Glycemic Control In Adult Patients Research Articles

Plasma proteome profiling reveals the therapeutic effects of the PPAR pan-agonist chiglitazar on insulin sensitivity, lipid metabolism, and inflammation in type 2 diabetes

Chiglitazar is a novel peroxisome proliferator-activated receptor (PPAR) pan-agonist, which passed phase III clinical trials and was newly approved in China for use as an adjunct to diet and exercise in glycemic control in adult patients with Type 2 Diabetes (T2D). To explore the circulating protein signatures associated with the administration of chiglitazar in T2D patients, we conducted a comparative longitudinal study using plasma proteome profiling. Of the 157 T2D patients included in the study, we administered chiglitazar to a specific group, while the controls were given either placebo or sitagliptin. The plasma proteomes were profiled at baseline and 12 and 24 weeks post-treatment using data-independent acquisition mass spectrometry (DIA-MS). Our study indicated that 13 proteins were associated with chiglitazar treatment in T2D patients, including 10 up-regulated proteins (SHBG, TF, APOA2, APOD, GSN, MBL2, CFD, PGLYRP2, A2M, and APOA1) and 3 down-regulated proteins (PRG4, FETUB, and C2) after treatment, which were implicated in the regulation of insulin sensitivity, lipid metabolism, and inflammation response. Our study provides insight into the response of chiglitazar treatment from a proteome perspective and demonstrates the multi-faceted effects of chiglitazar in T2D patients, which will help the clinical application of chiglitazar and further study of its action mechanism.

Practical Applications of a Nausea and Vomiting Model in the Clinical Development of Additional Doses of Dulaglutide.

Dulaglutide 3.0 and 4.5 mg weekly doses were approved for additional glycemic control in adult patients with type 2 diabetes inadequately controlled with metformin and 0.75 or 1.5 mg weekly doses of dulaglutide. Effects such as nausea and vomiting are commonly reported with dulaglutide and other glucagon-like peptide-1 receptor agonist therapies. Based on a pharmacokinetic/pharmacodynamic model-informed approach, a stepwise dose-escalation scheme with 4-week intervals between dose increments was suggested to mitigate gastrointestinal events for dulaglutide. These gastrointestinal events are dose dependent and attenuate over time with repeated dosing. A Markov chain Monte Carlo pharmacokinetic/pharmacodynamic joint model was developed using AWARD-11 data (N = 1842) to optimize dulaglutide dose escalation to 3.0 and 4.5 mg to mitigate gastrointestinal events. Model simulations evaluated probabilities of nausea and vomiting events for various dosing scenarios in patients needing higher doses for additional glycemic control. The model indicated that patients may dose escalate from 1.5 to 3.0 mg, then 4.5 mg weekly after at least 4 weeks on each dose. No clinically meaningful differences in nausea or vomiting events were expected when patients escalated to 3.0 or 4.5 mg following initiation at 0.75 or 1.5 mg dulaglutide. Based on the findings of this model, a minimum 4-week duration at each dose before escalation was appropriate to reduce gastrointestinal events of dulaglutide, consistent with observed gastrointestinal events data from the AWARD-11 study and supporting the currently recommended dose-escalation regimen of dulaglutide doses of 3.0 and 4.5mg for additional glycemic control.

The Effect of Telemedicine in Glycemic Control in Adult Patients with Diabetes during the COVID-19 Era-A Systematic Review.

Telemedicine can be an effective tool for managing chronic diseases. The disruption in traditional diabetes care resulting from the COVID-19 pandemic led to global interest in telemedicine. With this manuscript, we evaluated the use of telemedicine for the management of diabetes during the pandemic and its impact on glycemic control, focusing on retrospective and prospective studies which included adult, non-pregnant patients with diabetes. We evaluated whether there was an improvement in HbA1c, time in range (TIR), glucose management indicator (GMI), mean glucose values, hypoglycemic episodes, time below range (TBR), or hospitalizations for hypoglycemia/DKA, depending on the available information provided. This review article highlights the benefits of telemedicine during the global state of emergency, which altered the standard of healthcare delivery. Across the studies reported in this review, telemedicine was shown to be an effective tool for the management of diabetes, illustrating its potential to be the new standard of care. Although these improvements may be confounded by potential extraneous factors present during the pandemic, telemedicine was shown to positively impact glycemic control. Overall, this article highlights the benefits of telemedicine on glycemic control during the global state of emergency, which altered the standard of care. With the rollback of COVID-19 restrictions, and a return to the office, this article emphasizes the necessity to study how telemedicine can be best utilized for diabetes management when compared to the traditional standard of care.

Effect of the historic Spanish heatwave over glycemic control in adult patients with type 1 diabetes

AimTo evaluate the effect of the historic Spanish heatwave (9th–26th July 2022) over glycemic control in adults with type 1 diabetes (T1D). MethodsCross-sectional retrospective analysis of adult patients with T1D in Castilla-La Mancha (south-central Spanish region) using intermittently scanned continuous glucose monitoring (isCGM) during and after the heatwave. Primary outcome was change in time in range (TIR) 3.0–10 mmol/L (70–180 mg/dL) of interstitial glucose in the two weeks following the heatwave. ResultsA total of 2701 T1D patients were analyzed. We detected a TIR reduction of 4.0 % (95 % CI −3.4, −4.6; P < 0.001) in the two weeks following the heatwave. Patients in the highest daily scan frequency quartile (>13 scans/day) during the heatwave showed the greatest deterioration in TIR after it concluded (−5.4 % [95 % CI −6.5, −4.3; P < 0.001]). The percentage of patients meeting all the recommendations of the International Consensus of Time in Range was greater during the heatwave than after it ended (10.6 % vs. 8.4 %, P < 0.001). ConclusionsAdults with T1D had better glycemic control during the historic Spanish heatwave compared to the following period.

The use of long-acting insulin degludec in adult patients with type 2 diabetes mellitus in real clinical practice in Russia

BACKGROUND: Effective glycaemic control remains the most important task in managing the risks of Diabetes type 2 complications development. In this regard, the choice of insulin preparations with minimal variability of action is of utmost importance since this approach allows achieving the maximum treatment effectiveness and adequate safety level.AIM: The aim of this study was to investigate insulin degludec treatment effect on glycemic control in adult patients with Diabetes Mellitus (DM) type 2 in a real-world clinical setting in the Russian Federation.MATERIALS AND METHODS: The open prospective study was conducted in 2020–2021 in 35 clinical centers in 31 cities of the Russian Federation. The study included adult patients with type 2 DM treated according to Russian routine clinical practice. The prospective follow-up period was 26 weeks. The main study endpoints were changes in HbA1c level, fasting plasma glucose, insulin daily doses, number, and characteristics of different types of hypoglycaemia episodes and adverse events (AEs), and patient preferences compared to previous treatment.RESULTS: The study enrolled 494 patients. By the end of follow-up period:The mean HbA1c decrease was 1.6% (p&lt;0.0001).Fasting plasma glucose level decreased by 3.4 mmol/L (p&lt;0.0001).Daily basal and prandial insulin doses decreased by 1.6 IU/day (p&lt;0.0001) and 2.1 IU/day (p&lt;0.01), respectively.Severe episodes of hypoglycemia did not occur, while the incidence of nonsevere episodes decreased significantly.76 patients (15.4%) had 105 AEs, of which 41 (in 33 patients, 6.7%) were serious.COVID-19 was the most frequent AE reported in 21 patients (4.3%).Only in one case insulin degludec was withdrawn due to the patient’s pregnancy and the AEs that arose from it.Most patients (98.6%) preferred insulin degludec to previous treatment.CONCLUSION: The study demonstrated a statistically significant improvement in glycemic control, accompanied by basal insulin dose decrease combined with the absence of severe episodes of hypoglycemia, and significant decrease of nonsevere episodes (total and nocturnal). These results led to a large proportion of patients wanting to continue insulin degludec treatment preferring the medicine over previous treatment.

Glycemic Control in Type 1 Diabetes Mellitus and COVID-19: What We Learned From the Lockdown Experience.

Confinement measures that were imposed during the COVID-19 pandemic drastically changed the routines of the population. Some studies on the impact of confinement on glycemic control suggest a reduction of 0.1 to 0.5% in glycated hemoglobin. The objective of this study was to evaluate the impact of the COVID-19 pandemic lockdown on glycemic control in adult patients with type 1 diabetes mellitus. An observational retrospective cohort study of patients with type 1 diabetes mellitus followed in a Diabetes Unit was performed. The study compared the metabolic control of these patients before (between January 1st and March 18th, 2020) and after (between May 3rd and July 31st, 2020) the lockdown. The study included 102 patients with type 1 diabetes mellitus (51% females), with a median age of 36 years (interquartile range 18.75, (24.25-43)) and a median duration of diabetes of 15 years (interquartile range 13, (8-21)). After lockdown, a significant decrease of 0.28±0.71% in glycated hemoglobin was observed (7.88±1.33% vs 7.59±1.23%, p=<0.001). In patients using continuous glucose monitoring a significant improvement in time in range was also noted (47.25±17.33% vs 49.97±18.61%, p=0.008). This study demonstrated an improvement in glycemic control after the lockdown. This might be explained by the positive impact of stable schedules, healthy meals and greater availability to make therapeutic adjustments to glycemic control. The fact that diabetes was considered a risk factor for the development of severe COVID-19 disease might also influence patients to increase their efforts to optimize their glycemic control.

Dorzagliatin: First Approval.

Dorzagliatin (HuaTangNing) is an oral glucokinase activator that is being developed by Hua Medicine for the treatment of type 2 diabetes mellitus (T2DM), type 1 diabetes mellitus (T1DM) and diabetic kidney disease (DKD). Dorzagliatin improves glycaemic control by activating pancreatic and hepatic glucokinase in a glucose-dependent manner. In September 2022, dorzagliatin (with diet control and exercise) as monotherapy and as an add-on to metformin (when glycaemic control is inadequate with metformin alone) was approved in China for improving glycaemic control in adult patients with T2DM. This article summarizes the milestones in the development of dorzagliatin leading to this first approval.

Comparative Glycemic Control in Adult Patients with Type 2 Diabetes on Herbal and Conventional Glucose-Lowering Agents in Nairobi County, Kenya

Background: Some diabetic patients seek care exclusively from traditional herbal practitioners. It is not known if the care provided by herbalists is effective in maintaining optimal glycemic control.&#x0D; Aim: To compare glycemic control in adult patients with type 2 diabetes on treatment with conventional medicines against those on herbal glucose-lowering therapies.&#x0D; Study Design: Descriptive cross-sectional study.&#x0D; Place and Duration of Study: Patients on conventional treatment were recruited from the Endocrinology and Diabetes Outpatient Centre at Kenyatta National Hospital. The comparative group was enrolled from the New Life Herbal Clinic. The study was carried out between March 2019 and December 2021.&#x0D; Methodology: We recruited 80 patients on treatment with conventional antidiabetic therapies at Kenyatta National Hospital (KNH) and 37 patients on herbal therapies at New Life Herbal Clinic (NLHC). A structured questionnaire was used to collect sociodemographic and clinical data. Consecutive sampling was used to recruit the study participants. Glycated hemoglobin (HbA1C) levels were measured at the time of the patient visit.&#x0D; Patients with HbA1c levels &lt;7% were considered to have achieved adequate glycemic control. Descriptive and inferential data analysis was performed on all the variables and compared across the two study arms. Regression analysis was performed to identify variables associated with glycemic control for each treatment group. Data were entered into and analyzed using SPSS software version 26 (SPSS Inc, Chicago, USA). P-values &lt;0.05 were considered to be statistically significant.&#x0D; Results: Patients on conventional antidiabetic medications had significantly lower mean HbA1c levels (7.40+1.92) % compared to (8.34+1.97) % in the herbal treatment arm (P=0.016). Significant differences in mean HbA1c % were reported in patients on a combination of 5-6 herbs (7.06 +1.54) % compared to those on 3-4 herbs (8.63+1.91) % (P= 0.045). Significant predictors of adequate glycemic control (HbA1c&lt; 7%) were having a past HbA1c check ( (aOR= 3.098 (95% C.I=1.258-7.631) P=.014), adherence to medications ( (aOR= 6.055 (95% C.I=1.623-22.593) P= .007), treatment with Launaea cornuta ( (aOR= 7.143 (95% C.I=1.462-34.893) P= 0.015) and being married (aOR=2.870 (95% C.I=1.054-7.818) P=0.039).&#x0D; Conclusion: Patients on treatment with conventional agents reported better glycemic control compared to those on herbal therapies. Regular monitoring of HbA1c, adherence to medications, having a spouse and treatment with Launaea cornuta may enhance blood glucose control in patients with type 2 diabetes.

Intragastric prepyloric enteral nutrition, bolus vs continuous in the adult patient: A systematic review and meta-analysis.

Bolus and continuous nutrition are commonly used enteral nutrition (EN) administration methodologies. Currently, there is insufficient evidence to establish which is the most effective method for reducing gastrointestinal complications in adult patients. The aim of this review is to evaluate the impact of bolus/intermittent EN compared with continuous EN for the following outcomes: diarrhea, constipation, emesis/vomiting, gastric residual volume, aspiration, and glycemic control in adult patients receiving intragastric prepyloric EN in the hospital setting. Bibliographical research was performed on the following databases: PubMed, Embase, CINAHL, and the Cochrane Central Register of Controlled Trials. The review included all randomized and nonrandomized controlled trials of patients aged ≥18 years with preserved gastrointestinal function. Meta-analysis was performed by Review Manager V.5.3. Seven studies including 551 patients were included in the meta-analysis. Five of these studies reported that the diarrhea rate was higher in the bolus feeding group (risk ratio [RR] = 2.50; 95% CI, 1.17-5.34; P = 0.02), and another five of these studies indicated that the aspiration rate was higher in the continuous feeding group (RR = 0.55; 95% CI, 0.35-0.87; P = 0.01). There were no significant differences for the other outcomes. In conclusion, intermittent EN appears to reduce the incidence of aspiration in the hospital setting; however, it may increase the risk of diarrhea. For future research, we hypothesize the joint use of continuous nutrition until the patient reaches tolerance and then passing to bolus nutrition, thus reducing the incidence of aspiration and enabling a physiological nutrition intake.

Joint associations of fresh fruit intake and physical activity with glycaemic control among adult patients with diabetes: a cross-sectional study

ObjectiveTo investigate the joint associations of fresh fruit intake and physical activity with glycaemic control in adult patients with diabetes mellitus (DM).DesignIt was an observational study involving adult patients with...

Association Between Poor Sleep Quality and Glycemic Control in Adult Patients with Diabetes Referred to Endocrinology Clinic of Guilan: A Cross-sectional Study.

BackgroundDiabetes is a prevalent chronic medical comorbid condition worldwide. Diabetes mellitus is associated with various sleep disorders.ObjectivesWe aimed to determine the prevalence of poor sleep and the main factors of sleep interruptions in patients with diabetes mellitus. We further evaluated the association of sleep interruptions with glycemic control in this cohort.MethodsWe conducted a cross-sectional study on 266 patients with type 1 and type 2 diabetes recruited from a university outpatient endocrinology clinic. Patients completed a checklist including demographic and disease-related characteristics in addition to the Pittsburgh Sleep Quality Index (PSQI) to evaluate sleep quality. Using the PSQI cutoff score of 5, we created two subgroups of good sleepers (GS) and poor sleepers (PS).ResultsOur results showed that good sleeper and poor sleeper patients with diabetes were significantly different regarding sex, employment status, BMI, presence of diabetes-related complications, HbA1c, and 2-hour postprandial blood sugar (2HPPBS) (all significant at P < 0.05). The most prevalent factors of sleep interruptions were “waking up to use a bathroom”, “feeling hot”, “pain”, “having coughs or snores”, and “bad dreams”. Among the subjective factors of sleep interruption, problems with sleep initiation, maintenance, or early morning awakenings in addition to having pain or respiratory problems such as coughing or snoring had the most significant associations with HbA1c.ConclusionsOur study showed significant subjective sleep disturbances (both quality and quantity) in patients with diabetes mellitus (both type I and II) and its association with diabetes control. We further identified the main factors that led to sleep interruptions in this cohort.

Chiglitazar: First Approval.

Chiglitazar (Bilessglu®) is an orally administered, non-thiazolidinedione small-molecule agonist of α, δ and γ peroxisome proliferator-activated receptors (PPARs) being developed by Chipscreen Biosciences for the treatment of type 2 diabetes (T2D) and non-alcoholic steatohepatitis. In October 2021, chiglitazar was approved in China for use as an adjunct to diet and exercise to improve glycaemic control in adult patients with T2D. The drug is also in phase 2 clinical development in China for the treatment of non-alcoholic steatohepatitis. This article summarizes the milestones in the development of chiglitazar leading to this first approval for the treatment of T2D.

642-P: A Model-Based Evaluation of Nausea and Vomiting Events for Additional Doses of Dulaglutide in Existing and Dulaglutide-Naïve Patients with Type 2 Diabetes

Dulaglutide (DU) 3 mg and 4.5 mg once weekly (QW) doses were recently approved for additional glycemic control in adult patients with type 2 diabetes. If needed, a dose-escalation scheme from 1.5 mg to 3 mg and then 4.5 mg can be applied after at least 4-weeks on each dose. For GLP-1 receptor agonists, such as DU, common gastrointestinal (GI) side effects include nausea (N) and vomiting (V). These GI effects are dose-dependent but attenuate over time with chronic dosing. To enhance prescriber understanding of GI effects following dose escalation in existing and DU-naïve patients, a Markov chain Monte Carlo pharmacokinetic/pharmacodynamic joint model was developed with Phase 3 AWARD-11 data (n=1842) which compared 3 mg and 4.5 mg DU to 1.5 mg, to evaluate probabilities of daily N and V events. The model was initiated with priors from a similar Phase 2 model (n=317). In this model, dose increment raised the probability of developing a GI event, and preceding N events enhanced the probability of V events. Development of GI tolerance to N and V was both time and DU concentration dependent. Model-predictions of the percentage of patients presenting with ≥1 N or V event per day for a given dosing scenario were generated via simulations of 100 trials with 300 patients per scenario from the AWARD-11 dataset and compared with the AWARD-11 dose-escalation scheme over a 52-week duration. Patients already on DU 1.5 mg QW for at least 4 weeks can escalate to 3 mg QW any time, and if needed increase to 4.5 mg QW after 4 weeks on 3 mg. Simulations showed ≤3% and ≤1% increase in N and V events, respectively compared to AWARD-11 dose escalation scheme. For DU-naïve patients starting at 0.75 mg QW, N and V events were reduced by ≤2% and ≤1%, respectively, after escalating to 1.5 mg QW and 3 mg after ≥4 weeks at each dose. Whether in DU-naïve patients or those already on 1.5mg, simulations showed no meaningful increase in N and V when dose escalation occurred at intervals of at least 4 weeks. Disclosure L. Tham: Employee; Self; Eli Lilly and Company. J. S. K. Lim: Employee; Self; Eli Lilly and Company. C. Tang: Employee; Self; Eli Lilly and Company, Employee; Spouse/Partner; Novartis AG. H. Jung: Employee; Self; Eli Lilly and Company, Stock/Shareholder; Self; Eli Lilly and Company. M. Konig: Employee; Self; Eli Lilly and Company. L. Loo: Employee; Self; Eli Lilly and Company, Employee; Spouse/Partner; Eli Lilly and Company.

176-LB: The Impact of COVID-19 Infection on Subsequent Glycemic Control

Recent studies suggest COVID-19 infection has a detrimental effect on glycemic control in patients with diabetes in the acute care setting. However, there is limited information about the impact of COVID-19 on glycemic control in the months following infection. In this retrospective observational study, we examined the correlation between COVID-19 infection and glycemic control in adult patients with elevated A1c in a single health system (n=3,295). Patients were selected from a cohort of those age 18 years or older who were tested for COVID-19 between 3/1/2020 and 11/1/2020. COVID positive patients were identified through positive SARS-CoV-2 PCR or a COVID flag in the EMR. COVID negative patients were randomly selected in a 3:1 ratio from all patients who had a negative COVID test in the same week as each positive patient. Patients from this cohort were included if they had a baseline A1c ≥ 5.7% measured in the preceding six months and at least two weeks prior to their COVID positive (n=670) or COVID negative (n=2,625) test date, as well as an endpoint A1c ≥ 5.7% at least three months after this date. The study population was 54% female, 60% White, 20% Hispanic, and 13% Black with a mean BMI 32 ± 7.3 kg/m2, age 64.1 ± 13.6 yrs, and baseline A1c of 7.7± 1.6 %; 81% of patients had a diagnosis of type 2 diabetes. In a linear regression model, COVID-19 infection was significantly associated with increased endpoint A1c (coefficient = 0.14, 95% CI [0.03 - 0.25], p = 0.01). Baseline A1c, male sex, and Hispanic ethnicity were also significantly associated with increased A1c, while age and median income based on zip code were associated with decreased A1c. In conclusion, prior COVID-19 infection appears to be associated with worse glycemic control at least 3 months post-infection compared to patients who did not contract COVID-19. Additional research is needed to determine if this association is present in other patient populations as well as the physiologic and socio-demographic causes for this finding. Disclosure E. G. Thurber: None. M. E. Mcdonnell: Stock/Shareholder; Spouse/Partner; Abbott Diabetes. G. Cromwell: None. M. Johnson: None. D. C. Simonson: Stock/Shareholder; Spouse/Partner; Phase V Technologies, Inc. N. E. Palermo: None.

185-LB: Effect of the COVID-19 Lockdown on Glycemic Control in Adult Patients with Type 2 Diabetes Mellitus

Objective: The rapid emergence of the SARS-COV2 virus that caused COVID-19 pandemic in early 2020 led to authorities instituting lockdown protocols to curb spread of the virus. Prior studies in patients with T1DM have demonstrated a short-term favorable or neutral effect of the lockdown on glycemic parameters; however, data is limited in T2DM patients. We sought to identify how the lockdown affected the glycemic control of adult patients with T2DM within a specific region of New York Design &amp; Methods: In this retrospective cohort study, we analyzed data from patients with regular outpatient visits within an integrated-delivery health system in South Bronx, New York who had A1C levels measured within 6 months prior to the initiation of lockdown (Mar ’20) and a repeat A1C within 3 months after the first phase of reopening in New York (June ’20). Analysis of comparison between pre- and post-lockdown HbA1c values was performed using paired samples T-test. Results: A total of 2489 adult patients with an established diagnosis of T2DM and A1C levels available during the study period were identified. 632 patients were excluded due to pregnancy, prediabetes, new-onset diabetes, residency in long-term care facility or hospital admission during the study period. Age range was 18 to 95 years with a mean age of 61. 58% of the patients were female and 41% male. Mean pre-lockdown A1C was 7.64% and mean post-lockdown A1C was 7.76%, indicating an increase of 0.122% (95% CI, 0.0613-0.1827) Conclusions: The COVID-19 lockdown was associated with a small but statistically significant increase in HbA1C levels (0.122%) in a large cohort of community-dwelling adult patients with type 2 diabetes in South Bronx. Interruptions to regular outpatient care, difficulty in obtaining medications from pharmacies, changes in physical activity or diet and psychological stress related to the pandemic may have been potential contributing factors and need to be addressed to avoid further worsening of diabetes control in the longer term. Disclosure I. O. Malik: None. K. Naher: None. K. Thrupthi: None. B. Zaidi: None. V. Leung: None.

Effects of novel flash glucose monitoring system on glycaemic control in adult patients with type 1 diabetes mellitus: protocol of a multicentre randomised controlled trial

IntroductionOptimal glycaemic control is beneficial to prevent and delay microvascular complications in patients with type 1 diabetes mellitus (T1DM). The benefits of flash glucose monitoring (FGM) have been proved among...

Semaglutide: A Novel Oral Glucagon-Like Peptide Receptor Agonist for the Treatment of Type 2 Diabetes Mellitus.

Diabetes mellitus (DM) is a complex and chronic condition that requires continuous medical care. Uncontrolled hyperglycemia can lead to serious microvascular and macrovascular complications, such as coronary artery disease, peripheral arterial disease, and stroke. Type 2 DM occurs when the pancreas is unable to produce adequate insulin to regulate glucose levels and when there is a decrease in sensitivity to insulin in the body. Insufficient glucagon-like peptide (GLP-1), a normal body hormone, plays an important role in the pathophysiology of DM. The introduction of the GLP-1 receptor agonists expanded therapeutic options in achieving glycemic control in adult patients. In 2005, the US Food and Drug Administration approved exenatide as the first injectable formulation, which led to the advancement of other injectable formulations within the class of GLP-1 receptor agonists. In 2019, semaglutide was approved as the first oral GLP-1 receptor agonist addressing the unmet needs in patients who benefit from therapy with this therapeutic class yet are unwilling to use an injectable drug. This article will provide an overview of the GLP-1 receptor agonists, including the pharmacology of semaglutide, its clinical evidence and role in therapy in type 2 DM.

Real-world evidence of glycemic control among patients with type 2 diabetes mellitus in India: the TIGHT study

ObjectiveTo determine glycemic control in adult patients with type 2 diabetes receiving antidiabetic therapy as part of routine healthcare in India.Research design and methodsThis was a retrospective analysis of cross-sectional...

1079-P: Glycemic Control and Change in Insulin Dose with Real-Life Use of Hybrid Closed-Loop System

Optimal glycemic control with minimal hypo- and hyperglycemia in type 1 diabetes (T1D) is difficult to achieve. New technologies such as hybrid closed loop (HCL-670G) system could help to improve glycemic control and prevent complications. We report a single-center 6-month experience regarding changes in metrics for glycemic control in adult patients with T1D on the Medtronic® 670G system. There were 139 patients (mean±SD age 41±12 years, 60% women) with T1D who were on a pump and CGM for at least 3 months prior to initiating 670G system, and who had at least six months of follow-up on 670G. We analyzed the changes in HbA1c, daily insulin dose, and BMI from baseline (just prior to initiating 670G system) at 3 and 6-months of 670G use. The mean percent time in auto-mode was 71% at 3 months and 73% at 6 months, with a range of 0-99% at both time points. Use of the 670G system significantly improved HbA1c with no change in BMI (Table). Percent time in auto-mode was significantly correlated to HbA1c at 3 (r=-0.26, p=0.009) and 6 months (r=-0.32, p=0.002). Daily bolus and total insulin dose increased at 3 months but were not significantly higher than pre-670G after 6 months of 670G use. We conclude that HCL use in real-life improves glucose control without increasing body weight or insulin dose. Disclosure D.A. Giordano: None. J.K. Snell-Bergeon: None. H. Joseph: None. S.K. Garg: Advisory Panel; Self; Eli Lilly and Company, Roche Pharma, Sanofi-Aventis, Zealand Pharma A/S. Research Support; Self; Eli Lilly and Company, WebMD. H.K. Akturk: Advisory Panel; Self; Sanofi. Research Support; Self; Eli Lilly and Company, MannKind Corporation, REMD Biotherapeutics. Speaker's Bureau; Self; MannKind Corporation.

1210-P: Pooled Analysis of the Safety and Efficacy of Ertugliflozin in the Elderly

Ertugliflozin (ERTU), an SGLT2 inhibitor, improves glycemic control in adult patients (pts) with T2DM. Elderly pts with T2DM are underrepresented in clinical studies, often present with multiple co-morbidities and are more susceptible to adverse events (AEs). Pooled analyses based on 7 phase 3 studies from the VERTIS program evaluated the safety and efficacy of ERTU in subgroups of pts aged &amp;lt;65 and ≥65 years. Pts with T2DM received ERTU (5 or 15 mg ± sitagliptin [SITA] 100 mg) or control (placebo [PBO], glimepiride or SITA). Safety data were evaluated up to 104 weeks. Efficacy was assessed in a subset of 3 PBO-controlled studies at 26 weeks. Baseline (BL) characteristics were similar between pts aged &amp;lt;65 (n=3605) and ≥65 years (n=1254), with the exception of mean BL estimated glomerular filtration rates (90.2 mL/min/1.73 m2 in pts &amp;lt;65 and 71.4 mL/min/1.73 m2 in pts ≥65). The safety profile of ERTU was similar in both age groups, except for a higher incidence of volume depletion AEs with ERTU relative to control (2.4% vs. 1.1%) in pts ≥65. Excluding pts with BL moderate renal impairment, incidence of renal-related AEs was similar across groups in pts ≥65 (ERTU [0.6%] vs. control [0.8%]), suggesting age alone does not increase risk of renal-related AEs. In the 3 PBO-controlled studies, documented hypoglycemia (4.4% vs.6.0%) and severe hypoglycemia rates (0.4% vs. 0.4%) with ERTU were comparable in pts &amp;lt;65 and ≥65. Efficacy of ERTU by age group is shown in the Figure. Disclosure R.E. Pratley: Consultant; Self; Sanofi US. Other Relationship; Self; AstraZeneca, Eli Lilly and Company, GlaxoSmithKline plc., Janssen Global Services, LLC., Janssen Research &amp; Development, Lexicon Pharmaceuticals, Inc., Ligand Pharmaceuticals, Inc., Merck Sharp &amp; Dohme Corp., Mundipharma, Novo Nordisk Inc., Pfizer Inc., Sanofi, Takeda Development Center Americas, Inc. S. Dagogo-Jack: Board Member; Self; Jana Care Inc. Consultant; Self; Janssen Pharmaceuticals, Inc., Merck &amp; Co., Inc., Sanofi-Aventis. Research Support; Self; AstraZeneca, Novo Nordisk Inc. Stock/Shareholder; Self; Dance Biopharm Holdings Inc. B. Charbonnel: Consultant; Self; AstraZeneca, Merck Sharp &amp; Dohme Corp., Novo Nordisk A/S, Sanofi, Servier. Speaker's Bureau; Self; AstraZeneca, Eli Lilly and Company, Merck Sharp &amp; Dohme Corp., Novo Nordisk A/S, Sanofi, Takeda Pharmaceutical Company Limited. S.M. Patel: Stock/Shareholder; Spouse/Partner; Janssen Pharmaceuticals, Inc. Stock/Shareholder; Self; Merck &amp; Co., Inc. M.A. Hickman: Employee; Self; Pfizer Inc. J. Liu: Employee; Self; Merck &amp; Co., Inc. L. Tarasenko: Employee; Self; Pfizer Inc. M.C. Ellison: Employee; Self; Merck &amp; Co., Inc. I. Gantz: Employee; Self; Merck &amp; Co., Inc. S.G. Terra: Employee; Self; Pfizer Inc. Funding Merck Sharp &amp; Dohme Corp; Pfizer Inc.