bluuebunny/crossref_metadata_2025_split huggingface dataset:
1025-P: Degludec-to-Glargine Transition: The First Real-World Study
Authors: CHAO JING , HIRSCH IRL B. 
Published: June 2020

Switching from insulin degludec (iDeg) to another basal insulin is often needed upon admission. No study has reported glycemic data or how clinicians switch patients from iDeg to insulin glargine (iG100) during the acute transition period. We present the first real-world study of transitioning from iDeg to iG100 when patients with T1D or T2D are admitted to the hospital.
This is a retrospective chart review of 244 admissions to a tertiary care center between 2/1/16-10/31/19 to identify patients with T1D and T2D transitioning from iDeg to iG100 inpatient by hospitalists and surgeons. Inclusion criteria: using iDeg ≥ the 4 days prior to admission; documentation of the home dose of iDeg; and having ≥ 24 hours of BG data from the time of admission. Exclusion criteria: not using iDeg consistently within 4 days prior to admission; inability to verify home dose of iDeg; BG &gt;250mg/dL on admission; and using corticosteroids or IV insulin within 4 days of admission. Thirty-one patients with T2D and 7 patients with T1D had analyses performed on their BG values, home iDeg doses, and inpatient iG100 doses between day 1-4 of the admission.
Clinicians gave iG100 at 0-100% of home iDeg dose anytime between 24-72 hours after the last iDeg dose. Patients with T2D used a median of 30U of iDeg at home (range 8-100U) and had a median/SD BG of 170 ± 40mg/dL. No patient with T2D had a BG&lt;70mg/dL, 48% had BG of 250-300mg/dL, and 16% had BG&gt;300mg/dL. Patients with T1D used a median of 13U of iDeg at home (range 3-55U) and had a median/SD BG of 177 ± 53mg/dL. Two patients of T1D had BG&lt;70mg/dL, 86% had BG of 250-300mg/dL, 71% had a BG &gt;300mg/dL, and 0% developed DKA during the transition.
Despite clinicians ordering arbitrary doses and timing of iG100 for this transition, patients with T2D maintained their BG in a safe range, but patients with T1D developed more glycemic variability with hypo- and overt hyperglycemia. Using evidence and knowledge of iDeg’s PK and PD, developing consensus guidelines emphasizing safety of patients with T1D undergoing iDeg to iG100 transition is possible.

Disclosure
J. Chao: None. I.B. Hirsch: Consultant; Self; Abbott, Bigfoot Biomedical, Roche Diabetes Care. Research Support; Self; Medtronic, Omnipod.
1027-P: Predicting Response to Bolus Insulin
Authors: EBY ELIZABETH L. , KELLY NEAL R. , BLODGETT MOIRA , STUBBINS CALLIE , MEADOWS ERIC , BENNEYWORTH BRIAN D. , FARIES DOUGLAS E. 
Published: June 2020

Predicting success on a new step in therapy currently relies upon clinical expertise and heuristics. Even after the transition to bolus insulin, many people with diabetes fail to achieve glycemic control. Our objective was to develop a predictive model to classify patients into expected levels of success upon bolus insulin initiation. Machine learning methods were applied to a large nationally representative insurance claims database. Commercially insured adults with T2DM were identified at first observed use of bolus insulin injections. Those with ≥2 HbA1c values in the 15-month follow-up period (N=15,331) were included. HbA1c goal achievement was defined as &lt;8% or at least a 1% reduction from baseline. We trained boosted decision tree ensembles (XGBoost) to assign people into Class 0 (never meeting goal), Class 1 (meeting but not maintaining goal), or Class 2 (meeting and maintaining goal) based on the demographic and clinical data available prior to initiating bolus insulin. Overall, the model’s ROC was 0.79 with greater performance on predicting those in Class 2 (ROC=0.92) than those in Classes 0 and 1 (ROC’s = 0.71 and 0.62, respectively). Among the patients with highest (top 10%) probability of being in each of the three categories, the model accurately separates Class 2 from the others but had difficulty distinguishing between Class 0 and 1 patients. Over 98% of patients predicted to be either Class 0 or Class 1 with high probability were true Class 0 or Class 1 patients. However, only 42% of those highly predicted as Class 0 were Class 0, with &gt;50% being Class 1. Average HbA1c values in the year prior to starting bolus insulin was the most influential predictive factor. Results suggest that predictive modeling using routine healthcare data was reasonably accurate in classifying patients initiating bolus insulin who will achieve and maintain HbA1c goals. The model was less accurate differentiating between patients who never met and those who did not maintain goals. Incorporation of behavioral, psychosocial, or other factors could improve predictions.

Disclosure
E.L. Eby: Employee; Self; Eli Lilly and Company. N.R. Kelly: Consultant; Self; Eli Lilly and Company. Employee; Spouse/Partner; Optum, Inc. Employee; Self; Optum, Inc. Stock/Shareholder; Spouse/Partner; UnitedHealth Group. Stock/Shareholder; Self; UnitedHealth Group. M. Blodgett: None. C. Stubbins: None. E. Meadows: Employee; Self; Eli Lilly and Company. Employee; Spouse/Partner; Eli Lilly and Company. Stock/Shareholder; Spouse/Partner; Eli Lilly and Company. Stock/Shareholder; Self; Eli Lilly and Company. B.D. Benneyworth: Employee; Self; Eli Lilly and Company. D.E. Faries: Employee; Self; Eli Lilly and Company.

Funding
Eli Lilly and Company
1032-P: Time-in-Range during Short-Term Intensive Insulin Therapy Is Associated with Clinical Outcomes in Patients with Newly Diagnosed Type 2 Diabetes
Authors: LIU LIEHUA , XU LIJUAN , KE WEIJIAN , ZHANG PEISHAN , XU CHANGLIU , ZANG DENG , LI YANBING 
Published: June 2020

Background: Short-term intensive insulin therapy (SIIT) can reverse β cell dysfunction and induce glycemic remission in patients with newly diagnosed type 2 diabetes. Elimination of glucotoxicity to the maximum extent was considered the major mechanism. This study aimed to investigate the association of time in range (TIR) of predefined glycemic targets during SIIT with clinical outcomes after the therapy.
Methods: SIIT was given to 95 patients with newly diagnosed T2DM using insulin pump. Strict glycemic control (premeal, bedtime or 3am BG 3.9-6.0 mmol/L, 2hBG 3.9- 8.0 mmol/L) was achieved and maintained for 2 weeks. TIR was defined by calculating the percentage of daily eight-point blood glucose values (before and 2 hours after each meal, at bedtime and 3am) within the above-mentioned near-normoglycemic targets. Intravenous glucose tolerance tests were performed before and after SIIT with acute insulin response (AIR), HOMA IR and HOMA B calculated. Patients were followed for 1 year after withdrawal of insulin.
Results: Overall mean TIR was 68±11% during SIIT. After SIIT, both AIR and HOMA B increased while HOMA IR decreased. TIR during SIIT was significantly associated with improvement of AIR (r=0.36, P&lt;0.001) but not with change of HOMA B (r=0.11, P=0.29) or HOMA IR (r=-0.17, P=0.11). One-year remission was observed in 59% (56/95) patients. Higher proportion of patients with TIR≥70% obtained glycemic remission for over 1 year compared with those with TIR&lt;70% (71.4% vs. 49.1%, P=0.036) . In a logistic regression model, TIR≥70% was associated with higher 1- year glycemic remission after adjusting for Age, BMI and baseline A1c (OR 2.60, 95% CI 1.10-6. 13, P=0.03).
Conclusion: Higher TIR during SIIT indicates better recovery of βcell function and long-term glycemic outcomes.

Disclosure
L. Liu: None. L. Xu: None. W. Ke: None. P. Zhang: None. C. Xu: None. D. Zang: None. Y. Li: None.

Funding
National Key Research and Development Program of China (2018YFC1314100); Key Research and Development Program of Guangdong Province (2019B020230001); National Natural Science Foundation of China (81800716)
1038-P: Insulin Glargine 300 U/ml (Gla-300) vs. First-Generation Standard-of-Care Basal Insulin Analogs (SOC-BI) in Insulin-Naïve Patients with Type 2 Diabetes (T2D): Impact of Renal Function on the Outcomes of the Randomized Pragmatic Real-Life Achieve Control S
Authors: MENEGHINI LUIGI , CHENG ALICE , EVENOU PIERRE , GILL JASVINDER , MOHAMED AYAD , UMPIERREZ GUILLERMO E. 
Published: June 2020

In the 12-month ACHIEVE Control study, significantly more insulin-naive patients with T2D treated with Gla-300 vs. SOC-BI (glargine 100 U/mL or detemir) achieved the primary composite endpoint of individualized HEDIS A1c target attainment at 6 months without documented symptomatic (≤70 mg/dL) or severe hypoglycemia. This post-hoc analysis explored outcomes in subgroups with estimated glomerular filtration rate (eGFR) of &lt;60, 60 to &lt;90, and ≥90 mL/min/1.73 m2. Patients with eGFR &lt;60 mL/min/1.73 m2 were older and had longer T2D duration. Within each eGFR subgroup, baseline characteristics were generally balanced between treatment groups. Within subgroups, odds ratios for clinical outcomes generally showed trends favoring Gla-300 vs. SOC-BI, consistent with the overall study population (Figure). In patients with eGFR &lt;60 mL/min/1.73 m2, the odds ratio point estimates for absence of documented symptomatic (≤70 mg/dL and &lt;54 mg/dL) or severe hypoglycemia at 6 and 12 months strongly favored Gla-300 (&gt;1.40). The results suggest a potential benefit of Gla-300 vs. SOC-BI for avoiding hypoglycemia in patients with compromised renal function that warrants further evaluation in prospective studies.

Disclosure
L. Meneghini: Advisory Panel; Self; Novo Nordisk Inc., Sanofi US. Consultant; Self; Applied Therapeutics, Sanofi US. A. Cheng: Advisory Panel; Self; Abbott, AstraZeneca, Boehringer Ingelheim (Canada) Ltd., Boehringer Ingelheim International GmbH, Eli Lilly and Company, HLS Therapeutics, Inc., Janssen Pharmaceuticals, Inc., Medtronic, Merck & Co., Inc., Novo Nordisk A/S, Sanofi. Research Support; Self; Applied Therapeutics, Sanofi. Speaker’s Bureau; Self; Abbott, AstraZeneca, Boehringer Ingelheim (Canada) Ltd., Boehringer Ingelheim International GmbH, Eli Lilly and Company, Insulet Corporation, Janssen Pharmaceuticals, Inc., mdBriefCase, Medtronic, Merck & Co., Inc., Merck Sharp & Dohme Corp., Novo Nordisk A/S, Sanofi. P. Evenou: Employee; Self; Sanofi. J. Gill: Other Relationship; Self; Sanofi US. A. Mohamed: None. G.E. Umpierrez: None.

Funding
Sanofi US
1039-P: Treatment Patterns and Outcomes before and after Human Regular U-500 Insulin Initiation in Patients with Type 2 Diabetes Previously on &lt;200 Units/Day of Insulin
Authors: HOOD ROBERT C. , FAN LUDI , POLLOM ROY D. , BORRA SUJANA , HUANG AHONG , CHEN JIELING 
Published: June 2020

Introduction: U-500 regular insulin (U-500R) was developed to help severely insulin-resistant patients meet high insulin requirements (&gt;200 units/day). Here, we described in real-world setting a patient cohort using ≤200 units/day of standard concentration insulin or non-U500R concentrated insulin per pharmacy claims, who were then transitioned to U-500R with an average total daily dose (TDD) of &gt;200 units/day.
Methods: Adults with ≥2 T2D claims who initiated U-500R (index) and had ≥1 HbA1c value in both 9-month pre- and 9-month post-index periods in the Veterans Health Administration database (01JAN2014-30JUN2017) were included. Treatment patterns and outcomes (observed TDDs for index claim, observed TDD, HbA1c, and hypoglycemia events per patient per year (PPPY) in pre and post-index periods) were assessed in both periods. Paired t-test or McNemar’s test was used for descriptives. Mixed linear model (MLM) and zero-inflated negative-binomial mixed model (ZINBM) were used to confirm the effect of U-500R exposure on HbA1c and hypoglycemia, respectively, adjusting for demographics, BMI, comorbidity index and TDD.
Results: Of 1,191 U-500R initiators, mean age was 63 years with 82% white, 96% male, and a mean BMI of 40. TDD for index U-500R claim was 354 units. Mean TDDs (147 units vs. 346 units), HbA1c (9.6% vs. 8.6%), and hypoglycemia (2.0 vs. 3.3) differ significantly pre- and post-index (p≤0.05), respectively. MLM confirmed HbA1c significantly dropped by 0.8% (p&lt;0.01). ZINBM showed a 0.5 PPPY increase in hypoglycemia post-index (p&lt;0.01).
Conclusions: Using insulin claims data, U-500R initiation resulted in a significant TDD increase of 199 units, which was accompanied by a significant drop in HbA1c and a slight increase in hypoglycemia. The low TDD and poor glucose control prior to U-500R initiation indicated poor patient compliance to the prescribers’ dosing intentions.

Disclosure
R.C. Hood: Advisory Panel; Self; Eli Lilly and Company, Insulet Corporation. Speaker’s Bureau; Self; Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, Janssen Pharmaceuticals, Inc., Novo Nordisk Inc. L. Fan: Employee; Self; Eli Lilly and Company. Stock/Shareholder; Self; Eli Lilly and Company. R.D. Pollom: Employee; Self; Eli Lilly and Company. Employee; Spouse/Partner; Eli Lilly and Company. Stock/Shareholder; Self; Eli Lilly and Company. Stock/Shareholder; Spouse/Partner; Eli Lilly and Company. S. Borra: Employee; Self; STATinMED. Other Relationship; Self; Eli Lilly and Company. A. Huang: Employee; Self; STATinMED. Other Relationship; Self; Eli Lilly and Company. J. Chen: None.
104-LB: Glucose-Insulin-Potassium (GIK) as a Proposed Treatment for Normoglycemic Diabetic Ketoacidosis: An Old Friend for a New Foe?
Authors: ESPINOZA-PERALTA DIEGO , MONJARDIN-ROCHIN JOSE ALFONSO , BÚRQUEZ-GONZÁLEZ MARIA E. , MIRELES-ZAVALA LEONOR G. 
Published: June 2020

Introduction: Glucose, Insulin, and potassium (GIK) infusions were introduced into medical practice to reduce myocardial injury during a heart attack in 1962. Euglycemic diabetic ketoacidosis (EDKA) is a clinical triad comprising increased anion gap metabolic acidosis, ketonemia or ketonuria and blood glucose levels &lt;250mg/dL. Based on common treatment delays due lack of hyperglycemia, we decided to start a new proposed protocol for patients with confirmed EDKA that included the use of GIK and compared them with historical controls before the protocol was established. GIK solution was prepared with Dextrose 5% solution 500 cc, 10 UI of short acting insulin al 10 mmol KCl. At al initial rate of 100 ml/hr.
Objectives: Describe general characteristics and compare time to remission, length of ICU stay and length of hospital time between patients with SGLT2i-associated EDKA in whom GIK was used compared to standard care.
Design: A Cohort study was designed to compare objectives between EDKA patients treated with a GIK-adapted protocol versus previous patients treated with standard of care of DKA. Patients and Methods: 4 Patients with EDKA treated with new protocol were compared with 7 previous patients treated with ADA recommendations for DKA.
Results: 41.66% of patients were male, type 2 diabetes was initially diagnosed in 66.66% of patients. No differences in ER characteristics between standard vs. GIK group. The use of GIK as an add-on treatment to standard care was associated with a significant lower time to resolution (1.5±0.5 vs. 3.57±1.61, p&lt;0.01), fewer ICU days (2.5±0.57 vs. 5.57±1.98, p&lt;0.01), in-hospital days (4.5±0.577 vs. 11.85±3.43, p&lt;0.01). No differences in hypoglycemic or hipo/hyperkalemia were found.
Conclusions: With the wide use of SLGT2 inhibitors there has been a similar increase in the number of SGLT2i-associated EDKA. Were propose a different way of management of these patients. More research is needed in this field and entity.

Disclosure
D. Espinoza-Peralta: None. J. Monjardin-Rochin: None. M.E. Búrquez-González: None. L.G. Mireles-Zavala: None.
104-OR: Lifestyle Interventions in Persons with IGT Prolong the Time Free of Major Diabetes-Related Complications: 30-Year Results of the Da Qing Diabetes Prevention Outcome Study (DQDPOS)
Authors: GONG QIUHONG , ZHANG PING , WANG JINPING , CHEN YANYAN , AN YALI , FENG XINXING , CHENG YILING J. , MA JIXIANG , BENNETT PETER H. , LI GUANGWEI 
Published: June 2020

Lifestyle interventions in persons with impaired glucose tolerance (IGT) delay the onset of diabetes, but freedom from complications is a major goal of diabetes prevention and management. The extent that lifestyle intervention can delay the onset of the common but serious complications of diabetes is ill-defined. We assessed freedom from any serious diabetes-related complication in the 30-year follow-up data from the Da Qing Diabetes Prevention study in which 576 adults with IGT, randomized to control or lifestyle intervention groups for six-years, were followed from the time of randomization to determine the onset of diabetes and occurrence of any serious diabetes-related complication defined as CVD events or death, severe retinopathy, nephropathy, neuropathy, or death due to acute diabetes complications or infection. We estimated differences between the intervention and control groups in the incidence and time free of serious complications. Lifestyle interventions significantly increased the time free of major serious diabetes-related complications (Table). The study provides yet further evidence supporting the value of implementing lifestyle interventions in persons with IGT.

Disclosure
Q. Gong: None. P. Zhang: None. J. Wang: None. Y. Chen: None. Y. An: None. X. Feng: None. Y.J. Cheng: None. J. Ma: None. P.H. Bennett: Advisory Panel; Self; World Health Organization. Stock/Shareholder; Self; Eli Lilly and Company, Pfizer Inc., Unilever, UnitedHealth Group. Other Relationship; Self; American Diabetes Association, European Association for the Study of Diabetes, European Diabetic Nephropathy Study Group, International Diabetes Federation, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health. G. Li: None.
1057-P: Long-Term Testosterone Therapy Results in Remission of Type 2 Diabetes (T2DM) in 34.3% (61 of 178) Men with Hypogonadism and T2DM in a Real-World Registry Study
Authors: HAIDER KARIM S. , HAIDER AHMAD , SAAD FARID 
Published: June 2020

Background: In 2018, ADA Standards of Medical Care in Diabetes added measurement of testosterone levels in men with T2DM as new recommendation.
Methods: A registry of men with hypogonadism (testosterone ≤12.1 nmol/L) was initiated in 2004 in a urological practice setting. 356 of 858 patients (41.5%) had T2DM diagnosed and treated in a diabetes center. Of these men, 178 received testosterone undecanoate (TU) injections 1000 mg/12 weeks (T-group) following an initial 6-week interval. Anthropometric and metabolic parameters were measured at least twice a year. Fasting insulin was used to calculate HOMA-IR.
Results: After a mean follow-up of 7.7±3.0 (minimum 2, maximum 11 years), 61 patients (34.3%) were in remission, defined as discontinuation of all diabetes medications and stable HbA1c &lt;6.5%. In men who went into remission, HbA1c dropped from 8.7±1.0% at baseline to 5.4±0.1% at the last measurement, HOMA-IR from 10.2±2.5 to 1.7±0.5. In men who never received insulin, HOMA%S increased from 11.1±1.5 to 15.8±2.4. Anthropometric parameters: Body weight declined progressively from 113.6±13.8 to 90.9±8.4 kg by 22.6±8.0 kg, waist circumference from 111.1±7.5 to 98.3±4.6 cm by 12.6±4.3 cm. All patients were on metformin at baseline. 22 patients were on insulin. The average observation time was 130.7±25.9 months (10.9±2.2 years). The average time to discontinuation of diabetes medication was 8.6±2.9 years, average follow-up after achieving remission 2.5±2.3 years. Medication adherence to TU was 100% as all injections were administered in the office and documented. PSA and hematocrit stayed within normal range during the entire observation period.
Discussion: The effects of testosterone were likely mediated by sustained weight loss, increased lean body mass and a profound and sustained reduction of insulin resistance.
Conclusions: Long-term testosterone treatment in men with hypogonadism may result in remission of T2DM.

Disclosure
K.S. Haider: None. A. Haider: None. F. Saad: Consultant; Self; Bayer AG. Stock/Shareholder; Self; AbbVie Inc., Bayer AG.

Funding
Bayer AG
1088-P: Postprandial Dynamics of Glucagon Secretion in Type 2 Diabetic Patients: Changes Associated with Short-Term Improvements in Glycemic Control
Authors: KANAI RINA , MORI YUTAKA , NISHIMURA RIMEI 
Published: June 2020

Objective: Type 2 diabetic patients were examined for their postprandial dynamics of glucagon secretion as well as for changes in these dynamics associated with short-term improvements in their glycemic control.
Methods: A total of 75 type 2 diabetic patients admitted for glycemic control who were not receiving incretin-related drugs (I) and SGLT2 inhibitors (S) at admission, 5 type 1 diabetic patients, 5 nondiabetic patients were subjected to meal tolerance tests (MTTs) during early morning fasting hours at admission. Blood samples were drawn from these patients preprandially, and 30, 60, and 120 minutes postprandially to measure their glucose, C-peptide and glucagon (Mercodia) values. Of the type 2 diabetic patients, those who improved glycemic control without both I and S (n = 10), were examined for changes in the postprandial dynamics of glucagon associated with improvements in glycemic control.
Results: The AUC C-peptide values was shown to be the lowest in type 1 diabetic patients, followed by type 2 diabetic patients and nondiabetic patients, and with AUC-glucose values and AUC-glucagon values were shown to be the highest in type 1 diabetic patients, followed by type 2 diabetic patients and nondiabetic patients. Of the type 2 diabetic patients, those with BMI ≥ 25 kg/m2 and BMI &lt; 25 kg/m2 were not significantly different in their AUC glucose, while those with BMI ≥ 25 kg/m2 had significantly larger AUC C-peptide and AUC glucagon values than those with BMI &lt; 25 kg/m2. MTTs performed after improving glycemic control showed significantly smaller AUC glucose, significantly elevated AUC C-peptide, and significantly smaller AUC glucagon values in those improving glycemic control without both I and S after admission.
Conclusions: Study results are in agreement with the conventional finding that decreased α-cell insulin action associated with decreased insulin secretion or insulin resistance leads to glucagon over-secretion secondarily.

Disclosure
R. Kanai: None. Y. Mori: None. R. Nishimura: Research Support; Self; Boehringer Ingelheim Pharmaceuticals, Inc. Speaker’s Bureau; Self; Abbott, AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly Japan K.K., Medtronic, Merck & Co., Inc., Novo Nordisk Inc., Sanofi K.K., Takeda Pharmaceutical Company Limited.