bluuebunny/crossref_metadata_2025 huggingface dataset:
867-P: Empagliflozin-Based Quadruple Therapy vs. Insulin Glargine–Based Therapy in Type 2 Diabetes—Three-Year Follow-up Data
Authors: JEONG KU EU , OH TAEKEUN
Published: June 2023

Objectives: To directly compare the long-term effectiveness and durability of sodium glucose co-transporter 2 (SGLT2) inhibitor, an empagliflozin-based quadruple therapy and insulin glargine-based therapy in patients with poorly controlled type 2 diabetes (T2D).

Research Design and Methods: Eligibility for this 3-year, open-label, prospective observational study was T2D patients (HbA1c, 7.5 - 12.0%) despite three distinct OADs (metformin, 2000 mg/day; dipeptidyl peptidase-4 inhibitor, maximal dose; and glimepiride ≥6 mg/day) between January 2017 and December 2021. Empagliflozin (25 mg/day, n = 167) or insulin glargine (n = 166) was added as the next agent. Outcomes included the time-to-treatment adjustment, changes in HbA1c level, and safety. Propensity score matched comparison and Kaplan-Meier estimation analysis were used.

Results: The estimated median time to treatment adjustment for empagliflozin group was 36.1 months (95% confidential interval [CI], 31.1 - 41.2), which was significantly longer than 18.3 months for the insulin glargine-based therapy (95% CI, 14.5 - 22.0). The mean change in HbA1c from baseline to month 36 were -1.5±1.0% and -1.0±1.4% in the empagliflozin group and the insulin glargine group, respectively (P=0.043). FPG showed a similar trend, although there was no statistical significance (-61.3±54.5 mg/dL vs -4.0±97.5 mg/dL, empagliflozin and insulin glargine group, respectively, P=0.129). Body weight showed a significant decrease in the empagliflozin group (-3.1±3.7 kg, P=0.003), whereas a significant increase in the insulin glargine group (3.2±2.6 kg, P<0.001).

Conclusions: This study demonstrated that the effectiveness of empagliflozin as a quadruple combination therapy has been sustained for 3 years. In general, empagliflozin treatment was better than insulin glargine-based combination therapy.

Disclosure

E.Ku: None. T.Oh: None.
870-P: Empagliflozin and the Risk of Gout—Analysis from the Empagliflozin Comparative Effectiveness and Safety (EMPRISE) Study
Authors: TESFAYE HELEN , PAIK JULIE M. , ZABOTKA LUKE , HTOO PHYO T. , SCHMEDT NIKLAS , KOENEMAN LISETTE , SEMAN LEO J. , WEXLER DEBORAH J. , PATORNO ELISABETTA
Published: June 2023

Hyperuricemia is frequently observed in patients with type 2 diabetes (T2D) and is associated with increased risk of gout. Empagliflozin lowers serum urate levels by enhancing its urinary excretion. Using claims data from 2 commercial insurance datasets and Medicare (2014-2019), we evaluated the association between treatment with empagliflozin and the risk of incident gout in routine clinical practice. After excluding patients with a history of gout or gout medications, we identified 102,262 pairs of 1:1 propensity score-matched adults with T2D initiating empagliflozin or a DPP4 inhibitor (DPP4i) (Cohort 1), and 131,216 pairs initiating empagliflozin or a GLP-1 receptor agonist (GLP-1RA) (Cohort 2). We estimated pooled HR and RD/1,000 PY with their 95% CI adjusting for 141 baseline covariates and conducted stratified analyses within multiple subgroups (Table). Over a mean follow-up of ~8 months on treatment, the risk of gout was lower in patients initiating empagliflozin compared with patients initiating DPP4i [HR, 0.69 (0.60, 0.79); RD -2.27 (-3.08, -1.46)] or GLP-1RA [HR 0.83 (0.73, 0.94); RD -0.99 (-1.66, -0.32)]. Results were consistent within sex, age, BMI, HF, CKD subgroups and among users of diuretics (Table). In clinical practice, the initiation of empagliflozin was associated with a lower risk of incident gout compared with the initiation of DPP4i or GLP-1RA.

Disclosure

H.Tesfaye: None. J.M.Paik: None. L.Zabotka: None. P.T.Htoo: Employee; Johnson & Johnson. N.Schmedt: Employee; Boehringer Ingelheim International GmbH. L.Koeneman: Employee; Eli Lilly and Company, Stock/Shareholder; Eli Lilly and Company. L.J.Seman: Employee; Boehringer Ingelheim Pharmaceuticals Inc. D.J.Wexler: Other Relationship; Novo Nordisk A/S. E.Patorno: Research Support; Boehringer Ingelheim Inc., National Institutes of Health, Patient-Centered Outcomes Research Institute, US Food and Drug Administration.
874-P: Effect on Renal Function of SGLT2i Treatment in Hospitalized Patients with Type 2 Diabetes—A Real-World Study
Authors: BASHKIN AMIR , KRUZEL-DAVILA ETTY , TZFONI ITAI
Published: June 2023

Background: SGLT2-I use is expanding greatly; however, temporary treatment hold is recommended in high risk states for kidney failure. Hospitalization is often associated with such risk, so the present study aimed to evaluate the effect on kidney function of SGLT2-I treatment in-hospital.

Methods: This retrospective case-control study conducted in internal medicine patients included only those treated with SGLT2-I for >24 hours, and creatinine level was tested up to 48 hours before the start of treatment and after the end. Change in renal function was determined per eGFR (CKD-EPI formula). Factors most influencing in-hospital renal function were identified using backward regression.

Results: Among 186 patients included, 66.7% (124) were male, mean age 66.4±8.3 years. Main reasons for hospitalization were atherosclerotic CVD 23.7% (44), heart failure 17.2% (32), and infectious disease 15.6% (29). Median in-hospital SGLT2-I use was three days (interquartile range 2-5 days) and 73.1% (144) received SGLT2-I before hospitalization. Prior eGFR was not low in most participants: in 65.1% (121) >60 ml/min/1.73 m2, and in only 13.4% <45. A high correlation was found between eGFR before and after treatment (r=0.8, p<0.001), with no drop in eGFR for the majority; however in 21% (39) it declined >10%, in 11.3% (21) >20%, in 4.8% (9) >30%, and in only 2.7% (5) >40%. The following factors were found to be significantly associated with a decrease in eGFR both >20% and >30%, including in-hospital initiation of SGLT2-I, in-hospital furosemide treatment, a background of insulin treatment, and age >70 years. In 93 patients treated with SGLT2-I prior to hospitalization and who did not receive in-hospital furosemide, none had a drop in eGFR >30% and only two >20%.

Summary: In-hospital SGLT-2 treatment in type 2 diabetes is likely very safe from a renal standpoint in those treated pre-admission with SGLT2-I and not receiving furosemide.

Disclosure

A.Bashkin: None. E.Kruzel-davila: None. I.Tzfoni: None.
878-P: Absolute Amount of Urinary Glucose Excretion, Not the Change, Is the Measure Determinant for the Effects of SGLT2 inhibitors
Authors: HAMAMOTO YOSHIYUKI , YAMADA YUICHIRO , SEINO YUTAKA
Published: June 2023

SGLT2 inhibitors exhibit hypoglycemic effect via increased urinary glucose excretion (UGE) by inhibiting glucose reabsorption in the kidney. Although the effects of SGLT2 inhibitors are theoretically dependent on UGE, clinical trials have shown renoprotective effect even in severely impaired kidney function. Thus, we aimed to investigate the relationship between UGE and various parameters before and after the administration of SGLT2 inhibitors. The patients newly administered SGLT2 inhibitors and measured 24-hour UGE before and after the administration during hospitalization for diabetes education were included. Body weight (BW), blood ketone levels, hematocrit (Ht), eGFR, and 7-point SMBG (DBG) were measured, and the correlations between the parameters before(b-), after (a-) and the change (Δ-) were analyzed by simple linear regression. A total of 32 patients (age 59.3±10.9 years, 19 males) were included (empagliflozin 5, tohogliflozin 6, dapagliflozin 2, canagliflozin 4, luseogliflozin 15). The mean A1C and BW were 8.8±1.2% and 77.7±11.5kg, and mean UGE, average of DBG at baseline were 15.4 ± 27.5g/day and 10.3±2.0mM/L, respectively. As shown in table, ΔDBG showed correlation only with UGE before and after administration but not with ΔUGE. In conclusion, hypoglycemic effect of SGLT2 inhibitors is dependent on absolute amount of UGE but not on ΔUGE after administration.

Disclosure

Y.Hamamoto: None. Y.Yamada: Speaker's Bureau; Novo Nordisk Pharma Ltd., Teijin Pharma Limited, Ono Pharmaceutical Co., Ltd., Sumitomo Pharma Co., Ltd. Y.Seino: Research Support; Terumo Corporation, Nippon Boehringer Ingelheim, Arkray Marketing, Taisho Pharmaceutical Holdings Co., Ltd., Novo Nordisk, Ono Pharmaceutical Co., Ltd., Speaker's Bureau; Merck & Co., Inc., Nippon Boehringer Ingelheim, Arkray Marketing, Taisho Pharmaceutical Holdings Co., Ltd., Novo Nordisk, Ono Pharmaceutical Co., Ltd.
88-LB: The Microvascular Effects of the Noninsulin Standard Antidiabetic Medications—A Literature Systemic Review of Randomised Controlled Clinical Studies
Authors: WEN SONG
Published: June 2023

Backgrounds: As many advances have been made in recent decades in the understanding of the pathophysiology of diabetic macrovascular complications and novel pharmacological approach, few investigations on the importance and how the hypoglycemic medications that are currently available in reducing diabetic microvascular complications, though this amelioration can be achieved via intensive glycemic control such as insulin therapy. This study reviews the implications of diabetic microvascular complications by non-insulin antidiabetic medications.

Methods: We searched and screened the literature of randomized clinical trials that reported the effects of drugs on diabetic microvascular complications, including diabetic nephropathy (DN), diabetic peripheral neuropathy (DPN), diabetic retinopathy (DR) from multiple clinical databases. We extracted the indices of estimated glomerular filtration rate (eGFR) and urinary albumin to creatinine ratio (UACR) or urinary albumin excretion rate (UAE), and indices for DPN or DR. Comparisons were made between certain classes of non-insulin antidiabetic medications.

Main Results: The analyses showed the urinary albumin to creatinine ratio (UACR) or urinary albumin excretion rate (UAE) showed variations in both the effects and significance of the decline. In addition, due to the unavailable of a unified standard metric index on DPN or DR, we compiled different common measures on the DPN or DR, and also found disparities in both the effect and significance of each medication.

Conclusions: Till now, all the reviewed non-insulin hypoglycemic medications showed different degrees of preventing diabetic microvascular complications. As emerging or ongoing trials will reveal the implications of diabetic microvascular prevention, more results with higher quality in comparative efficacy between different classes of non-insulin antidiabetic medications could serve as more powerful evidence for recommendation and utilized in clinical personalized treatment practices.

Disclosure

S. Wen: None.

Funding

Fudan Zhangjiang Clinical Medicine Innovation Fund Project (KP0202118)
881-P: Heterogenous Effects of SGLT2 Inhibitors on Nephrolithiasis in Older Adults with Type 2 Diabetes
Authors: LI YUJIA , SHAO HUI , GUO YI , ZHANG YONGKANG , FONSECA VIVIAN , SHI LIZHENG , BIAN JIANG , WINTERSTEIN ALMUT G. , GUO JINGCHUAN
Published: June 2023

Mechanistic studies suggested that sodium-glucose cotransporter-2 inhibitors (SGLT2i) may reduce the risk of nephrolithiasis. We aimed to further assess this association using a real-world population of type 2 diabetes (T2D) patients. Among a 15% random sample of 2017-2018 Medicare fee-for-service beneficiaries with T2D, we identified new initiators of SGLT2i or dipeptidyl peptidase-4 inhibitors (DPP4i). We followed the cohort until the first medical encounter with diagnosis of nephrolithiasis, death, or 12/31/2018. Inverse probability treatment weighting was used to balance the baseline covariates including sociodemographics, prior comorbidities and medications. Of 116,506 included individuals (age 72±10 years, 53% women), 0.96% developed nephrolithiasis over a median follow-up of 360 days. The crude incidence rate was 9.89 (95% confidence interval [CI] 8.49-11.52) and 11.02 (95% CI 10.34-11.73) per 1000 person-years in the SGLT2i group and DPP4i group, respectively. SGLT2i exposure was associated with a significantly lower risk of nephrolithiasis (hazard ratio 0.81 [95% CI 0.66-0.99]). This effect was more evident in men, non-Hispanic Black (NHB) individuals, and those without a history of nephrolithiasis. (Figure) SGLT2i was associated with a lower risk of nephrolithiasis, and the effect was more pronounced in men, NHB, and those without a history of nephrolithiasis.

Disclosure

Y.Li: None. H.Shao: Consultant; Lilly Diabetes. Y.Guo: None. Y.Zhang: None. V.Fonseca: Consultant; Abbott, Corcept Therapeutics, Eli Lilly and Company, Other Relationship; BRAVO4HEALTH, LLC, Research Support; Fractyl Health, Inc., Stock/Shareholder; Amgen Inc. L.Shi: None. J.Bian: None. A.G.Winterstein: Consultant; Bayer Inc., Genentech, Inc., Ipsen Biopharmaceuticals, Inc., Research Support; Merck Sharp & Dohme Corp. J.Guo: Consultant; Pfizer Inc., Research Support; PhRMA Foundation, NIH - National Institutes of Health.
883-P: Effects of YG1699 and Sotagliflozin on Blood Glucose and Urinary Glucose Excretion in SD Rats
Authors: LI JACKY , XU ROGER W. , HE JIAOJUAN , LAPUERTA PABLO
Published: June 2023

Background and Aims: YG1699, a dual inhibitor of SGLT1 and SGLT2, recently showed greater glucose lowering than dapagliflozin in patients with type 1 diabetes. This study examined the potential mechanism of glucose reduction in rats.

Materials and methods: Sprague Dawley rats received either 0.3, 1, 3, or 10mg/kg of YG1699, or 3, 10mg/kg of LX4211 (sotagliflozin), or vehicle by oral gavage (n=8 per group). Fifteen minutes later, 2g/kg glucose was orally administered, and blood glucose was measured at 0, 20, 40, 60, 90, 120, and 150 mins. The area under the curve (AUC) for glucose over time was calculated. In the urinary glucose excretion (UGE) test, 24-hour urine samples were collected after vehicle, 1, 3, or 10mg/kg doses of YG1699, or 3mg/kg sotagliflozin (n=5 per group). Differences between groups were evaluated by ANOVA.

Results (See Table 1): 1, 3, and 10mg/kg doses of YG1699 and 3and 10mg/kg of sotagliflozin reduced glucose AUC and increased UGE compared to vehicle.

Conclusion: Significant reductions in post-prandial glucose with YG1699 and sotagliflozin are associated with increased UGE. Glucose AUC after 10mg/kg YG1699 was less than 50% of vehicle.

Disclosure

J.Li: None. R.W.Xu: Consultant; Youngene Therapeutics. J.He: None. P.Lapuerta: Board Member; 4M Therapeutics, Consultant; Youngene Therapeutics, ViaCyte, Inc., Encuragen, Capsida, Provention Bio, Inc., Decibel Therapeutics, Crinetics, Next Phase Therapeutics.
887-P: Renal Benefit of Dapagliflozin Therapy in Hyperfiltering Type 2 Diabetes Patients
Authors: BASKOY GOZDE , QIN YUEJUAN , CERSOSIMO EUGENIO , SOLIS-HERRERA CAROLINA , ADAMS JOHN M. , DEFRONZO RALPH A. , TRIPLITT CURTIS L.
Published: June 2023

Aim: To investigate the benefits of dapagliflozin [DAPA] on renal hemodynamics in type 2 diabetes patients [T2D] with glomerular hyperfiltration.

Design and Methods: 24 T2D with elevated [HYPER] and normal [NORMO] GFR, measured by Iohexol, randomized to either DAPA, 10mg/day [DAPA/HYPER, n=6; DAPA/NORMO, n=6] or metformin+glipizide [CON/HYPER, n=6; CON/NORMO, n=6] for 4 months. Hyperfiltration was defined as GFR>125ml/min/1.73m2. Renal plasma (blood) flow [RP(B)F] measured with PAH divided by (1-Hct), mean arterial pressure [MAP], filtration fraction [FF] and renal vascular resistance [RVR] were determined before and after treatment.

Results: A1c[%] decreased similarly in DAPA/HYPER (8.3±0.2 vs. 6.8±0.2), CON/HYPER (8.7±0.3 vs. 7.2±0.1), DAPA/NORMO (8.6±0.3 vs. 7.3±0.2) and CON/NORMO (8.2±0.3 vs. 7.4±0.2). Body weight[Kg] was reduced in DAPA/HYPER (89±4 vs. 84±4) and DAPA/NORMO (90±3 vs. 87±2) but not in CON/HYPER (86±4 vs. 87±3) and CON/NORMO (87±4 vs. 91±3) (p<0.05). GFR declined by 17% in DAPA/HYPER and by 8% in DAPA/NORMO (both, p<0.05) but did not change in CON. FF and RVR fell in DAPA but not in CON. Renal hemodynamics at baseline [PRE-Tx] and after 4 months [POST-Tx] are shown in the table.

Conclusion These results indicate that dapagliflozin, but not metformin+glipizide therapy, normalizes glomerular hyperfiltration and reduces renal vascular resistance in hyperfiltering type 2 diabetes patients.

Disclosure

G.Baskoy: None. Y.Qin: None. E.Cersosimo: None. C.Solis-herrera: None. J.M.Adams: None. R.A.Defronzo: Advisory Panel; AstraZeneca, Bayer Inc., Boehringer-Ingelheim, Novo Nordisk, Research Support; AstraZeneca, Boehringer-Ingelheim, Merck & Co., Inc., Speaker's Bureau; AstraZeneca. C.L.Triplitt: Speaker's Bureau; Novo Nordisk.

Funding

AstraZeneca; Texas Diabetes Institute
894-P: Sodium–Glucose Cotransporter 2 Inhibitors and Risk of Dementia in People with Type 2 Diabetes—A Population-Based Cohort Study
Authors: TANG HUILIN , ELIZABETH SHAABAN C. , WU YONGHUI , MAGOC TANJA , DONAHOO WILLIAM T. , DEKOSKY STEVEN T. , BIAN JIANG , GUO JINGCHUAN
Published: June 2023

Background: SGLT2 inhibitors show promising associations with decreased dementia risk. However, it is unclear which population subgroups would benefit the most.

Methods: Using electronic health records data from the OneFlorida+ Clinical Research Network, we identified individuals with T2D (aged ≥ 50 years) who initiated SGLT2 inhibitors or sulfonylureas from Jan 1, 2016 - Jan 31, 2022. The study outcome was incident dementia. We applied a causal machine learning approach - doubly robust learning - to estimate the conditional average treatment effects (CATE) in the overall cohort and heterogeneous treatment effect subgroups using a summary decision tree model.

Results: Among 36,756 individuals with T2D, 3.2% in the SGLT2 inhibitor group and 6.4% in the sulfonylureas group developed dementia over a 3.4-year follow-up. In the overall cohort, SGLT2 inhibitors were associated with a lower risk of dementia (Risk Difference [RD], -10.3%; 95% confidence interval [CI], -12.0% to -8.6%) compared to sulfonylureas. We identified four subgroups with varying risks for dementia, determined by traumatic brain injury, ever-smoking, and epilepsy (Figure).

Conclusion: SGLT2 inhibitors were associated with a lower risk of dementia in people with T2D compared to sulfonylureas, with significant variability across subgroups.

Disclosure

H.Tang: None. C.Shaaban: None. Y.Wu: None. T.Magoc: None. W.T.Donahoo: None. S.T.Dekosky: Advisory Panel; Acumen Pharmaceuticals, Cognition Therapeutics, Other Relationship; Biogen, Prevail Pharmaceuticals, UpToDate, Up-To-Date. J.Bian: None. J.Guo: Consultant; Pfizer Inc., Research Support; PhRMA Foundation, NIH - National Institutes of Health.

Funding

National Institute of Diabetes and Digestive and Kidney Diseases (R01DK133465)
897-P: Real-World Glycemic Outcomes of >400 Adults with Type 2 Diabetes Using the Omnipod 5 Automated Insulin Delivery (AID) System with Cloud-Based Data Management
Authors: PETERS ANNE L. , PASQUEL FRANCISCO J. , HUYETT LAUREN M. , SNOW KENNETH , MENDEZ JOSE J. , HADJIYIANNI IRENE , LY TRANG T.
Published: June 2023

The Omnipod 5 AID System is a novel tubeless hybrid closed-loop system approved for use in people with type 1 diabetes ages 2 and up and was recently evaluated in adults with type 2 diabetes (T2D) during an 8-week outpatient feasibility study. The System allows for personalized therapy through customizable glucose targets from 110-150mg/dL in 10mg/dL increments and enables automatic upload of data for all users, facilitating unprecedented access to evaluate real-world outcomes. Continuous glucose monitoring (CGM) and insulin data from Omnipod 5 users with T2D aged ≥18y in the US with ≥90 days of data available in the cloud-based data management system were included. Data from 417 users with sufficient CGM data (≥75% of days with ≥220 readings) and using the lowest target (110mg/dL) for ≥50% of the time, aged 18 to 49y (n=108), 50 to 64y (n=156), and ≥65y (n=153), were available at the time of analysis. Users were aged mean±SD 57.9±12.8y with median 131 days of system use. Outcomes are shown in the Table. Median time in target range (70-180mg/dL) was 68.7%, 71.7%, and 74.0% for each age group, respectively. Time spent in hypoglycemia (<70mg/dL) was low (median 0.3%) in each age group. These data are the first to provide valuable insights to the highly favorable impact of AID on real-world glycemic outcomes among adults with T2D using the Omnipod 5 System.

Disclosure

A.L.Peters: Advisory Panel; Abbott Diabetes, Medscape, Novo Nordisk, Vertex Pharmaceuticals Incorporated, Zealand Pharma A/S, Research Support; Abbott Diabetes, Dexcom, Inc., Insulet Corporation, Stock/Shareholder; Omada Health, Inc., Livongo. F.J.Pasquel: Consultant; Dexcom, Inc., Medscape, Research Support; Dexcom, Inc., Ideal Medical Technologies. L.M.Huyett: Employee; Insulet Corporation, Stock/Shareholder; Insulet Corporation. K.Snow: Employee; Insulet Corporation. J.J.Mendez: None. I.Hadjiyianni: Employee; Insulet Corporation, Stock/Shareholder; Insulet Corporation, Eli Lilly and Company. T.T.Ly: Employee; Insulet Corporation.

Funding

Insulet Corporation
901-P: Real-World Evidence Supporting the Use of Advanced Hybrid Closed-Loop in Poorly Controlled Type 1 Diabetic Patients
Authors: RATHMES GIULIA , GRAF SOPHIE F. , CAVELTI-WEDER CLAUDIA
Published: June 2023

Background: The advanced hybrid closed loop (a-HCL) algorithm of the MiniMed 780G includes automated basal and correction bolus insulin and offers the possibility to choose between three glucose targets. The aim was to evaluate the effectiveness of the a-HCL compared to its predecessors, the predictive low glucose suspension (PLGS, MiniMedTM 640G) and the standard hybrid closed loop (s-HCL, MiniMedTM 670G), and to assess which group of patients benefitted the most from the implementation of the a-HCL.

Methods: Type 1 diabetes patients >18 years of age followed at the University Hospital Zurich (USZ), who initially used a PLGS or a s-HCL and were subsequently switched to the a-HCL until December 2021, were included in the study. Glucose metric data regarding HbA1c, time in range (TIR), time above range (TAR), time below range (TBR), average sensor glucose (SG), and variation coefficient (VC) was retrospectively analyzed before and after the conversion to the a-HCL.

Results: 88 patients were screened, and 71 patients were included in the analyzes. After the implementation of the a-HCL, there was a significant decrease in HbA1c (pre 7.3±0.7% to post a-HCL 6.8±0.5%, p<0.001), SG (8.8±1.2 mmol/L to 7.9±0.8 mmol/L, p<0.001) and a significant increase in TIR (73.5% to 81%, p<0.001). Additionally, a significant decrease in TAR (23% to 17%, p<0.001) was observed, while TBR (1.5% to 1%, p=0.573) and the VC did not significantly change (33±6.6% to 32.4±5.8%, p=0.313). The changes in glycemic control were most pronounced in patients with a higher baseline HbA1c, a higher baseline SG, a lower baseline TIR, and a higher VC, all measures of poor glycemic control. Furthermore, patients with a body-mass index (BMI) >30kg/m2 achieved the greatest changes in HbA1c and TIR.

Conclusion: In conclusion, our data support the use of a-HCL in all patients, but especially in poorly controlled type 1 diabetic patients with a high BMI.

Disclosure

G.Rathmes: None. S.F.Graf: None. C.Cavelti-weder: None.
908-P: Incorporating Shared Decision Making (SDM) to Improve Adoption of Connected Insulin Pens (CIP)
Authors: ODUGBESAN ORI , XAVIER NEENA A. , WRIGHT TREVON , NELSON GRACE , FRIEDMAN JARED , ALEPPO GRAZIA , O'MALLEY GRENYE , MCKEE ALEXIS M. , MIYAZAKI BRIAN , MYERS ALYSON K. , EBEKOZIEN OSAGIE ,   T1D EXCHANGE QUALITY IMPROVEMENT COLLABORATIVE (T1 DX-QI)
Published: June 2023

Background: CIP can improve glycemic control and quality of life for people with diabetes on multiple daily injections (MDI). Despite its benefits, providers may sub optimally prescribe CIP. The purpose of this study is to use quality improvement methods to successfully implement a validated attitude assessment to foster SDM conversations around CIP.

Method: The T1D Exchange recruited seven pediatric and adult diabetes centers to participate in this project from June - November 2022. The centers applied QI principles to implement the Diabetes Technology Attitude (DTA) questionnaire, a validated tool to facilitate SDM conversations. Positive responses prompted discussion about CIP. Each center contributed their data from a sample of people with Type 1 Diabetes (T1D) and Type 2 Diabetes on Insulin (T2D) who responded to the DTA.

Result: Eighty-eight people with diabetes and CGM but not on CIP naive completed the SDM tool. Over 70% of both T1D and T2D patients agreed that diabetes technology made their lives easier, does ‘more good than bad,’ and that they feel lucky to live in a time with so much technology (Figure 1). Sixty-nine percent of the cohort were prescribed CIP as a result of intentional SDM conversations based on the DTA results.

Conclusion: Validated SDM tools, such as DTA, can be a viable, low burden strategy to introduce conversations on the use of diabetes technology like CIP in clinical practice.

Disclosure

O.Odugbesan: None. A.K.Myers: Research Support; Neurocrine Biosciences, Inc. O.Ebekozien: Advisory Panel; Medtronic, Research Support; Eli Lilly and Company, Dexcom, Inc. D.T1d exchange quality improvement collaborative (t1: n/a. N.A.Xavier: Employee; Eli Lilly and Company, Speaker's Bureau; Boehringer Ingelheim and Eli Lilly Alliance. T.Wright: None. G.Nelson: None. J.Friedman: None. G.Aleppo: Advisory Panel; Medscape, Consultant; Bayer Inc., Insulet Corporation, Research Support; Dexcom, Inc., Eli Lilly and Company, Emmes, Insulet Corporation, Fractyl Health, Inc., WellDoc, Speaker's Bureau; Dexcom, Inc. G.O'malley: Research Support; Dexcom, Inc., Abbott Diabetes, Tandem Diabetes Care, Inc., Omnipod, Eli Lilly and Company. A.M.Mckee: Advisory Panel; Medtronic, Novo Nordisk. B.Miyazaki: None.

Funding

Eli Lilly and Company
910-P: Real-World Clinical Data on the Extended Infusion Set
Authors: KWA TIMOTHY , ZHANG GINA , ROY ANIRBAN , LIU MARGARET , ANSELMO EVAN , SHIN JOHN , COHEN OHAD , CHATTARAJ SARNATH
Published: June 2023

Objective: The Medtronic Extended infusion set (EIS) is the first and only infusion set approved for up to 7-day use. Prior studies established clinical safety and efficacy of the EIS. The purpose of this retrospective analysis was to assess real-world data on the EIS performance and user behaviors associated with the EIS including wear duration and asynchronous reservoir changes.

Methods: A limited launch of the EIS outside the US (OUS) included MiniMed™ 640G/670G/780G users. Due to regional legal requirements, aggregated pump data from EIS users were not separated from other user data. To identify EIS users, an algorithm was developed based on the expected behavior patterns associated with an infusion set change, e.g., tubing fills. From the same cohort, individuals using the EIS (n=108) versus regular 3-day sets (n=414) were identified by a mean or median time between substantial tubing fills. To assess synchronous and asynchronous set/reservoir changes, reservoir changes were determined based on pump rewind commands in the CareLink™ system.

Results: Mean EIS use lifetime was 6.74 days, with >70% of sets used for more than 6 days. No user complaint was received during limited launch. The EIS set change rate at 7 days (168 hrs) was 48.2%, and was comparable to the 48.9% rate of 3-day sets at 3 days (72 hrs). In addition, CareLink™ data indicated that while users with a total daily dose (TDD) of insulin less than 40 U may not require an asynchronous reservoir fill, some users with higher TDD did asynchronously and successfully change their reservoirs while retaining the infusion set.

Conclusion: In the OUS limited EIS launch, the EIS performed similarly to the pivotal trial results, with no user complaints. As expected, pump users with TDD less than 40 U changed the infusion set and reservoir at the same time on the seventh day. The product has launched in the US and may potentially reduce user burden by effectively halving the number of required infusion set changes compared to standard 3-day sets.

Disclosure

T.Kwa: Employee; Medtronic. G.Zhang: Employee; Medtronic. A.Roy: Employee; Medtronic. M.Liu: Employee; Medtronic. E.Anselmo: Employee; Medtronic. J.Shin: Employee; Medtronic. O.Cohen: Employee; Medtronic. S.Chattaraj: Employee; Medtronic.
911-P: Changes in Metrics of Continuous Glucose Monitoring during COVID-19 in Children and Adolescents with Type 1 Diabetes
Authors: YOUNG KIM HWA , SHIN SOHYUN , YOUNG KIM SE , KIM JAEHYUN
Published: June 2023

Background: Data on the changes in glucose control in pediatric patients with type 1 diabetes (T1D) affected by COVID-19 is lacking. We aimed to evaluate changes in metrics of continuous glucose monitoring (CGM) system during COVID-19 infection in children and adolescents with T1D.

Methods: We included 21 children and adolescents with T1D, aged younger than 20 years, with at least 70% of CGM readings during COVID-19. Symptoms of COVID-19 infection were investigated through a questionnaire. The effects of COVID-19 on metrics of CGM were assessed at five different time points [2 weeks before-COVID-19 (Time 1), 1 week before-COVID-19 (Time 2), 1 week during COVID-19 (Time 3), 1 week after COVID-19 (Time 4), and 2 weeks after COVID-19 (Time 5)].

Results: Of 21 patients (6 males and 15 females), mean age was 11.4 ± 4.7 years, and mean disease duration was 5.1 ± 4.8 years. All had at least one related symptoms (mean duration of symptoms of 5.2 ± 3.7 days); no one required hospitalization. Glucose management indicator (GMI) and the percentage of time spent above range (> 250 mg/dL) were significantly higher at Time 3 compared to Time 5 (7.8 ± 1.4 % vs 7.2 ± 1.4 %; P = 0.001 and 18.3 ± 18.5 % vs 13.0 ± 15.7 %; P = 0.016, respectively). According to the insulin delivery methods, GMI at Time 2 was significantly higher compared to Time 5 in patients treated with multiple daily injection (MDI) (n = 13) but not in those using continuous subcutaneous insulin infusion (CSII) (n = 6).

Conclusion: Pediatric patients with T1D experience mild COVID-19 infection with worsening glycemic control during COVID-19. The use of CSII is more effective in maintaining stable glycemic control during COVID-19 infection compared to MDI therapy.

Disclosure

H.Kim: None. S.Shin: None. S.Kim: None. J.Kim: None.
914-P: Veteran Experiences with Hybrid Closed-Loop (HCL) Insulin Delivery Systems in Type 1 Diabetes (T1D)
Authors: AZZAWI SHAMS , DEJONCKHEERE MELISSA , THOMPSON HOLLY , HURREN KATHRYN , LEONE VIRGINIA A. , BUSUI RODICA , PIATT GRETCHEN , LEE JOYCE M. , MIZOKAMI-STOUT KARA R.
Published: June 2023

While HCL systems are increasingly recommended, data regarding veteran experiences are limited. We performed semi-structured interviews to characterize veteran experiences with HCL systems at the VA Ann Arbor Healthcare System. We used qualitative description methodology to elicit participant experiences with HCL and identify factors that could improve practice. Semi-structured interviews were conducted with veterans with T1D using an HCL device for at least 6 months. The interview guide was developed based on a modified Theory of Planned Behavior, examining the domains of attitudes/knowledge, network support, and perceived behavioral control. Inductive thematic analysis of interview transcripts was performed to understand factors that contribute to the overall HCL experience. Nine HCL users (mean age 68 years, mean A1c 7.4%, mean diabetes duration 30 years, 78% Medtronic HCL users, 22% Tandem HCL users) were interviewed. Participants reported that HCL systems ease self-management burden, increase lifestyle flexibility, and enhance the perception of safety. However, challenges in alarm fatigue exist. Participants were satisfied with their outpatient multidisciplinary network support but noted significant gaps in inpatient support for HCL use. Lastly, participants reported an improved sense of confidence in diabetes management using HCL systems. Key facilitators for successful HCL use were a desire to stay healthy for their spouse and to avoid long-term diabetes complications. Our findings confirm that HCL systems improve self-management and enhance safety in veterans as well, similar with prior reports in non-veterans with T1D. Veterans felt supported in using these systems as outpatients though challenges remain for HCL systems in the inpatient setting. Future studies should focus on improving network support for inpatient use of these devices.

Disclosure

S.Azzawi: None. M.Dejonckheere: None. H.Thompson: None. K.Hurren: None. V.A.Leone: None. R.Busui: Board Member; American Diabetes Association, Consultant; Averitas Pharma, Inc., Lexicon Pharmaceuticals, Inc., Nevro Corp., Novo Nordisk, Roche Diagnostics, Procter & Gamble, Research Support; Novo Nordisk, Medtronic, National Institutes of Health. G.Piatt: None. J.M.Lee: Advisory Panel; GoodRx, Consultant; Tandem Diabetes Care, Inc. K.R.Mizokami-stout: None.

Funding

National Institute of Diabetes and Digestive and Kidney Diseases (P30DK020572-43S1)
916-P: The Demographic Variables Associated with Diabetes Technology Knowledge or Use in Adults with Type 2 Diabetes
Authors: YE YUTING , ACEVEDO-MENDEZ BERNARDO A. , IZARD STEPHANIE , MYERS ALYSON K.
Published: June 2023

Background: Studies in populations with type 1 diabetes highlight the racial-ethnic disparities in the use of diabetes technology. Our project aims to investigate racial-ethnic and socioeconomic disparities in diabetes technology knowledge and use in adult patients with type 2 diabetes (T2D) in ambulatory setting.

Method: We recruited adults aged 40 and older with T2D who visited one of four internal medicine practices between July 1, 2018 and June 30, 2021. We selected patients in the electronic record who use insulin, have English as a primary language, and have an email address. Eligible participants were invited to participate via an email link to a REDCap questionnaire. All variables were summarized descriptively using frequencies and percentages, and were compared across groups using Pearson’s Chi-Square Test or Fisher’s Exact Test.

Results: We included 116 patients in the analysis, most of whom were white (62%), elderly Medicare recipients. Those who are of racial-ethnic minoritized groups are less likely to have knowledge of CGM (p = 0.013) or insulin pumps (p = 0.001). Patients who have high school education or less have less awareness of insulin pumps (p = 0.041). Interestingly, neither awareness nor use of CGM or insulin pump were found to be associated with income.

Conclusion: This cross-sectional analysis suggests that racial-ethnic minoritized groups or those with lower education have lower knowledge of CGM or insulin pumps and this disparity cannot be explained by differences in socioeconomic status. Providers need to be aware of their potential implicit biases in relation to education and prescription of diabetes technology.

Disclosure

Y.Ye: None. B.A.Acevedo-mendez: None. S.Izard: None. A.K.Myers: Research Support; Neurocrine Biosciences, Inc.
919-P: Assessment of Eating Disorder Risk in Adolescents and Young Adults Starting an On-Body Automated Insulin Delivery (AID) System
Authors: TROJANOWSKI PAIGE J. , ESCOBAR ESTELLA , BERGET CARI , FORLENZA GREGORY P. , O'DONNELL HOLLY K.
Published: June 2023

Individuals with type 1 diabetes are at higher risk for eating disorders than the general population. Body image satisfaction and disordered eating are infrequently evaluated when starting an insulin pump, even though wearing additional technology may impact body image and/or eating behavior. This pilot study describes the use of the validated Screen for Early Eating Disorder Signs (SEEDS) questionnaire prior to and 3 mo after starting Omnipod 5 (OP5) in a small sample of adolescents and young adults (TABLE 1). Average SEEDS total scores, which indicate eating disorder risk, fell in the low risk category (≤68), with 73% of responders being identified as low risk at both time points. Compared to the SEEDS validation sample, participants were younger (15.1 v 19.2 yrs) and had slightly lower HbA1c’s (8.0 v 8.4) but had similar racial backgrounds and age at diagnosis. The SEEDS demonstrated very good to excellent reliability at both time points. No differences in overall or subscale SEEDS scores were observed between baseline and 3 mo follow-up (p>0.05). These preliminary results suggest that the SEEDS is a viable tool to assess eating disorder risk and body image concerns in adolescents and young adults who are starting a new AID system, such as OP5. Use of this self-report measure could improve detection of individuals at risk for disordered eating.

Disclosure

P.J.Trojanowski: None. E.Escobar: None. C.Berget: Consultant; Insulet Corporation, Dexcom, Inc., Other Relationship; Tandem Diabetes Care, Inc. G.P.Forlenza: Advisory Panel; Medtronic, Consultant; Dexcom, Inc., Insulet Corporation, Tandem Diabetes Care, Inc., Lilly Diabetes, Research Support; Medtronic, Abbott, Dexcom, Inc., Insulet Corporation, Tandem Diabetes Care, Inc. H.K.O'donnell: None.

Funding

National Institute of Diabetes and Digestive and Kidney Diseases (5T32DK063687); JDRF (5-ECR-2019-736-A-N)
930-P: Advanced Hybrid Closed-Loop System Is Associated with Increase in Tighter Glycemic Range—One-Year Observational Study
Authors: RIZZI ALESSANDRO , TARTAGLIONE LINDA , LAURA LEO MARIA , LUCACCINI PAOLI LORENZO , TOSTI GIULIA , POPOLLA VALENTINA , PITOCCO DARIO
Published: June 2023

Background and Aims: Advanced hybrid closed loop systems (AHCL) are associated with improvement of HbA1c and time in range (TIR). However AHCL give the possibility to gain even tighter glycemic control. Thus, the aim of this study was to evaluate the efficacy of AHCL to increase time spent in tighter glycemic range (TR, 70-140 mg/dl) and to assess any difference between younger and older subjects.

Methods: In an observational retrospective single center study, adults with T1DM using AHCL with predictive integrative derivative (PID) algorithm were enrolled. All participants were recruited at Diabetes Care Unit - Fondazione Policlinico Agostino Gemelli in Rome (IT). Data about TR and standardized metrics have been collected before starting AHCL and 3, 6, 9 and 12 months after AHCL initiation. We compared TR variation over time between younger (age <65 years) and older (≥65 years) subjects. Change in TR over time was evaluated with a linear mixed-effect model including age-group and presence of diabetic complications.

Results: We enrolled 75 subjects with T1DM, age 50.5 (14.2) years [mean (standard deviation)], 35 females (46%), duration of disease 24.7 (13.3) years. 17 subjects (23%) were older and 58 (77%) were younger. 39 (52%) subjects were already using an insulin pump before starting AHCL and 36 (48%) were on multiple daily injections. HbA1c before AHCL was 7.6 (0.98) and 12 months after ACHL was 7.2 (0.6) (p=0.03). TR significantly increased over 12 months in the overall populations (TR before AHCL 37.6% (15.3) vs TR 12 months 52.9 % (12.8), p<0.001). Age or presence of complications did not affect the improvement of TR (p=0.38). TR 50% corresponded to mean TIR 76.2%

Conclusions: AHCL is associated with significant improvement in tighter glycemic control. This improvement is not different between younger and older subjects. AHCL is an effective and safe system to aim to strict metabolic control in all subjects with T1DM.

Disclosure

A.Rizzi: None. L.Tartaglione: None. M.Leo: None. L.Lucaccini paoli: None. G.Tosti: None. V.Popolla: None. D.Pitocco: None.
931-P: Use of a Continuous Glucose Monitor System (CGM) in Latinx Patients with Type 2 Diabetes (DM2) Improves A1C and CGM Metrics—Real-Life Experience in a Latinx Diabetes Clinic
Authors: THATTE ARITA , WRIGHT LORENA A.
Published: June 2023

Objective: There have been few studies of CGM benefits in the Latinx population with DM2, an ethnic group disproportionately affected. We hypothesized that in this population, the use of CGM results in a greater % decrease of A1c than in those without; and that in CGM users, mean glucose, time in range (TIR), below range (TBR) and coefficient of variation (CV) also improves in a 1-year period.

Methods: Review of electronic records included Spanish speaking Latinx DM2 patients, age 31-78, baseline A1c ≥8.0 ≤13.0%, on insulin. We included age, gender, BMI, baseline insulin regimen: basal, bolus or both, and A1c at the time CGM was offered ±4 months and post 12-months±4 months. Linear regression was used to calculate % change in A1c. CGM metrics were recorded at the same timepoints and analyzed using T-tests.

Results: CGM users: n=30, age 54.3±13.2, 67% female, BMI 34.4±7.9, 20% were on basal (29% at 12 months), 3% on bolus insulin (0% at 12 months) and 77% on both (67% at 12 months) and 4% on no insulin at 12 months, baseline A1c was 8.8% ±1.6 and 8.1±1.3 at 12 months, p=0.02. Mean % decrease in A1c in 1 year 5.1%±12.8. Baseline mean glucose was 202mg/dl±58 and 173±35 at 12 months, p= 0.001. TIR went from 47 to 60%, p= 0.003, TBR and CV did not change. Non-CGM users: n=27, age 52.9±12.1, 56% male, BMI 35.2 ±9.4, 30% were on basal (19% at 12 months), 4% on bolus insulin (0% at 12 months) and 67% on both (81% at 12 months), baseline A1c was 9.0%±1.6 and 8.5± 1.6 at 12 months, p=0.06. Mean % decrease in A1c in 1 year 4.7±13.1. There was no difference in % change in A1c between CGM vs non-CGM groups, p=.34.

Discussion: Both groups had improvements in A1c from baseline, but significant only in CGM users. The data support that adoption of CGM in Spanish speaking Latinx patients with DM2 on insulin results in better glycemic control, based on improved mean glucose and TIR, without an increase in hypoglycemia: TBR and CV; furthermore, this technology was well received by patients.

Disclosure

A.Thatte: None. L.A.Wright: None.
934-P: Effectiveness of a Digital, Personalized Lifestyle Program in People with Diabetes in Improving Glycemic Variability and Time in Range—An Urban Indian Real-World Study
Authors: SOORAGONDA BASAVARAJ , FATEMA ZAREEN , M MAHESH D.
Published: June 2023

Background: Glycemic variability (GV) and Time in range (TIR) are evolving parameters helping people with diabetes (PwD) have better outcomes. The OneCare diabetes program offers CGM-monitored, digital personalized education through CDEs as health coaches and OneCare app for tracking patient’s behaviour.

Methods: In a 3-month prospective study, enrolled PwD (n=31) were equipped with 14 days of CGM (Abbott freestyle) at the beginning and end of OneCare program. Using 96 daily glucose readings from each patient’s CGM, GV values were obtained from days 2 to 4, of the first sensor (CGM1), and days 12 to 14, of the second sensor (CGM2) ending at day 90. GV was calculated using EasyGV© software. Demographics, HbA1c and glycemic parameters were captured at time points. The health coach guided the progress through weekly calls.

Results: 62 evaluable CGM tracings, were included in the study. At 90-day follow-up, HbA1c [%] had decreased by 1.9 from 8.7 (1.2) to 6.8 (0.8), weight [kg] decreased from 74.1 (12.2) to 70.6 (10.5), FPG [mg/dl] from 148.13 (55.5) to 107.5 (20). There were significant improvements seen between the CGM1 vs CGM2 of the GV metrics including %Coefficient Variation {28.52% (8.5); 25.85% (8.2); p=0.02}, Mean Average Glucose [mg/dL] {80.9 (34.4); 62.65 (32.6); (p=<.001)}, Standard deviation of blood glucose {38.76 (14.59); 32.78 (11.2); (p = .01)} and MAGE {97.78 (31.9); 85.86 (28.68) (mg/dl); (p= .04)}. Significant improvements in TIR (%) were seen on follow up {54.4 (21.8); 67.4 (20.9)}. Percentage of people achieving the target TIR (>70%) increased significantly from 25.8% to 54.8% (p<0.001). On follow-up, 60%(n=20) patients required lesser medication for diabetes control.

Conclusion: PwD who participated in OneCare's CGM-assisted DSME program had definite improvements in GV, TIR along with other metabolic parameters. The results encourage a larger prospective study to validate the findings.

Disclosure

B.Sooragonda: None. Z.Fatema: Employee; Wellwork Technologies Private Limited, India. M.D.M: None.
944-P: Continuous Glucose Monitoring (CGM) Sampling Duration to Estimate Long-Term Glycemic Control in Adults with T2D Not Using Insulin
Authors: BACON SAM , THOMPSON NELS , FERRELL DAVID , FUNG JASON
Published: June 2023

Objective: Current consensus is that 10-14 days of continuous glucose monitoring (CGM) sampling time is adequate to assess long-term glycemic control in T1D and insulin-using T2D populations. Optimal CGM sampling duration has not been widely studied in people with T2D not using insulin. We studied the relationship between true and estimated long-term (90-day) glycemic control in people with T2D not using insulin.

Methods: The study population (N = 829) was composed of adults with T2D enrolled in Level2, a virtual specialty clinic, with CGM data on 75% (68) of the 90 days preceding an A1c lab result and no insulin fills during this period. The mean age and A1c were 56 years and 6.7% respectively. We computed the median absolute percentage error (MAPE) and Pearson correlations (R) between glycemic metrics from sampling periods of increasing duration and the full 90-day period. Because this population was at low risk for hypoglycemia glucose management indicator (GMI) and time above range (>180 mg/dL, TAR) were the primary outcomes of interest. We also assessed the correlations between GMI and A1c.

Results: GMI and TAR from 14-day measurements were highly correlated (R = 0.92) with 90-day values, increasing to R = 0.94 with 30-day measurements. Correlations of GMI and A1c were high with 14 and 30 days (R = 0.79, R = 0.82) but did not exceed R = 0.85 with longer sampling periods. MAPE was 2.2 (SD = 2.6) and 1.5 (SD = 2.1) for GMI with 14- and 30-day measurements, respectively, and 29.2 (SD = 47.4) and 21.2 (SD = 27.1) for TAR.

Conclusion: In the T2D population not using insulin, 14 days of CGM data is sufficient to estimate long-term mean glucose and the discordance with A1c is consistent with previous studies of people with T1D and insulin-using T2D. TAR is subject to greater error than in previous studies of people with T1D and insulin-using T2D and more work is needed to understand this discrepancy.

Disclosure

S.Bacon: Employee; Optum Labs, Research Support; Level2. N.Thompson: Employee; Level2, Stock/Shareholder; UnitedHealth Group. D.Ferrell: Stock/Shareholder; Level2, Medexpress Urgent Care. J.Fung: Employee; Level2.