70-180 mg/dl) were evaluated.
Results: The average number of active days and BG logs by the participants was 75.9 days (95% CI: 66.0-85.7 days) and 73 logs (95% CI: 67-79 logs), respectively. The BG values and logs are summarized in Table 1. There was a significant reduction in BG from M0 to M2 after which the BG was stable over M4 and M6. There was also a reduction in the number of hypoglycemia logs and a corresponding increase in the number of in-range BG logs from M0 through M6.
Conclusion: This study shows that an iPDM using SMBG and WDTx can be an effective and affordable tool for improving glycemic control and reducing hypoglycemia events in resource limited countries like India.

Disclosure
A. Krishnakumar: Employee; Self; Wellthy Therapeutics. V. Kumar: None. B.D. Saboo: None. V. Khatry: None. S. Joshi: Consultant; Self; Wellthy Therapeutics. R.R. Adhikary: Employee; Self; Wellthy Therapeutics. S. Kolwankar: Employee; Self; Wellthy Therapeutics. V. Mattoo: None.
944-P: HbA1c Change Is Associated with Retinopathy Outcomes during GLP-1RA CVOT Follow-Up
Authors: BETHEL ANGELYN , DIAZ RAFAEL , CASTELLANA NOELIA , GERSTEIN HERTZEL C. , LAKSHMANAN MARK 
Published: June 2020

Long-term glucose control reduces retinopathy risk. We examine the association between HbA1c change and retinopathy in the first year or at final follow-up in GLP-1 RA cardiovascular outcomes trials (CVOTs). A random-effects model meta-analysis included 6 CVOTs reporting retinopathy events, using within-trial event definitions. Univariate meta-regression analyses describe the association between HbA1c change and retinopathy events. Meta-analysis showed no significant effect of GLP-1 RA on retinopathy risk (odds ratio [OR] 1.10; 95% CI 0.93, 1.30), with moderate heterogeneity between studies (I2=52.2%; Q-statistic p-value=0.063). HbA1c change and retinopathy were significantly associated at 1-year (slope=1.40, p-value=0.002) and overall (Figure), with 0.1% HbA1c reduction associated with 15% increased OR in the first year, declining to 8.0% increase over longer follow-up. In these studies of varying duration (1.3 to 5.4 years), GLP-1 RA treatment was not significantly associated with increased retinopathy risk. HbA1c reduction rate is correlated with risk for retinopathy in people with diabetes and additional CV risk factors. Clinicians should consider retinopathy status when initiating any therapy that rapidly lowers HbA1c.

Disclosure
A. Bethel: Employee; Self; Eli Lilly and Company. R. Diaz: None. N. Castellana: None. H.C. Gerstein: Advisory Panel; Self; Abbott, AstraZeneca, Boehringer Ingelheim (Canada) Ltd., Eli Lilly and Company, Merck & Co., Inc., Novo Nordisk Inc., Sanofi. Consultant; Self; Kowa Pharmaceuticals America, Inc. Research Support; Self; AstraZeneca, Boehringer Ingelheim (Canada) Ltd., Eli Lilly and Company, Merck & Co., Inc., Novo Nordisk Inc., Sanofi. Other Relationship; Self; Boehringer Ingelheim (Canada) Ltd., Eli Lilly and Company, Sanofi. M. Lakshmanan: Employee; Self; Eli Lilly and Company. Stock/Shareholder; Self; Eli Lilly and Company. Stock/Shareholder; Spouse/Partner; Eli Lilly and Company.

Funding
Eli Lilly and Company
948-P: A Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HM15136, a Novel Long-Acting Glucagon Analogue, in Healthy Subjects
Authors: HUH KI YOUNG , SHIN WONJUNG , BAEK EUNHYE , SEO SUJIN , LEE WOOSUN , BAEK SEUNGJAE , LEE HOWARD 
Published: June 2020

HM15136 is a novel long-acting glucagon analogue with an extended half-life. In vivo efficacy studies of HM15136 in animal models showed its therapeutic potential in congenital hyperinsulinism, hypoglycaemia post-bariatric surgery, and obesity. We performed a randomized, double-blind, placebo-controlled first-in-human trial to assess the safety, pharmacokinetics, and pharmacodynamics of a single subcutaneous dose of HM15136 in healthy adults. Fifty-six subjects of a mean age, BMI, and HbA1c of 31.1 years, 23.1 kg/m2, and HbA1c 5.2%, respectively, randomly received HM15136 or its matching placebo in a ratio of 6:2 in 7 cohorts (10, 20, 30, 50, 80, 100, and 120 µg/kg). All adverse events were mild in severity and transient. Neither serious adverse event nor discontinuation due to adverse event occurred during the study. The most frequent Treatment Emergent Adverse Event was nausea (7.2%, only in the 100 and 120 µg/kg groups). Injection site erythema, which was barely noticeable and spontaneously subsided without sequelae, was reported in 2 out of 42 subjects who received HM15136. HM15136 was slowly, but steadily absorbed with the peak serum concentration reaching 34.2-65.2 hours after dose. The terminal half-life ranged from 69.8 to 85.6 hours, which was significantly greater than that of glucagon (&lt; 1 hour). HM15136, particularly at doses &gt;50 µg/kg, increased mean serum glucose from baseline by up to 27.7 mg/dL, which was maintained until 17 days after dose.
In conclusion, a single subcutaneous dose of HM15136 at 10-120 µg/kg was safe and well-tolerated. The long half-life of HM15136, coupled with increase in serum glucose for ∼2 weeks, may warrant a weekly dosing regimen.

Disclosure
K. Huh: None. W. Shin: None. E. Baek: None. S. Seo: None. W. Lee: None. S. Baek: Employee; Self; Hanmi Pharmaceutical. H. Lee: None.
959-P: Indirect Treatment Comparison (ITC) of IGlarLixi vs. IDegLira in Adults Inadequately Controlled by GLP-1 Receptor Agonists (GLP-1RAs)
Authors: HOME PHILIP , ARODA VANITA R. , FAZELI MIR SOHAIL , WHITTINGTON CRAIG , GOSWAMI HARDIK , SHAUNIK ALKA , POURRAHMAT MIR-MASOUD , BLONDE LAWRENCE , KALRA SANJAY 
Published: June 2020

In people with type 2 diabetes uncontrolled by GLP-1 RAs, fixed-ratio combination (FRC; basal insulin + GLP-1 RA) is a recommended option. A PICO-framework systematic review of RCTs followed by an ITC was performed to compare the efficacy and safety of the FRCs iGlarLixi (insulin glargine 100 U/mL + lixisenatide) and IDegLira (insulin degludec + liraglutide) in this population. A fixed effects model was used on the two eligible RCTs. Outcomes: change from baseline to week 26 in HbA1c, clinic fasting plasma glucose (FPG), self-monitored plasma glucose (SMPG), and body weight; proportion achieving HbA1c &lt;6.5 or &lt;7.0 %; hypoglycemia incidence. Baseline characteristics were similar across studies. Significant mean differences were seen in change in HbA1c and FPG favoring IDegLira, but not pre- or postprandial SMPG (breakfast or daily average) or weight (Table). Similar proportions achieved HbA1c targets. Hypoglycemia comparisons suffered from varying definitions, sulfonylurea (SU) use and eligibility, and few events in the GLP-1 RA arms (incidence: 32% [confirmed ≤3.1 mmol/L, 28% without SU] with IDegLira and 9% or 28% [symptomatic &lt;3.0 or ≤3.9 mmol/L] with iGlarLixi). This ITC shows similar FRC HbA1c glycemic target achievement but suggests divergent differences in other glycemia results and hypoglycemia, likely due to different study design and titration application.

Disclosure
P. Home: Advisory Panel; Self; Roche Diabetes Care. Consultant; Self; Mundipharma International, Novartis AG, Sanofi. Research Support; Self; GlaxoSmithKline plc., Merck & Co., Inc., Sanofi. Other Relationship; Self; AstraZeneca, Boehringer Ingelheim International GmbH. V.R. Aroda: Consultant; Self; Duke, Novo Nordisk Inc., Sanofi. Employee; Spouse/Partner; Merck & Co., Inc. Research Support; Self; Applied Therapeutics, Fractyl Laboratories, Inc., Novo Nordisk Inc., Sanofi. Other Relationship; Self; IMNE, Medscape. M. Fazeli: None. C. Whittington: Employee; Self; Sanofi US. H. Goswami: None. A. Shaunik: None. M. Pourrahmat: Other Relationship; Self; Sanofi US. L. Blonde: Advisory Panel; Self; AstraZeneca, Gilead Sciences, Inc. Consultant; Self; Merck & Co., Inc., Novo Nordisk A/S, Sanofi. Research Support; Self; Janssen Scientific Affairs, LLC., Novo Nordisk A/S, Sanofi. Speaker’s Bureau; Self; Janssen Pharmaceuticals, Inc., Sanofi. S. Kalra: Advisory Panel; Self; Eli Lilly and Company. Speaker’s Bureau; Self; Novo Nordisk A/S, Sanofi-Aventis.

Funding
Sanofi
99-LB: Multiscale Biological Rhythms in Individuals with T1D on DIY Closed-Loop and SAPT
Authors: LEWIS DANA M. , GRANT AZURE D. , KRIEGSFELD LANCE 
Published: June 2020

Background: Circadian and ultradian rhythms in BG have been observed in individuals without diabetes and are regulated both by time of day and meal intake, with ultradian fluctuations generally of smaller amplitude than circadian fluctuations. We assessed relative stability of circadian and ultradian rhythms in individuals without T1D (n=16), and individuals with T1D using two different therapies: sensor-augmented pump therapy (SAPT, n=100) and DIY closed loop (n=30).
Methods: Frequency decomposition using continuous morlet wavelet transformation (A to C) were created to assess change in rhythmic composition of normalized blood glucose data.
Results: Example Wavelet (C) in T1D illustrates high power in the 1-6H range, and lower power in the ~24H range for nearly all time points. The ratio of power in the 23-25H (circadian) range to power in the 1-6H (ultradian) range was calculated to estimate relative stability of circadian to ultradian rhythms. Those without T1D showed higher circadian compared to ultradian power, whereas both groups with T1D showed a comparably lower ratio (D).
Conclusion: Wavelet analysis of BG in individuals with and without T1D reveals a difference in relative strength of daily and hourly rhythms, independent of therapy type. These results suggest current therapies do not recreate expected daily rhythmicity in blood glucose, perhaps due the lifespan of rapid-acting insulin and meal patterns.

Disclosure
D.M. Lewis: Research Support; Self; JDRF. A.D. Grant: None. L. Kriegsfeld: None.

Funding
JDRF
991-P: High Treatment Satisfaction with 3-Day Insulin Patch Is Independent of Patient Demographics
Authors: PEYROT MARK , JOHNS DON , REES BUDDUG R. , ROOK ROBERT , WARNER JAY L. , LEVY BRIAN L. 
Published: June 2020

This post-hoc analysis explores whether high treatment satisfaction seen with a 3-day wearable patch for mealtime insulin subcutaneous delivery is applicable across different patient groups. The randomized multi-country study of adults (n=278, age: 59.2±8.9 years) with type 2 diabetes transitioned patients from basal-only to basal plus mealtime insulin therapy using one of two methods of mealtime insulin delivery. Patients were randomized 1:1 to deliver mealtime insulin using either a 3-day insulin patch or an insulin pen. Published data demonstrated that basal plus mealtime insulin therapy using either device similarly reduced A1C (1.7% patch, 1.6% pen). However, patients were more satisfied with patch than pen (Overall Satisfaction, Insulin Delivery System Rating Questionnaire (IDSRQ) p&lt;0.01). In this abstract, comparison of IDSRQ satisfaction was analyzed by age, sex and BMI. There were no significant (p&lt;0.05) interactions between baseline patient demographics and device. None of the subgroups favored pen over patch. Notably, patients above 65 years preferred the patch similarly to those below 65 years of age; resistance to new technology was not seen. Patch was similarly preferred by those of all body masses and both genders.
In summary, the data indicate that the 3-day insulin patch is suitable for patients independent of demographics, and preferred to pen overall.

Disclosure
M. Peyrot: Advisory Panel; Self; Eli Lilly and Company. Consultant; Self; CeQur Corporation, Eli Lilly and Company. Research Support; Spouse/Partner; Eli Lilly and Company. D. Johns: None. B.R. Rees: Employee; Self; CeQur Corporation. R. Rook: Consultant; Self; CeQur Corporation. J.L. Warner: Employee; Self; CeQur Corporation. B.L. Levy: Consultant; Self; CeQur Corporation, Digma Medical, iGlucose, LifeScan, Inc., QuiO Technologies.