bluuebunny/crossref_metadata_2025 huggingface dataset:
413-P: Renal Tubular Damage Marker, Urinary N-acetyl-b-d-glucosaminidase, as a Predictive Marker of Hepatic Fibrosis in Type 2 Diabetes
Authors: KIM HAE KYUNG , KIM YOUNG-EUN , LEE MINYOUNG , LEE YONG-HO , KANG EUN SEOK , CHA BONG-SOO , LEE BYUNG-WAN
Published: June 2021

Background: Nonalcoholic steatohepatitis is closely associated with the progression of diabetic kidney disease (DKD) in type 2 diabetes (T2D). We investigated whether urinary N-acetyl-β-D- glucosaminidase(u-NAG), an early renal tubular damage biomarker in DKD, could be related to the degree of hepatic fibrosis in patients with T2D.

Methods: A total of 300 patients with T2D were enrolled in the study. Hepatic steatosis and fibrosis were determined using transient elastography. The levels of urinary biomarkers, including u-NAG, albumin, protein, and creatinine, and glucometabolic parameters were measured.

Results: Based on the median value of u-NAG to creatinine (u-NCR), subjects were divided into normal and high u-NCR groups. The high u-NCR group showed a significantly longer duration of diabetes, worsened hyperglycemia, and a more enhanced hepatic fibrosis index. A higher u-NCR was associated with a greater odds ratio for the risk of higher hepatic fibrosis stage (F2 OR 1.99; 95% CI [1.04-3.82]; F3 and F4 OR 2.40, 95% CI [1.52-3.80]). In addition, u-NCR was an independent predictive marker for more advanced hepatic fibrosis even after adjusting for several confounding factors (β = 1.58, P <0.01).

Conclusions: The elevation of u-NAG was independently associated with a higher degree of hepatic fibrosis in patients with T2D. Considering the common metabolic milieu of renal and hepatic fibrosis in T2D, the potential use of u-NAG as an effective urinary biomarker reflecting hepatic fibrosis in T2D needs to be validated in the future.

Disclosure

H. Kim: None. Y. Kim: None. M. Lee: None. Y. Lee: None. E. Kang: None. B. Cha: None. B. Lee: None.
415-P: Prevalence of Gastroparesis Symptoms in Diabetic Patients in the Western Region of Saudi Arabia, 2019
Authors: BUKHARI ABDULRAHMAN A. , ALSAYARI MAYADA M.
Published: June 2021

Gastroparesis is a well-established diabetes complication with conflicting data regarding its prevalence. Gastroparesis impacts quality of life, increases direct health-care costs and is associated with morbidity and mortality. Other possible consequences include erratic glycemic control, alteration in drug absorption and hypoglycemia.

Objectives: To estimate the prevalence of diabetic gastroparesis symptoms in T2DM patients attending PHC centers and to determine the associated factors

Methods: A cross sectional study which included a representative sample of patients attending PHC centers of the Ministry of National Guards Health Affairs, Western Region-Saudi Arabia. Simple random sampling technique was adopted to select the study population. Patient interviewing technique was adopted to fill the Arabic version of GSCI. Information on demographics and personal characteristics, diabetes duration, type of treatment and other variables were obtained.

Results: The study involved 365 participants, 66.3% were females, 52.9% aged 40-59 years and 31.8% with disease duration 10-20 years. A GCSI with a score of ≥ 1.9 was used to diagnose gastroparesis symptoms. Prevalence of gastroparesis symptoms was 7.9%. The most frequent symptoms were bloating (34.8%) then stomach fullness (26.6%) and the least frequent was vomiting (4.1%). The most frequently used agent was metformin (84.9%). 47.1% of participants had HbA1C between (7-9%) and 37.9% of them have gastroparesis symptoms (p 0.318). 69% of participants with gastroparesis symptoms were using metformin (p 0.012). 10.3% of participants with gastroparesis symptoms were not using any diabetes medications (p 0.037). 25% of participants with CHD had gastroparesis symptoms (p 0.001).

Conclusion: Up to our knowledge, this is the 1st local multi-city and primary care-based study. The prevalence of gastroparesis symptoms was 7.9%. Gastroparesis symptoms were significantly associated with the use of metformin, CHD and participants not on any medication.

Disclosure

A. A. Bukhari: None. M. M. Alsayari: None.
422-P: Intrinsic Brain Connectivity in Chronic Painful Diabetic Neuropathy: A Resting-State fMRI Study
Authors: TEH KEVIN , WILKINSON IAIN D. , SHILLO PALLAI RAPPAI , SLOAN GORDON P. , TESFAYE SOLOMON , SELVARAJAH DINESH
Published: June 2021

Painful diabetic neuropathy (DN) is a common, distressing complication of diabetes that is discordant with the degree of peripheral nerve pathology. Very little is known about the cerebral processes involved in pain processing in painful DN. Here we investigated resting-state brain connectivity associated with prolonged pain in DN.

Methods: 58 subjects and 36 matched controls were compared with regard to both behavioural measures of pain perception and resting-resting state functional Magnetic Resonance Imaging. The resting-state fMRI brain connectivity was investigated using 20 seed regions located in cardinal pain processing brain regions. Resting-state fMRI analysis was performed using the NITRC Functional Connectivity (CONN) Toolbox and SPM8 (welcome Trust Centre for Neuroimaging London, UK) in Matlab 2014a (the MathWorks, Natick, MA, USA). Functional connectivity matrices between the pre-specified seeds were calculated and the HV versus painful DN phenotype interaction examined.

Results: Relative to controls, painful DPN patients displayed increased brain connectivity predominately for the supplementary motor areas (p<0.01) and the primary sensorimotor cortex (p<0.001). Similar results were found when painful DPN subjects were compared with those with No DPN. Conversely, we observed an increase in brain connectivity between the primary somatosensory cortex and cingulate cortex (p<0.01), prefrontal cortex (p<0.01) and amygdala (p<0.01) between painful and painless DPN patients.

Conclusion: Our study provides experimental evidence of increased connectivity between frontal midline regions that are implicated in affective pain processing and bilateral sensorimotor regions in painful DPN patients.

Disclosure

K. Teh: None. I. D. Wilkinson: None. P. Shillo: None. G. P. Sloan: None. S. Tesfaye: Advisory Panel; Self; Angellini, Bayer AG, Eva Pharma, Wörwag Pharma, Speaker’s Bureau; Self; Abbott, AstraZeneca, Grunenthal Group, MSD Corporation, Novo Nordisk, Pfizer Inc. D. Selvarajah: None.

Funding

Health Education England/University of Sheffield Knowledge Exchange Fund; National Institute for Health Research; EME
43-LB: Evaluating Health Status in the PRONTO-Pump-2 Study
Authors: PACZKOWSKI ROSIRENE , PIRAS DE OLIVEIRA CAROLINA , CHO JANG IK , GOLDYN ANDREA , POON JIAT LING , HANKOSKY EMILY R. , IGNAUT DEBRA A.
Published: June 2021

Background: In PRONTO-Pump-2, a Phase 3, 16-week, randomized, double-blind clinical trial in patients with type 1 diabetes on continuous subcutaneous insulin infusion, ultra rapid lispro (URLi) showed superior postprandial glucose control and noninferior HbA1c reduction, with less hypoglycemia compared to Humalog® (Lispro). Although primarily reported as mild in severity, incidence of infusion site reactions was higher with URLi compared to Humalog (37.7% vs. 10.1%). We assessed patient-reported health status in the PRONTO-Pump-2 trial as an exploratory measure.

Methods: The EQ-5D-5L (which includes a visual analogue scale rating perceived health [VAS; 0-100 from worst to best imaginable health state]) was administered at baseline and endpoint (week 16 or early discontinuation) to patients on URLi (N=215) or Humalog (N=217). The EQ-5D-5L assesses 5 dimensions of health status (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) for which a health state index score ranging from less than 0 (worse than death) to 1 (perfect health) is calculated. Change from baseline to endpoint (last observation carried forward) in scores was analyzed using an ANCOVA model.

Results: At endpoint, mean health state index scores showed no significant differences between treatments (URLi, 0.88 [standard error 0.009]; Humalog, 0.89 [0.009]) with an increase from baseline of +0.01 (0.009) within each treatment. On the dimension of pain/discomfort, distribution of responses was similar between treatments. Endpoint VAS scores were also similar between URLi and Humalog (80.2 [0.82] and 80.8 [0.78], respectively) but decreased from baseline within each treatment: URLi, -1.1 (0.82); Humalog -0.5 (0.78).

Conclusion: In PRONTO-Pump-2, the EQ-5D-5L indicated no differences in health status, including the pain/discomfort dimension, between patients on URLi versus Humalog, despite more frequent reports of infusion site reactions with URLi treatment.

Disclosure

R. Paczkowski: Employee; Self; Eli Lilly and Company, Employee; Spouse/Partner; Amgen Inc., Stock/Shareholder; Self; Eli Lilly and Company, Stock/Shareholder; Spouse/Partner; Amgen Inc. C. Piras de oliveira: Employee; Self; Eli Lilly and Company, Stock/Shareholder; Self; Eli Lilly and Company. J. Cho: None. A. Goldyn: Employee; Self; Eli Lilly and Company. J. Poon: Employee; Self; Eli Lilly and Company. E. R. Hankosky: Employee; Self; Eli Lilly and Company, Stock/Shareholder; Self; Eli Lilly and Company. D. A. Ignaut: Employee; Self; Eli Lilly and Company.

Funding

Eli Lilly and Company
43-OR: Islet Autophagic Flux Is Impaired Prior to the Onset of Type 1 Diabetes
Authors: CLARK AMY L. , YAN ZIHAN , REMEDI MARIA S. , DIWAN ABHINAV
Published: June 2021

Type 1 diabetes (T1D) is an autoimmune disease resulting from the destruction of pancreatic beta cells. Early events within the islet leading to T1D include increased beta cell ER and oxidative stress and increased inflammatory cytokines. Autophagy is a cellular pathway activated by cell stressors which leads to decreased cellular levels of ER stress and oxidative stress, and inactivates inflammatory pathways. While there is a good amount of data suggesting impaired autophagy in type 2 diabetes, relatively little is known about changes in autophagy during the development of T1D. In the following study we characterized changes in the autophagy pathway during development of T1D using NOD mice. We compared gene expression and autophagic flux in islets from female NOD mice prior to the onset of diabetes at 4, 8,10, and 12 weeks of age. At 10 weeks of age the inflammatory cytokines IL1-B and IL-6 and the ER stress marker CHOP were markedly elevated in NOD islets. In addition, at 10 weeks of age, TFEB expression was also significantly elevated in islets; indicating activation of the autophagy pathway. We then evaluated autophagic flux in NOD islets by measuring LC3-II accumulation in the presence or absence of chloroquine, an inhibitor of autophagosome to lysosomal fusion. LC3-II accumulation after CQ exposure was significantly lower in islets starting at 8 weeks of age, demonstrating an impairment in autophagic flux which precedes the development of islet ER stress and diabetes. This study demonstrates activation of the autophagy pathway when islets are expressing high ER and inflammatory stress markers during the development of T1D. However, despite activation, autophagic flux is reduced. Impairments in the autophagy pathway may worsen beta cell ER, oxidative and inflammatory stress, ultimately leading to cell death and hastening the progression to diabetes. These data suggest that therapies targeting restoration of autophagy should be evaluated as interventions to delay or prevent T1D.

Disclosure

A. L. Clark: None. Z. Yan: None. M. S. Remedi: None. A. Diwan: None.

Funding

Washington University Diabetes Research Center (P30DK020579 to A.L.C.); National Institutes of Health (R01DK123163, R56DK098584 to M.S.R.)
447-P: The Efficacy and Safety Trial of ENERGI-F703 in Diabetic Wound Healing: A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Clinical Trial
Authors: YOUNG GUANG-HUAR , LIN JIUN-TSAI , CHENG YI-FANG , CHEN HAN-MIN , HUANG CHUN-FANG
Published: June 2021

Diabetic foot ulcers (DFUs) is a catastrophic ailment that exerts serious medical and psychological impact on diabetic patients. ENERGI-F703 is a hydrogel containing 0.02% adenine as a prodrug for the replenishment of cellular ATP levels to accelerate diabetic wound healing. To demonstrate its efficacy and safety in patients with DFU, 141 patients with type 2 diabetes (T2D) ≥ 20 years old with HbA1c 6.5-12 % and intractable DFUs (Wagner grade 1-3 without active osteomyelitis) were enrolled, randomized 2:1 ENERGI-F703 group (67.4%) to vehicle group (32.6%) for 12 weeks. Most target ulcers were grade 2 (63.6%, N=84) and located mainly on the foot sole (30.3%, N=40) or toe (27.3%, N=36). The primary endpoint was complete ulcer closure rate at the end of treatment. Secondary endpoints included the time required to complete ulcer closure, the accumulated confirmed ulcer closure rate and percentage change in ulcer size at each of the post-treatment visit, and adverse event incidence. Patients with confirmed complete ulcer closure were follow-up for additional 12 weeks and patients with incomplete ulcer closure were additional 4 weeks. An intend-to-treat (ITT) population of 132 subjects and a per-protocol (PP) population of 107 were included in efficacy analyses. Among the PP population with Wagner grade 1 or 2 target ulcers, we observed a significantly higher response rate in the ENERGI-F703 group compared to the vehicle group (48.0% vs. 20.8%, P = 0.0250). Among the ITT population, we also observed a higher response rate in the ENERGI-F703 group compared to the vehicle group (40.3% vs. 20.7%, P = 0.0656). Time to complete target ulcer closure was also faster among patients receiving ENERGI-F703 Gel in both the ITT population (P = 0.0380) and PP population (P = 0.0180). There were no suspected unexpected serious adverse reactions observed throughout the study. Our study showed that ENERGI-F703 Gel is an effective and well-tolerated treatment for DFU.

Disclosure

G. Young: Employee; Self; Energenesis Biomedical Co., Ltd. J. Lin: Employee; Self; Energenesis Biomedical Co., Ltd. Y. Cheng: Employee; Self; Energenesis Biomedical Co., Ltd. H. Chen: None. C. Huang: Employee; Self; Energenesis Biomedical Co., Ltd.
454-P: Pharmacist-Led Diabetes Self-Management Education and Reduction of Readmission Rates at a County Hospital
Authors: MULALA LISELI , LENHOFF TAMARA
Published: June 2021

Pharmacist-led Diabetes Self-Management Education and Reduction of Readmission Rates at a County Hospital With 10.5% of the US population or 34.2 million people affected by diabetes, education is greatly needed. The American Diabetes Association (ADA) and the Association for Diabetes Care and Education Specialists (ADCES) state that Diabetes Self-Management Education or Training (DSME/T) improves diabetes management, which can avoid hospital admissions and readmissions. Although DSME/T has traditionally been provided by nurses and dieticians, pharmacists can play a part, given their expertise in medication management, non-pharmacological therapies, and monitoring. The ADA and ADCES recommend that people with diabetes receive DSME/T at diagnosis, annually, when factors influence self-management, and at transitions of care. Therefore, a pharmacist-led transitions of care program was developed to reduce readmissions for patients with diabetes at Zuckerberg San Francisco General Hospital and Trauma Center. This hospital serves a diverse, low-income, and unhoused patient population, increasing the challenges of diabetes management. Pharmacists and pharmacy trainees were given a refresher course on DSME/T. Low-health literacy handouts in several languages, as well as demonstration kits, glucometers, insulin and insulin supplies, were all utilized for patient education. The objective of the study was to determine whether using pharmacists as educators, could reduce hospital readmissions. In 2017, provision of DSME/T at this institution was less than 5% and increased to 74% by December 2019, with the implementation of this program. The rate of readmission for patients with diabetes who received DSME/T was 11.7% compared to 19.2% for those who did not; an absolute risk reduction in readmission of 7.5%. Pharmacists and pharmacy trainees should use DMSE/T to help reduce readmissions, improve outcomes, and increase the national levels of patients with diabetes receiving DSME/T.

Disclosure

L. Mulala: None. T. Lenhoff: None.
459-P: An Examination of Introductory Sessions Offered by CDC-Recognized National Diabetes Prevention Program Lifestyle Change Programs
Authors: WILLIAMS PAMELA , ELKINS WENDI , PROIA KRISTA , TAYEBALI ZOHRA , AXELROD KATHLEN , ESQUIVEL NIKIE S. , SMITH AKIMI , PORTERFIELD DEBORAH
Published: June 2021

The Centers for Disease Control and Prevention (CDC)’s National Diabetes Prevention Program (National DPP) lifestyle change program (LCP) is effective in preventing or delaying type 2 diabetes among people with prediabetes. Increasing enrollment in the National DPP LCP remains a priority. Some LCPs attempt to increase enrollment by offering introductory sessions, pre-enrollment sessions that aim to recruit, engage, and enroll participants based on emerging evidence linking introductory sessions with increased enrollment. As part of a national survey of CDC-recognized organizations offering the National DPP LCP, we examined the content and characteristics of introductory sessions currently offered. Of the 544 organizations who reported offering introductory sessions, the majority provide essential information by overviewing the organization’s LCP (98%) and providing information about type 2 diabetes prevention (79%) during the session. Most provide social support by offering an opportunity to meet the coach (86%) and for program staff and participants to mingle (69%), but only 36% offer light refreshments. Most assess eligibility and readiness to change by offering participants an opportunity to take a risk test to determine eligibility (74%), assess their readiness to join (63%), and to enroll in the program, if interested (71%). Only 34% provide resources for participants not eligible for the program. Session characteristics intended to overcome behavioral barriers to enrollment as identified in prior studies are less common: 39% conduct activities to help participants feel that they can be successful, 38% include testimonials from successful program participants, and 26% assess how soon a participant plans to enroll. There is room for improvement in incorporating behavioral science principles in introductory sessions. Future work will examine associations between specific introductory session characteristics and enrollment.

Disclosure

P. Williams: None. W. Elkins: None. K. Proia: None. Z. Tayebali: None. K. Axelrod: None. N. S. Esquivel: None. A. Smith: None. D. Porterfield: None.
473-P: Feasibility and Acceptability of a Direct-to-Home Diabetes Self-Management Education and Support Telemedicine Program (DSMES) with High-Risk Patients in a Rural, Underserved Area
Authors: KRALL JODI S. , NG JASON , JOHNSON PATRICIA A. , REYNOLDS SHARI L. , SIMINERIO LINDA M.
Published: June 2021

Ongoing support is critical to DSMES effectiveness, but difficult to realize, particularly in underserved areas with limited resources. The purpose of this study, initiated February 2020, was to evaluate the feasibility and acceptability of Telemedicine for Reach, Education, Access, Treatment, and Ongoing Support (TREAT-ON), a DSMES model delivered primarily through direct-to-home videoconferencing.

Methods: High risk patients with diabetes (A1c >9% or unplanned care) from rural federally qualified health centers were referred to TREAT-ON. Participants completed an initial face-to-face or virtual visit with a Diabetes Care and Education Specialist (DCES) to assess needs and develop self-management treatment plan and behavioral goals. Planned follow-up visits, used to support achieving and sustaining goals and outcomes, were conducted through videoconferencing. To assess feasibility and acceptability over first 3-months of participation, visit frequency, duration, completion rates, and technology issues were tracked and patients completed the Telehealth Usability Questionnaire (TUQ).

Results: Participants (n=25) were 60% female, 92% White, mean age 47.6±13.6y, mean A1c 11.5±1.8% and 76% had Medicare or Medicaid. They participated in 3 video visits, on average, lasting a mean of 35 minutes/visit. Of all scheduled video visits (n=99), 71% were successfully completed and 23% had technology issues (difficulty setting up system, connectivity issues). The TUQ revealed that participants were highly satisfied with the TREAT-ON videoconferencing approach (4.7/5), finding it useful (4.5/5), easy to learn/use (4.5/5), reliable (4.3/5), with quality interface (4.6/5) and interaction (4.7/5).

Conclusion: This telehealth DSMES model offers a promising approach to improve opportunities for ongoing support to vulnerable individuals in underserved communities.

Disclosure

J. S. Krall: Research Support; Self; Becton, Dickinson and Company, Sanofi. J. Ng: Research Support; Self; Sanofi-Aventis. P. A. Johnson: None. S. L. Reynolds: None. L. M. Siminerio: Advisory Panel; Self; Abbott Diabetes, Bayer U. S., Research Support; Self; Becton, Dickinson and Company.

Funding

National Institute of Diabetes And Digestive and Kidney Diseases (R34DK123370)
478-P: Effect of Nonpharmacological Management of Chronic Constipation in Diabetic Patients
Authors: NISHIMORI EITA , NAKA MOTOJI
Published: June 2021

Background: Chronic constipation is highly prevalent in diabetic patients. The treatment of chronic constipation in general patients is mainly lifestyle modification and pharmacological therapy. The efficacy of non-pharmacological treatment, i.e., behavioral therapy to improve lifestyle and defecation habits, for chronic constipation in diabetic patients is not well known. This study aimed to determine the efficacy of non-pharmacological management for chronic constipation in diabetic patients.

Methods: We conducted a questionnaire on defecation for diabetic patients aged 20 to 75 years at Asama General Hospital outpatient clinic. Patients diagnosed with chronic constipation according to Rome IV criteria were randomly assigned to two groups. The intervention group instructed behavior therapy to improve constipation. Specifically, we provided guidance on defecation behavior, exercise, water and dietary fiber intake, and guidance on a defecation diary recording daily defecation status. The other group received usual medical care as a control group. The questionnaire was conducted again at the next outpatient clinic.

Results: Eighty of 545 diabetic patients (14.7%) had chronic constipation. The average age of constipated patients was 59.3 years, frequency of defecation 3.7 times/week, stool form (Bristol Stool Form Scale) 2.8, straining during defecations 78,8% and sensation of incomplete evacuation of defecations 42.5%. After the intervention, there was a significant increase in the frequency of defecation (4.8 vs. 3.9 times/week, P=0.008) and improvement in constipation symptoms (P=0.018) in the intervention group compared to the control group. In addition, stool form and straining during defecations were significantly improved before and after comparison within the intervention group (P <0.05).

Conclusion: Our findings suggest that non-pharmacological management, including behavioral therapy for chronic constipation in diabetic patients, was effective.

Disclosure

E. Nishimori: None. M. Naka: None.
50-OR: Validation of Fear of Hypoglycemia Screener: Results from the T1D Exchange Registry
Authors: LIU JINGWEN , POON JIAT LING , BISPHAM JEOFFREY , PEREZ-NIEVES MAGALY , HUGHES ALLYSON , CHAPMAN KATHERINE S.M. , MITCHELL BETH , SNOEK FRANK J. , FISHER LAWRENCE
Published: June 2021

Objective: To examine reliability and validity of a newly developed fear of hypoglycemia (FoH) screener as a practical and actionable tool for in-clinic use in adults with type 1 diabetes (T1D), in accordance with ADA’s position on psychosocial care.

Methods: In this validation study, adults with T1D were recruited from the T1D Exchange Registry to complete a draft screener online; potential items were previously identified from literature review, and interviews with health care professionals (HCPs) and people with T1D. Standard psychometric analyses assessed reliability and validity of the screener. The final FoH screener comprised 9 items assessing 2 domains - “worry” (6 items) and “behavior” (3 items).

Results: The final sample comprised 592 adults with T1D (age 43.1 ± 15.3 years; duration of T1D 24.1 ± 15 years, 66.7% females, 91.6% White, 5.2% Hispanic, self-reported HbA1c 7.1% ± 1.2%). Approximately 30% of participants reported severe hypoglycemia in the past 12 months; 33.4% reported impaired awareness of hypoglycemia. The FoH screener showed internal consistency (Cronbach’s α=0.88) and was highly correlated (r=0.71-0.75) with the Hypoglycemia Fear Survey (“worry” and “behavior” subscales and total scores), confirming reliability. Construct validity of the FoH screener was demonstrated with significant correlations with depression (r=0.44), anxiety (r=0.47), Diabetes Distress Subscales (powerlessness, management distress, hypoglycemia distress) (r=0.49-0.66); These correlations are considered moderate. Additionally, multivariable regression analysis showed that higher FoH screener scores were significantly associated with higher HbA1c (regression coefficient, β=0.04) and multi-morbidities (β=0.03).

Conclusions: This 9-item FoH screener demonstrated good reliability and validity. Further research is planned to assess clinical usability to help appropriately identify patients and assist effective HCP-patient conversations around FoH.

Disclosure

J. Liu: None. J. Poon: Employee; Self; Eli Lilly and Company. J. Bispham: None. M. Perez-nieves: Employee; Self; Eli Lilly and Company. A. Hughes: None. K. S. M. Chapman: None. B. Mitchell: Employee; Self; Eli Lilly and Company, Stock/Shareholder; Self; Eli Lilly and Company, Stock/Shareholder; Spouse/Partner; Eli Lilly and Company. F. J. Snoek: Advisory Panel; Self; Abbott Diabetes, Lilly Diabetes, Novo Nordisk, Roche Diabetes Care, Sanofi, Research Support; Self; Novo Nordisk, Sanofi. L. Fisher: Consultant; Self; Ascensia Diabetes Care, Lilly Diabetes, Speaker’s Bureau; Self; Dexcom, Inc.

Funding

Eli Lilly and Company
503-P: Intensive Lifestyle Interventions for Treatment towards Remission of Type 2 Diabetes: A Case Series
Authors: KARLSEN MICAELA , PANIGRAHI GUNADHAR , KELLY JOHN
Published: June 2021

Background: Lifestyle interventions, including very low-calorie diets and liquid meal replacements, have been shown to achieve blood glucose improvements or remission. However, intensive lifestyle intervention using solid foods without calorie restriction has not been studied.

Objective: The objective of this study is to describe changes in blood glucose, medication use and diabetes status among 50 patients who were prescribed intensive lifestyle changes to treat type 2 diabetes (T2D).

Methods: Physicians were recruited by the American College of Lifestyle Medicine to submit case histories of patients who achieved blood glucose improvements and/or remission in QuestionPro, an online survey platform.

Results: A total of 12 physicians reported on 50 patients, including 1 physician who reported on 37 patients. Mean (SD) age of patients was 66.4 (12.8) years (range 20-84), and 64% of patients were male. Primary lifestyle interventions included a whole food, plant-based diet (n=43), coaching program (n=3), ADA diet (n=2), whole food diet (n=1) and calorie restricted diet <1800kcal (n=1). No liquid meal replacements or other calorie restrictions were reported. Mean biometrics (SD) for time periods pre-intervention; 3-6 months post-; and most recent follow-up were: HbA1c 7.6 (1.5); 5.7 (0.3); 5.8 (0.4), fasting glucose 150.1 (53.4); 101.0 (30.8) ;105.2 (25.0), BMI 34.9 (14.4); 30.0 (6.0); 28.6 (5.2). A majority of patients were taking diabetes medications prior to interventions. At 3-6 months post intervention, a total of n=20 patients were not taking diabetes medications and of these, n=10 achieved either HbA1c<5.7 % or FSG<100 mg/dL. At most recent follow-up, n=21 were not taking diabetes medications and of these, n=9 achieved both HbA1c<5.7% and FSG<100 mg/dL, with n=1 for at least 12 months.

Conclusion: Patients can improve blood glucose and may achieve remission of T2D using a whole food, plant-based dietary pattern, without liquid meal replacements.

Disclosure

M. Karlsen: None. G. Panigrahi: None. J. Kelly: None.
509-P: Type 1 Diabetes Management and the Impact on Caregiver Quality of Life
Authors: JEWELL VANESSA D.
Published: June 2021

After a child’s type 1 diabetes diagnosis, significant demands may be placed on the family. Families are thrust into a new routine focused on daily diabetes management that include continuous monitoring of their child’s blood glucose levels, nutritional needs, activity and sleep patterns, stress and emotional responses, and medication administration, among others. Additionally, the caregivers become inundated with time and financial strain for travel for new medical appointments, management of healthcare insurance policies, and medical bills, causing some caregivers to cease employment or secure a job that allows for increased time flexibility. The purpose of this mixed methods study was to examine how caring for a child living with type 1 diabetes impacts caregiver quality of life, burden, and roles. Through convenience sampling, caregivers (n=43) completed an electronic demographic survey, Burden Scale for Family Caregivers, WHOQoL, followed by an individual phenomenological interview (n=6). The majority of caregivers reported moderate burden (48%) or severe to very severe burden (20%). A significant large negative correlation was found between caregiver burden and quality of life (r = -0.73, p<0.01), indicating that as burden increased, quality of life decreased. Interview findings revealed three themes: relationship maintenance difficulties lead to decreased social support; declining productive occupations; and a strong desire for education and advocacy. Due to caregivers reporting difficulty with maintaining their own health and well-being while caring for a child living with type 1 diabetes, it is imperative for interprofessional diabetes health care teams to develop novel interventions aimed to improve family quality of life.

Disclosure

V. D. Jewell: Research Support; Self; Dexcom, Inc.
51-LB: Emotional Impact of Hypoglycemia and Use of Glucagon: Perspectives of People with T1D
Authors: HUGHES ALLYSON , CHAPMAN KATHERINE S.M. , BISPHAM JEOFFREY , HEYDARIAN NAZANIN M. , DIMSITS JEANNETT , WEINZIMER STUART A. , WOLF WENDY
Published: June 2021

Introduction: Severe hypoglycemia is an ongoing barrier to achieving glycemic targets. Glucagon is an effective, yet underutilized treatment for severe hypoglycemia. This study characterized the emotional impact of severe hypoglycemia, glucagon perceptions, and barriers to glucagon use for people with T1D.

Methods: Participants included individuals recruited from the T1D Exchange online community. The current study conducted 7 focus groups consisting of adults with T1D (n = 38, average age 49.4, SD = 16.11 years). Average duration of diabetes was 34.4 years (SD = 17.3) and average self-reported A1c was 6.8% (SD = 0.7). Focus groups were recorded, transcribed, and thematically analyzed.

Results: A range of emotions was expressed about severe hypoglycemia including fear, anxiety, stress, frustration, shame, and embarrassment. Due to hypoglycemia unawareness, participants discussed relying on CGM to make hypoglycemia treatment decisions. Multiple participants self-administered glucagon to prevent or treat a severe hypoglycemic event. Although overnight hypoglycemia and CGM alarms were described as important, some participants also viewed them as sleep disruptors for themselves and their partners. Participants frequently identified prescription cost and insurance deductibles as barriers to glucagon use. Participants were also concerned about ease of administration—how difficult it is to prepare the glucagon in an emergency situation. Many participants expressed a preference for auto-injectables over nasal administration. Timing of glucagon action and time to recovery were high priorities. Some participants, while they had not self-administered glucagon, were interested in a mini-dose glucagon they could self-administer.

Conclusions: These results provide insight into the real-world impact of diabetes management in persons with T1D and highlight the attitudes about severe hypoglycemia and emergency glucagon treatment.

Disclosure

A. Hughes: None. K. S. M. Chapman: None. J. Bispham: None. N. M. Heydarian: None. J. Dimsits: Employee; Self; Zealand Pharma A/S. S. A. Weinzimer: Advisory Panel; Self; Dompe, Zealand Pharma A/S, Speaker’s Bureau; Self; Medtronic. W. Wolf: None.
513-P: Associations of Common Mental Health Disorders with Impaired Awareness of Hypoglycaemia in Type 1 Diabetes
Authors: PIERI BEATRICE , BERGIN-CARTWRIGHT GABRIELLA , HOTOPF MATTHEW , HUSSAIN SUFYAN
Published: June 2021

Objective: This cross-sectional study aimed to assess the prevalence of mental health disorders and impaired awareness of hypoglycemia (IAH) in type 1 diabetes, as well as examine associations between these and sociodemographic and clinical characteristics. It also assessed the hypothesis that symptoms of common mental health disorders are independently associated with IAH.

Methods: Data was collected from patients attending a diabetes outpatient clinic between January 2016 and April 2018 who completed questionnaires as part of routine clinical care. Probable depression (pMDD), probable anxiety (pGAD) and IAH were measured using validated self-report tools. Associations were examined with multiple regression models, adjusting for sociodemographic and clinical characteristics.

Results: Data from 950 patients was included in the sample. 93 patients (9.8%) met criteria for pMDD; 89 patients (9.4%) met criteria for pGAD; and 215 (22.6%) patients met criteria for IAH. Only depression was independently associated with IAH after adjustment for covariates when depression and anxiety were included in the same model (OR 3.27 (CI 1.74-6.15)). However, both depression and anxiety were associated with increased odds of IAH and robust to adjustment, when included separately (OR 3.64 (CI 2.19-6.04), and OR 2.46 (CI 1.46-4.14), respectively).

Conclusions: The robust independent relationship between symptoms of common mental health disorders, and in particular depression, with IAH demonstrates the need for routine psychological assessment and management in people with type 1 diabetes patients and IAH. This data also provides further support for the inclusion of mental health support strategies alongside the use of technology in hypoglycemia awareness restoration programmes.

Disclosure

B. Pieri: None. G. Bergin-cartwright: None. M. Hotopf: Research Support; Self; Biogen, Janssen Pharmaceuticals, Inc., Lundbeck, Merck Sharp & Dohme Corp., UCB Japan Co. Ltd. S. Hussain: Speaker’s Bureau; Self; Novo Nordisk.
515-P: The Impact of COVID-19 Worries on Diabetes Distress and Depressive Symptoms in Older Adults with Type 2 Diabetes
Authors: KIM MIN JUNG , PARK CHANG G. , FRITSCHI CYNTHIA
Published: June 2021

Objectives: The 2019 coronavirus (COVID-19) pandemic has created serious physical and mental problems in older adults with diabetes. Aging, obese adults with type 2 diabetes (T2D) are especially vulnerable to COVID-19 morbidity and mortality. COVID-19 related worries may exacerbate their diabetes-related psychological symptoms of diabetes distress or depression. Our team investigated the impact of COVID-19 worries on levels of diabetes distress and depressive symptoms in older adults with T2D.

Methods: Data were collected using an online survey from June to December 2020 across the United States. COVID-19 worries were measured using eight questions (scale range 0-4) developed by Barbara and Kim (2020). Psychological symptoms were assessed using the Diabetes Distress Scale (DDS) and Patient-Reported Outcomes Measurement Information System (PROMIS) depression version 1.0. Data were analyzed using bivariate correlation and tobit regression analyses.

Results: A total of 84 adults aged ≥ 60 years with T2D were included (age 68.46 ± 5.41, female 54.76%, White 77.38%). Participants reported moderate COVID-19 worries (1.70 ± .93), little or no diabetes distress (1.55 ± .63), and fewer depressive symptoms than the U.S. normative sample (48.92 ± 8.10). COVID-19 worries were associated with DDS total and emotional and regimen-related subscores (r = .25-.34) and PROMIS depression scores (r = .41). One point increase in COVID-19 worries increased DDS-total by .25, DDS-emotional by .34, DDS-physician by .58, DDS-regimen by .42, and PROMIS depression by 3.95.

Conclusions: The COVID-19 pandemic created worries that worsened common diabetes-related psychological symptoms. Our results indicated that diabetes distress, especially emotional and physician- and regimen-related distress, should be closely monitored in addition to depressive symptoms in this population during and after the pandemic, as these symptoms have been associated with poor self-care.

Disclosure

M. Kim: None. C. G. Park: None. C. Fritschi: None.

Funding

National Institute on Aging (P30AG022849); University of Illinois Seth and Denise Rosen Memorial Research Award; Sigma Theta Tau International (Alpha Lambda Chapter)
531-P: “I Feel Human, I Feel Normal”: A Qualitative Study of Experiences with Control-IQ Technology in Early Adopters
Authors: SINGH HARSIMRAN , MCELWEE-MALLOY MOLLY , SANCHEZ HAIDEE , HABIF STEPHANIE
Published: June 2021

The Tandem Diabetes Care® t:slim X2TM insulin pump with Control-IQTM technology is an advanced hybrid closed-loop system, cleared by the FDA in December 2019. To date various studies have demonstrated glycemic and patient-reported improvements using this system. However, there are no published qualitative studies evaluating real-world experiences of using Control-IQ technology. As part of a larger, real-world study involving people with type 1 diabetes (T1D) using Control-IQ technology, we randomly selected and invited participants (Ps) to phone interviews to discuss their experiences using this system. Semi-structured, in-depth interviews were conducted in May-June 2020. They were audio-recorded and transcribed verbatim. Interviews were conducted by two experienced health professionals and lasted an average of 23 minutes (range 9-50 minutes). Interview transcripts were imported into NVivo V.12 for data coding and analysis. Interviews were analyzed using inductive thematic analysis. In all, 27 T1D adults (14 women, 13 men) were interviewed. Four major themes (T) emerged: the initiation phase (T1), successes (T2), and challenges (T3) with Control-IQ technology, and its impact on quality of life (QoL) (T4). Ps reported taking some time to trust the new automated system and “feeling comfortable in letting it do its thing” (T1). Improved sleep quality, glycemic control (HbA1c), and sensor time in range were commonly reported by Ps (T2) along with reduced burden of diabetes management (T2). A few Ps discussed their need for the system to be more aggressive while managing hyperglycemia (T3). Overall, Ps described valuable improvements in their QoL, including reduced stress and decision-making around diabetes management, and increased freedom and spontaneity in daily life (T4). These qualitative findings highlight the significant impact of Control-IQ technology on Ps glycemic control, psychological health, and their ability to engage in daily life activities.

Disclosure

H. Singh: Employee; Self; Tandem Diabetes Care. M. Mcelwee-malloy: Employee; Self; Tandem Diabetes Care. H. Sanchez: Employee; Self; Tandem Diabetes Care. S. Habif: Employee; Self; Tandem Diabetes Care.
537-P: Predictors of Engagement in Clinical Care: CoYoT1 to California
Authors: GARCIA JAQUELIN J. FLORES , REID MARK W. , PYATAK ELIZABETH , FOX D. STEVEN , FOGEL JENNIFER L. , SALCEDO-RODRIGUEZ ELIZABETH , BISNO DANIEL I. , MILLER DEBRA , MITTAL ANUVA , RAYMOND JENNIFER
Published: June 2021

Background: Current type 1 diabetes (T1D) care models do not effectively engage racially and ethnically diverse Adolescents and Young Adults (AYA) indicating a need for new approaches. Objective: To assess clinical and demographic predictors of care engagement among diverse AYA with T1D.

Methods: In an ongoing 15-month randomized controlled 2x2 trial with pragmatic care assignment, 53 AYA ages 16-25 received either quarterly usual T1D care (in-person or via telehealth (TH)), or CoYoT1 Care, which includes bimonthly T1D group sessions via TH and quarterly patient-centered care provider visits (in-person or via TH). Participant engagement was measured by the proportion of clinic visits attended out of all offered to date, per participant, including all currently enrolled. Predictors of engagement included: pre-trial clinic attendance, care group assignment (CoYoT1 or usual care), demographic, and clinical variables. All were entered into a multiple linear regression model, then reduced via stepwise regression.

Results: Participation in CoYoT1 Care was associated with a 12% greater attendance rate (p=0.006) relative to usual care. Participants who retained their pre-trial care providers during the study attended clinic visits 7% more frequently than those randomized to a new provider (p=0.06). Participants’ who identified as African American (p=0.001) or Multi-racial (p=0.002) attended clinic visits at least 16% more frequently than participants from other groups; Latinx ethnicity was not associated with more or less frequent attendance. Females attended clinic visits 10% less frequently than non-females (p=0.006). Baseline A1c was also negatively associated with attendance rate, with each percentage increase in A1c associated with a 2% reduction in attendance rate (p=0.01).

Conclusion: CoYoT1 Care successfully engaged patients from diverse backgrounds. The model warrants further investigation to identify which intervention components most promote engagement.

Disclosure

J. J. Flores garcia: None. J. Raymond: None. M. W. Reid: None. E. Pyatak: None. D. Fox: None. J. L. Fogel: None. E. Salcedo-rodriguez: None. D. I. Bisno: None. D. Miller: None. A. Mittal: None.

Funding

The Donaghue Foundation
543-P: Challenges in Glucose Management in Young Adults during the COVID-19 Pandemic
Authors: SAYLOR JENNIFER , LEE SARA , COMMISSARIAT PERSIS V. , SABINO ANNA , PIERRE DANIELLE ST.
Published: June 2021

Aim: Young adults (YA) with type 1 diabetes (T1D) are particularly vulnerable to direct and indirect effects of COVID-19 on their diabetes care, due to the intensive nature of managing their disease while simultaneously transitioning into adulthood during this ongoing global health crises. This study examined glucose management and diabetes-related hospitalizations in YA with T1D during the COVID-19 pandemic.

Method: Surveys were distributed electronically to YA between 17-30 years old and associated with the College Diabetes Network at two timepoints (spring and fall 2020). The survey included questions about hospitalization for diabetic ketoacidosis and/or severe hypoglycemia and challenges filling prescriptions. Chi-Square statistics were used for analyses.

Results: No demographic differences were found between the spring (n=473) and fall (n=375) participants. There was a significant increase in hospitalizations for severe hypoglycemia from 3.4% in the spring to 10.4% in the fall (p<.001). In the spring, 21% of participants reported difficulty filling prescriptions due to COVID-19, compared to 7.3% in the fall. Among those who reported difficulty filling prescriptions, insulin (Spring [n=58], Fall [n=43]) and CGM supplies (Spring [n=41], Fall [n=22]) were most commonly cited. Reported hospitalizations for DKA increased from 6.7% in the spring to 10.1% in the fall and trending towards statistical significance (p=.077).

Conclusions: YA with T1D reported increased incidence of severe hypoglycemia hospitalization during COVID-19, with many YA reporting difficulty filling and obtaining insulin and CGM supplies. Increased support may be necessary to protect health outcomes during this difficult time. Future work should utilize longitudinal methods to further assess the impacts of the COVID-19 pandemic on diabetes management.

Disclosure

J. Saylor: None. S. Lee: None. P. V. Commissariat: None. A. Sabino: None. D. St. pierre: None.
550-P: Unique Associations of Depressive Symptoms and Diabetes Distress with Quality of Life (QoL) in Youth with Type 1 Diabetes (T1D)
Authors: SHAPIRA AMIT , VOLKENING LISA K. , LAFFEL LORI M.
Published: June 2021

Youth with T1D often experience emotional distress, which can negatively impact QoL. We sought to understand associations of depressive symptoms and diabetes distress with QoL in youth with T1D. Participants (N=420; 50% male; ages 8-17 years; T1D duration 6.4±3.7 (M±SD) years; A1c 8.3±1.0%; 69% pump treated; 70% having parent with college degree) completed the Pediatric Quality of Life Inventory Generic Core Scales (PedsQL)and measures of depressive symptoms (Center for Epidemiologic Studies Depression Scale [CESD]) and diabetes distress (Problem Areas in Diabetes-Pediatric version [PAID-Peds]). Multivariable linear modeling determined independent associations of depressive symptoms and diabetes distress with total, physical, and psychosocial QoL, adjusting for sex, age, T1D duration, A1c, pump therapy, insulin dose, and parent education. Total PedsQL score was 85±13, (physical subscale 89±12, psychosocial subscale 82±15); CESD score was 9±9; PAID-Peds score was 37±24. CESD and PAID-Peds were both correlated with A1c (CESD: p=.01, PAID-Peds: p<.0001); QoL scales were not correlated with A1c. CESD and PAID-Peds were correlated with total, physical and psychosocial QoL (all p<.0001). In multivariable analyses, more depressive symptoms were associated with poorer total (∆R2=.52, p<.0001), physical (∆R2=.35, p<.0001), and psychosocial (∆R2=.51, p<.0001) QoL, adjusting for diabetes distress and sociodemographic/diabetes factors. More diabetes distress was associated with poorer total (∆R2=.05, p<.0001) and psychosocial (∆R2=.06, p< .0001) QoL, adjusting for depressive symptoms and sociodemographic/diabetes factors; more diabetes distress marginally contributed to poorer physical QoL (∆R2=.01, p=.002). Findings suggest unique, negative associations of both depressive symptoms and diabetes distress with QoL. Targeting both depressive symptoms and diabetes distress may help improve QoL in youth with T1D.

Disclosure

A. Shapira: None. L. K. Volkening: None. L. M. Laffel: Consultant; Self; AstraZeneca, Boehringer Ingelheim International GmbH, Dexcom, Inc., Dompe, Insulogic LLC, Janssen Pharmaceuticals, Inc., Laxmi Therapeutic Devices, LifeScan, Lilly Diabetes, Medtronic, Provention Bio, Inc.

Funding

National Institutes of Health (R01DK089349, R01DK095273, T32DK007260, P30DK036836); JDRF (2-SRA-2014-253-M-B)