bluuebunny/crossref_metadata_2025 huggingface dataset:
101-LB: Phase 3 Trial to Evaluate Efficacy and Safety of Gemigliptin and Dapagliflozin Dual Add-on Therapy to Metformin—SOLUTION 2 Study
Authors: SOO PARK KYONG , AH HAN KYUNG , CHEOL HWANG YOU , MOON SHINJE , CHO HOCHAN , JIN YOO HYE , CHOI SUNGHEE , CHON SUK , KIM KYOUNG-AH , NYUN KIM TAE , GOO KANG JUN , PARK CHEOL-YOUNG , CHUL WON JONG , LEE SEUNG-HWAN , HEE KIM NAN , SEOK KANG EUN , JUN KIM DONG , KIM SANGYONG
Published: June 2023

Background: Type 2 diabetes mellitus (T2DM) patients inadequately controlled with metformin alone require an addition of other medications with complementary mechanism of action. Gemigliptin, a dipeptidyl peptidase-4 inhibitor, and Dapagliflozin, a sodium-glucose cotransporter-2 inhibitor, can be considered as additional options. In this clinical trial, efficacy and safety of treatment of gemigliptin and dapagliflozin were evaluated in T2DM patients inadequately controlled with metformin monotherapy.

Method: Total 469 T2DM patients receiving treatment with stable metformin for ≥ 8 weeks before screening were randomized to gemigliptin and dapagliflozin (n=157) or gemigliptin (n =156) or dapagliflozin (n =156), respectively. The primary endpoint was the change in HbA1c at 24 weeks from baseline.

Results: At 24-week treatment, the HbA1c change from baseline in dual add-on of gemigliptin and dapagliflozin showed a significant reduction (LS Mean -1.34%) compared to gemigliptin add on (-0.90%; difference -0.44% [95% CI -0.58% to -0.31%]) and dapagliflozin add on (-0.78%; difference -0.56% [95% CI -0.69% to -0.42%]). Most of the reported adverse events were mild with no episodes of severe hypoglycemia.

Conclusion: This study demonstrated that triple therapy of gemigliptin and dapagliflozin dual add-on to metformin was effective and well tolerated in T2DM patients.

Disclosure

K. Park: None. K. Han: None. Y. Hwang: None. S. Moon: None. H. Cho: None. H. Yoo: None. S. Choi: None. S. Chon: None. K. Kim: None. T. Kim: None. J. Kang: None. C. Park: None. J. Won: None. S. Lee: Advisory Panel; LG Chem. Speaker's Bureau; Dong-A Pharm. Advisory Panel; CKD Pharm. Speaker's Bureau; Novo Nordisk, Lilly. Advisory Panel; Daiichi Sankyo. Speaker's Bureau; Boehringer Ingelheim Inc. N. Kim: None. E. Kang: None. D. Kim: None. S. Kim: None.
1011-P: Humanistic and Economic Burden of Patients with Cardiorenal Metabolic Conditions—A Systematic Literature Review
Authors: FERDINAND KEITH , NORRIS KEITH C. , RODBARD HELENA W. , TRUJILLO JENNIFER
Published: June 2023

Background: A comprehensive understanding of the burden of CRM conditions is needed to guide targeted interventions.

Objective: This SLR assessed the humanistic and economic burden of T2D, CVD (including HF), and CKD.

Methods: Following PRISMA guidelines, Embase and Medline databases were systematically searched to identify observational, RWE, and economic-model studies in populations ≥18 years old with CKD, T2D, and CVD. Outcomes of interest included humanistic (e.g., health related QoL, functional impairment, QALY) and economic burden. English-language studies from Jan 2011 to Jan 2022 were included. Relevant abstracts/posters also were identified from ACC, AHA, ASN, and ADA from the 2 previous years.

Results: Of 22 studies identified (13 US; 9 non-US) and included, 1 Chinese study reported QoL data (depressive symptoms of CKD and T2D), 8 reported healthcare resource utilization (HCRU), 7 reported cost, and 6 reported HCRU and cost. Multimorbidity and advanced stages of CKD were associated with higher medical costs and HCRU for patients with CRM across all studies. Increasing age was associated with more comorbidities, leading to greater economic burden among patients ≥65 years old. Higher costs and HCRU were observed in patients with all 3 conditions (T2D, CVD, CKD) compared to those with fewer comorbidities. Higher healthcare expenditures and HCRU was observed among urban insured compared with uninsured populations. Black patients had lower odds of using healthcare services compared to patients who identified as White, Asian/Pacific Islander, or Hispanic ethnicity.

Conclusions: This SLR identified a clear trend of increasing healthcare costs and HCRU commensurate with an increasing number of CRM comorbidities. Further research evaluating the economic and humanistic burden of CRM conditions, especially in patients from racial/ethnic groups, is needed.

Disclosure

K.Ferdinand: Consultant; Amgen Inc., Boehringer Ingelheim Inc., Novartis, Medtronic, Pfizer Inc. K.C.Norris: None. H.W.Rodbard: Advisory Panel; Merck Sharp & Dohme Corp., Pacira BioSciences, Inc., Research Support; Eli Lilly and Company, Medtronic, Sanofi, Novo Nordisk. J.Trujillo: Advisory Panel; Novo Nordisk, Sanofi.

Funding

Boehringer Ingelheim and Eli Lilly and Company Diabetes Alliance
1019-P: Implementation Analysis of Pharmacist-Managed Insulin Dosing in an Acute Care Hospital
Authors: HADIPRODJO ALICIA G. , SCOTT EVELYN M. , WENG RENEE
Published: June 2023

Hyperglycemia is associated with negative health outcomes such as increased infection, increased thrombosis, decreased wound healing and prolonged hospitalization. The 2022 ADA guidelines for hospitalized patients recommend targeting blood glucose (BG) 140-180 mg/dL in both critically and non-critically ill patients and managing persistent hyperglycemia with insulin. Data evaluating the impact of a pharmacist-managed insulin dosing protocol is currently lacking. The objective of this study was to evaluate the safety and efficacy of a pharmacist-managed basal-bolus (BB) insulin dosing protocol for inpatient hyperglycemia management. This single-center, retrospective, observational study included patients > 18yo with three consecutive BG concentrations 180-350mg/dL admitted to the critical care, telemetry, and medical/surgical floors. The insulin per pharmacy dosing protocol was implemented in December 2020. A total of 494 patients were included in the pre-implementation group (January-November 2020) and 668 patients in the post-implementation group (July-December 2021). No significant difference in baseline characteristics were observed between the two groups. For primary outcome, post-implementation group had a statistically significant higher percentage of normoglycemia defined as BG 70-180 mg/dL (63.4% vs. 50.2%, p<0.01) and a statistically significant lower percentage of hyperglycemia defined as BG >180 mg/dL (35.1% vs. 48.2%, p<0.01). No difference in hypoglycemia rate between the two groups were observed (1.6% vs. 1.5%, p>0.1) confirming protocol safety. For secondary outcome, no difference in average length of stay between the two groups, although goal BG<180 mg/dL was achieved on day 2 in post-implementation group vs. day 6 in pre-implementation group. This study suggests that pharmacists can effectively and safely manage inpatient hyperglycemia in both critically ill and non-critically ill patients utilizing a standardized BB insulin dosing protocol.

Disclosure

A.G.Hadiprodjo: None. E.M.Scott: None. R.Weng: None.
1038-P: Evaluation of an Outpatient Pathway for Management of Pediatric Patients with New-Onset Diabetes
Authors: AZOVA SVETLANA , BASKARAN CHARUMATHI , EINIS SARA , FORTIN JENNIFER A. , SILVA MARISA , AAMODT KRISTIE , ETHIER BENJAMIN G. , NANAVATI SONAL , GARVEY KATHARINE , RHODES ERINN
Published: June 2023

Background: Education and management for new onset diabetes (NOD) does not always require hospitalization. A pathway for outpatient management of pediatric NOD patients after initial evaluation and long-acting insulin dose in the emergency department was developed at a tertiary academic medical center.

Methods: A multidisciplinary team identified key initial eligibility criteria for outpatient NOD management including absence of DKA, age ≥3 years, and beta-hydroxybutyrate (BOHB) <1 mmol/L. Data tracking, chart review, and endocrine provider surveys determined reasons for exclusion or non-participation. Control charts tracked and analyzed monthly utilization. Refinement of the pathway occurred through iterative PDSA cycles.

Results: The pathway launched in September 2020. To date, 58 eligible children (33%) have completed the pathway (monthly median 33%). One patient was hospitalized after newly identified social concerns. Increase of BOHB cut-off to 1.5 mmol/L and option of rapid-acting insulin bolus for borderline BOHB resulted in significant shift in utilization from mean 23% to 41%. Barriers to participation include limited space availability, weekend presentation, and patient/family refusal.

Conclusion: Data suggest that outpatient management is feasible for select patients with NOD but requires flexible resources and supportive patient messaging regarding outpatient education.

Disclosure

S.Azova: None. E.Rhodes: None. C.Baskaran: None. S.Einis: None. J.A.Fortin: None. M.Silva: None. K.Aamodt: None. B.G.Ethier: None. S.Nanavati: None. K.Garvey: None.
1041-P: Health Care Transition Practices in the T1D Exchange Quality Improvement Collaborative
Authors: MALIK FAISAL , CASES-VILLABLANCA JESSE , HILLIARD MARISA E. , LYONS SARAH , JACOBSEN LAURA M. , ROBERTS ALISSA J. , MUCCI ANDREA , AGARWAL SHIVANI , DEMETERCO-BERGGREN CARLA , ALONSO GUY T. , EBEKOZIEN OSAGIE , CORATHERS SARAH , COLLABORATIVE T1DX-QI
Published: June 2023

Background: Implementation of a structured health care transition (HCT) process is associated with positive outcomes in population health, experience of care, and health care utilization.

Objective: To describe pediatric and adult clinic HCT practices in the T1D Exchange Quality Improvement Collaborative (T1DX-QI).

Methods: Got Transition’s Six Core Elements of HCT offer a structured approach to the phases of transition support: 1) transition and care policy, 2) tracking and monitoring, 3) transition readiness, 4) transition planning, 5) transfer of care, and 6) transfer completion. T1DX-QI institutions (n=53) were surveyed to examine the integration of the Six Core Elements into diabetes HCT practices.

Results: The survey response rate was 94.3% (n=50 clinics; 33 pediatric, 17 adult). A majority of T1DX-QI pediatric clinics (72.7%, n=24) report having a HCT policy compared to 29.4% (n=5) of adult clinics. Among pediatric institutions, 45.4% (n=15) maintain a tracking system to identify transition-aged youth, 39.4% (n=13) formally assess HCT readiness, 52% (n=17) document and update a plan of care for transition and 27.3% (n=9) have a process in place to confirm successful transfer of care completion with adult diabetes providers. Approximately two-thirds of T1DX-QI pediatric institutions (63.6%, n=21) have a formal structured HCT program and 29% (n=6) of these HCT programs report incorporating all 6 elements.

Conclusions: Data from T1DX-QI centers highlight opportunities to further enhance transition preparation and receivership for emerging adults with type 1 diabetes. The Six Core Elements offer a potential avenue to structure improvement initiatives since many diabetes clinics only partially incorporate these elements in current practice. Partnerships between pediatric and adult diabetes centers should be considered as part of quality improvement efforts to facilitate incorporation of challenging HCT elements such as transfer of care completion.

Disclosure

F.Malik: None. G.T.Alonso: None. O.Ebekozien: Advisory Panel; Medtronic, Research Support; Eli Lilly and Company, Dexcom, Inc. S.Corathers: None. T1dx-qi collaborative: n/a. J.Cases-villablanca: None. M.E.Hilliard: None. S.Lyons: None. L.M.Jacobsen: None. A.J.Roberts: None. A.Mucci: None. S.Agarwal: Advisory Panel; Medtronic, Consultant; Beta Bionics, Inc., Research Support; Abbott Diabetes, Dexcom, Inc. C.Demeterco-berggren: Speaker's Bureau; Glooko, Inc.

Funding

The Leona M. and Harry B. Helmsley Charitable Trust
1053-P: VDOP (Virtual Diabetes Optimization Program) for High-Risk Veterans with Uncontrolled Diabetes
Authors: ADEL THOMAS , HANSEN JILL M. , REESER KELLY , TAXMAN JILLIAN , JOHNSON CHRISTOPHER , WHITTLE JEFF , MENDEZ CARLOS E.
Published: June 2023

Type 2 diabetes is 2.5 times more prevalent in veterans compared to the general population. VDOP (Virtual Diabetes Optimization Program) set out to examine the effectiveness of a multifaceted, virtual intervention program aimed to improve diabetes control in high-risk veterans. Patients referred to VDOP had uncontrolled diabetes (A1c ≥ 8%, or on high insulin doses (≥ 1 unit/kg), or experiencing repeated hypoglycemia), and at least one of the following comorbidities: obesity, cardiac, kidney, liver disease, or sleep apnea. Once enrolled in the program, veterans had glucose monitors and activity trackers connected to a cloud platform, and met weekly with the dietician, occupational therapist, and clinical pharmacist in staggered visits. The VDOP care team conducted weekly huddles under the supervision of a physician diabetologist. Intended program duration is 12-24 weeks. To date, 11 veterans have completed participation with a mean duration of 16 weeks. Most participants were older males (10 male, mean 62 years old). Veterans completing the program showed on average significant improvement in glycemic control (-2.5% A1c), weight loss (-18.8 lbs. or -7.8%), and decreased total daily insulin doses (-72.8%). With ongoing recruitment, we plan to monitor sustainability of improved metrics, cost, and impact on quality of life of the VDOP program on high-risk veterans with uncontrolled diabetes.

Disclosure

T.Adel: None. J.M.Hansen: None. K.Reeser: None. J.Taxman: None. C.Johnson: None. J.Whittle: None. C.E.Mendez: Speaker's Bureau; Siemens.

Funding

U.S. Department of Veterans Affairs Office of Connective Care
1054-P: A Physician Survey Focusing on Dose Escalation for Type 2 Diabetes Medications
Authors: BOYE KRISTINA , JORDAN JESSICA , MALIK RALEIGH , CYR ROBYN A. , MATZA LOUIS S.
Published: June 2023

Objectives: T2D medications often require dose escalation to optimize effectiveness. Physician perceptions of treatment characteristics of type 2 diabetes (T2D) medications have previously been examined, but little is known about perceptions of escalation to the optimal dose. This study examined physicians’ perceptions of dose escalation for medications used to treat T2D.

Methods: Data on dose escalation and other factors influencing decision-making for T2D treatment were collected via an online survey of US physicians in 2022.

Results: The sample included 501 physicians (348 primary care, 153 endocrinologists). Dose escalation was not frequently considered a primary factor keeping patients’ from reaching treatment goals (mentioned as a factor by only 7.6% of the sample) or a barrier to prescribing T2D medication (16.2%). Factors more likely to keep patients from reaching treatment goals included unhealthy diet (86.6%) and medication adherence (77.4%). The most common reasons that physicians reported for escalating dose levels with their patients are presented in Table 1.

Conclusions: Although common with T2D treatments, dose escalation was not perceived to be a significant barrier to prescribing medication or attainment of treatment goals. Multiple factors contribute to the decision to escalate a dose.

Disclosure

K.Boye: Employee; Eli Lilly and Company. J.Jordan: None. R.Malik: Employee; Eli Lilly and Company. R.A.Cyr: None. L.S.Matza: Research Support; Eli Lilly and Company.

Funding

Eli Lilly and Company
1059-P: Spotlight-AQ RCT and AI Results—Improving Physical and Mental Health Outcomes for Adults with Type 1 or Type 2 Diabetes
Authors: BARNARD KATHARINE , KELLY RYAN C. , COHEN LAUREN , BARNARD ETHAN , LIU YUFAN , PHIRI PETER , MENDEZ OSCAR , PRICE HERMIONE
Published: June 2023

Background: Existing therapeutic interventions are well known, yet most people with diabetes do not consistently achieve blood glucose targets for optimal health, despite the large range of treatment options available.

Aim: To explore the efficacy of a novel clinical intervention addressing physical and mental health within routine consultations across healthcare settings.

Methods: A multi-centre, parallel group, individually randomised trial comparing consultation length in adults with T1D or T2D for ≥6 mths to the Spotlight Consultations platform compared to usual care. Secondary outcomes: HbA1c and validated measures of depression, diabetes distress, anxiety, functional health status and HCP burnout. Results: n=98 adults with T1D or T2D; any HbA1c and receiving any diabetes treatment participated (n=49 intervention). Consultation duration for intervention participants was reduced in intervention consultations by 0.5-4.1 mins (3-14%) versus no change in the control group (-0.9 - +1.28 mins) across 15 and 30 consultations. HbA1c improved in the intervention group by 6mmol/mol (range 0-30) versus control group 3mmol/mol (range 0-8). Moderate improvements in psychosocial outcomes observed in intervention group: functional health status; reduced anxiety, depression and diabetes distress; improved well-being. None were statistically significant. HCPs reported improved communication and greater focus in consultations. Artificial Intelligence examination highlighted therapy and psychological burden were most important in predicting HbA1c levels.

Conclusion: Spotlight-AQ was associated with shorter, more useful consultations; with improved HbA1c and moderate benefits on psychosocial outcomes. Results reflect the importance of a biopsychosocial approach to routine care visits. Spotlight-AQ is viable across healthcare settings for improved outcomes.

Disclosure

K.Barnard: Advisory Panel; Abbott Diabetes, Roche Diabetes Care, Sanofi, Consultant; LifeScan Diabetes Institute, Tandem Diabetes Care, Inc., Research Support; Novo Nordisk. R.C.Kelly: None. L.Cohen: None. E.Barnard: None. Y.Liu: None. P.Phiri: None. O.Mendez: None. H.Price: Consultant; AstraZeneca, Speaker's Bureau; Novo Nordisk, AstraZeneca, Boehringer Ingelheim and Eli Lilly Alliance.

Funding

Southern Health NHS Foundation Trust
106-LB: Postprandial Glucose Management among Adults Living with Type 1 Diabetes Using Single-Hormone and Dual-Hormone Automated Insulin Delivery Systems
Authors: LEBBAR MAHA , MOLVEAU JOSÉPHINE , BOUDREAU VALERIE , RABASA-LHORET RÉMI , WU ZEKAI
Published: June 2023

Introduction: Despite the rapid advances of diabetes technologies, postprandial glucose management remains a challenge for people living with type 1 diabetes (pwT1D). We aim to assess the efficacy of single-hormone (SH) compared to dual-hormone (DH) automated insulin delivery (AID) systems in postprandial glucose management.

Methods: Post-hoc analysis of a randomized controlled crossover inpatient trial including three standardized meals (taken at 8am, 12 pm, and 5pm) during a 24-hour period, comparing SH-AID and DH-AID among pwT1D. Data from meals of each participant was pooled. Primary outcome was time in range % (TIR%, 70 to 180 mg/dL), calculated by continuous glucose monitoring during the 4-hour postprandial period. Paired t-test was used to compare the two groups.

Results: Eighteen adult participants were included (mean age [SD] 43 [14] years, mean duration of T1D 20 [11] years, mean HbA1c 7.6% [1.0], mean daily insulin intake 26.70 [11.04] units). Postprandial TIR% was similar between SH and DH-AID (66.4% vs 70.2%, p=0.443). Less time in postprandial hypoglycemia (<70 mg/dL) was observed in the DH-AID group compared to SH-AID (5.4% vs 11.9%, p=0.019). No difference was observed in postprandial time spent in hyperglycemia (>180 mg/dL), glycemic variability indices or insulin intake between the two groups.

Conclusion: Compared with SH-AID, DH-AID reduces postprandial hypoglycemia, while other postprandial glucose metrics remain similar among adult pwT1D.

Disclosure

M. Lebbar: None. J. Molveau: None. V. Boudreau: None. R. Rabasa-lhoret: Consultant; Dexcom, Inc., Abbott, Janssen Pharmaceuticals, Inc., Novo Nordisk Canada Inc., Sanofi, Lilly, Tandem Diabetes Care, Inc., Insulet Corporation. Z. Wu: Other Relationship; Eli Lilly and Company.
1060-P: After-Hours Nurse Line Utilization Decreased Call Burden in an Academic Pediatric Endocrinology Practice
Authors: CHOUDHARY ABHA
Published: June 2023

Background: Optimal management of childhood diabetes benefits from access to a 24-hour support line. If staffed by on-call physicians, repeated interruptions to sleep can lead to physician burn out. Utilization, and outcomes of an after-hours nurse call service in a pediatric endocrinology practice have not been previously reported.

Methods: Barton Schmitt guidelines, which are widely accepted as the standard for telephone triage care, were modified to include our institution specific diabetes management protocols. We analyzed demographics, reasons for call, clinical presentation to the emergency room, and clinical disposition of the callers.

Results: After we instituted our after-hours nurse triage service (September 2019), the call burden to the on-call physicians decreased by 70%. Patients who called the after-hours line before coming to the emergency room were less sick (higher pH and lower glucose) and were more likely to be discharged home. We cannot infer causality from our data. Nevertheless, given that <10% of patients called first, encouraging earlier and more consistent utilization of the nurse line seems like a low-cost intervention that might reduce hospital admissions for diabetic ketoacidosis. After-hours service was utilized well by our patients of all races and insurance statuses. We noted that language was a barrier in utilization which is an opportunity for improvement.

Disclosure

A.Choudhary: None.
1065-P: Utilizing a Novel Telemedicine Clinic for Managing Patients with Type 2 Diabetes
Authors: SOTOMAYOR FIORELLA , GOTHONG CHIKARA , HERNANDEZ REYNIER , ASH GARRETT I. , SCOTT WILLIAM H. , PINAULT LILLIAN , GOMEZ-PERALTA FERNANDO , SINGH LAKSHMI G. , SORKIN JOHN D. , (ELIAS) SPANAKIS ILIAS
Published: June 2023

Objective: To examine whether a new Diabetes Telemedicine (DT) clinic can lead to improved glycemic control compared to standard of care (SoC).

Design: Pilot RCT of patients with type 2 diabetes (T2D) randomized to DT clinic or SoC. DT intervention comprised of continuous glucose monitoring, “connected” insulin pens/caps, telecommunication systems (i.e. video conferencing, online messaging and telephone) and promoting physical activity (PA) by providing brief counseling and exercise physiologist consultation. SoC was managed using point of care glucometer, traditional insulin pens, in-person visits and provider counseling on PA. Primary outcome was change in HbA1c. Secondary outcomes were time in range (TIR) 70-180 mg/dl, time above range (TAR)>180 mg/dl and time below range (TBR)< 70 mg/dl. Patients also completed senior fitness test, assessed by Hedge’s g effect size.

Results: A total of 18 patients (17 male) have been recruited, 11 patients were black and 7 white, all non-Hispanic. 14 completed 90 days in the trial. Non statistically significant differences were seen. DT had an 1.6% (mean SE 0.60) HbA1c reduction vs 0.4 (0.69) in SoC [difference -1.2% (0.92), p=0.19]. TIR 70-180 mg/dl increased 8.5% (13.6) (DT) vs 4.4% (15.8) (SoC) [difference +4.1% (20.8), p=0.84]. DT had a decrease in TAR>180 mg/dl of 8.7% (13.7) compared to 4.4% (15.8) in SoC [difference -4.3% (21.0), p=0.85] and TBR<70 mg/dl 0.16% (0.60) (DT) vs 0.13% (0.69) (SoC) [difference of 0.03% (0.92), p=0.97]. DT had improved aerobic capacity (6-minute walk test 402±62 to 418±69m, g=0.53) and strength in the lower- (30-second chair stand 9.0±2.6 to 11.5±2.6 stands, g=0.91) and upper-body (30-second weighted arm curl 17.4±5.3 to 21.0±6.3 curls, g=0.72). SoC had no meaningful changes in aerobic capacity or lower/upper-body strength (g=-0.05 to 0.18).

Conclusion: Patients with T2D managed with DT had a non-statistically significant improvement of glucose control and improved physical fitness performance compared to patients in SoC.

Disclosure

F.Sotomayor: None. I.Spanakis: Research Support; Dexcom, Inc. C.Gothong: None. R.Hernandez: None. G.I.Ash: None. W.H.Scott: None. L.Pinault: None. F.Gomez-peralta: Advisory Panel; Abbott Diabetes, Insulcloud S.L., Speaker's Bureau; A. Menarini Diagnostics, Boehringer Ingelheim and Eli Lilly Alliance, Lilly Diabetes, Novartis, Novo Nordisk. L.G.Singh: None. J.D.Sorkin: None.
1066-P: Gaps in Guideline-Indicated Prescribing of GLP1RA/SGLT2i in Patients with T2DM and Cardiorenal Disease according to ADA Standards of Care
Authors: LINGVAY ILDIKO , BOWEN MICHAEL E. , MAI CHRISTINE , MARBLE KELSEA , PAK JONATHAN , BASIT MUJEEB A.
Published: June 2023

We evaluated the treatment gap in prescribing guideline-directed therapies in patients with T2DM and cardiorenal disease using EHR data from a large academic medical center. Eligible patients had T2DM and an outpatient encounter after January 1, 2019 in either endocrinology, cardiology, nephrology, or primary care. Eligibility subgroups were defined using ADA 2022 Standards of Care: ASCVD (N=1,962) - ‘SGLT2i or GLP1RA’; HFrEF or HFpEF or CKD stage 3 (N=5,537) - ‘SGLT2i Only’; ASCVD and HF or CKD stage 3 (N=1,773) - ‘SGLT2i primary’; CKD stage 4/5 (N=1,547) - ‘GLP1RA Only’. We extracted prescriptions for any GLP1RA or SGLT2i since 2006 to characterize ever prescribed and currently prescribed. The treatment gap for patients (N=10,819) ever prescribed ranged from 45.5% for those who should have been prescribed either an SGLT2i or GLP1RA to 71.9% for those eligible for GLP1RA only (Panel A). The treatment gap was >20% higher for currently prescribed across all subgroups, ranging from 73.5% to 92.1% across the subgroups (Panel B). Large treatment gaps in prescribing of guideline-directed cardiorenal protective agents in high-risk patients with type 2 diabetes exist. While all subgroups were sub-optimally treated, those with CKD stage 4/5 had the largest gap. These findings will inform multi-faceted interventions geared to improve the care of such high-risk patients.

Disclosure

I.Lingvay: Advisory Panel; Novo Nordisk A/S, Lilly Diabetes, Boehringer-Ingelheim, Sanofi, Consultant; Carmot Therapeutics, Inc., Merck Sharp & Dohme Corp., Janssen Scientific Affairs, LLC, Pfizer Inc., Intercept, Intarcia, Valeritas, TargetRWE, Shionogi, Zealand Pharma, Structure, Bayer, Research Support; Novo Nordisk A/S, Boehringer-Ingelheim. M.E.Bowen: Research Support; Boehringer-Ingelheim. C.Mai: None. K.Marble: None. J.Pak: None. M.A.Basit: Research Support; Boehringer Ingelheim Inc., Verily Life Sciences.

Funding

Boehringer Ingelheim
1071-P: Impact of the GluCare Health Model of Care in Diabetics with NAFLD as Measured Using Shear Wave Ultrasound—A Three-Month Outcomes Study
Authors: CACCELLI MILENA , SAID YOUSEF , ALEABOVA SOFIA , PALSKY CAROLYN , HASHEMI ALI , ALMARZOOQI IHSAN
Published: June 2023

Introduction: Type 2 diabetes (T2D) and obesity are risk factors for nonalcoholic fatty liver disease (NAFLD). Newer and non-invasive imaging techniques of transient elastography and shear wave elastography provide the opportunity to measure liver stiffness (1). Shear Wave Ultrasound (SWU) is a non-invasive imaging technique that has been increasingly used in the management of patients with diabetes (2). Continuous monitoring and engagement approach, such as the one utilized by GluCare.health, has been proven to effectively improve metabolic conditions associated with diabetes in trials (3). This integrated care model uses data-driven personalization of interventions to increase patient's access and engagement with health provider to surpass outcomes of traditional care methods (4). Methods: Retrospective review of medical records of 47 patients, evaluated at GluCare (Dubai, UAE), from 18 to 70 years old with T2D and body mass index (BMI) over 25. All the patients were under anti diabetic drugs. BMI and data from a SWU model FT100 were collected and compared between the first visit and after 3 months GluCare.health intervention. Correlations between 3-month changes in BMI, liver ultrasound attenuation parameter (UAP) and stiffness were explored using statistical analysis. Results: Average changes in BMI over the first three months of treatment were statistically significant (p<0.001). The average UAP decrease was significant at 10 % level (p=0.086) and every unit decreased in BMI was associated with 7.23 dB/m reduction in UAP (p<0.05). The average change in liver stiffness was not statistically significant (p>0.1). The analysis also found a significant correlation between changes in BMI and stiffness at the 5% significance level, with a moderately strong correlation (r=0.38). Conclusion: The study suggests that the GluCare.Health intervention may be effective in reducing BMI in patients with diabetes, and it may also have some effect on NAFLD.

Disclosure

M. Caccelli: None. Y. Said: None. S. Aleabova: None. C. Palsky: None. A. Hashemi: None. I. Almarzooqi: None.
1074-P: Multicenter Quality Improvement Project—Increasing Social Determinants of Health (SDOH) Screening across Six Diabetes Centers in the United States
Authors: ODUGBESAN ORI , WRIGHT TREVON , YAYAH JONES NANA-HAWA , PAT GALLAGHER MARY , ILKOWITZ JENIECE , DEI-TUTU SELORM A. , DEWIT EMILY L. , IZQUIERDO ROBERTO , DESIMONE MARISA , HESS EMILIE J. , RIOLES NICOLE , EBEKOZIEN OSAGIE
Published: June 2023

Background: Social Determinants of Health (SDOH) are strongly associated with outcomes for patients with diabetes. Incorporating widespread clinic SDOH screening programs is challenging. We aim to demonstrate the use of Quality Improvement (QI) interventions in expanding SDOH screening practices across 5 pediatric and 1 adult diabetes center in the T1D Exchange Improvement Collaborative (T1DX-QI).

Method: The centers applied QI principles to design iterative plan-do-study-act (PDSA) cycles to develop and expand interventions to improve screening rates. The interventions include staff training, creating a social risk index, using EHR patient-facing portal, partnership with community organizations, referral to clinic, and community resources. The centers shared monthly aggregate data with the coordinating center. Statistical Process Control charts were created and analyzed for significant shifts.

Result: All centers successfully implemented SDOH screening, and improvement ranged from 41% to 68%. Overall screening increased from baseline by 56% in 24 months.

Disclosure

O.Odugbesan: None. E.J.Hess: None. N.Rioles: None. O.Ebekozien: Advisory Panel; Medtronic, Research Support; Eli Lilly and Company, Dexcom, Inc. T.Wright: None. N.Yayah jones: Consultant; Medtronic. M.Gallagher: None. J.Ilkowitz: None. S.A.Dei-tutu: None. E.L.Dewit: None. R.Izquierdo: None. M.Desimone: None.
1079-P: Implementation of Diabetes E-consult Service Eliminates Barriers to Specialty Expertise
Authors: MITRI JOANNA , CIBOTTI GRANOF NANCY , HERZLINGER BOTEIN SUSAN , MEHTA SANJEEV N.
Published: June 2023

Background: Electronic physician consultations (e-consults) with endocrinologists represent a safe and effective alternative to many referrals for diabetes care. E-consults represent an important, but underutilized, modality to address the shortage of endocrinologists. Aim: To implement a scalable diabetes e-consult service for a large network of primary care practices in the United States.

Methods: Primary care providers (PCPs) from 40 practices used a designated email to consult endocrinologists based at a diabetes center. Endocrinologists also had remote access to the electronic health records used by consulting PCPs. E-consults provided individualized recommendations for management, evaluation, targeted education or referral to the diabetes center in addition to targeted education. Provider experience surveys were completed online by PCPs and specialists after each consult.

Results: Between Feb-Sep 2022, 55 e-consults were completed; 86% within 2 business days. The service was positively reviewed by PCPs; 96% reported the e-consult was helpful, 86% reporting more confidence in diabetes care; and 64% reported the e-consult saved them time. A majority of e-consults (PCP, 79%; endocrinologist, 77%) required <10 mins to complete. Specialists made no recommendations for a patient referral to the diabetes center.

Conclusions: A diabetes e-consult service can be rapidly implemented with minimal administrative support. It has the potential to bring greater diabetes expertise to primary care practices and save the PCPs time while avoiding unnecessary referrals to endocrinology practices. Future analyses will address the clinical impact of the e-consult service.

Disclosure

J.Mitri: Other Relationship; Novo Nordisk, Research Support; Kowa Company, Ltd. N.Cibotti granof: None. S.Herzlinger botein: None. S.N.Mehta: None.
11-OR: Fetal Renal Hypoxia Response to Maternal Overnutrition
Authors: TAKIYAMA TAKAO , TAKIYAMA YURI , BESSHO RYOICHI , KITSUNAI HIROYA , TAKIYAMA YUMI
Published: June 2023

Currently, 50% of women of reproductive age are obese, and one in seven live births is affected by hyperglycemia in mothers with gestational diabetes. To examine the impact of intrauterine overnutrition on the kidneys of the offspring, we generated a novel mouse model by feeding female C57BL6J mice with either control diet (CD) or high-fat diet (HFD, 60% Lipid) during gestation and feeding the male offspring with CD after weaning, allocated to two groups of male offspring, CD and HFD. CD and HFD had similar body weights, blood pressure and urinary albumin levels, but lower serum creatinine levels in HFD (CD; n=17, HFD; n=11, p<0.001), which might be due to renal hyperfiltration. Histologically, HFD presented renal tubular vacuolation at 4 weeks of age and glomerulosclerosis and intrarenal arteriosclerotic lesions at 15 weeks of age. Moreover, perirenal beige fat phenotype was lost in HFD at 4 week of age, presenting white adipose cells unlike the small adipose cells in CD, suggesting that maternal overnutrition induced systemic metabolic abnormality in offspring. Synchrotron phase-contrast micro-CT showed that HFD at 14.5 dpc showed asignificant increase in total kidney volume (CD; n=4, HFD; n=6, p<0.001). On the contrary, no significant difference in renal artery diameter was observed (p=0.52). Blood flow is determined by the supplying vascular diameter due to Murrays’ minimum energy hypothesis. Therefore, we studied the ratio of blood flow as the 3rd power of the diameter of fetal renal artery per renal volume, indicating no significant difference between CD and HFD (p=0.42). Despite of preserved blood supply, the protein expression of HIF-1α, the key hypoxic transcription factor, was higher in HFD than that in CD, suggesting increased oxygen demand due to maternal overnutrition-induced renal metabolism. Maternal overnutrition induces supply-demand mismatch leading to renal hypoxia in the fetus, which persists into adulthood in the offspring, which might promote susceptibility to diabetic nephropathy.

Disclosure

T.Takiyama: None. Y.Takiyama: None. R.Bessho: None. H.Kitsunai: None. Y.Takiyama: Research Support; Boehringer Ingelheim Japan, Inc., Taisho Pharmaceutical Holdings Co., Ltd., Ono Pharmaceutical Co., Ltd., Abbott Japan Co., Ltd., Roche Diabetes Care, MSD Life Science Foundation, Japan Society for the Promotion of Science, Teijin Pharma Limited, Kyowa Kirin Co., Ltd., Sumitomo Dainippon Pharma Co., Ltd., Eli Lilly Japan K.K.
111-LB: Smart Insulin Pen Correction Doses Delivered within Three Hours of a Previous Insulin Dose Improve Glycemia
Authors: HEUNGYONG IM GLEN , SMITH MADISON , MACLEOD JANICE , VIGERSKY ROBERT A.
Published: June 2023

Background: An important feature of the InPen™ Smart Insulin Pen (SIP) is its ability to track active insulin, enabling opportunities to safely calculate correction doses any time after a bolus. This study investigated the frequency of users delivering correction doses and its impact on glycemia when delivered within 3 hours of a previous dose in both adult and pediatric InPen users with T1D or T2D.

Methods: A retrospective cohort analysis was performed using deidentified sensor glucose (SG) data from N=857 individuals with sufficient SG data (at least 70% of SG data each day), ≥3 boluses per day, and ≥1 correction dose per day on average in the 60-to-90th day period after starting InPen-use Jan 2022-Dec 2022. Each user's proportion of corrections delivered within 3 hours of a previous dose (notated PC3) was calculated, and users were split into two groups based on the median of PC3. Glycemic outcomes including percentage TIR, 70-180 mg/dL), TBR, <70 mg/dL and TAR, >180 mg/dL and average SG were determined from the latest 14 days of device use. Comparisons between groups were conducted using t-tests (Mann Whitney U test when data were non-normal) at ≤0.05. Duration of insulin action (DIA) distributions were also described.

Results: The median PC3 of the overall group was 32.5% (range 0-100%). The upper half of the group (≥32.5%) showed significantly higher TIR (57.8% vs 50.5%, p<0.0001), lower TAR (40.2% vs 47.8%, p<0.0001), and lower SG (175.7 mg/dL vs 190.8 mg/dL, p<0.0001), compared with the lower half (<32.5%). There was no significant change in TBR (1.9% vs 1.8%, p=0.77). Of the 857 users, 55.2% had DIA >3 hours (3.6±0.84; range 2-8). The average DIA of the upper half and the lower half were 3.4±0.8 hours and 3.8±0.8 hours, respectively (NS).

Conclusion: InPen™ SIP users who delivered at least 1 correction dose a day within 3 hours of a previous dose achieved overall higher TIR without an increase in TBR, when compared to those who administered correction insulin >3 hours after their previous dose.

Disclosure

G. Im: Employee; Medtronic. M. Smith: Employee; Medtronic. J. Macleod: Employee; Medtronic. R. A. Vigersky: Employee; Medtronic.
1114-P: Patient-Reported Outcomes (PROs) during a Study of Feasibility of Continuous Glucose Monitor (CGM) Use in Publicly Insured Youth with Type 2 Diabetes (T2D)
Authors: TANENBAUM MOLLY L. , HANES SARAH , HOOD KOREY K. , MAAHS DAVID M. , SHAH SEJAL
Published: June 2023

Publicly insured youth of minority and lower SES backgrounds are disproportionately impacted by the burden of T2D. The role of CGM use in this population is understudied, and patient-reported outcomes are important to assess while examining feasibility and acceptability of CGM adoption. This study assessed PROs during a feasibility study of CGM use. Youth were provided or prescribed flash CGM using established clinic workflows; PROs were collected from youth and parents at baseline, 3 and 12-month visits using age-appropriate measures (PAID-diabetes distress; PedsQL-health-related quality of life; PROMIS Global Health; DTA-diabetes technology attitudes). Baseline and 3-month data are presented. Participants at baseline included 30 youth with T2D (M age 15.1 years; 53% female; 90% Hispanic; 60% Spanish-speaking; 87% using insulin; M HbA1C 10.2%); 19 parents completed PROs at baseline. Parents and youth had moderate-to-positive attitudes about diabetes technology. Youth endorsed fair levels of global health; and youth and parents endorsed fair general and diabetes-related health-related quality of life. These PROs point to potential areas for future study to understand sources of lower self-reported health and quality of life, and to develop tailored interventions to address PROs while supporting CGM use in publicly-insured youth with T2D.

Disclosure

M.L.Tanenbaum: None. S.Hanes: None. K.K.Hood: Consultant; Cecelia Health. D.M.Maahs: Advisory Panel; Medtronic, LifeScan Diabetes Institute, MannKind Corporation, Consultant; Abbott, Research Support; Dexcom, Inc. S.Shah: Research Support; Boehringer-Ingelheim, Takeda Pharmaceutical Co., Ltd.
1132-P: It Takes 6!—Recruiting Marginalized Youth with T1D for Shared Medical Appointments (SMA) Pilot Study
Authors: GRUNDMAN JODY , MAJIDI SHIDEH , PERKINS AMANDA G. , STREISAND RANDI , MONAGHAN MAUREEN , MARKS BRYNN E.
Published: June 2023

Introduction: Minority youth are underrepresented in diabetes technology trials. An ongoing pilot study is recruiting 20 publicly insured, insulin pump naive youth ages 8-12 with T1D who identify as NHB or Latinx with recent HbA1c >8% to participate in a study using SMAs to improve T1D self-management and sustained CGM use. We aimed to identify the most successful recruitment strategies.

Methods: Potentially eligible youth are identified through weekly review of diabetes appointments. Families are then contacted in-person at a clinic visit, by phone, or text-message. We reviewed the number of in-person, phone, and text-message attempts for all eligible participants, as well as the number of youth who enrolled, refused, or who have not yet been successfully contacted.

Results:79 youth were identified as potentially eligible. 56% (n=44, 16±13 contact attempts) have been successfully contacted; 18% (n=14, 6±4 contact attempts) enrolled. 64% (n=9/14) of enrolled and 18% (n=12/65) of non-enrolled were approached at a clinic visit, 14% (n=2/14) of enrolled and 40% (n=26/65) of non-enrolled via phone, and 50% (n=7/14) of enrolled and 46% (n=30/65) of non-enrolled via text-message (p<0.001). 38% (n=6/16) of those who scheduled an enrollment visit after being contacted by phone/text attended the visit versus 63% (n=10/16) contacted at a clinic visit (p<0.001). 38% (n=30, 10±9 contact attempts) refused to participate; 27% (n=9) did not want to travel to the study site, 17% (n=5) refused CGM, and 53% (n=16) declined research participation. 46% (n=35, 12±5 contact attempts) have not yet been successfully contacted.

Conclusions: Historically marginalized youth enrolling in this SMA study required an average of 6 contact attempts for study participation. Purposeful in-person recruitment strategies, being mindful of the low rates of technology use among this community and mistrust in the healthcare system, is needed to promote diversity and inclusion in T1D research.

Disclosure

J.Grundman: Research Support; American Diabetes Association, Dexcom, Inc. S.Majidi: None. A.G.Perkins: Research Support; Tandem Diabetes Care, Inc., Dexcom, Inc. R.Streisand: None. M.Monaghan: Employee; National Institute of Diabetes and Digestive and Kidney Diseases, Research Support; American Diabetes Association. B.E.Marks: Research Support; Tandem Diabetes Care, Inc., Dexcom, Inc., Medtronic.

Funding

American Diabetes Association (7-21-PDFHD-09 to J.G.)
1137-P: Improvements in Diabetes-Related Quality of Life (DRQL) and Emotional Distress with Hybrid Closed-Loop (HCL) Technology in Marginalized Families with Suboptimally Controlled Type 1 Diabetes (T1D)
Authors: PERKINS AMANDA G. , GRUNDMAN JODY , MEIGHAN SEEMA , MONAGHAN MAUREEN , STREISAND RANDI , MARKS BRYNN E.
Published: June 2023

Background: Prior HCL studies enrolling participants with well-controlled T1D and limited financial, racial-ethnic, and socioeconomic diversity have shown limited success in improving patient-reported outcomes (PROs). We evaluated changes in PROs among marginalized youth with T1D and their parents after 6 months of Tandem t:slim X2 insulin pump with Control-IQ technology use.

Methods: This non-randomized 6-month pilot study enrolled 15 publicly insured, non-Hispanic Black (NHB) youth with T1D and hemoglobin A1c (HbA1c) ≥10% (Mage 14.6 ± 3.7 yrs, MT1Dduration 8.5 ± 4.8 yrs, MA1c11.9±1.4%). Youth and parent PROs at baseline and 6-months were compared using paired t-tests. The following constructs were assessed using validated PROs: DRQL using T1D and Life (T1DAL), emotional distress using Problem Areas in Diabetes (PAID), positive expectancy of technology using INSPIRE, and self-management behaviors using Diabetes Management Questionnaire (DMQ).

Results: Thirteen participants completed the study. HbA1c decreased from 11.7±1.3% to 9.6±1.6% over 6 months (p=0.001). TIDAL scores increased among parents and youth (p-T1DAL +7.1 to 70±13, p=0.01; y-T1DAL +8 to 69±12, p=0.03). PAID scores decreased among parents and youth (p-PAID -25 to 43±30, p=0.01; y-PAID -19.4 to 23±19, p=0.02). There were no changes in parent or child INSPIRE (p=0.23, p=0.88) or DMQ scores (p=0.44, p=0.16).

Conclusions: Six months of Tandem t:slim X2 insulin pump with Control-IQ technology in marginalized youth with T1D improved HbA1c, DRQL, and diabetes-related distress among parents and youth despite no change in diabetes self-management behaviors or decrease in positive expectancy of HCL. Including diverse populations in T1D research and supporting equal access to HCL technology for all people with T1D may demonstrate psychosocial benefits with no additional burden for youth and their parents.

Disclosure

A.G.Perkins: Research Support; Tandem Diabetes Care, Inc., Dexcom, Inc. J.Grundman: Research Support; American Diabetes Association, Dexcom, Inc. S.Meighan: Speaker's Bureau; Dexcom, Inc. M.Monaghan: Employee; National Institute of Diabetes and Digestive and Kidney Diseases, Research Support; American Diabetes Association. R.Streisand: None. B.E.Marks: Research Support; Tandem Diabetes Care, Inc., Dexcom, Inc., Medtronic.

Funding

Tandem Diabetes Care, Inc. (TDC20210226); National Institutes of Health (K23DK129827); Dexcom, Inc.
1140-P: Increasing Insulin Pump Use in Youth with New-Onset T1D
Authors: VAKHARIA MILI , BUCKINGHAM DON A. , LYONS SARAH , DESALVO DANIEL , SONABEND RONA Y. , KIM GRACE K.
Published: June 2023

Background: Insulin pump therapy is associated with enhanced quality of life (QoL) and lower HbA1c levels in youth with T1D. At our institution, we noted underutilization of insulin pumps and variability in prescribing practices. Thus, we led a quality improvement initiative to increase insulin pump use in youth age <18 years with new-onset T1D (duration <1 year) from baseline of 17% to >25% from January 2021 to November 2022.

Methods: A series of Plan-Do-Study-Act cycles began at one of our three campuses with spread to all locations, including education of diabetes educators and providers about a newly created pump initiation algorithm with action plan for sick day management, standardized prescribing recommendations with intent to mitigate prescribing biases, early introduction of pumps by 90 days from diagnosis, and advanced scheduling of post-pump follow ups.

Results: P-Chart (Figure 1) shows an increase in percentage of patients with new onset T1D on insulin pump therapy from a process average of 17% to 21%.

Conclusion: Our QI efforts on standardizing the approach to pump therapy initiation and multidisciplinary education led to an increase in insulin pump uptake in our new-onset T1D cohort. We plan to evaluate improvement in HbA1c levels, pump related hospitalization rates, and impact on QoL in our patient cohort.

Disclosure

M.Vakharia: None. D.A.Buckingham: None. S.Lyons: None. D.Desalvo: Consultant; Dexcom, Inc., Research Support; Insulet Corporation. R.Y.Sonabend: None. G.K.Kim: None.