bluuebunny/crossref_metadata_2025_split huggingface dataset:
1055-P: Glucose Management Indicator Results from Real-World Data of 1,838 Patients with Type 1 Diabetes Using the Omnipod® Insulin Management System with Continuous Glucose Monitoring and Cloud-Based Data Management
Authors: LAYNE JENNIFER E. , JANTZ JAY , ZHENG YIBIN , HE JIALUN , BENJAMIN ERIC , LY TRANG T. 
Published: June 2019

Glucose Management Indicator (GMI) is a new term for estimating A1C from CGM data which is intended to inform glucose management for people with diabetes. This analysis assessed GMI and glycemic metrics for a large cohort of pediatric, adolescent and adult patients with T1D using data from the Omnipod® Insulin Management System (Insulet Corp, Acton, MA), real-time CGM (Dexcom, San Diego, CA) and data management system (Glooko, Mountain View, CA). Usage data uploaded to the data management system from January 2015 through September 2018 were matched via device serial number to a second database of self-reported demographic data and de-identified. CGM data from patients who used CGM &gt;50% of days over ≥3 months of system use were analyzed. Glycemic profiles and insulin use for 1,838 patients stratified by age &lt; 6 y, 6 to &lt;12 y, 12 to &lt;18 y and ≥18 y are reported in the Table. GMI was 7.8%, 7.5%, 7.4%, 7.0%, respectively, across age groups. Corresponding estimated A1C by ADAG method was 8.2%, 7.7%, 7.6% and 7.0%. Data from this large, real-world cohort of patients with T1D across age groups provide valuable insights to GMI and glycemic metrics, and demonstrate that the use of tubeless insulin pump with CGM is associated with favorable glycemic control when compared to large national registries such as the T1D Exchange.

Disclosure
J.E. Layne: Employee; Self; Insulet Corporation. J. Jantz: Employee; Self; Insulet Corporation. Employee; Spouse/Partner; Insulet Corporation. Y. Zheng: Employee; Self; Insulet Corporation. Stock/Shareholder; Self; Insulet Corporation. J. He: Employee; Self; Insulet Corporation. E. Benjamin: Employee; Self; Insulet Corporation. T.T. Ly: Employee; Self; Insulet Corporation.

Funding
Insulet Corporation
1058-P: The Use of Metabolic Digital Twins to Personalize Mealtime Insulin Dosing in Type 1 Diabetes Clinical Management
Authors: SMITH TENELE A. , SERON MARIA M. , GOODWIN GRAHAM C. , MEDIOLI ADRIAN M. , KING BRUCE R. , SMART CARMEL E. , HARRIS MARK , ONEAL DAVID N. , RAFFERTY JORDAN , HOWLEY PETER 
Published: June 2019

Introduction: Type 1 diabetes guidelines recommend that mealtime insulin dosing accounts for fat and protein. However, implementation remains a challenge.
Aim: To evaluate an individual’s glycemic response to a high fat, high protein meal (HFHP) and develop a personalized ‘metabolic digital twin’ (MDTwin) capable of predicting an optimal insulin dose and delivery pattern which accounts for meal fat and protein.
Method: Participants (n=9) using pump therapy; mean age 13.9 ±3.2 years (5 male), T1D duration 4.8 ±3.8 years, and HbA1c 49 mmol/mol (6.7 ±0.6%) wore Dexcom G5 CGMS and were given an insulin dual wave bolus (insulin to carbohydrate ratio [ICR] x1, ICRx1.2, ICRx1.4 or ICRx1.6) and ate a HFHP (C:30g, F:40g, P:50g) on 4 mornings. Individual MDTwins were fitted by System Identification methodology combined with a statistical quantification using the ICRx1 and ICRx1.6 CGMS traces. MDTwins were validated using the ICRx1.2 and ICRx1.4 traces.
Results: The MDTwins identified individual insulin and distribution requirements to achieve optimal postprandial glycemic control (Figure). MDTwins identified marked inter-individual variability in insulin dose and distribution requirements.
Conclusion: MDTwins can potentially be used to inform and individualize insulin dosing strategies for meal fat and protein to produce optimal glycemic outcomes. Further research is required.

Disclosure
T.A. Smith: None. M.M. Seron: None. G.C. Goodwin: None. A.M. Medioli: None. B.R. King: None. C.E. Smart: None. M. Harris: None. D.N. ONeal: None. J. Rafferty: None. P. Howley: None.

Funding
Diabetes Australia
1067-P: Open Source Artificial Pancreas System (APS) vs. Combination Insulin Pump with Flash Glucose Monitoring in Adults with Type 1 Diabetes: An Observational Study
Authors: WILMOT EMMA G. , LANGELAND LINN , MCLAY ALASDAIR , TAYLOR NICOLA ,   ISKANDAR RAUF IDRIS
Published: June 2019

Despite the rising number of Open Source APS (Open APS) users in the UK, little is known about their glucose outcomes in comparison with conventional approved management strategies for type 1 diabetes. We therefore compared glucose outcomes (HbA1c, Time in Range, TIR and Time Below Range, TBR) of people on continuous subcutaneous insulin infusion (CSII) with either Open APS versus FreeStyle Libre (FSL) flash glucose monitor.
Data were extracted from the National Association of British Clinical Diabetologists (ABCD) FSL audit tool for people using CSII and FSL (N=30) and compared with Open APS users (N=9). Demographic parameters were as follows: Open APS users (mean age 44.2; 44% female, diabetes duration 25 years, mean Open APS use of 11 months) and CSII/FSL users (mean age 59.3 years; 78% female; diabetes duration 26 years; mean CSII/FSL use of 5.9 months).
Mean HbA1c in the 12 months prior to initiating Open APS was 7.3±1.4%. This was significantly reduced to 6.2±0.4% post Open APS (P=0.046). Those who started FSL, had a mean pre-FSL HbA1c of 7.6±0.8%, which reduced to 7.2±0.6% at follow-up (P=0.030).
30-day TIR, defined as % of glucose data 3.9-10mmol/l, achieved by Open APS users (N=9) was significantly higher than the FSL users (N=25) (83.6±7.2% vs. 55.9±11.5%; P&lt;0.001). Similarly, 30-day TBR for the Open APS users was significantly lower than the FSL users (2.5±1.8% vs. 5.7±4.7%, P=0.006) respectively. None of the people on Open APS or FSL experienced hospital admissions or severe hypoglycaemic events during this observational period.
In conclusion, despite a lower initial HbA1c, the cohort of Open APS users achieved a greater reduction in HbA1c, significantly greater TIR and less TBR, compared with CSII/FSL users. Further work is required to explore the potential benefits of Open Source APS compared to conventional approved strategies.

Disclosure
E.G. Wilmot: Advisory Panel; Self; Dexcom, Inc. Research Support; Self; Diabetes UK. Speaker's Bureau; Self; Abbott, Eli Lilly and Company, Novo Nordisk Inc., Sanofi. L. Langeland: None. A. McLay: Speaker's Bureau; Self; Eli Lilly and Company. N. Taylor: None. I.R. Idris: None.
1070-P: Assessment of Effectiveness and Satisfaction of Use of the Automatic Injection System GensuPen 2
Authors: CYPRYK KATARZYNA , ZURAWSKA-KLIS MONIKA 
Published: June 2019

Success in treating diabetes is highly dependent on the patient's satisfaction with the therapy. The aim of the study was to assess the effectiveness and satisfaction of the use of Automatic Injection System GensuPen2 device which is a pen with a spring-assisted insulin release mechanism and a laterally located trigger. 4707 adult insulin treated diabetic patients (50.44% women) from all over Poland took part in the study. For 42% of subjects, the previously used pen was changed to the GensuPen2. During the first visit demographic and medical data were gathered. HbA1c was measured and the questionnaires concerning the satisfaction with the currently used pen and evaluation of pain severity, satisfaction with the treatment (all three are 5-point scales), and the health-related quality of life (HRQoL) were filled out twice - at the beginning and after 12 weeks of the study. The mean age was 64.8±10.1 years and duration of diabetes was 9.9±6.5 years. Impaired visual function was found in 13.7% and 12.3% of the subjects had an impaired manual efficiency. After 12 weeks, HbA1c level dropped from 8.26±1.17% to 7.72±0.89% (P &lt;0.001). Satisfaction with the use of pen increased from on average 3.33 to 4.31 points (P &lt;0.001) after switching to GensuPen2. Evaluation of pain severity revealed that discomfort and pain related to insulin injection decreased from on average 3.82 to 2.41 points (P &lt;0.001). Insulin therapy with the use of GensuPen2 was comfortable for 94.48% of patients. More than half of the patients were more satisfied with GensuPen2 than with the previously used pen, and 98.63% of subjects declared that they did not want to return to previous pen. Satisfaction with diabetes treatment raised from 81.2% to 94.5% (P &lt;0.001). The HRQoL increased from on average 5.81 to 7.39 points (P &lt;0.001). The use of the GensuPen2 by diabetes patients improved metabolic control, increased satisfaction with diabetes treatment and the use of insulin pen, reduced the pain during injection, and improved their quality of life.

Disclosure
K. Cypryk: Advisory Panel; Self; Eli Lilly and Company, Novo Nordisk A/S. Speaker's Bureau; Self; Abbott, Servier. M. Zurawska-Klis: Speaker's Bureau; Self; Polfa Tarchomin S.A. Other Relationship; Self; Berlin-Chemie AG, Lilly Diabetes, Novo Nordisk Inc.

Funding
Bioton
1071-P: Uptake of Continuous Subcutaneous Insulin Infusion Therapy by Adults with Type 1 Diabetes
Authors: GAJEWSKA KATARZYNA ANNA , SREENAN SEAMUS , BIESMA REGIEN , BENNETT KATHLEEN 
Published: June 2019

Introduction: Continuous Subcutaneous Insulin Infusion (CSII) treatment for people with type 1 diabetes (T1D) is fully funded in Ireland via the Long-Term Illness scheme (LTI) and, similarly as in some other developed countries such as Germany, Sweden or the UK, does not involve any out-of-pocket expenses for the person with T1D. Uptake of CSII in adults has been reported to vary from 6.7% (Wales, 2018), through 15.6% (England, 2018) up to &gt;50% in the United States (in 2012). However, available evidence on the uptake of CSII, particularly in adults, is scarce.
The aim of this study was to estimate the uptake of CSII in Ireland.
Methods: A retrospective cross-sectional study was conducted utilizing the Irish Health Service Executive Primary Care Reimbursement Service (HSE-PCRS) national pharmacy claims database data from the years 2011-2016. Individuals with T1D were identified by co-prescription of insulin and glucometer test strips without any prolonged course (&gt;12 months) of oral hypoglycemic agents prior to commencing insulin. Individuals using CSII were identified by a prescription of infusion sets.
Results: Of all adults with T1D (&gt;18 years of age) meeting our criteria (n=19,551), only 5.84% (n=1141) were claiming infusion sets (95% CI 5.51% - 6.16%). The uptake of CSII varied geographically across Ireland from as low as 1.68% to 8.35%.
Conclusions: In comparison to other countries where CSII therapy is fully covered, uptake of CSII was low in Irish adults. The determinants of the uptake (barriers to and facilitators in accessing this diabetes-related technology) are under more in-depth investigation.

Disclosure
K.A. Gajewska: None. S. Sreenan: Advisory Panel; Self; Abbott, AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Novo Nordisk Inc. Other Relationship; Self; Eli Lilly and Company. R. Biesma: None. K. Bennett: None.

Funding
Health Research Board (SPHeRE/2013/1)
1089-P: Ultra Rapid Lispro (URLi) Improves Postprandial Glucose (PPG) Control and Time in Range (TIR) in T1D Compared with Humalog (Lispro): PRONTO-T1D Continuous Glucose Monitoring (CGM) Substudy
Authors: BODE BRUCE W. , CAO DACHUANG , LIU RONG , HARDY THOMAS , BUE-VALLESKEY JULIANA M. 
Published: June 2019

Ambulatory glucose profiles were evaluated in 269 (22%) patients (pts) in PRONTO-T1D assigned to double-blind URLi (n=97) or lispro (n=99) given at start of the meal, or open-label URLi (n=73) given 20 min after the meal (URLi +20). Primary endpoint was incremental AUC0-2h (iAUC) after breakfast. Blinded CGM (Dexcom G4 Platinum) was worn for 14 days before baseline and week 26. Pts reflected main study population: mean A1C at week 26 was 7.15% - URLi, 7.12% - lispro, 7.35% - URLi+20.
Compared to lispro, URLi had significantly smaller breakfast iAUC0-2h with estimated treatment difference (ETD) -28.1 mg.h/dL, p=0.048; more daytime TIR (71-180 mg/dL) ETD +43.6 min, p=0.020; and similar nighttime TIR. Time &lt;50 mg/dL and &gt;180 mg/dL were both numerically lower with URLi in daytime, with less time &lt;50 mg/dL at nighttime vs. lispro: 7.0 vs. 12.6 min, p=0.023.
PPG control in pts who marked meal times improved with URLi, while URLi +20 showed greater PPG variability (Figure). Glucose variability via CV and SD metrics was similar between groups, but less glucose variability was noticeable in CGM profiles of pts treated with URLi.
When injected at the start of the meal, URLi resulted in significantly better PPG control and increased daytime TIR vs. lispro without increasing time in hypoglycemia. CGM results augment findings from PRONTO-T1D.

Disclosure
B.W. Bode: Consultant; Self; ADOCIA, Lexicon Pharmaceuticals, Inc., Novo Nordisk Inc. Research Support; Self; Becton, Dickinson and Company, Dexcom, Inc., Diasome Pharmaceuticals, Inc., Eli Lilly and Company, Eyenuk Inc., Insulet Corporation, National Institutes of Health, Novo Nordisk Inc., Sanofi Research & Development, Senseonics, Xeris Pharmaceuticals, Inc. Speaker's Bureau; Self; AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Janssen Pharmaceuticals, Inc., Novo Nordisk Inc., Sanofi US, Senseonics. Stock/Shareholder; Self; AgaMatrix, Glytec, LLC. D. Cao: Employee; Self; Eli Lilly and Company. R. Liu: Employee; Self; Eli Lilly and Company. Employee; Spouse/Partner; Eli Lilly and Company. T. Hardy: Employee; Self; Eli Lilly and Company. Stock/Shareholder; Self; Eli Lilly and Company. J.M. Bue-Valleskey: Employee; Self; Eli Lilly and Company.

Funding
Eli Lilly and Company
1091-P: Association between Mild and Severe Hypoglycemia in People with T1 and T2 Diabetes Enrolled in Randomized Controlled Trials for Assessing Insulin Therapy
Authors: ROUSSEL RONAN , MOUTAIROU ABDUL , RIVELINE JEAN-PIERRE , GAUTIER JEAN-FRANCOIS , POTIER LOUIS 
Published: June 2019

Background and Aims: Hypoglycemia is a major threat of insulin therapy, but only severe events are often considered as valid endpoints. Surrogates are required; mild events are logical candidates. The International Hypoglycemia Study Group (IHSG) proposed thresholds (3.9 and 3.0 mmol/L) for representative mild events, but evidence is scarce.
Materials and Methods: We studied the correlation of the rate (or the incidence) of non-severe events with the rate (or the incidence) of severe events in a study-level systematic analysis of published data (1/1/00-6/1/18) in insulin-treated patients. Mild event was defined as either “any hypoglycemia,” or “severe or confirmed &lt;3.9 mmol/L,” or “severe or confirmed &lt;3.0,” with a tolerance of +/-0.4 mmol/L to manage the multiplicity of definitions. Nocturnal period was defined as per study design, therefore not homogeneously. Severe events were mostly defined as per IHSG.
Results and Conclusion: 127 out of 15570 studies were eventually included. Pearson R² are presented (Figure). The mild hypoglycemia were usually better correlated with incidence rather than rate of severe events. Incidence of severe or confirmed &lt;3.0 mmol/L, especially if limited to the night, appeared to be the best surrogate for incidence of severe events.

Disclosure
R. Roussel: Advisory Panel; Self; Merck Sharp & Dohme Corp., Sanofi. Consultant; Self; Abbott, AstraZeneca, Eli Lilly and Company, Medtronic, Novo Nordisk A/S, Physiogenex. Research Support; Self; Janssen Pharmaceuticals, Inc. A. Moutairou: None. J. Riveline: Board Member; Self; Abbott, Lilly Diabetes, Novo Nordisk Inc. Consultant; Self; Novo Nordisk Inc. Research Support; Self; Air Liquide, Amgen Inc. Speaker's Bureau; Self; Abbott, Lilly Diabetes, Sanofi. J. Gautier: None. L. Potier: Advisory Panel; Self; Merck Sharp & Dohme Corp. Consultant; Self; Sanofi.

Funding
Sanofi
1092-P: Effect of Inappropriate Resuspension of Insulin Pen on Amount of Dispensed Insulin
Authors: DECHATES BOTHAMAI , JUNNU SARAWUT , KONGMALAI TANAWAN , SRISAWAT CHATCHAWAN , SRIWIJITKAMOL APIRADEE 
Published: June 2019

Background: Inappropriate resuspension of NPH insulin resulted in inaccurate dose of insulin, however those studies estimated the amount of insulin based on the cloudiness of insulin, which did not correctly reflex the amount of insulin.
Objective: To study the effect of inappropriate resuspension of premixed insulin pen on the amount of dispensed insulin which was directly determined using a more accurate Ultra-High performance Liquid Chromatography (UHPLC) technique.
Methods: The premixed 70/30 autopen was used in this study. Four methods of insulin resuspension were evaluated (n=5, for each method), i.e., upright position without resuspension (upright), horizontal position without resuspension (horizon), resuspension by tipping over 5x (5x), and 20x (20x, control). 30 unit of insulin from 1st injection of each pen were collected. Then, 30 units of insulin in each pen were discarded every 20 minutes for 8 times, each pen were kept in the initial resuspension method between each injection, and the last 30 unit of insulin in each pen were collected. Collected insulin were analyzed by UHPLC.
Results: Table showed the UHPLC results.
Conclusions: Inappropriate insulin pen resuspension or the lack thereof have significantly affect the amount of dispensed insulin by 3-6%, and this resulted in inaccurate dose of insulin throughout the used of that pen.

Disclosure
B. Dechates: None. S. Junnu: None. T. Kongmalai: None. C. Srisawat: None. A. Sriwijitkamol: None.
11-LB: Nonsevere Hypoglycemia Predicts Increased Risk of Subsequent Severe Events in Patients with Type 2 Diabetes
Authors: HELLER SIMON R. , HACHMANN-NIELSEN ELISE , KVIST KAJSA 
Published: June 2019

It is well-known that higher rates of non-severe hypoglycemic episodes (NSHEs) associate with a greater risk of severe hypoglycemic episodes (SHEs) in patients with type 1 diabetes. We investigated whether a similar association existed in patients with type 2 diabetes (T2D). We explored if annual rate of NSHEs was associated with time to first SHE, cardiovascular (CV) death, time to first major adverse CV event (MACE), and all cause death in patients with T2D using data from LEADER, a CV outcomes trial with 9340 patients with T2D.We used a Cox proportional hazards model adjusted for randomized treatment arm, and annual rate of NSHE as a time-dependent covariate with three levels; A: &lt;2 NSHEs per year (reference), B: 2−11 NSHEs, or C: ≥12 NSHEs. Hazard ratios were used to estimate the association between NSHE and each of the outcomes. Higher rates of NSHE were associated with a higher rate of severe hypoglycemia, MACE, CV death, and all-cause death in patients with T2D (Figure); our results suggest that in this T2D population, a high rate of NSHEs may be associated with more harmful outcomes.

Disclosure
S.R. Heller: Advisory Panel; Self; Eli Lilly and Company, Novo Nordisk A/S, Sanofi-Aventis, Takeda Pharmaceutical Company Limited, Zealand Pharma A/S. Consultant; Self; Novo Nordisk A/S. Speaker’s Bureau; Self; Eli Lilly and Company, Novo Nordisk A/S. E. Hachmann-Nielsen: Employee; Self; Novo Nordisk A/S. K. Kvist: Employee; Self; Novo Nordisk A/S. Stock/Shareholder; Self; Novo Nordisk A/S.

Funding
Novo Nordisk
1107-P: Ultra Rapid Lispro (URLi) Accelerates Insulin Lispro Absorption and Insulin Action vs. Humalog (Lispro) in Patients with T1D
Authors: LINNEBJERG HELLE , ZHANG QIANYI , LABELL ELIZABETH S. , REDDY SHOBHA , COUTANT DAVID E. , HOEVELMANN ULRIKE , PLUM-MOERSCHEL LEONA , HERBRAND THERESA , LEOHR JENNIFER 
Published: June 2019

URLi is a novel prandial insulin lispro formulation developed to more closely match physiological insulin secretion. This randomized, double-blind, 2 period, crossover, 10 h euglycemic clamp study assessed PK and glucodynamics after one 15U SC dose of URLi and lispro in 41 patients with T1D (mean ± SD age, 32.0 ± 6.8 y; duration of T1D, 17.7 ± 9.3 y; HbA1c, 7.2 ± 0.6%; BMI, 24.8 ± 2.4 kg/m2).
After dosing URLi, onset of insulin lispro appearance in the serum was faster (1.3 vs. 6.8 min; p&lt;0.0001) and early insulin lispro exposure was greater (7.2 fold in the first 15 min and 2.7-fold in the first 30 min; both p&lt;0.0001) vs. lispro. The duration of exposure, when serum lispro levels fell below the limit of quantification, was 74 min shorter with URLi (p&lt;0.0001).
Onset of insulin action was also faster (20 vs. 31 min; p=0.0007) and early action was increased 2.8 fold (p&lt;0.001) in the first 30 min for URLi vs. lispro. Late insulin action (glucose infused from 4 h to end of the clamp) was reduced by 54% (p&lt;0.0001) and duration of action was 43.6 min shorter with URLi (Figure).
Total insulin lispro exposure and glucose infused during the clamp did not differ and tolerability was similar between URLi vs. lispro.
In patients with T1D, URLi accelerated insulin absorption with a reduced late exposure and overall shorter duration vs. lispro, resulting in faster onset of insulin action and reduced late insulin action.

Disclosure
H. Linnebjerg: Employee; Self; Eli Lilly and Company. Stock/Shareholder; Self; Eli Lilly and Company. Q. Zhang: Employee; Self; Eli Lilly and Company. Stock/Shareholder; Self; Eli Lilly and Company. E.S. LaBell: Employee; Self; Eli Lilly and Company. Stock/Shareholder; Self; Eli Lilly and Company, Johnson & Johnson, Novartis AG. S. Reddy: Employee; Self; Eli Lilly and Company. Stock/Shareholder; Self; Eli Lilly and Company. D.E. Coutant: Employee; Self; Eli Lilly and Company. Employee; Spouse/Partner; Eli Lilly and Company. U. Hoevelmann: None. L. Plum-Moerschel: None. T. Herbrand: None. J. Leohr: Employee; Spouse/Partner; Accenture. Employee; Self; Eli Lilly and Company. Stock/Shareholder; Spouse/Partner; Accenture. Stock/Shareholder; Self; Eli Lilly and Company.

Funding
Eli Lilly and Company
1117-P: Metformin Increases Blood Lactic Acid in Elderly Diabetic Veterans with Stage 3 CKD
Authors: GOSMANOV AIDAR R. , GOSMANOVA ELVIRA 
Published: June 2019

Aim: Recently, the FDA endorsed metformin (MET) use in type 2 diabetes (T2D) patients with stage 3 CKD (CKD3). However, MET safety in elderly T2D subjects with CKD3 is unknown.
Methods: We studied lactic acid (LA) levels in ambulatory elderly male U.S. Veterans with stable nondiabetic CKD3 (eGFR 30-59ml/min/1.73m2) (Group 1) and diabetic CKD3 not on MET (Group 2) and on MET (Group 3) for at least 6 months. Hyperlactatemia was defined as LA &gt;2mmol/L. Patients with history of HIV, advanced CHF, alcohol abuse, and liver cirrhosis were excluded. Clinical and biochemical characteristics were analyzed using ANOVA, χ2 test and Fisher’s exact tests.
Results: Mean LA levels were similar at 1.3±0.3 and 1.3±0.4 mmol/L in Group 1 (N=24, age 74.9±6.4 years, BMI 29.5±4.0kg/m2) and Group 2 (N=28, age 74.4±6.2 years, BMI 32.5±5.8kg/m2), respectively; while, LA was significantly higher in Group 3 (N=40, age 71.7±5.0 years, BMI 33.9±7.5kg/m2) at 2.0±1.0mmol/L compared with Group 2 subjects (P&lt;0.001). Only 1 patient in each Group 1 (4.2%) and Group 2 (3.6%) had hyperlactatemia, as compared with 17 pts in Group 3 (42.5%) (P&lt;0.05). Mild lactic acidosis (LA 5.2mmol/L, bicarbonate 18meq/L, anion gap 16) resolving with MET discontinuation was diagnosed in one Group 3 subject. Average daily MET dose in Group 3 was 1325±581mg and glycemic control was equal in Groups 2 and 3 (HbA1c 7.5±1.3 vs. 7.6±1.3%). There was no difference in mean LA level or frequency of hyperlactatemia between Group 3 pts with CKD stage 3A (eGFR 45-59, MET 1394±619mg/day) and stage 3B (eGFR 30-44, MET 1000±0mg/day). No differences in age, BMI, weight, eGFR, and HbA1c were seen in Group 3 pts with and without hyperlactatemia except trend towards higher MET dose in the hyperlactatemia patients (1500±560 vs. 1196±574 mg/day, P=0.1).
Conclusions: MET increases risk of hyperlactatemia in elderly men with T2D and CKD3 without clear predisposing factors while not offering explicit therapeutic advantage. We recommend using lower MET doses in elderly diabetic men with stage 3 CKD.

Disclosure
A.R. Gosmanov: None. E. Gosmanova: Advisory Panel; Self; Amgen Inc.