bluuebunny/crossref_metadata_2025 huggingface dataset:
824-P: Does Utilization of a Three-Month Multidisciplinary Endocrinology Treatment Team Improve Glycemic Control and Reduce Therapeutic Inertia in High-Risk Patients with Diabetes
Authors: IQBAL ANIRA , BROOME DAVID T. , ISAACS DIANA , RAO PRATIBHA
Published: June 2021

Elderly patients with diabetes and poor glycemic control are at higher risk of complications. We examined the effects of utilizing a 3-month multidisciplinary team, including an endocrinologist, diabetes educator, and pharmacist, on glycemic control in order to extend specialized care and reduce therapeutic inertia in high-risk patients cared for by primary care physicians. The purpose of our study was intensification of medical management of high-risk elderly patients with diabetes through a quality improvement (QI) project with HbA1c value as the primary outcome. We identified 176 patients with diabetes in our primary care clinics who were >/= 50 years old and had a HbA1C >/= 9%. Of these, 22 patients were agreeable to be scheduled to follow up with a provider in our Endocrinology and Metabolism Institute as a new patient. In April 2020, baseline data was obtained (HbA1c, Albumin: Creatinine, blood pressure, BMI, lipid panel and 10-year ASCVD risk %). They were then seen by an endocrinologist and sequentially followed up by a clinical diabetes educator and a pharmacist. At the end of 12 weeks, post-intervention data was collected. Patients were then followed by their primary care physician as needed.

Results: We enrolled 22 eligible patients with type 2 diabetes in our study. The mean age was 72 +/- 7 years with a pre-study HbA1c of 9.6 +/- 1.3%, BMI of 31.0 + 5.6 kg/m2, average albumin: creatinine of 195.1 +/- 298.3 mg/g. At the end of the study, the average HbA1c value was 7.6 +/- 0.9%, and represented a 2.0% decline (95% CI 8.0-9.3, p-value < 0.01). There was a 74.4 mg/g reduction in albuminuria (95% CI 61.1-282.4, p = 0.48) and a 0.5 kg/m2 increase in BMI (95% CI 29.0-33.4, p = 0.76).

Conclusion: Through use of a 3-month strategic multi-disciplinary QI initiative in high-risk patients with diabetes, we significantly improved glycemic control measured by HbA1c. A limitation of our study was the small study size.

Disclosure

A. Iqbal: None. D. T. Broome: None. D. Isaacs: Consultant; Self; InPen, Insulet Corporation, LifeScan, Speaker’s Bureau; Self; Abbott Diabetes, Dexcom, Inc., Novo Nordisk, Xeris Pharmaceuticals, Inc. P. Rao: None.
83-LB: Adherence and Persistence in Patients with T2D Initiating Once-Weekly vs. Once-Daily Injectable GLP-1RA in U.S. Clinical Practice: STAY Study
Authors: LIEBL ANDREAS , ARORA RIYA , FAURBY MADS , DA ROCHA FERNANDES JOAO DIOGO , POLONSKY WILLIAM H.
Published: June 2021

Introduction: Reducing dosing frequency may reduce treatment burden and improve adherence and persistence. We assessed persistence and adherence in patients with T2D initiating once-weekly (OW) or once-daily (OD) injectable glucagon-like peptide-1 receptor agonists (GLP-1 RAs) in US clinical practice.

Methods: Adults (≥ 18 years) with T2D included in the IBM MarketScan Explorys Claims-EMR Data Set for ≥ 180 days pre- and ≥ 365 days post-index, who were GLP-1 RA- and insulin-naïve at first claim for OW or OD injectable GLP-1 RA (index period: 1 Jul 2012-31 Jan 2019; follow-up: index date + 365 days), were propensity score matched 1:1 by age, sex, Charlson Comorbidity Index score, baseline HbA1c and weight (90 days pre-index), and use of sulfonylureas, metformin, DPP-4 inhibitors and SGLT-2 inhibitors (180 days pre-index). Persistence was defined as stay time (patients who had not discontinued [≥ 60 days not covered by medication] within 12 months were censored at 360 days) and assessed using Kaplan-Meier analysis and Cox proportional hazard models. Adherence was defined as proportion of days covered (PDC) ≥ 0.8.

Results: The matched cohorts (n = 784 each) had similar characteristics. Compared with OD GLP-1 RAs, OW were associated with significantly higher persistence (median stay time, 333 days vs. 269 days; hazard ratio 0.80, p < 0.01) and better relative adherence at 6 months (+23%) and 12 months (+35%), irrespective of glycemic improvement and weight change. Mean HbA1c reduction was also greater for OW than for OD treatments at 6 months (-1.1% vs. -0.9%) and 12 months (-0.9% vs. -0.7%). Over 12 months, adherent patients experienced greater mean changes in HbA1c with both OW (-1.1%) and OD (-1.0%) regimens than patients with PDC < 0.8 (-0.6% each).

Conclusions: Our results suggest that, in a real-world setting, OW injectable treatments are associated with better persistence and adherence than OD regimens, irrespective of glycemic or weight control.

Disclosure

A. Liebl: Advisory Panel; Self; AstraZeneca, Becton, Dickinson and Company, Boehringer Ingelheim International GmbH, Eli Lilly and Company, MSD, Novo Nordisk, Roche, Speaker’s Bureau; Self; AstraZeneca, Bayer, Becton, Dickinson and Company, Boehringer Ingelheim International GmbH, Bristol Myers Squibb, Dexcom, Inc., Eli Lilly and Company, Medtronic, MSD, Novo Nordisk, OmniaMed, Roche, Sanofi. R. Arora: Employee; Self; Novo Nordisk. M. Faurby: Employee; Self; Novo Nordisk A/S. J. Da rocha fernandes: Employee; Self; Novo Nordisk A/S, Stock/Shareholder; Self; Novo Nordisk A/S. W. H. Polonsky: Advisory Panel; Self; Intarcia Therapeutics, Inc., Consultant; Self; Abbott Diabetes, ADOCIA, Boehringer Ingelheim Pharmaceuticals, Inc., Dexcom, Inc., Insulet Corporation, Lilly Diabetes, Novo Nordisk, Onduo LLC., Sanofi US.

Funding

Novo Nordisk A/S
844-P: Impact of Hypoglycemic Awareness on Diabetes Care during the SARS CoV Pandemic
Authors: WATT CHARLES , KNIGHT MARI-LYNET , RANGEL ELIZABETH SANCHEZ , GUNAWAN FELONA , HWANG JANICE J.
Published: June 2021

A recent report by Potier et al found that patients with T1DM had improved glycemic control during the pandemic, possibly due to changes in behavioral and lifestyle patterns. However, very little is known regarding how patients with normal hypoglycemia unawareness (NAH) or impaired awareness (IAH) have responded to changes in diabetes management during the pandemic.

Fifteen participants with T1DM from the Greater New Haven area participated in this study, which is part of a larger ongoing clinical study. Participants completed questionnaires measuring awareness (Clarke Score), current quality of diabetes care (Diabetes Treatment Satisfaction), and symptom severity (Hypo AQ) twice, pre-pandemic (prior to March 2020) and during pandemic (September to November 2020). Nine individuals had NAH (3F/6M, Clarke mean 1.00 ± SEM 0.4, age 32 ± 12 yrs, A1C 8.2 ± 1.3%, BMI 24.7 ± 4.7) and six had IAH, (4F/2M, Clarke 4.33 ± .3, age 39 ± 14, A1C 7.3 ± 0.9%, BMI 30.1 ± 7.4). There were no significant demographic differences between groups except for Clarke score.

Among IAH patients, symptom severity (pre: 13.8 ± 0.910, during: 11.50 ± 0.957, p = 0.04) and treatment satisfaction (pre: 26.17 ± 1.99, during: 31.33 ± 1.542, p = 0.013) were significantly improved during the pandemic. Self-reported frequency of hypoglycemic episodes was unchanged (p = 0.741). In contrast, among NAH participants, there were no changes in severity of symptoms (p = 0.822), satisfaction of treatment (p = 0.407), or frequency of hypoglycemic episodes (p = 1.000).

Our results indicate that pandemic associated changes in diabetes care and management had differential effects on patients with and without hypoglycemic unawareness. Further studies to identify the specific factors driving these differences will be beneficial to improving the clinical care of patients with IAH.

Disclosure

C. Watt: None. M. Knight: None. E. Sanchez rangel: None. F. Gunawan: None. J. J. Hwang: None.

Funding

National Institute of Diabetes and Digestive and Kidney Diseases (DK020495)
857-P: A Risk Stratification Approach to Diabetes Care Delivery Services
Authors: ZUPA MARGARET , KRALL JODI S. , COLLINS KEVIN , NG JASON , SIMINERIO LINDA M.
Published: June 2021

Diabetes self-management education and support (DSMES) is known to improve diabetes treatment outcomes, but this limited resource is not always targeted toward the highest risk patients in current models of care. Predictive modeling, which relies on large data sets to predict outcomes, is one tool which can be used to direct resources to patients with the greatest need for these services.

University of Pittsburgh Medical Center (UPMC) diabetes care providers along with members of the clinical analytics team created a predictive model, including patient age, HbA1c, and insulin use among other factors, to assess individual patient risk of future poor glycemic control. The model was applied to patients who received DSMES via diabetes care and education specialists (DCES) from December 2018 to December 2020 to evaluate the impact of DSMES according to risk strata. Patients were categorized into high, medium and low risk groups based on clinical data prior their initial DSMES encounter. HbA1c change was calculated using the HbA1c prior to DSMES and most recent HbA1c.

Of 1,247 patients eligible for retrospective assessment, 50% were categorized as low risk (n=621), 4% (n=55) medium, and 46% high risk (n=571). Mean HbA1c change after DSMES was -0.54% for low risk, -0.72% for medium risk, and -1.19% for the high risk group. Mean HbA1c after DSMES was 7.6% for low risk, 9.7% for medium risk and 9.6% for high risk patients. 57.5% of low, 59% of medium and 46.6% of high risk patients were seen by an endocrinologist.

In this analysis, high risk patients who received DSMES had larger improvement in HbA1c and were less likely to be seen by an endocrinologist. To optimize utilization of diabetes care regarding DCES, predictive modeling can be used to target resources to the highest risk patients.

Disclosure

M. Zupa: None. J. S. Krall: Research Support; Self; Becton, Dickinson and Company, Sanofi. K. Collins: None. J. Ng: Research Support; Self; Sanofi-Aventis. 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 (5T32DK007052-45)
864-P: Treatment Burden and Quality of Life Conversations during Clinical Encounters: A Videographic Analysis
Authors: HAIDER SHANZAY , EL KAWKGI OMAR M. , CLARK JENNIFER , BRESLIN MAGGIE , BOEHMER KASEY , MONTORI VICTOR M. , LIPSKA KASIA J.
Published: June 2021

Aim: Patients with diabetes mellitus (DM) experience significant burden of disease and poorer quality of life compared with patients without diabetes. Yet, data on how these aspects are raised, discussed, and addressed during clinical encounters are sparse. We aimed to analyze the nature of discussions about quality of life (QoL), treatment burden (TB), hypoglycemia, sexual function, and social support during clinician-patient encounters focused on diabetes care.

Methods: A total of 41 previously recorded patient-clinician encounters were used for videographic analysis. Encounters were recorded primarily from family medicine and internal medicine clinics, and all patients had a diagnosis of DM. Two coders analyzed the videos for discussions about QoL, TB, hypoglycemia, sexual function, and social support using an a priori developed codebook that defined the domains. When a topic was raised, coders evaluated the nature of the conversation, provider response, time spent on topic, and any solutions proposed by the clinician.

Results: Of the 41 videos analyzed, 85.4% included some discussion regarding QoL (58.5%), TB (51.2%), social support (9.8%) or hypoglycemia (2.4%). Sexual function was not brought up in any of the encounters. On average, 15% of the clinical encounter time was spent on QoL, TB, social support, or hypoglycemia. In contrast, 4.5% of the encounter focused on HbA1c. When an aspect arose within the encounter, clinicians acknowledged the patient’s concern without providing a solution in 45.8% of the cases.

Conclusion: Consistent with patient experiences, we found that a significant portion of clinical encounters conversations were devoted to QoL and TB, with a greater amount of time spent on these than HbA1c goals. Yet, when these topics arose during encounters, solutions were seldom provided. Sexual dysfunction, a common complication of DM, was not discussed in our sample.

Disclosure

S. Haider: None. O. M. El kawkgi: None. J. Clark: None. M. Breslin: None. K. Boehmer: None. V. M. Montori: None. K. J. Lipska: None.
867-P: Variation in the Setting of Type 2 Diabetes Diagnosis Disclosure
Authors: GU KRISTINE , GONG CHELSEA , BLATCHINS MARUTA A. , MISHRA PRANITA , GRANT RICHARD W. , GOPALAN ANJALI
Published: June 2021

The disclosure of a new type 2 diabetes (T2D) diagnosis shapes patients’ T2D-related experiences, with more supportive approaches linked with better self-care and lower diabetes distress. Given changes in patient-provider communication and greater use of telemedicine, we examined the setting of T2D disclosures among adults in a large, integrated healthcare delivery system.

Physicians reviewed charts of a random sample of 200 adults diagnosed with T2D between 2014-2018 to determine the diagnosis disclosure setting. Identified settings were an in-person visit, telemedicine visit (telephone/video), secure message via the online patient portal, mailed letter, or voicemail. These settings were further categorized into 2-way synchronous communication (in-person/telemedicine), 2-way asynchronous communication (secure message), and 1-way asynchronous communication (letter/voicemail). We examined differences in disclosure setting by patient demographics.

The disclosure setting was discernible for 197/200 individuals; 55.3% received the diagnosis via 2-way synchronous communication (25.4% in-person, 29.9% telemedicine), 23.9% via 2-way asynchronous communication, and 20.8% via 1-way asynchronous communication (18.8% letter, 2% voicemail). Disclosure setting did not differ by age, gender, or level of neighborhood deprivation. Latinx individuals were overrepresented among those receiving the diagnosis via 1-way asynchronous communication (42.5% vs. 17.1% 2-way synchronous vs. 8.7% 2-way asynchronous, p=0.001) and had lower online patient portal enrollment (59%).

The heterogeneity in T2D diagnosis disclosure setting suggests a lack of standard practices for communicating a T2D diagnosis. The common use of asynchronous modalities is concerning given the gravity of the diagnosis, especially when established best practices for communicating bad news to patients exist.

Disclosure

K. Gu: None. C. Gong: None. M. A. Blatchins: None. P. Mishra: None. R. W. Grant: None. A. Gopalan: None.

Funding

Kaiser Permanente Northern California
872-P: Impact of Telemedicine Consultations during the COVID-19 Pandemic on Glycemic Control of Diabetes Patients
Authors: DISSANAYAKE ASHINI , PAWLOWSKA MONIKA , SCHROEDER BENJAMIN , MACKENZIE-FEDER JESSICA , WHITE ADAM
Published: June 2021

Due to the COVID-19 pandemic, our endocrinology clinic transitioned to virtual care on March 18, 2020. The literature suggests that self-monitoring of blood glucose paired with telemedicine consultations is an effective strategy for diabetes management, however it is unclear whether telemedicine remains effective in the context of the sudden lifestyle changes caused by the pandemic, including non-essential service closures, travel restrictions, lockdowns, and psychosocial impacts. Patients with diabetes are uniquely affected by these restrictions, as glycemic control is heavily dependent on lifestyle and access to essential medications and supplies. The purpose of this project is to determine the impact of telemedicine consultations in the context of the COVID-19 pandemic on the glycemic control of patients seen at our clinic. A retrospective chart review was performed on 300 type 1 and 2 diabetes patients seen at least once within the 6 months preceding (pre-COVID) and following (post-COVID) March 18, 2020. The primary outcome measure was hemoglobin A1c. For patients with more than 1 A1c value in each time frame, the most recent A1c was used. Demographic information was also collected. There was no significant difference in the pre-COVID and post-COVID A1c values (p=0.40) of the entire sample. There was no significant difference in the pre-COVID and post-COVID A1c values when the sample was stratified by age, diabetes duration, use of CGM, or use of pump. However, there was a significant increase in A1c for females post-COVID (p<0.05). This difference was not observed for males (p=0.22). Our data suggests that telemedicine is an overall effective strategy for optimizing glycemic control of patients with type 1 and type 2 diabetes during the pandemic, with no significant difference in A1c. However, the gender-specific effect of telemedicine consultations during COVID-19 on the glycemic control of females with diabetes indicates a need for further study and intervention.

Disclosure

A. Dissanayake: None. M. Pawlowska: Advisory Panel; Self; Novo Nordisk. B. Schroeder: Advisory Panel; Self; AstraZeneca, Novartis Pharmaceuticals Canada Inc. J. Mackenzie-feder: None. A. White: Advisory Panel; Self; Abbott Diabetes, AstraZeneca, Boehringer Ingelheim (Canada) Ltd., Eli Lilly and Company, Janssen Pharmaceuticals, Inc., Merck & Co., Inc., Novo Nordisk Canada Inc.
878-P: The Association between Demographics, Insulin Rationing, and Glycemic Control Assessed by Hemoglobin A1c
Authors: MENON TRISHA , ZHANG MENG , MYERS ALYSON
Published: June 2021

Introduction: Insulin cost continues to rise, making affordability difficult for patients. This study looks at the relationship between demographic variables, insulin rationing and glycemic control.

Methods: Patients with a diagnosis of type 2 diabetes who use insulin in a resident primary care practice were approached to participate. 131 surveys were conducted by phone (two patients declined), with questions about demographics, medical history, and insulin rationing. Data was summarized using frequency and percentage. Chi-squared/Fisher’s exact test was performed to evaluate the relationship between insulin rationing and variables including age, gender, race, insurance, smoking status, duration of diabetes and insulin use, insulin type, and history of hypertension, hyperlipidemia, obesity, cardiovascular disease, anemia, malignancy, or autoimmune disease. Logistic regression analysis was performed to determine if there is relationship between insulin rationing and hemoglobin A1c (HbA1c) greater than or equal to 8% (Yes/No).

Results: Race, gender, smoking status and diabetes duration were associated with insulin rationing. Specifically, black and Asian (vs. white) (p=0.012), males (p=0.049), smoking (yes) (p=0.032) and longer diabetes duration (more than 10 years) (p=0.025) were more likely to ration insulin. Insurance type (p=0.054), age (p = 0.419), and duration of insulin use (p=0.804) were not associated with rationing. Interestingly, comorbidities that confound diabetes control did not affect rationing. There was no association between insulin rationing and HbA1c values greater than or equal to 8% (p = 0.205, Odds ratio 0.37, 95%CI = 0.08 to 1.72).

Conclusions: This study did not show an association between insulin rationing and glycemic control, but demonstrated an association with rationing in demographic variables like race and gender. The results of this study were limited by sample size, cross-sectional design and possibly response bias.

Disclosure

T. Menon: None. M. Zhang: None. A. Myers: None.
886-P: Impact of Endocrine E-Consultation on SGLT2i and GLP-1 RA Prescription
Authors: RASHEED AMNA , KOMPALA TEJASWI , NEINSTEIN AARON B.
Published: June 2021

Background: Though GLP1 receptor agonists (GLP1RA) and SGLT2 inhibitors (SGLT2i) decrease risk of cardiovascular and renal complications in DM2, uptake has been slow. The impact of specialist care and electronic consultation (e-consult) on prescribing of these medications is unknown.

Methods: We performed a case-control study to determine predictors for real-world prescription of GLP1RA and SGLT2i at an academic medical center. From 1/1/2017 to 8/19/2020, all patients with DM2 and known atherosclerotic cardiovascular disease (ASCVD) were identified. We randomly selected 177 patients with a current prescription for SLGT2i and/or GLP1RA, and 177 with no current or prior SGLT2i or GLP1RA use. Demographics, clinical characteristics, and healthcare utilization data were obtained.

Results: Patients with active SGLT2i and GLP1RA prescriptions were younger (66.5 vs. 70.7, p < 0.01), had higher BMI (31.8 vs. 28.8, p<0.01), higher A1c (8.3 vs. 7.0, p<0.01) and more likely male (56.5 % vs. 43.5 %, p <0.01). There were no differences in insurance type, language, patient portal enrollment, or diabetes complications severity index scores. Patients with current prescriptions were more likely to have either an endocrinology visit or e-consult (OR 5.6, p<0.01), and more likely to have an endocrinology e-consult alone (OR 2.4, p=0.03) as compared to patients without current prescriptions. Endocrinology (4.1 vs. 1.1, p< 0.01) and cardiology (3.1 vs. 2.1, p < 0.01) visits were higher among patients with active prescriptions, whereas the number of primary care and nephrology visits were similar in the two groups.

Conclusions: Although diabetes complications, including prior ASCVD, were similar between the two groups, patients prescribed SGLT2i or GLP1RA were more likely to have seen an endocrinologist or have had an endocrinology e-consult. Targeted, proactive outreach from endocrinologists to primary care providers via e-consults should be explored as a method to increase guideline-based prescribing of SGLT2i and GLP1RA.

Disclosure

A. Rasheed: None. T. Kompala: Consultant; Self; Eli Lilly and Company, Employee; Self; Livongo. A. B. Neinstein: Consultant; Self; Eli Lilly and Company, Intuity Medical , Medtronic, Roche Diabetes Care, Steady Health.
888-P: Food Insecurity and Type 2 Diabetes in Children: A Systematic Literature Review
Authors: BLACKBURN JYE , BRES HANNAH , DEVENISH GEMMA , HARRAY AMELIA
Published: June 2021

Background and Aim: The incidence of children and adolescents being diagnosed with type 2 diabetes (T2D) in Western Australia is increasing, with approximately three in five of these children from Aboriginal or Torres Strait Islander descent. The ability to afford, access and acquire nutritionally adequate and culturally appropriate foods could play a role in the risk of developing T2D. Internationally, studies have looked at the association between T2D and food insecurity, yet no systematic review of the literature has been conducted. This systematic review aims to determine the relationship between food insecurity and T2D in children and adolescents, including Indigenous and culturally and linguistically diverse groups.

Research Method: PubMed, MEDLINE (Ovid), CINHAL Plus with full text (EBSCO) and Cochrane Library databases were searched to identify the available literature. The search was restricted by publication date of 1990 - present, English language and human studies. Children (aged 1-18 years) diagnosed with either impaired glucose tolerance (IGT) or T2D and experience food insecurity, were included in the systematic review. Study selection, data extraction and synthesis and risk of bias assessment was completed by two independent reviewers.

Results: A total of 10 studies comprising of 47,085 participants were included in the systematic review. Eight studies found an association between food insecurity and T2D, however, this association varied between studies. Different methodologies were used to measure food insecurity, IGT and T2D prevalence, which is a potential factor for the variation in the association within the selected studies.

Conclusion: Evidence suggests the ability to afford, access and acquire nutritionally adequate and culturally appropriate foods is associated with IGT and T2D in children and adolescents. More longitudinal cohort studies on a larger, more representative sample need to be conducted to determine the extent of this relationship.

Disclosure

J. Blackburn: None. H. Bres: None. G. Devenish: None. A. Harray: None.
90-LB: Soliqua (Lixilan): Sustained Long-Term Cost Efficacy and Safety When Used in Combination with Metformin and Glimepiride
Authors: KABADI UDAYA M. , EXLEY SARAH
Published: June 2021

Background: Rx with SU and Metformin lowered daily dose of insulin glargine with desirable glycemia. However, Soliqua trials excluded SU and subjects with morbid obesity. Objective: Assess long term efficacy and safety of Soilqua with Glimepiride and Metformin in subjects with type 2 diabetes. Subjects: 31 adults with type 2 diabetes wre identified as currently using Soliqua via EMR. One is excluded as therapy < 3 months. A1c >7.5% with 1) Glimepiride, Metformin and Basal insulin , 2) Metformin and/or DPP 4 inhibitors and/or other SUs and /or GLP1 RA and/or Basal and/or prandial insulin. Subjects with gastroparesis, Triglycerides > 300 mg/dl and pancreatitis are excluded.

Methods: Oral drugs besides Glimepiride and Metformin, Basal and prandial insulin and GLP1 RA were stopped. Glimepiride 8 mg, Metformin 1000-2000 mg were started with Soliqua daily dose pre-breakfast based on previous basal insulin dose and increased by 2 units every 3 days until AM sugar >80<130 mg/dl was attained or dose of 60 units was reached. Comparisons are conducted forBW (kg), fasting glucose (mg/dl) and A1c (%) prior to initiation of therapy and at the time of analysis.

Results: BMI ranged between 22-67. Duration of diabetes is 4-24 years. Duration of therapy range, 5-47 (mean 16± 6 )months. Fasting glucose declined from 167±15 to 118± 4 and A1c dropped from 9.7±0.8 to 7.6±0.3. No severe hypoglycemia was reported. In 4 morbidly obese subjects, fasting glucose and A1c declined though not achieving desirable goals despite receiving maximal dose, 60 units. Mean daily dose of Soliqua was lower (0.38±0.08 units /kg BW compared to pivotal trials (0.44 units /kg BW).

Conclusion: Soliqua is cost effective and safe in the long term in all subjects irrespective of BMI, when administered in combination with glimepiride and metformin. Moreover, it may be useful when administered with Glimepiride and Metformin in more subjects with higher BMI without attaining maximum daily dose in comparison to pivotal trials.

Disclosure

U. M. Kabadi: None. S. Exley: None.
900-P: Continuous Glucose Monitoring in Youth with Type 2 Diabetes: A Pilot and Feasibility Study
Authors: CHESSER HANNAH , SRINIVASAN SHYLAJA , WONG JENISE C.
Published: June 2021

Objective: Real-time continuous glucose monitoring (CGM) is effective for diabetes management in T1D and adults with T2D, but has not been assessed in youth with T2D. The objective of this study was to assess the feasibility and acceptability of CGM use in youth with T2D.

Methods: Youth (13- 21 years old) with T2D ≥ 6 months and A1c > 7%, on any FDA approved treatment regimen were included. After a blinded run-in period, participants were given a Dexcom G6 CGM system for 12 weeks. The use and acceptability of the real-time CGM were evaluated by sensor usage, surveys, and focus group qualitative data.

Results: Youth (n=8) had median age 19.4 (IQR 15.5-20.6) years, were 75% female, 50% hispanic/latino ethnicity, 50% non-English speaking at home, and 91% had public insurance. Baseline A1c was 11.7 (±2.8)% with mean diabetes duration of 2.5 (IQR 1.4 - 5.1) years and 75% were on basal insulin. Of the 7 participants who have completed the CGM intervention, all reported CGM was a positive experience (50% very positive, 50% slightly positive), easy to use (50% very easy, 50% easy), and useful (83% useful, 17% useful). All participants desired to continue to use real-time CGM in the future. 85% were “extremely” likely to recommend real-time CGM to friends. 67% of participants self-reported eating fewer meals while using CGM. All participants used sensors for the duration of the study.

Conclusion: Real-time CGM is feasible and acceptable for youth with type 2 diabetes. Larger randomized controlled trials are needed to assess effects on glycemic control, healthy lifestyle changes, and diabetes distress.

Disclosure

H. Chesser: None. S. Srinivasan: None. J. C. Wong: Advisory Panel; Self; Provention Bio, Inc., Research Support; Self; Dexcom, Inc., Tandem Diabetes Care.
925-P: Participation in Daily Physical Activity (PA) Improves Glycemic Control in Youth with T1D
Authors: LA BANCA REBECCA O. , VOLKENING LISA K. , DESROCHERS HANNAH , DASSAU EYAL , MEHTA SANJEEV N. , LAFFEL LORI M.
Published: June 2021

Aim: PA is an important part of diabetes management. ADA recommends that youth with T1D participate daily in ≥60 minutes of moderate to vigorous PA. We prospectively assessed daily PA in youth with T1D and compared demographic and diabetes variables according to frequency of PA ≥60 minutes/day.

Methods: Youth (N=125, ages 8-17) with T1D completed 3-day PA records every 3 months for 18 months. Diabetes treatment data and A1c were collected at the same time. For each youth, we calculated the % of days with ≥60 minutes PA and compared those with ≥60 minutes PA on <50% vs. ≥50% of days. Youth with at least 6 days of PA data over 18 months were included. In analyses, baseline age, T1D duration, and pump use were used; mean values over the 18-month period for A1c, insulin dose, and BMI percentile were used.

Results: Youth (50% male, 90% white, 74% pump-treated) had a mean±SD age 12.8±2.5 years, T1D duration 6.0±3.2 years, and A1c 8.2±0.9%. Youth had a median of 16 (IQR 12-17) PA record days. The % of days with ≥60 minutes PA ranged from 0 to 100% (median 53% [IQR 35-71%]), with 59% of youth reporting ≥60 minutes PA on ≥50% of days. Youth with ≥60 minutes PA on ≥50% of days were younger (12.4 vs. 13.5 years, p=.02), had shorter T1D duration (5.2 vs. 7.0 years, p=.002), lower daily insulin dose (0.86 vs. 1.00 u/kg, p=.002), and lower A1c (8.1 vs. 8.4%, p=.03) than youth with ≥60 minutes PA on <50% of days. There were no significant differences in sex (51 vs. 47% male, p=.64), race/ethnicity (93 vs. 84% white, p=.11), BMI percentile (69 vs. 70%, p=.85), or pump use (74 vs. 73%, p=.82) between those with ≥60 minutes PA on ≥50% vs. <50% of days. There was a notable temporal difference in youth having ≥60 min PA on ≥50% of days in the summer (75%), fall (51%), winter (58%), and spring (65%), respectively (p=.004).

Conclusion: A substantial proportion of youth with T1D do not exercise per recommendations. Given associations of PA with lower A1c, additional efforts to support exercise management in T1D are needed along with support for PA throughout the year.

Disclosure

R. O. La banca: None. L. K. Volkening: None. H. Desrochers: None. E. Dassau: Consultant; Self; Eli Lilly and Company, Employee; Self; Eli Lilly and Company, Research Support; Self; Dexcom, Inc., Tandem Diabetes Care, Speaker’s Bureau; Self; Dexcom, Inc., Roche Diabetes Care, Stock/Shareholder; Self; Eli Lilly and Company. S. N. Mehta: 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 (K12DK094721, P30DK036836); Iacocca Family Foundation
934-P: HbA1c Trajectories across Childhood through Emerging Adulthood Vary as a Function of Race Crossed with Income, Education, and Type of Health Insurance
Authors: MELLO DANIEL , RAYMOND JENNIFER , TORRES SANCHEZ ALEJANDRA , MAIN ALEXANDRA , WIEBE DEBORAH
Published: June 2021

Among youth with type 1 diabetes (T1D), non-Latino Whites, and those from higher socioeconomic status (SES) homes, typically show lower average HbA1c (A1c) levels, and slower deterioration in A1c across childhood through emerging adulthood. However, different SES metrics (income, educational achievement, type of health insurance) may have unique associations with T1D management, and the complex interplay between race/ethnicity and multiple SES metrics in T1D across development has yet to be systematically examined. This study investigated how a diverse sample of youth with T1D may vary in A1c across childhood through emerging adulthood as a function of multiple SES metrics. Medical records from a metropolitan clinic serving socioeconomically, ethnically, and racially diverse youth (N = 614; 36.7% Latino, 18.6% non-Latino White, 6.8% Black, 3% Asian/Pacific Islander, 35% Other Race/Multiracial; 48.9% Female) were coupled with US Census Tract data to index important measures of SES: Median neighborhood household income, % of the population with ≥ high school education (from US Census Tract data); type of health insurance: Private vs. Public/No Insurance (from medical records). Black youth had higher average A1c than Whites, Latinos, and Asian/Pacific Islanders, even after controlling for SES. Latinos had slower deterioration in A1c than all other racial groups across development, but this disappears after covarying SES. Income, education, and type of health insurance individually linked only to average A1c, with no associations to trajectories, but only insurance remained predictive of average A1c when all SES metrics are simultaneously covaried. Ethnic comparisons in average A1c and trajectories across development varied depending on income, education, and insurance status between groups, providing new insight for clinicians, researchers, and policymakers to help youth properly manage T1D.

Disclosure

D. Mello: None. J. Raymond: None. A. Torres sanchez: None. A. Main: None. D. Wiebe: None.
945-P: Elevated Blood Pressure in Pregnant Women with Gestational Diabetes According to the WHO Criteria: Importance of Obesity
Authors: BIRUKOV ANNA , GLINTBORG DORTE , SCHULZE MATTHIAS B. , JENSEN TINA K. , ANDERSEN LOUISE B. , KRÄKER KRISTIN , POLEMITI ELLI , JENSEN BOYE L. , JOERGENSEN JAN S. , DECHEND RALF , ANDERSEN MARIANNE S.
Published: June 2021

Objective: Hypertension before and during early pregnancy has been associated with an increased risk of gestational diabetes mellitus (GDM) in retrospective analyses. We investigated the prospective blood pressure patterns in a population-based cohort of pregnant women, who were stratified according to their metabolic status in early 3rd trimester.

Research Design and Methods: We recorded blood pressure longitudinally during pregnancy in 1,230 women from the Odense Child Cohort, Denmark. Fasting glucose and insulin were measured at gestational weeks 28-30. Metabolic status was evaluated according to the World Health Organization (WHO) 2013 threshold for GDM (GDM-WHO: fasting plasma glucose ≥5.1 mmol/l), insulin and homeostatic model assessment of insulin resistance (HOMA-IR). Relationships between metabolic status in 3rd trimester and blood pressure trajectories throughout pregnancy were evaluated with adjusted linear mixed models.

Results: GDM-WHO prevalence was high, 40% (498/1,230). Significant associations between GDM-WHO and blood pressure were seen only in overweight women, with 2.48 (1.08; 3.88) mmHg higher systolic and 1.58 (0.57; 2.58) mmHg higher diastolic trajectories in women with GDM-WHO compared with differences of -0.38 (-1.51; 0.75) and 0.03 (-0.83; 0.89) mmHg in lean women with GDM-WHO. The associations were independent of progression to gestational hypertension. Blood pressure trajectories in pregnancy were elevated across insulin and HOMA-IR quartiles.

Conclusions: GDM-WHO was associated with moderate elevations of blood pressure troughout pregnancy. The relationships were independent of progression to overt gestational hypertension, but largely modified by overweight status.

Disclosure

A. Birukov: None. R. Dechend: None. M. S. Andersen: None. D. Glintborg: None. M. B. Schulze: None. T. K. Jensen: None. L. B. Andersen: None. K. Kräker: None. E. Polemiti: None. B. L. Jensen: None. J. S. Joergensen: None.

Funding

German Ministry of Education and Research; State of Brandenburg (82DZD00302)
948-P: Serum Elabela Is Associated with Inflammatory Abnormalities in Gestational Diabetes Mellitus
Authors: CHEN YANNA , SHI MIN , ZHANG HONG
Published: June 2021

Gestational diabetes mellitus (GDM) is a common disease in pregnant women, which mechanisms remain unclear. Apelin-APJ system contributes to the energy homeostasis in middle and terminal pregnancy. Elabela (ELA) is another endogenous ligand of apelin receptor (APJ), which is expressed highly in the placenta. Few studies have focused on the role of ELA in GDM and the association between ELA and inflammatory cytokines. In this study we mainly compare the concentrations of serum Elabela between 33 diabetes pregnant women (GDM group) with 33 healthy pregnant women (control group). The inflammatory biomarkers including IL-1β, IL-6 and TNF-α were measured and evaluated the relationship with ELA. There were significant differences in serum Elabela (P<0.05), fasting plasma glucose (FPG), one-hour glucose, two-hour glucose in the OGTT (P<0.001), HOMA-IR (P<0.001), cytokine IL-1β(P<0.05) between GDM group and control group. ELA had significant correlations with FPG (r=-0.254, P=0.039), fasting insulin (r=-0.258, P=0.036), HOMA-IR (r=-0.275, P=0.026), and IL-1β (r=-0.789, P=0.000). And stepwise multiple linear regression analysis presented IL-1β and FPG most significantly affected the ELA levels. This study showed that decreased ELA levels were significantly associated with increased glucose levels and insulin resistance in GDM, which might be mediated by inflammatory factors, such as IL-1β. Serum ELA levels might be a clinical biomarker for GDM.

Disclosure

Y. Chen: None. M. Shi: None. H. Zhang: None.

Funding

National Natural Science Foundation of China (81200595, 81400807)
963-P: Preconception Counseling in Women with Diabetes: SEARCH for Diabetes in Youth Study
Authors: ROBERTS ALISSA J. , SAUDER KATHERINE A. , STAFFORD JEANETTE M. , MALIK FAISAL , PIHOKER CATHERINE , BOGHOSSIAN NANSI S. , EHRLICH SHELLEY R. , PETTITT DAVID J. , DABELEA DANA , BELLATORRE ANNA , DAGOSTINO RALPH , JENSEN ELIZABETH T.
Published: June 2021

Preconception counseling is recommended for all women with diabetes, starting at puberty, with a focus on achieving glycemic targets and improving maternal and fetal outcomes through educating women about pregnancy planning. We examined self-reported receipt of preconception counseling and its association with sociodemographic and clinical factors in 648 female adolescents and young adult participants with diabetes in the SEARCH for Diabetes in Youth study in 2016-2019. Crude (Chi-square and t-tests) and adjusted (logistic regression) associations were evaluated. At a mean age of 22.4 (SD 4.5) years, 31.9% were receiving diabetes care from a pediatric provider, 51.1% from an adult provider, and 17.0% from a provider who treats all ages. Only 55.4% reported ever receiving preconception counseling, which significantly differed by provider type (p>0.001). Receipt of preconception counseling was lowest among women seeing pediatric providers (38.6%) versus adult (63.1%) or all-age providers (63.6%), but differences were attenuated after adjustment for age, diabetes type, race/ethnicity, insurance type, and clinical site. With adjustment, older vs. younger age (aOR 1.20; 95% CI 1.13-1.26), type 1 vs. type 2 diabetes (aOR 1.62; 95% CI 1.02-2.56), and public vs. private health insurance (aOR 2.08; 95% CI 1.31-3.29) were associated with increased odds of reporting preconception counseling. Approximately half of female adolescents and young adults with diabetes reported not receiving preconception counseling, especially those who were younger, had type 2 diabetes or had private health insurance. Efforts to consistently deliver preconception counseling are warranted to reduce the risk for adverse pregnancy complications in this population, as well as avert substantial health issues and associated cost burdens in offspring.

Disclosure

A. J. Roberts: None. A. Bellatorre: None. R. Dagostino: Consultant; Self; AstraZeneca, Biogen, Daiichi Sankyo. E. T. Jensen: None. K. A. Sauder: None. J. M. Stafford: None. F. Malik: None. C. Pihoker: None. N. S. Boghossian: None. S. R. Ehrlich: None. D. J. Pettitt: None. D. Dabelea: None.

Funding

National Institute of Diabetes and Digestive and Kidney Diseases (1UC4DK108173); Centers for Disease Control and Prevention (1U18DP006131, U18DP006133, U18DP006134, U18DP006136, U18DP006138, U18DP006139)
969-P: Diabetes Mellitus Is Associated with Increased Biological Age
Authors: BAHOUR NADINE , AGUAYO-MAZZUCATO CRISTINA
Published: June 2021

Chronological age (CA) is the age given in years since birth whereas biological age (BA) is based on quantifiable changes on a cellular level measured through biomarkers. BA has a strong correlation with morbidity and mortality accounting for individual differences in the rate of aging and longevity. Since type 2 diabetes (T2D) is associated with increased morbidity and mortality, we hypothesized that BA would be increased in T2D diagnosed individuals and could be calculated with biomarkers from routine visits. In this study, we obtained deidentified data from three cohorts: (1) T2D (n= 686), (2) T1D (n= 540) (as a metabolic control) from Joslin Diabetes Center and (3) nondiabetics (n= 522) from the 2017-2018 National Health and Nutrition Examination Survey. Ages ranged from 20-80 years and for analysis, persons with diabetes were matched by age and gender to subjects without diabetes. Eight clinical biomarkers significantly correlated with CA in people without diabetes (p-values from 1.1 x10-98 to 5.6 x10-3). The Klemera and Doubal method (KDM) was used to calculate BA and results were confirmed using multiple linear regression. We observed a strong correlation between CA and BA in people without diabetes (R2 = 0.94, p< 0.0001) validating the biomarkers and KDM in our population. BA of people with T2D was, on average, 12 years higher than people without diabetes (p= 5.2 x10-187). BA of people with T1D was 15 years higher (p= 2.3 x10-236). The biomarkers with the strongest correlation to increased BA in T2D were systolic blood pressure (R2= 0.29, p< 2 x10-16) and A1c (R2= 0.27, p< 2 x10-16), suggesting that BA is dynamic and can be modified. Linear regression confirmed a significant increase of BA in persons with diabetes.

In conclusion, increased BA in people with diabetes suggests accelerated aging, a critical concept for integrating the cellular understanding of aging with the environment and which can enhance future research on the relation between aging biology and diabetes.

Disclosure

N. Bahour: None. C. Aguayo-mazzucato: Consultant; Self; eGenesis.

Funding

Joslin Diabetes Center (to C.A-M.)
970-P: Prediction of Cardiovascular Disease Risk among Patients with Type 2 Diabetes Using Repeated Measurements of Blood Pressure, Cholesterol, and Hemoglobin A1c
Authors: XU ZHE , WOOD ANGELA M.
Published: June 2021

Background: Cardiovascular disease (CVD) risk prediction models among people with type 2 diabetes mellitus (T2DM) are mostly based on single measures of risk predictors. Few have considered incorporating repeated risk predictor measures. We aimed to investigate whether using repeated measurements of risk predictors improves CVD risk prediction in T2DM patients.

Methods: We analyzed primary care data (2004-2017) from the UK Clinical Practice Research Datalink for 83,910 individuals aged 40-85 years, with confirmed T2DM but without CVD before study entry. In a 2/3 derivation sample, we derived age- and sex-specific prediction models with predictors including systolic blood pressure (SBP), total and HDL cholesterol, hemoglobin A1c (HbA1c), duration of T2DM, hypertension treatment, smoking, atrial fibrillation, and ethnicity. In stage 1, repeated measures of SBP, cholesterol, and HbA1c were summarized using: a) last observation carried forward; b) cumulative mean; c) longitudinal models with random intercept and slope. In stage 2, we fitted Cox regression models to predict 10-year CVD risk using summarized predictor values from stage 1 and last observed values for categorical predictors. Model performance was evaluated in a 1/3 validation sample.

Results: Compared with the model using last observation carried forward values, the cumulative means and the longitudinal model led to no substantial improvement in risk discrimination with changes in C-index by -0.0016 (95% CI: -0.0030, -0.0003) and 0.0011 (95% CI: -0.0001, 0.0023), respectively; the overall net reclassification was improved by 0.035 (95% CI: 0.009, 0.061) for the cumulative means model and 0.062 (95% CI: 0.033, 0.090) for the longitudinal model.

Conclusion: Incorporating repeated measurements of blood pressure, cholesterol, and HbA1c into CVD risk prediction models for T2DM patients slightly improves risk reclassification but not discrimination.

Disclosure

Z. Xu: None. A. M. Wood: None.

Funding

Alan Turing Institute/British Heart Foundation; UK National Institute for Health Research Cambridge Biomedical Research Centre
99-LB: A Phase 2b Study of Oral Insulin (Capsulin) Administered to Patients with Type 2 Diabetes
Authors: NEW ROGER R.C. , BOGUS MICHAL , TRAVERS GLEN N. , NAMJOSHI GAJANAN S.
Published: June 2021

Data from 93 patients, divided into three equal groups, were used to compare the efficacy of three different doses of insulin - 75iu, 150iu and 300iu - administered twice daily in enteric-coated capsules containing Diabetology’s Axcess™ oral delivery formulation. The study was conducted in 16 centres in India, and comprised a population diagnosed with diabetes for less than two years, with an average BMI of 25.7 kg/m2 and a mean HbA1c of 8.14%. There were no concomitant medications employed other than metformin, whose dose was fixed throughout the study. The study met its primary endpoint of fall in HbA1c ≥0.5 with a high level of significance, and falls in fasting plasma glucose, postprandial glucose, triglycerides and LDL cholesterol were also noted. There was no weight gain in any of the groups over the three-month period. The group demonstrating the highest level of efficacy was the 150iu twice daily group, which was the original anticipated target dose, based on previous studies. The data support progression of Diabetology’s oral insulin programme towards conduct of large-scale phase 3 studies.

Disclosure

R. R. C. New: Employee; Self; Diabetology Ltd. M. Bogus: None. G. N. Travers: Stock/Shareholder; Self; Axcess Ltd, Diabetology Ltd, Proxima Concepts Ltd, Stock/Shareholder; Spouse/Partner; Axcess Limited, Proxima Concepts Ltd. G. S. Namjoshi: None.
Irrigative assessment of Sasyk water quality
Authors:   Odessa State Environmental University, Yurasov Serhii , Kuzmina Viktoriia ,   Odessa State Environmental University, Karaulov Vitalii ,   State Ecological Inspectorate of the South-Western District (Mykolaiv and Odessa Regions)
Published: June 2021

The article is dedicated to the problem of artificial Lake Sasyk which was transformed from a salty water estuary into a freshwater reservoir at the expense of the Danube waters. In the first decades, the irrigative water conditions were not achieved due to the arrival of salts from the bottom sediments. Currently, the water quality formation process in Lake Sasyk has stabilized, but the problem of land irrigation remains urgent. The article gives an irrigation assessment of the quality of the Sasyk reservoir according to various methods considering observations in the HPS-2 region from 2007 to 2017. A detailed typification of irrigation waters based on Alekin O. A. water typing is proposed. It was found that mineralization and the content of sodium and magnesium ions in the Sasyk waters promote salinization and alkalinization of soils. For the safe use of this water for irrigation, both chemical reclamation and dilution with water are necessary.