bluuebunny/crossref_metadata_2025 huggingface dataset:
74-LB: Impact of Mild and Moderate High Blood Glucose Excursions on Daily Living in Adults with Type 1 Diabetes
Authors: HUGHES ALLYSON , BISPHAM JEOFFREY , GAREY COLLEEN , LIU JINGWEN , FULLER LILY , NYKAZA EDWARD T. , MENO JASON A. , MCAULIFFE-FOGARTY ALICIA
Published: June 2019

Introduction: Severe hyperglycemic events and diabetic ketoacidosis (DKA) have significant effects on daily activity however, the effect of mild and moderate glucose excursions on functioning and quality of life (QoL) remains unknown. This study aimed to assess the impact of these excursions on well-being in a well-managed population with type 1 diabetes (T1D) using survey and CGM data.

Methods: Adults with T1D (N = 71), 68.6% female, 93.2% white, aged 44.11 years, average A1c 6.51%, with diabetes for 26.65 years, completed an online survey through T1D Exchange Glu and uploaded CGM data via Tidepool.

Results: Moderate high blood glucose (HBG) excursions were most strongly related to QoL (WHO-5) and happiness (Subjective Happiness Scale, SHS). Participants with fewer mild (> 180 mg/dL) HBG excursions had higher WHO-5 scores indicating better QoL when controlling for income and duration of diabetes. Participants who had longer durations in the same range, regardless if it was time in range or mild or moderate hyperglycemia, had higher SHS scores indicating greater happiness when controlled for income and duration of diabetes.

Conclusions: This study illustrates the impact of mild HBG excursions and glycemic variability on QoL in people with T1D. HBG excursions were related to QoL and glycemic variability was related to happiness further supporting the urgency to decrease the amount of time hyperglycemic. These results indicate the need to increase time in range and decrease overall blood glucose variability. A limitation includes convenience sampling in a very well-managed population. Future research should further investigate the relationships of these factors in a diverse sample.

Disclosure

A. Hughes: None. J. Bispham: None. C. Garey: None. J. Liu: None. L. Fuller: None. E.T. Nykaza: None. J.A. Meno: None. A. McAuliffe-Fogarty: None.
747-P: Risk Factors for Hypoglycemia in Type 1 Diabetes Individuals during Intensive Sport Exercise—Data from the “SportGiveChance: Diabetic Runners and Cyclists for More Sport for All in Europe” Event
Authors: HOHENDORFF JERZY , UCIEKLAK DAMIAN , SKUPIEN JAN , MATEJKO BARTłOMIEJ , GIACOMO ANGELICA DI , MALECKI MACIEJ , KLUPA TOMASZ
Published: June 2019

Introduction: Hypoglycemia fear seems to be the strongest barrier to physical activity for individuals with type 1 diabetes mellitus (T1DM). The aim of the study was to describe clinical characteristics of participants with T1DM in the intensive sporting event of runs and bike rides, and investigate factors associated with reported hypoglycemia events during the competition, in particular the use of continuous and flash glucose monitoring systems (CGM/FGM).

Methods: The sporting event took place in Spoleto, Italy from 30 August to 2 September 2018. An online survey was distributed among 150 participants with diabetes. Only T1DM patients were invited to complete the survey that included questions on baseline clinical characteristics as well as glucose control and meal related issues during the competition. Logistic regressions were used to determine factors associated with reported hypoglycemia.

Results: There were 35 T1DM individuals who completed the questionnaire; 18 subjects were CGM/FGM users, while the others performed self-measured blood glucose measurements (SMBG) on glucose meters. Mild hypoglycemia episode during the competition was reported by 4 CGM/FGM users and 6 non-users (OR:0.73, CI:0.34-1.53). No severe hypoglycemic episode was reported. BMI≥25 kg/m2 (OR:2.56, CI:1.10-5.98) and subjectively very hard or maximal intensity of the competition (OR:4.09, CI:1.51-15.89) was associated with higher risk of hypoglycemia.

Conclusions: Selected patients with T1DM can participate in intensive sport competitions with relatively low risk of hypoglycemia regardless of either CGM/FGM or SMBG use.

Disclosure

J. Hohendorff: Other Relationship; Self; Abbott, Ascensia Diabetes Care, Novo Nordisk A/S, Sanofi-Aventis. D. Ucieklak: None. J. Skupien: None. B. Matejko: Research Support; Self; Roche Diabetes Care. Other Relationship; Self; Ascensia Diabetes Care. A. Di Giacomo: None. M. Malecki: Advisory Panel; Self; Abbott Laboratories, AstraZeneca, Bioton, Boehringer Ingelheim Pharmaceuticals, Inc., Lilly Diabetes, Merck Sharp & Dohme Corp., Novartis Pharmaceuticals Corporation, Novo Nordisk Inc., Sanofi-Aventis. Speaker’s Bureau; Self; Merck & Co., Inc. T. Klupa: Advisory Panel; Self; Abbott, AstraZeneca, Bioton, Lilly Diabetes, Novo Nordisk A/S. Employee; Spouse/Partner; Ascensia Diabetes Care. Other Relationship; Self; Ascensia Diabetes Care, Boehringer Ingelheim Pharmaceuticals, Inc., Medtronic MiniMed, Inc.
78-LB: Detailing the Experiences of People with Diabetes Using Do-It-Yourself Artificial Pancreas Systems—Qualitative Analysis of Responses to Open-Ended Items in an International Survey
Authors: CLEAL BRYAN , BRAUNE KATARINA , O’DONNELL SHANE , HAUCK BASTIAN , LEWIS DANA M. , SKINNER TIMOTHY C. , RAILE KLEMENS
Published: June 2019

There is currently a wave of interest in Do-it-Yourself Artificial Pancreas Systems (DIYAPS) but knowledge about how the use of these systems impacts on the lives of those that develop and use them remains limited. Until now, only a select few have been able to give voice to their experiences in a research context. In this study we present data that addresses this shortcoming, detailing the lived experiences of people using DIYAPS in an extensive and diverse way.

An online survey with 34 items was distributed to DIYAPS users recruited through the Facebook groups “Looped” (and regional sub-groups) and Twitter pages of the Diabetes Online Community (DOC). Participants were posed two open-ended questions in the survey, where personal DIY APS stories were garnered; including knowledge acquisition, decision-making, support and emotional aspects in the initiation of DIY APS, perceived changes in clinical and quality of life (QoL) outcomes after initiation and difficulties encountered in the process. All answers were analysed using thematic content analysis.

In total, 886 adults responded to the survey and there were a combined 656 responses to the two open-ended items.

Knowledge of DIYAPS was largely obtained via exposure to the communication fora that constitute the DOC. The DOC was also a primary source of practical and emotional support. Dramatic improvements in clinical and QoL outcomes were consistently reported. The emotional impact on everyday life was overwhelmingly positive. Acquisition of the requisite devices to initiate DIYAPS was sometimes problematic.

The extensive testimony from users of DIYAPS acquired in this study provides new insights regarding the contours of this evolving phenomenon, highlighting factors inspiring people to adopt such solutions and underlining the transformative impact effective closed-loop systems bring to bear on the everyday lives of people with diabetes.

Disclosure

B. Cleal: None. K. Braune: Advisory Panel; Self; Medtronic MiniMed, Inc. Speaker’s Bureau; Self; Dexcom, Inc. S. O’Donnell: None. B. Hauck: Consultant; Self; Bayer AG, Eli Lilly and Company, LifeScan, Inc., Novo Nordisk A/S, Roche Diabetes Care, Roche Pharma. D.M. Lewis: Consultant; Self; Diabeloop SA, Roche Diabetes Care. T.C. Skinner: None. K. Raile: Advisory Panel; Self; Abbott, Lilly Diabetes.
804-P: Alcohol Consumption Patterns among Young Adults with Type 1 Diabetes
Authors: ROBERTS ALISSA J. , LAW JENNIFER R. , SUERKEN CYNTHIA , REBOUSSIN BETH A. , LAWRENCE JEAN M. , TAPLIN CRAIG , MAYER-DAVIS ELIZABETH , PIHOKER CATHERINE
Published: June 2019

The objective of this study is to describe alcohol consumption behaviors in young adults with T1D and to examine the associations between alcohol consumption, HbA1c, and episodes of severe hypoglycemia in prior 6 months. Data from 602 SEARCH for Diabetes in Youth Study participants age ≥18 years. with T1D were collected from 12/2011 to 6/2015 (50% female, mean age 21.3(SD 2.4), 22% race/ethnic minority). Participants were characterized as alcohol non-drinkers (n=269), drinkers but non-binge drinkers (n=167), or binge drinkers (n=166) based on reported consumption in the past 30 days, using the National Institute on Alcohol Abuse and Alcoholism definition of binge drinking (≥4 drinks females, ≥5 drinks males). Analyses were conducted using one-way ANOVAs, chi-square tests, and logistic regression modeling looking at drinking status and clinical markers. Overall, 55.3% of participants had consumed alcohol in the past 30 days; 27.6% reported binge drinking. Males consumed alcohol more frequently (7.3 days vs. 4.5 days, p<0.0001), consumed more alcohol per occasion (4.7 drinks vs. 3.0 drinks, p=0.0001), and were more likely to be binge drinkers than females (34.2% vs. 20.9%, p= 0.0003). In comparison with 18-20 year old, participants ≥21 years were more likely to have consumed alcohol in the past 30 days and more likely to be binge drinkers, but average number of drinks consumed at a time did not differ. Binge drinkers were older (OR 1.4, 95% CI = 1.2-1.6), had higher parental education (OR 2.6, 95% CI =1.4-4.9), and were more likely to be current (OR 10.5, 95% CI =5.8-19.2) or former (OR 5.8, 95% CI = 3.3-10.1) tobacco users compared to non-drinkers. After adjusting for demographic characteristics, binge drinking was not associated with HbA1c or severe hypoglycemic events relative to non-drinkers. Young adults with T1D in SEARCH report similar alcohol use but higher rates of binge drinking compared to the U.S. population. Binge drinking was not associated with poorer glycemic control or severe hypoglycemia in this cohort.

Disclosure

A.J. Roberts: None. J.R. Law: None. C. Suerken: None. B.A. Reboussin: None. J.M. Lawrence: None. C. Taplin: None. E. Mayer-Davis: None. C. Pihoker: None.

Funding

National Institutes of Health; Centers for Disease Control and Prevention
808-P: A New Measure of Diabetes-Specific Self-Compassion for Parents of Youth with Type 1 Diabetes (T1D)
Authors: TANENBAUM MOLLY L. , WONG JESSIE J. , HANES SARAH , HOOD KOREY K.
Published: June 2019

Managing T1D is highly demanding while offering little in terms of rewards or positive reinforcement. Parents often experience high levels of emotional distress and burden, with implications for parent and child wellbeing and parent self-efficacy for managing diabetes. Parents may also experience self-criticism regarding their management of T1D. Diabetes-specific self-compassion (SC), or being kind to oneself in the face of challenges that arise in managing diabetes, has the potential to buffer against the negative impact of diabetes distress. The purpose of this study was to create a new tool, the Diabetes-Specific Self-Compassion Scale (SCS-Dp), to assess diabetes-specific SC in parents of youth with T1D. We adapted a previously validated measure for adults with T1D; surveyed parents (N=198; parent: 88% female; 95% non-Hispanic white; M age=44±8.9; child: 46% female; M age=13±3.4, range 2-18 years; 83% insulin pump users; 40% CGM users; A1c from clinic data available for 76 participants: M A1c=8.1±1.3%) and conducted confirmatory factor analysis (CFA), reliability and construct validity analyses. The 19-item SCS-Dp had excellent internal consistency (ɑ=.94; range of item-total correlations: .52-.81). The CFA model showed evidence of good fit: SRMR=0.04; RMSEA=0.05; CFI=0.95; χ2(171)=1637.02, p<0.0001. Validity measures included diabetes distress, diabetes empowerment, diabetes numeracy, and A1c. As predicted, greater SC was associated with lower distress (r=-.68, p<.001) and greater empowerment (r=.43, p<.001) and was not associated with diabetes numeracy (p=.61). SCS-Dp was not associated with A1c (p=.28). Results suggest that the SCS-Dp is a reliable, valid measure of diabetes-specific SC in parents and may help determine points of intervention for this population. Interventions to increase diabetes-specific SC in parents may aid in ameliorating diabetes distress through increasing self-kindness in the context of diabetes-related challenges.

Disclosure

M.L. Tanenbaum: None. J.J. Wong: None. S. Hanes: None. K.K. Hood: Consultant; Self; Lilly Diabetes. Research Support; Self; Dexcom, Inc. Speaker's Bureau; Self; Johnson & Johnson Diabetes Institute.
813-P: Similarities and Differences in Adults’ Experiences with Type 1 and Type 2 Diabetes Distress
Authors: BEVERLY ELIZABETH A. , RENNIE ROCHELLE G. , GUSEMAN EMILY H. , HEALY AMBER
Published: June 2019

Diabetes is one of the biggest health problems in the U.S., affecting 9.4% of the population and 19.9% of people in southeastern Ohio. Despite the high prevalence of diabetes, it is understudied in this region. One critical outcome that has not been addressed is diabetes distress. The purpose of this study was to explore experiences of diabetes distress in adults with type 1 diabetes (T1D) and type 2 diabetes (T2D). A purposive sample of 36 adults participated in in-depth interviews (55.6% T2D, duration=13.9±13.6 years, A1C=7.6±1.9%, 58.3% on insulin; age=45.8±19.8 years; 58.3% female; 91.7% white). Two researchers independently coded the interviews, met to resolve discrepancies, and agreed on themes. Qualitative analysis revealed 4 themes: 1) Relentless Burden of Self-Care: Both T1D and T2D participants described how hard it was to manage the daily aspects of diabetes, with blood glucose monitoring reported as the most challenging behavior; 2) Perceived Lack of Support: The majority of T1D and T2D participants felt that family and friends did not understand how difficult it was to live with diabetes. Many of these participants chose to hide their diagnosis for fear of stigmatization; 3) Worry about the Inevitability of Complications: All of the participants addressed fears about developing complications, with several experiencing debilitating distress; and 4) Uncertainties about the Cost and Quality of Care: T2D participants voiced more concerns about the cost of care. With rising drug and diabetes supply costs, T2D participants expressed more unease about their future. Further, many T2D participants felt that their primary care providers did not know enough about diabetes to take care of them properly. T1D participants did not report these views.

In conclusion, T1D and T2D shared more common experiences with diabetes distress than not. In southeastern Ohio, people with T1D and T2D diabetes may benefit from group interventions that incorporate problem-solving therapy and emotion regulation.

Disclosure

E.A. Beverly: None. R.G. Rennie: None. E.H. Guseman: None. A. Healy: None.

Funding

American Osteopathic Association (1291708718)
846-P: Patients with T2D Are Willing To Do More than Their HCPs Expect to Overcome Therapeutic Inertia
Authors: CHAMBERLAIN JAMES , WOOD RICHARD , ROBERTS MICHELLE , EDELMAN STEVEN
Published: June 2019

Few patients on basal insulin (BI) reach suggested glycemic goals despite repeated dose titration attempts and availability of other support services/medications. An online quantitative survey was used to explore differences between patient and healthcare provider (HCP) priorities and perceptions of therapeutic regimens and approaches. It was completed by 305 T2D patients on BI >1 year and 240 HCPs. Patient and HCP preferences were compared regarding treatment priorities, estimated time to reach A1C goals, impact of not reaching goals, and willingness to change treatment and do more to reach goals.

Results showed the similarities and differences in patient and HCP views and priorities. Top patient priorities were to: maintain goals long term (62%), stay healthy (44%), and avoid weight gain (43%) vs. HCPs: avoid side effects (55%), consider treatment affordability (53%), and maintain goals long term (45%). It took longer than expected to meet A1C goals (35% each group); of patients, 49% expected goals would not be met; 61% wanted to reach goals faster; 80% were frustrated by slow progress to reach goals. More patients expected to reach goals in 1-5 years (42% vs. HCPs 16%); both groups wanted to reach goals in 6-12 months. More patients would try harder to reach goals than HCPs expected (37% vs. 16%), be willing to visit their HCP more often (42% vs. 17%), consider treatment changes (40% vs. 18%), and try a different injectable (45% vs. 34%). Within 12 months of starting BI, 17% of patients (vs. 68% of HCPs) expected no treatment addition. More endocrinologists (29% vs. PCPs 16%) anticipated titrating BI dose ≥100 U/day. In patients, 61% felt frustrated not reaching goals on BI, whereas HCPs estimated only 36% of patients would be frustrated.

In summary, patients are willing to do more than their HCPs expect. A better understanding of the disparate perceptions and preferences of patients and HCPs could enhance outcomes for T2D patients on BI not reaching glycemic goals and reduce unwarranted complications.

Disclosure

J. Chamberlain: Speaker's Bureau; Self; Merck & Co., Inc., Novo Nordisk Inc., Sanofi-Aventis. R. Wood: Other Relationship; Self; Multiple companies in the diabetes field (>10 companies). M. Roberts: None. S. Edelman: Advisory Panel; Self; BrightSight, InPen, Lexicon Pharmaceuticals, Inc., Novo Nordisk Inc. Board Member; Self; Senseonics. Speaker's Bureau; Self; AstraZeneca, Lilly Diabetes, MannKind Corporation, Merck Foundation, Sanofi-Aventis.

Funding

Sanofi U.S.
847-P: Diabetes-Specific Social Capital through Peer Support—A Study of Facilitators
Authors: JOENSEN LENE E. , OVERGAARD MATHILDE , NØRGAARD KIRSTEN , WILLAING INGRID
Published: June 2019

Peer support is a method often used in diabetes support and education programs to improve good health and wellbeing among people with diabetes. However, the evidence is insufficient to determine which peer support elements that are effective and the specific approaches to facilitation of peer support are often not explicitly described. Obtaining the experience of diabetes-specific social capital is one important outcome of peer support. However, little is known about how to enhance diabetes-specific social capital. The aim of this study was to explore facilitators of diabetes-specific social capital through peer support in group meetings. Data consisted of audio recordings of plenary discussions from eight peer support meetings conducted in a diabetes specialist clinic and researchers’ observation notes from the meetings. Furthermore, 25 of 30 participants were interviewed. Participants consisted of a group of adults with type 1 diabetes treated with insulin pump. Systematic text condensation was used to analyze data, showing that participants’ experiences of diabetes-specific social capital related to feeling trust, collectiveness, reciprocity and relevant experience sharing. The overall mechanisms found to facilitate diabetes-specific capital related to the provision of 1) practical and concrete insights 2) focused experience sharing and 3) an open and safe forum to talk about diabetes. Specific facilitators included opportunities for participants to e.g., show and tell how they managed diabetes, demonstrating practical diabetes routines during the meetings, experience diversity in how to manage diabetes and be able to joke about diabetes.

This study highlights concrete facilitators of diabetes-specific peer support which makes a significant positive difference to quality of everyday life with diabetes. Further studies are needed to explore in depth the effect of these mechanisms on emotional as well as physical health in larger and various diabetes populations.

Disclosure

L.E. Joensen: None. M. Overgaard: None. K. Nørgaard: Advisory Panel; Self; Abbott, Medtronic, Novo Nordisk A/S. Speaker's Bureau; Self; Bayer US, Medtronic, Roche Diabetes Care, Rubin Medical, Sanofi, Zealand Pharma A/S. Stock/Shareholder; Self; Novo Nordisk A/S. I. Willaing: None.
848-P: Understanding Diabetes-Related Stigma in African-American Churches: The Blame and Shame Game
Authors: PIATT GRETCHEN
Published: June 2019

Stigma impacts the way that communities, families, and partners interact with people living with diabetes, and undermines efforts to curtail the disease. We explored stigma and its associated attributes in 21 African American churches in 4 metropolitan areas. All churches are actively taking part in a 33-month, cluster randomized controlled trial focused on self-management support efforts to improve diabetes outcomes. Baseline data for participants (n=309) [(mean age: 65.3±11.1 years, 100% African American, 25.6% male, 50.8% obese (BMI>=30 kg/m2), mean diabetes distress scale score: 2.0±0.98] were examined to determine levels of stigma using the Type 2 Diabetes Stigma Assessment Scale (DSAS-2). DSAS-2 is a validated, 19-item scale with 3 subscales (Treated Differently, Blame and Judgement, and Self-Stigma). Average overall stigma scores were not significantly different by gender; however, there was a strong correlation between younger age and overall stigma (r=-0.19, p=0.001), feelings of being treated differently (r=-0.1, p=0.09), blame and judgement (r=-0.18, p=0.001), and self-stigma (r=-0.21, p<0.0001). The same pattern was apparent for participants who were obese. Obese participants were significantly more likely to feel overall stigmatization (p=0.03), blame and judgement (p=0.003) and self-stigma about their diabetes (p=0.04) compared to non-obese participants. After controlling for age, gender, obesity, and diabetes distress, younger male participants who experienced more diabetes distress were 1.4x more likely to feel stigmatized about their diabetes compared to their counterparts. The addition of distress to the models attenuated the association between stigma and obesity, suggesting that participants with higher distress levels often feel stigmatized about their diabetes. Future efforts aimed at ways to decrease distress levels, particularly in younger African American men, who oftentimes do not understand “why this happened to them" are paramount.

Disclosure

G. Piatt: None.

Funding

National Institutes of Health
852-P: Reduction in Emotional Burden in Type 2 Diabetes Is Associated with Improved Medication Adherence: Results from COMRADE
Authors: CUMMINGS DOYLE M. , BROWN MACKENZIE , LUTES LESLEY , HAMBIDGE BERTHA , CARRAWAY MARISSA A. , PATIL SHIVAJIRAO P. , ADAMS ALYSSA , LITTLEWOOD KERRY , EDWARDS SHEILA B. , GATLIN PEGGY
Published: June 2019

The presence of distress symptoms in patients with uncontrolled type 2 diabetes (T2D) negatively influences diabetes management behaviors (DMB) and increases the risk of co-morbid complications. Cognitive behavioral interventions (CBI) are successful at reducing these symptoms, but the role of reducing Emotional Burden (EB) on diabetes behaviors is poorly understood. A prospective randomized trial involving 139 patients (mean age = 52.6 +/- 9.5 years; 27% black; 78% female; BMI = 37.0 +/- 9.0) with uncontrolled T2D (mean A1c = 9.6 +/-2) compared the effectiveness of a 16-week severity-tailored CBI plus lifestyle coaching (n=67; IG=intervention group) to usual care (n=72; CG=control group) on reducing EB and its impact on DMB such as self-care behaviors and medication adherence. Trained staff at a rural primary care clinic measured EB (subscore of Diabetes Distress Scale-17), self-care behaviors (Summary of Diabetes Self-Care Activities, SDSCA), and medication adherence (ModMAS) at baseline and 12-months follow-up using validated instruments. There were no differences between groups at baseline in mean age, race, or gender. The average reduction in EB, average improvement in ModMAS, and average improvement in self-care (SDSCA) were all significantly greater in the IG (-1.00 +/- 1.17; +1.0 ± 2.0; +1.1 ± 1.3) than in the CG (-.06 +/- 1.38; + 0.17 ± 1.9; +0.58 ± 1.4) (p=0.0001; p = 0.02; p = 0.027, respectively). Mean improvement in ModMAS was significantly and progressively related to improvements in EB in the IG (worse/same EB = -0.25 ±0.96; moderately improved EB = +0.79 ± 1.9; markedly improved EB = +1.6 ± 2.2; p = 0.045). A linear regression model showed that EB remained significantly associated with ModMAS even when controlling for age, race, and treatment group (β = -0.55; 95% CI: -0.8 to -0.3; p = 0.0001). A severity-tailored CBI plus lifestyle coaching significantly improves EB in T2D patients which is associated with significantly improved medication adherence.

Disclosure

D.M. Cummings: None. M. Brown: None. L. Lutes: None. B. Hambidge: None. M.A. Carraway: None. S.P. Patil: Research Support; Self; Novo Nordisk Inc. A. Adams: None. K. Littlewood: None. S.B. Edwards: None. P. Gatlin: None.

Funding

Bristol-Myers Squibb Foundation
869-P: A Path Model of Quality of Life in Insulin-Treated Patients: A Nine-Month Prospective Study
Authors: WANG RUEY H. , LEE TAO-CHUN , HSU HUI-CHUN , CHEN SIH-YU
Published: June 2019

Background: Insulin therapy is recognized as a key component of effective diabetes management over the course of the diabetes. Nevertheless, insulin-treated patients report worse quality of life (QoL) than patients who receive oral drug therapy. Understanding the path model of QoL might help improve QoL in insulin-treated patients.

Purpose: To test a path model of QoL based on baseline diabetes distress and self-efficacy for insulin injection as well as 9-month resilience and decisional balance of insulin injection (DBIJ) (relative weight on the difference between perceived benefit and barriers for insulin injection) in insulin-treated patients.

Methods: A 9-month prospective design was employed. Questionnaires were used to collect data from 185 insulin-treated patients. At baseline, diabetes distress and self-efficacy for insulin injection were collected. QoL, resilience, and DBIJ were further collected 9 months later. Structural equation modeling was used to test a hypothesized model.

Results: Structural equation modeling supported the finding that baseline diabetes distress directly affected 9-month resilience (β=-0.31, p<0.001) and 9-month QoL (β=-0.51, p<0.001). Baseline self-efficacy for insulin injection directly affected 9-month DBIJ (β=0.29, p<0.01). The 9-month DBIJ directly affected 9-month QoL (β=0.29, p<0.01). Baseline diabetes distress indirectly affected 9-month QoL through 9-month resilience and 9-month DBIJ (βindirect=-0.29, p<0.01). The 9-month resilience directly affected 9-month DBIJ (β=0.67, p<0.001) and indirectly affected 9-month QoL through 9-month DBIJ (βindirect=-0.19, p<0.01).

Conclusions: Diabetes distress plays a crucial role in affecting QoL 9 months later. Healthcare providers should regularly assess diabetes distress and provide more timely intervention to improve QoL. Improving resilience and self-efficacy for insulin injection could be promising strategies to enhance DBIJ, and finally, improve QoL of insulin-treated patients.

Disclosure

R.H. Wang: None. T. Lee: None. H. Hsu: None. S. Chen: None.

Funding

Ministry of Science and Technology of the People´s Republic of China (2013ZX09401301)
87-LB: Reduced Risk of Metabolic Syndrome and T2DM after One Year in an Automated No-Coaches Online Behavior Change Program
Authors: BLOCK GLADYS , BLOCK TORIN , BLOCK CLIFFORD H.
Published: June 2019

Adults (n=339) at risk of diabetes, 68.1% with Metabolic Syndrome (MetSyn), were randomized to immediate intervention or to 6-month delayed control. Other than quarterly clinic visits for blood and weight measurement, there was no contact with study staff. The intervention, Alive-PD, was algorithm-driven, low-cost, and had no human coaching. Published 6-month results showed significant (p<0.001) treatment vs. control effects on HbA1c, glucose (FG), and weight.

Baseline means (SD) were: age 55 (8.9)y, BMI 31.2 (4.4), FG 109.9 (8.4) mg/dL, HbA1c 5.6 (0.3)%. Most were male (68.7%), college-educated (82%), and white (68%).

We calculated change from baseline to 12 months, and MetSyn severity Z-score (MetSynZ), a continuous variable associated with long-term risk for CVD, T2DM and MetSyn. We present data for those who provided 12-month biometric data (n=240), and also an intention-to-treat analysis for all 339 using Last Observation Carried Forward (LOCF).

In the 240 with 12-month data, pre-post improvements at 1 year were significant at p<0.001 for HbA1c, weight, waist, HDL, TG/HDL ratio and MetSynZ. The pre-post effect sizes ((12-month - baseline)/SD) were -0.50 for waist (half a SD), -0.43 for HbA1c and -0.36 for MetSynZ. These represent medium to low-medium effects. Changes, effect sizes and significance were similar in the LOCF n=339 analysis. Effect sizes of other analytes were significant but small. Only change in FG failed to maintain significance at 1 year.

Prevalence of metabolic syndrome was 68% at baseline, similar to that of the DPP sample (70%). It fell to 42% at 1 year, similar to that of DPP (45%). The MetSyn severity Z-score declined from 0.60 to 0.32, p<0.001. Insulin resistance by TG/HDL fell from 41% to 27% at 12 months.

These data indicate that at least for well-educated participants receiving quarterly clinic visits, this automated online coach-free program can help users achieve and maintain significant and non-trivial one-year reductions in risk of MetSyn and T2DM at relatively low cost.

Disclosure

G. Block: Other Relationship; Self; Turnaround Health (NutritionQuest). T. Block: Other Relationship; Self; Turnaround Health. C.H. Block: None.

Funding

National Institutes of Health
878-P: Beyond Tracking: The Benefits of Contextual Annotation in a Diabetes Digital Therapeutic
Authors: DUGAS MICHELLE , CROWLEY KENYON , WANG WEIGUANG , IYER ANAND K. , PEEPLES MALINDA M. , SHOMALI MANSUR , GAO GUODONG
Published: June 2019

Objective: Digital therapeutics manage chronic diseases by leveraging structured data like blood glucose/pressure, diet, etc. Addition of free-text notes associated with this data may help patients/providers make sense of trends by tracking unique concerns, providing the benefits of deeper cognitive processing. We explored the impact of contextual annotation in a digital therapeutic on A1C.

Method and Results: Free-text note usage from 3,142 users of BlueStar® digital therapeutic was summarized using NLP techniques. 941 users (29.9%) recorded 31,443 notes. A lexicon of note content was generated from the most common words (Table 1). We tested if note usage was associated with A1C reduction in a subgroup (N = 378) with two lab A1C values. A repeated measures ANCOVA, controlling for demographics and usage, showed the highest note takers exhibiting significantly larger declines in A1C (-2.13%) compared with those who took no notes (-0.86%) or very few notes (-0.79%), F(3,357) = 3.55, p =.02.

Conclusions: A substantial subgroup used free-text notes in BlueStar reflecting a diverse range of self-management themes from nondiabetes physical/mental health issues to core diabetes concerns like BG, medication, diet, and activity. Contextual annotation was associated with greater A1C improvement, suggesting that note-taking may offer unique benefit to digital therapeutic users; future studies should address causality.

Disclosure

M. Dugas: None. K. Crowley: None. W. Wang: None. A.K. Iyer: Employee; Self; WellDoc, Inc. M.M. Peeples: Employee; Self; WellDoc, Inc. M. Shomali: Consultant; Self; WellDoc, Inc. G. Gao: None.
883-P: Diabetes Distress: Provider Perspectives
Authors: JOHN ANN-MARIE
Published: June 2019

Purpose: Though many studies focus on patient perspectives of diabetes distress (DD), provider perceptions of DD require further investigation. Defined as diabetes-specific distress related to the emotional and behavioral burden of living with type 2 diabetes (T2DM), DD is a major psychological challenge to diabetes (DM) self-management. The purpose of this qualitative study was to explore how interdisciplinary interprofessional primary care team members identify factors that contribute to a DD future intervention.

Methods: A total of 18 providers from three rural nurse-managed clinics located in Northern Virginia participated in the study. Using purposive sampling, providers were interviewed for their perspectives on DD. Face-to-face interviews were conducted, digitally recorded, and transcribed. Two researchers coded the transcripts into themes. Data collection and analysis occurred sequentially using a constructivist grounded theory approach.

Results: Provider narratives identified a lack of awareness of DD in their experiences with T2DM-related psychological and emotional challenges in a low-income, immigrant, underserved patient populations. When asked about DD, most participants discussed biomedical aspects of DM management, such as diet, exercise, medications, and blood glucose management. The key facilitator identified by the few participants who recognized DD was the interdisciplinary team practice model. Perceived barriers included: (1) limited knowledge of DD by the healthcare team, (2) under recognition of DD in reported practice, (3) time constraints, and (4) limited clinical experience with treating or referring patients with DD to appropriate mental health services.

Conclusions: The American Diabetes Association (ADA) Standards of Medical Care in Diabetes recommends ongoing assessment and monitoring of DD to prevent and delay its progression. Therefore, the challenge is to enhance provider understanding of DD and promote strategies and activities that help reduce DD and improve diabetes outcomes.

Disclosure

A. John: None.
897-P: Continuous Glucose Monitoring (CGM) in Management of Patients with Severe Traumatic Brain Injury
Authors: DASKALOVA IVONA , TOTOMIROVA TZVETELINA , PETROV NIKOLAY , ARNAUDOVA MILA
Published: June 2019

Hyperglycemia after severe traumatic brain injury patients is frequent finding that has impact on clinical outcome and increases mortality. Management of increased blood glucose but also prevention of hypoglycemic episodes are crucial in those patients. The aim of our observation is to analyze the effect of CGM in management of diabetic patients with severe traumatic brain injury (TBI) Our study included 37 patients (20 men, 17 women, mean age 34.6±9.7 years) hospitalized in Intensive Care Unit. All patients have diabetes with duration 7.3±5.8 years, with severe TBI and Glasgow coma scale of 8 or less. For monitoring of glucose level patients real-time CGM - Paradigm Medtronic Minimed was placed for 5 days period. Simultaneous glucose measurements were performed four times daily. Patients received continuous venous infusion of fast acting insulin for maintaining glucose level below 10mmol/l. Number of CGM measurements was significantly higher compared to conventional monitoring of blood glucose (288 measurements vs. 4 measurements daily, p<0.05). None of the patients showed any problems with CGM-device like technical problems and irritation or allergy at the site of sensor insertion. More than one hypoglycemic episodes (blood glucose below 3.9mmol/) were detected in 37.8% (n=14) based on CGM data and only in 18.9% (n=7) from four-point profiles. CGM defined that patients spent about 54.9±12.2% of observed period in hyperglycemic state (blood glucose above 10mmol/l) while with conventional monitoring this time was 28.7±9.8% (p<0.05). Data from CGM allow more precise adjustment of insulin infusion for maintaining glucose in targets and preventing complications of insulin treatment. Results from real-time CGM has impact on the glycemic control in diabetic patients with severe TBI and should be recommended in protocols for management and used whenever it is possible.

Disclosure

I. Daskalova: None. T. Totomirova: None. N. Petrov: None. M. Arnaudova: None.
9-LB: Hypoglycemia in Patients with Diabetes: Therapeutic Strategies and Associated Risk Factors
Authors: MARKLEY WEBSTER SARA C. , KURGANSKY KATHERINE E. , PHILLIPS LAWRENCE S. , GAGNON DAVID R. , WILSON PETER W. , RHEE MARY K.
Published: June 2019

Use of insulin or sulfonylureas (SU) carries a risk of hypoglycemia, but the risk with different diabetes therapies, such as premixed insulin, is not well known. We conducted a case-control analysis of 297,263 patients with DIAB and 487,226 NONDIAB in the national VA database who had ≥4 primary care visits, ≥1 A1c, and ≥3 outpatient random plasma glucoses (RPG) in 2002-2003, and examined hypoglycemia by diabetic medication use and other risk factors, through 2012. Hypoglycemia was defined as severe (Emergency Department visit with hypoglycemia [EDHypo]) and by outpatient lab (RPGHypo = RPG <70 mg/dl); both were associated with increased mortality (2.1- and 1.5-fold, respectively, p<0.001). At baseline, DIAB had mean age 66 year, BMI 31 kg/m2, and A1c 7.5%; and were 98% male, 80% white, and 18% with retinopathy; NONDIAB were similar but had lower BMI. Among DIAB, 49% were on SU, 29% insulin (5% basal, 5% basal+SU, 1% bolus, 8% basal+bolus, 10% premixed), 11% otherRx (non-insulin/non-SU), 11% no meds. RPGHypo and EDHypo occurred in 6.8% and 0.3% of DIAB, respectively, vs. 2.1% and <0.1% of NONDIAB, p<0.001. During mean follow-up 7.5 year, 35% of DIAB (n=102,063; 229,612 events) had ≥1 RPGHypo, an incidence rate of 0.10 events/pt-year, and 4% had EDHypo. In adjusted models compared to otherRx, the risk of any hypo and EDHypo, respectively, was highest with basal+bolus (OR 1.4 and 17.8) and premixed insulin (OR 1.4 and 13.8), and lower with basal Insulin (OR 1.4 and 10.5), and SU (OR 1.2 and 5.1), all p<0.001. Black race and retinopathy also conferred higher risk of both any hypoglycemia and EDHypo (black race, OR 1.9 and 2.1; retinopathy OR 1.3 and 1.6, respectively; all p<0.001), much higher than the risk with A1c <6.0% (OR 1.0 and 1.3).

Conclusions: Clinically significant hypoglycemia, including both outpatient RPG <70 mg/dl and ED visits, is common in DIAB patients, particularly in those using basal+bolus or premixed insulin, and with black race or retinopathy, and should prompt consideration of altered management.

Disclosure

S.C. Markley Webster: Stock/Shareholder; Self; Dexcom, Inc. K.E. Kurgansky: None. L.S. Phillips: Advisory Panel; Self; Janssen Pharmaceuticals, Inc. Research Support; Self; AbbVie Inc., GlaxoSmithKline plc., Kowa Pharmaceutical Europe Co. Ltd., Novartis Pharmaceuticals Corporation, Novo Nordisk Inc., Pfizer Inc. Stock/Shareholder; Self; Diasyst Inc. Other Relationship; Self; Diasyst Inc., Janssen Pharmaceuticals, Inc. D.R. Gagnon: None. P.W. Wilson: None. M.K. Rhee: None.

Funding

Million Veteran Program
936-P: Annual Cost to Achieve Cost Effectiveness of Continuous Glucose Monitoring in Hypoglycemia-Unaware Type 1 Diabetes Patients Using Intensive Insulin in the United Kingdom
Authors: PINAR BILIR S. , CAMPBELL CARESSE , HELLMUND RICHARD , MUNAKATA JULIE
Published: June 2019

Background: Type 1 diabetes (T1D) patients with impaired awareness of hypoglycemia (IAH) face higher risk of severe hypoglycemic events. Continuous glucose monitoring (CGM) has been found to prevent severe hypoglycemic events in this population (van Beers 2016) compared to self-monitoring of blood glucose (SMBG). This study aimed to evaluate the annual cost of a hypothetical CGM intervention that would be cost-effective vs. SMBG in the United Kingdom (UK) according to a willingness-to-pay threshold of £30,000/QALY.

Methods: The IQVIA Core Diabetes Model was used to run analyses over multiple time horizons (50-, 5-, and 1-year to test impact of assuming continued intervention effects over time) with an IAH population reflecting the IN CONTROL study (van Beers 2016). This study evaluated impact of CGM on hypoglycemia in an IAH population. CGM intervention effects included: odds ratio 0.45 for severe hypoglycemic events (requiring third party intervention); 0.03 utility benefit associated with reduced finger prick requirements of CGM (Matza 2016). HbA1c was assumed equivalent between CGM and SMBG. All other inputs reflected published literature and/or public tariffs, with costs in 2018 GBP. Threshold analyses were performed to identify the annual cost of intervention associated with incremental cost-effectiveness ratio (ICER) threshold £30,000/QALY over each time horizon. Sensitivity analyses were also performed on key input variables.

Results: Over 50 years, up to £1,354 could be spent annually on CGM to achieve a £30,000/QALY ICER threshold. With shorter time horizons, the annual intervention cost to achieve cost-effectiveness was slightly lower, ranging from £1,344 over 5 years to £1,301 for a 1-year horizon.

Conclusions: Based on recent evidence that CGM reduces severe hypoglycemia in IAH T1D patients, CGM can be considered cost-effective in the UK at costs per year of up to approximately £1,350.

Disclosure

S. Bilir: Employee; Self; IQVIA. C. Campbell: Consultant; Self; Abbott. R. Hellmund: Employee; Self; Abbott Laboratories. Stock/Shareholder; Self; Abbott Laboratories. J. Munakata: Employee; Self; IQVIA.
95-OR: Interleukin-17 Receptor C Is a Regulator of Autoimmune Diabetes in Humans
Authors: CHAMBERLAIN CHESTER , WANG JUEHU , GITELMAN STEPHEN E. , GERMAN MICHAEL , ANDERSON MARK S.
Published: June 2019

Rare cases of monogenic type 1 diabetes (T1D) represent defects in critical pathways of immune tolerance and autoimmune disease. We therefore identified and recruited patients with likely monogenic causes of T1D and performed next-generation sequencing to discover new candidate genes and mechanisms of disease. We discovered a large kindred with an autosomal dominant inheritance pattern of T1D, with all affected members positive for autoantibodies and the index patient also having inflammatory bowel disease. Whole exome sequencing analysis of six family members across three generations revealed a novel mutation in the interleukin-17 receptor C gene (IL17RC) that cosegregated with T1D and was predicted to be both damaging and rare. No other mutations were identified. IL17RC is broadly expressed and encodes a single-pass transmembrane receptor that mediates the inflammatory activities of Th17 cells. We found that cells expressing the mutant IL17RC did not ectopically activate IL-17 signaling but instead had a hyperactive response to the Th17 cytokine IL17A and other inflammatory signals. Our data identifies inflammatory signaling via IL17RC as an important and novel regulator of autoimmune diabetes in humans.

Disclosure

C. Chamberlain: None. J. Wang: None. S.E. Gitelman: Advisory Panel; Self; Avortes, Intermountain Therapeutics, Lilly Diabetes, Tolerion, Inc. Research Support; Self; Caladrius Biosciences, Inc., Janssen Research & Development. Other Relationship; Self; Novo Nordisk Inc. M. German: Advisory Panel; Self; Encellin. Stock/Shareholder; Self; Encellin, Viacyte, Inc. M.S. Anderson: None.

Funding

The Leona M. and Harry B. Helmsley Charitable Trust; Larry L. Hillblom Foundation; Nora Eccles Treadwell Foundation; National Institutes of Health
965-P: Glucose Sensor Accuracy after Subcutaneous Glucagon Injections Near to Sensor Site
Authors: LAUGESEN CHRISTIAN , SCHMIDT SIGNE , TETZSCHNER RIKKE , NØRGAARD KIRSTEN , RANJAN AJENTHEN
Published: June 2019

Aim: To compare sensor accuracy (Medtronic Enlite2®) after a subcutaneous (s.c) injection of low-dose glucagon near vs. remote from sensor site.

Methods: Twelve adults with type 1 diabetes wore two continuous glucose monitors (CGMglucagon and CGMctrl) placed on each side of the abdomen during two overnight in-clinic visits. CGM values were compared with YSI values. Four hours prior to visit end, a s.c 100 µg glucagon injection was administered 0.2 cm next to the CGMglucagon, and 2 hours later another bolus was injected next to the same sensor. Afterwards, CGM performance was compared with 3-day self-monitoring of blood glucose (SMBG) in free-living conditions.

Results: Using YSI as comparator, the overall median absolute relative difference (MARD) for CGMglucagon (N=772) was 17.9% and 14.7% for CGMctrl (N=1352), p=0.15. The percentage of values in zone A+B of Clarke Error Grid Analysis was 96.9% for YSI-CGMglucagon and 97.0% for YSI-CGMctrl, p=0.98. With respect to SMBG, the MARD for CGMglucagon (N=319) was 19.3% and 13.8% for CGMctrl (N=464), p=0.02. The percentage of values in zone A+B for SMBG-CGMglucagon was 94.7% compared to 97.2% for SMBG-CGMctrl, p=0.77. The precision absolute relative deviation between sensors was 16.0%.

Conclusion: The study indicates that sensor accuracy may be affected by s.c. glucagon injections near to sensor site compared with distant injections. However, the effect may not be of clinical relevance.

Disclosure

C. Laugesen: None. S. Schmidt: Speaker's Bureau; Self; Novo Nordisk A/S. R. Tetzschner: None. K. Nørgaard: Advisory Panel; Self; Abbott, Medtronic, Novo Nordisk A/S. Speaker's Bureau; Self; Bayer US, Medtronic, Roche Diabetes Care, Rubin Medical, Sanofi, Zealand Pharma A/S. Stock/Shareholder; Self; Novo Nordisk A/S. A. Ranjan: None.

Funding

Danish Diabetes Academy
971-P: The Precision and Accuracy of Many Modern Blood Glucose Meters at High Altitude
Authors: ZENGMEI SUN , YUNHONG WU , SUYUAN WANG , YANFANG ZHAO , JING YANG , RONG XIAO , YAN YE , XUANYU YAO , HUIQIN ZHANG
Published: June 2019

Objective: Self-monitoring of blood glucose (SMBG) is an important method of glucose control in diabetic patients. The result of blood glucose meters are influenced by temperature, oxygen concentration, low atmospheric pressure or dry factors related to altitude. In this study, we aimed to evaluating the precision and accuracy of seven SMBG meters commonly used in plain market of China.

Methods: A total of 97 medical examinations living in NaQu distract (at altitude 3900m) were included in this study. We received 91 venous blood samples including seven glucose levels and 5 Venous blood samples including five glucose levels to analyze accuracy and precision respectively based on ISO15197:2013. Every sample was measured in duplicate by two meters of each brand of SMBG meter. Plasma separated to blood cells in 5 minutes and used for laboratory reference measurement in 30 minutes after obtain results by SMBG meters.

Results: Accuracy criteria were set at a bias<15% from reference glucose (when >5.6mmol/L)and<0.83 mmol/L from reference glucose(when<5.6mmol/L).There was only one brand SMBG meter consistent with standard of ISO. But the percentages of readings within Consensus Error Grid zone A and B of seven brand meters were all over 95% (98.9%∼100%). The precision of the result demonstrated that standard deviation for glucose concentration ≥5.6 mmol/L of seven brand meters were all less than 0.42 mmol/L. And coefficient of variation (CV) for glucose concentration <5.6 mmol/L were all less than 7.5%.

Conclusion: Altitude environment influenced the performance seriously of SMBG meters especially for accuracy. So choosing glucose meter brand should be cautious at high altitude.

Tab 1 Precision results of 7 brand glucose meters.

Disclosure

S. Zengmei: None. W. Yunhong: None. W. Suyuan: None. Z. Yanfang: None. Y. Jing: None. X. Rong: None. Y. Yan: None. Y. Xuanyu: None. Z. Huiqin: None.