Low Incidence Of Hypoglycemia Research Articles

Analysis of the Clinical Efficacy of Glimepiride Combined with Insulin in the Treatment of Elderly Diabetes

Objective: To explore the clinical efficacy and incidence of hypoglycemia in the treatment of elderly diabetes with glimepiride combined with insulin. Methods: A total of 100 patients diagnosed with diabetes in Qinghai Red Cross Hospital from January 2018 to January 2019 were selected and divided into an observation group and a control group according to the order of their visits, with 50 patients in each group. The observation group was treated with glimepiride combined with insulin, while the control group was treated with insulin alone. The blood sugar indicators, including glycated hemoglobin (HbA1c), fasting blood glucose (FBG), and 2-hour postprandial blood glucose (2h PBG), were compared between the two groups. Additionally, the incidence of hypoglycemia was compared, and the causes of hypoglycemia were analyzed and summarized, proposing corresponding countermeasures. Results: The glycated hemoglobin value of the observation group was lower than that of the control group, and the statistical analysis showed a significant difference (t = 3.54, P < 0.05). The fasting blood glucose value in the observation group was lower than that in the control group, with statistically significant differences (t = 4.08, P < 0.05). The 2-hour postprandial blood glucose value in the observation group was also lower than that in the control group, with a significant difference (t = 3.82, P < 0.05). The incidence of hypoglycemia in the observation group was 10%, while it was 56% in the control group, with a statistically significant difference between the two groups (χ2 = 5.813, P < 0.05). Conclusion: The efficacy of glimepiride combined with insulin in the treatment of elderly diabetes is significantly higher than that of insulin alone, with a lower incidence of hypoglycemia.

Does Monopolar Electrocautery Affect the Fetus during Cesarean Section?

Background and Objectives: This study aimed to assess the impact of monopolar electrocautery on the fetus during cesarean section. Materials and methods: A retrospective analysis was conducted with 552 patients delivered by cesarean section. Patients were grouped based on usage of monopolar electrocautery. In 272 patients, monopolar electrocautery was used to separate the tissues before the delivery. In 280 patients, no electrocautery was used. Newborn vital signs, Apgar scores, umbilical cord blood parameters, newborn serum parameters collected within 6th postpartum hour, and rate of newborn intensive care unit admission were compared. Results: The 1st and 5th minute Apgar scores were significantly higher in the electrocautery group; however, this difference lost its significance at the 10th minute. The median newborn pulse rate (148 (7) vs. 146 (6) beats per minute, p = 0.026), umbilical cord blood pH, and partial oxygen pressure were significantly higher in the electrocautery group compared to the no-electrocautery group (7.34 ± 0.06 vs. 7.31 ± 0.06, p < 0.001, and 25.5 (14.77) vs. 23 (16.08) mmHg, p = 0.025, respectively). The median umbilical cord blood serum calcium level was 1.51 (0.64) mmol/L in the electrocautery group, which was significantly lower than 1.9 (0.82) mmol/L in the no-electrocautery group (p = 0.002). The incidence of hypoglycemia was significantly lower in the electrocautery group than in the no-electrocautery group (2.2% vs. 5.7%, p = 0.035). Conclusions: Monopolar electrocautery during cesarean section affects the fetus, but it is safe to use it. Electrocautery is independently associated with umbilical cord blood pH and calcium level. Electrocautery may be associated with a lower incidence of hypoglycemia.

Glucometric parameter changes in patients with type 2 diabetes during ramadan fasting: A prospective comparative real-world study

BackgroundThis study assessed glucometric changes in Type 2 diabetes mellitus (T2DM) patients before, during, and after Ramadan fasting using an intermittently scanned continuous glucose monitoring system (isCGMS). MethodsThis prospective comparative study included T2DM patients aged 30–70 years who were receiving nonintensive insulin in Riyadh, Saudi Arabia. In addition to the baseline characteristics, glycated hemoglobin (HbA1c) and ambulatory glucose profile (AGP)-derived metric data were collected at three specific points: pre-, during-, and post-Ramadan. Self-care activities during Ramadan were evaluated using the Diabetes Self-Management Questionnaire (DSMQ). ResultsOverall, a total of 93 T2DM patients were enrolled in the study. Their mean age ±SD age was 47.9 ± 7.5 years, and 51.6 % of them were males. Compared with pre- and post-Ramadan, there was a significant decrease in HbA1c (p < 0.001 for both periods), average glucose level (p = 0.001 and p = 0.026, respectively), glucose variability (p = 0.043 and p = 0.005, respectively), and % time above the range of 181–250 mg/dL (p < 0.001 for both periods), as well as a significant increase in % time in target (70–180 mg/dL) during Ramadan (p < 0.001 for both periods). However, the % time below 54 mg/dL was slightly greater during Ramadan than both pre- and post-Ramadan (p < 0.001 and p = 0.002, respectively). Furthermore, 32.3 % reported inadequate self-care behaviors during Ramadan. ConclusionsRamadan fasting could improve glucose levels in T2DM patients who were not on intensive insulin, with a relatively low incidence of hypoglycemia.

Effect of switching from twice-daily basal insulin to once-daily insulin glargine 300 U/mL (Gla-300) in Brazilian people with type 1 diabetes

BackgroundLow adherence to the number of insulin injections and glycemic variability are among the challenges of insulin therapy in type 1 diabetes (T1D). The TOP1 study investigated the effect of switching from twice-daily (BID) basal insulin to once daily (OD) insulin glargine 300 U/mL (Gla-300) on glycemic control and quality of life.MethodsIn this 28-week, phase 4 trial, people with T1D aged ≥ 18 years, who were treated with BID basal insulin in combination with prandial rapid-acting insulin for at least 1 year, and had HbA1c between 7.5% and 10.0%, were switched to Gla-300 OD as basal insulin. The present study aimed to evaluate the impact of this change on HbA1c, glycemic profile, treatment satisfaction and safety. The change in HbA1c from baseline to Week 24 was the primary endpoint.ResultsOne hundred and twenty-three people with T1D (mean age 37 ± 11 years; 54.5% female) were studied. The disease duration was 20.0 ± 9.8 years, baseline HbA1c and fasting plasma glucose (FPG) were 8.6 ± 0.7% and 201 ± 80.3 mg/dL, respectively. After switching from BID to OD insulin regimen, no significant change in HbA1c was observed from baseline to Week 24 (p = 0.873). There were significant reductions in fasting self-monitoring blood glucose (SMBG) from baseline to Week 24 (175 ± 42 vs. 156 ± 38 mg/dL; p < 0.0001), and in glycemic profile (8-point SMBG) at several time points. There was a significant decrease in the proportion of patients with at least one hypoglycemic event (p = 0.025), in numbers of hypoglycemic events per patient-years of any type (p = 0.036), symptomatic (p = 0.007), and confirmed ≤ 70 mg/dL events (p = 0.049) from run-in to the last 4 weeks on treatment. There were significant improvements in treatment satisfaction (p < 0.0001), perceived hyperglycemia (p < 0.0001) scores and satisfaction with the number of injections between post-run-in and Week 24, and a significant decrease in fear of hypoglycemia.ConclusionsSwitch from BID basal insulin to OD Gla-300 as part of basal bolus therapy in T1D resulted in similar glycemic control as measured by HbA1c, but provided significant improvements in SMBG, daily glucose profile, a lower incidence of hypoglycemia and increased patient satisfaction.Trial registrationNCT03406000.

Resource setting impacts neonatal but not maternal survival in bitches treated for dystocia: 243 cases (2015-2020).

To compare maternal and fetal outcomes of dystocia managed surgically and nonsurgically at referral hospitals (RHs) versus community medicine clinics (CMCs), determine the rate of C-section, and evaluate the incidence of hypoglycemia and hypocalcemia in bitches presented with dystocia. Bitches presented with dystocia at 2 RHs and 2 CMCs. Information on signalment, presence of hypoglycemia and/or hypocalcemia, diagnostic imaging performed, nonsurgical and surgical interventions performed, maternal and fetal outcomes, and total cost of care was obtained from the electronic medical records of bitches presenting for dystocia between October 2015 and October 2020. Descriptive statistics were performed and outcome compared between RHs and CMCs using a Fisher exact test, with a P < .05 considered significant. 230 bitches were evaluated with 243 separate episodes of dystocia, with 183 (75%) episodes treated at an RH and 60 (25%) at a CMC. There was a low incidence of hypoglycemia (5% [9/178]) and ionized hypocalcemia (1% [2/164]). Seventy-three percent (177/243) of bitches underwent surgical intervention, 25% (61/243) received nonsurgical management, and 2% (5/243) transferred to their primary veterinarian. There was no difference in survival for bitches operated at an RH compared with a CMC. However, bitches operated at an RH were more likely (P = .04) to be discharged with at least 1 live neonate. In bitches diagnosed with dystocia, hypoglycemia and hypocalcemia were rare. The majority of bitches underwent a C-section. The setting where the C-section was performed did not impact maternal survival.

Assessing glycemic variability in critically ill patients: A prospective cohort study comparing insulin infusion therapy with insulin sliding scale

Glycemic variability (GV) has been associated with an increased mortality rate among critically ill patients. The clinical outcomes of having less GV even with slight hyperglycemia are better than those having tight glycemic control but higher GV. Insulin infusion remains the preferred method to control stress hyperglycemia in critically ill patients. However, its impacts on GV and clinical outcomes in critically ill patients still need further investigation. This study intended to evaluate the impact of insulin infusion therapy (IIT) compared to the insulin sliding scale (ISS) on the extent of GV and explore its impact on the clinical outcomes for critically ill patients. A prospective, single-center observational cohort study was conducted at a tertiary academic hospital in Saudi Arabia between March 2021 and November 2021. The study included adult patients admitted to ICUs who received insulin for stress hyperglycemia management. Patients were categorized into two groups based on the regimen of insulin therapy during ICU stay (IIT versus ISS). The primary outcome was the GV between the two groups. Secondary outcomes were ICU mortality, the incidence of hypoglycemia, and ICU length of stay (LOS). A total of 381 patients were screened; out of them, eighty patients met the eligibility criteria. The distribution of patients having diabetes and a history of insulin use was similar between the two groups. The GV was lower in the IIT group compared to the ISS group using CONGA (− 0.65, 95% CI [− 1.16, − 0.14], p-value = 0.01). Compared with ISS, patients who received IIT had a lower incidence of hypoglycemia that required correction (6.8% vs 2.77%; p-value = 0.38). In contrast, there were no significant differences in ICU LOS and ICU mortality between the two groups. Our study demonstrated that the IIT is associated with decreased GV significantly in critically ill patients without increasing the incidence of severe hypoglycemia. There is no survival benefit with the use of the IIT. Further studies with larger sample size are required to confirm our findings and elaborate on IIT's potential effect in reducing ICU complications in critically ill patients.

Real-world effectiveness and safety of insulin glargine 100 U/mL plus lixisenatide in adults with type 2 diabetes: An international, multicentre, 12-month, prospective observational study.

To assess the impact of insulin glargine (100 U/mL) and lixisenatide (iGlarLixi) fixed-ratio combination therapy on the overall management of glycaemia in patients with type 2 diabetes (T2D), previously inadequately controlled with oral antidiabetic drugs ± basal insulin or glucagon-like peptide-1 receptor agonists (GLP-1 RAs). This 12-month, international, multicentre, prospective, observational study included patients (age ≥ 18 years) with T2D who had initiated iGlarLixi within 1 month prior to study inclusion. Data were collected at study inclusion, month 3, month 6 and month 12 from patient diaries, self-measured plasma glucose, and questionnaires. The primary endpoint was change in HbA1c from baseline to month 6. Of the 737 eligible participants (mean age: 57.8 [standard deviation: 11.2] years; male: 49%), 685 had baseline and post-baseline HbA1c data available. The least squares mean change in HbA1c from baseline to month 6 was -1.4% (standard error [95% confidence interval (CI)]: 0.05 [-1.5, -1.3]). The absolute change from baseline at month 12 was -1.7% ± 1.9% (95% CI: -1.9, -1.5). There were 72 hypoglycaemia events reported during the study period, with a very low incidence of severe hypoglycaemia (two participants [rate: 0.003 events per patient-year]). This real-world observational study shows that initiation of iGlarLixi in people with T2D inadequately controlled on oral antidiabetic drugs ± basal insulin or GLP-1 RAs improves glycaemic control with a low incidence of hypoglycaemia.

Real-World Outcomes of Individualized Targeted Therapy with Insulin Glargine 300Units/mL in Insulin-Naïve Korean People with Type2 Diabetes: TOBE Study.

The TOujeo BEyond glucose control (TOBE) study evaluated clinical outcomes with insulin glargine 300units/mL (Gla-300) in insulin-naïve Korean people with type2 diabetes mellitus (T2DM) in a real-world setting. This 24-week, prospective, non-interventional, multicenter, open-label, single-arm, observational study included adults aged ≥ 20years with T2DM suboptimally controlled with oral hypoglycemic agents and/or glucagon-like peptide1 receptor agonists who require basal insulin. Eligible participants were assigned to either general target glycated hemoglobin (HbA1c < 7%) or individualized target groups as per physician's discretion considering guidelines and participants' characteristics. The primary endpoint was the proportion of participants achieving the HbA1c target (individualized or general) at 24weeks. Among 369 participants, 19.5% (72/369) of participants achieved the HbA1c target at week24; 37.5% (33/88) in the individualized and 13.9% (39/281) in the general target group. In both target groups, similar reductions in fasting plasma glucose and body weight were observed, with low incidence of hypoglycemia, and T2DM duration was significantly shorter in participants who did versus those who did not achieve the target HbA1c (individualized target group: 9.6 ± 8.0 versus 13.1 ± 8.4years, P = 0.0454; general target group: 10.2 ± 8.6 versus 12.8 ± 7.4years, P = 0.0378). This study showed that initiation of insulin therapy with Gla-300 in people with T2DM using an individualized approach is more effective in achieving an HbA1c target. Moreover, earlier initiation of insulin therapy in people with suboptimally controlled T2DM may increase the success rate of glycemic control. A graphical abstract is available with this article.

Reducing or Discontinuing Insulin or Sulfonylurea When Initiating a Glucagon-like Peptide-1 Agonist.

Hypoglycemia and weight gain are well-known adverse effects of insulin and sulfonylureas in patients with type 2 diabetes. Glucagon-like peptide-1 (GLP-1) agonist monotherapy has a low incidence of hypoglycemia, but when combined with insulin or sulfonylureas, patients have higher rates of hypoglycemia. The primary study outcome was to determine the percentage of patients with dose reductions or discontinuation of insulin or a sulfonylurea at baseline, 3, 6, and 12 months. Secondary outcomes included changes in hemoglobin A1c and body weight measured. This was a single-center, quality assurance, quality improvement, retrospective chart review of patients prescribed a GLP-1 agonist while on insulin and/or a sulfonylurea between January 1, 2019, and September 30, 2022, at a pharmacist-led patient aligned care team (PACT) clinic at the Wilkes-Barre Veterans Affairs Medical Center. This retrospective chart review included 136 patients. Throughout 12 months of following the pharmacist-led PACT clinic, 55 patients (57.3%) had ≥ 1 insulin dose reduction, 16 patients (29.6%) had ≥ 1 dose reduction of a sulfonylurea, 14 patients (14.6%) discontinued insulin, and 21 patients (38.9%) discontinued their sulfonylurea. Patients taking insulin and/or sulfonylurea in combination with a GLP-1 agonist may require a dose reduction or discontinuation of the diabetic agents. Patients on both insulin and sulfonylurea may need closer monitoring due to the higher incidences of discontinuations compared with patients on only 1 of these agents. Dose reductions or discontinuations of these diabetic agents can promote positive patient outcomes, such as preventing hypoglycemia, minimizing weight gain, increasing weight loss, and reducing hemoglobin A1c.

A comparative study of efficacy and safety of glimepiride versus gliclazide as an add on to metformin in Type 2 diabetes mellitus at a tertiary care hospital

Background: Type 2 diabetes mellitus (T2DM) is a chronic disorder with progressive pancreatic β-cell dysfunction and insulin resistance. Hyperglycemia associated with uncontrolled T2DM leads to various diabetes-related complications. Although metformin is the most preferred first-line drug, 5–10% of patients per year subsequently fail to achieve target HbA1c levels, subsequently requiring combination therapy. While efficacy and cost favor the use of sulfonylureas, hypoglycemic episodes limit its use. Newer generation sulfonylureas such as glimepiride and gliclazide are presumed to have lower incidence of hypoglycemia. Aims and Objectives: The aim of the study was to assess the efficacy and safety of glimepiride versus gliclazide as an add-on to metformin in T2DM. Materials and Methods: A total of 60 patients with T2DM (HbA1c 7.0–10.0%, on metformin monotherapy) were recruited and randomized into two groups of 30 cases each. Group A received glimepiride 2 mg as add-on to metformin 1500 mg and Group B received gliclazide 80 mg as add-on to metformin 1500 mg. HbA1c, lipid profile, body mass index, and total blood count were assessed at baseline and at the end 12 weeks of treatment. Fasting blood sugar (FBS) and post prandial blood sugar (PPBS) were assessed at the end of 4, 8, and 12 weeks and adverse events were assessed throughout the study period. Results: There was a significant decrease in HbA1c, FBS, and PPBS scores from baseline to the end of 12 weeks in both groups (P &lt; 0.001), but the difference was not statistically significant between the two groups (P &gt; 0.05). A significant decrease in lipid levels was observed in both groups except for high-density lipoprotein, low-density lipoprotein in the metformin + gliclazide group. The treatment was well tolerated in both groups, with the most common adverse events being nausea, diarrhea, and epigastric pain. Conclusion: Glimepiride and gliclazide are both equally effective as an add-on to metformin in improving glycaemic indices and are well tolerated in the management of uncontrolled T2DM.

THU276 The Use of Continuous Glucose Monitors for Management of Postbariatric Hypoglycemia

Abstract Disclosure: S. Jani: None. S. Bao: None. Postprandial hypoglycemia is a known complication of bariatric surgery. Mixed meal tolerance test performed in these patients often revealed hypoglycemia 1-3 hours after meals. Recent clinical studies using continuous glucose monitors (CGM) have shown the incidence of postbariatric hypoglycemia is much higher than previously identified. In addition to diet modification and medication treatment, CGM has become a more popular and useful tool in managing severe cases. We present a case of using CGM to manage postbariatric hypoglycemia. A 47 year old female with prior history of class 3 obesity treated with sleeve gastrectomy presented with hypoglycemia 2.5 years after her bariatric surgery. She complained of headache, anxiety, dizziness, and fatigue during a routine clinic visit, two hours after consuming a carbohydrate rich meal with simple sugars. Blood glucose was obtained and revealed severe hypoglycemia (glucose 38 mg/dL). This prompted an urgent referral to endocrinology. Review of glucose trends revealed multiple instances of postprandial hypoglycemia. Further labs suggested a low likelihood for insulinoma with no fasting hypoglycemia and HA1C normal at 5.3%. Postprandial hyperinsulinemic hypoglycemia was suspected clinically. Dietary modification with multiple small meals consisting of high protein, fiber and complex carbohydrates was recommended. Additionally, she was started on Libre 2 CGM for monitoring and prevention of severe hypoglycemia. Review of her CGM data during follow up visit demonstrated very low incidence of hypoglycemia and absence of severe hypoglycemia. Over time with continued use of her CGM and low incidence of hypoglycemia, she did not require medical therapy. Postprandial hypoglycemia after bariatric surgery can be severe and lead to disabling neuroglycopenic symptoms. With increased utilization of bariatric surgery, these postoperative complications will likely become more prevalent. In a Swedish nationwide study, the prevalence of postbariatric hypoglycemia was close to 0.2% in a cohort of 5040 patients. However, a more recent prospective study with a two-year observation of 333 patients after bariatric surgery using 2-hour glucose tolerance test revealed much higher prevalence of severe postprandial hypoglycemia (25.6%). Hypoglycemia was highest after gastric bypass surgery (32.6%), followed by sleeve gastrectomy (22.6%). Currently, there is no official guideline on utilization of CGM in management of hypoglycemia in nondiabetic patients. This case highlights the role of CGM in managing postbariatric hypoglycemia. CGM provides continuous glucose data, trends and alerts that can be a critical tool for patients to monitor, anticipate and prevent hypoglycemic events. Additionally, the real time data provided by CGM’s can help clinicians identify high risk patients who may benefit from the addition of medications to treat hypoglycemia. Presentation: Thursday, June 15, 2023

Efficacy and Safety of Insulin Glargine 300U/mL in People with Type2 Diabetes Uncontrolled on Basal Insulin: The 26-Week Interventional, Single-Arm ARTEMIS-DM Study.

IntroductionThe efficacy and safety of switching to insulin glargine 300 U/mL (Gla-300) in type 2 diabetes mellitus (T2DM) uncontrolled on basal insulin (BI) has been demonstrated in the North American and Western European populations; however, there is limited data from other geographical regions with different ethnicities. The ARTEMIS-DM study aimed to evaluate the efficacy and safety of Gla-300 in people with T2DM uncontrolled on BI from Asia, Latin America and Middle East Africa.MethodsThe ARTEMIS-DM was a 26-week, prospective, interventional, single-arm, phase IV study (NCT03760991). Adults with T2DM previously uncontrolled (glycated haemoglobin [HbA1c] 7.5–10%) on BI were switched to Gla-300. The primary endpoint was change in HbA1c from baseline to 26 weeks. Key secondary endpoints were changes in HbA1c (week 12), fasting plasma glucose (FPG), self-monitored plasma glucose (SMPG) and BI dose from baseline to week 26. The safety and tolerability of Gla-300 were also assessed.ResultsA total of 372 (50% male) participants were included, with mean (standard deviation [SD]) age 60.9 (10.0) years, duration of diabetes 13.11 (7.48) years and baseline HbA1c 8.67 (0.77)% (71.22 [8.44] mmol/mol). A total of 222 (59.7%) participants were using insulin glargine 100 U/mL and 107 (28.8%) were using neutral protamine Hagedorn insulin as previous BI. There were clinically significant reductions in mean HbA1c (− 0.82%; primary endpoint), FPG and SMPG levels at week 26. With a pre-defined titration algorithm, mean Gla-300 dose increased from 27.48 U (0.35 U/kg) at baseline to 39.01 U (0.50 U/kg) at week 26. Hypoglycaemia events occurred in 20.4% of the participants; 1 (0.3%) participant had a severe hypoglycaemia event.ConclusionIn people with T2DM uncontrolled on previous BI, switching to Gla-300 with optimal titration guided by an algorithm was associated with improved glycaemic control and low incidence of hypoglycaemia across multiple geographic regions.ClinicalTrials.gov identifierNCT03760991.Supplementary InformationThe online version contains supplementary material available at 10.1007/s13300-022-01271-7.

Safety and Effectiveness of Insulin Glargine 300 U/mL in Participants with Type 2 Diabetes Who Fast During Ramadan in The Gulf Region: A Subgroup Analysis of the Real-World ORION Study.

IntroductionTo evaluate the safety and effectiveness of insulin glargine 300 U/mL (Gla-300) in people with type 2 diabetes mellitus (T2DM) in the Gulf region who fast during Ramadan.MethodsORION was a real-world, prospective, observational study in people with T2DM treated with Gla-300 during pre-Ramadan, Ramadan, and post-Ramadan periods. This subgroup analysis included 222 participants from the Gulf region (Kuwait, Saudi Arabia, United Arab Emirates, and Qatar). The primary endpoint was the percentage of participants experiencing severe and/or symptomatic documented hypoglycemia (self-monitored plasma glucose [SMPG] ≤ 70 mg/dL) during Ramadan. Changes in glycated hemoglobin (HbA1c), fasting plasma glucose (FPG), SMPG, body weight, insulin dose, and adverse events (AEs) were also evaluated.ResultsThe primary endpoint was reported in one (0.5%) participant during Ramadan. The incidence rate of symptomatic documented hypoglycemia (SMPG ≤ 70 mg/dL) decreased from the pre-Ramadan (3.2%) to Ramadan period (0.5%), and no severe hypoglycemia events were reported during the study. Reductions were observed in HbA1c (mean ± standard deviation: − 0.51 ± 0.95% [− 5.5 ± 10.4 mmol/mol]), FPG (− 13.9 ± 47.5 mg/dL), and SMPG (− 6.1 ± 27.1 mg/dL). No significant changes were observed in body weight or Gla-300 dose. AEs were reported in 11 (5.0%) participants.ConclusionIn a real-world setting in the Gulf region, Gla-300 treatment in people with T2DM during Ramadan was associated with a low incidence of hypoglycemia and improved glycemic control.Trial RegistrationCTRI/2019/02/017636.Supplementary InformationThe online version contains supplementary material available at 10.1007/s13300-022-01225-z.

POSB30 Systematic Literature Review of Clinical, Economic, and Patient-Reported Benefits of Connected Insulin Pen Systems

Connected insulin pen systems may improve outcomes in insulin-treated people with diabetes (PwD), potentially reducing disease burden and improving suboptimal insulin use. Within this rapidly developing field, a systematic literature review (SLR) was conducted to summarise the current clinical, economic, and patient-reported benefits of this technology. A systematic search of Medline, Embase and Cochrane library databases (limits: randomised controlled trials [RCTs], observational studies, and economic models; publication date, 2015–2021; English-language), select conference proceedings (limits: 2018–2021), US and European clinical trial registries, and the grey literature (no limits) was performed following PRISMA guidelines. Subjects were Type 1 and 2 adult PwD. Technologies assessed included: connected insulin pens/systems, insulin smart caps/sleeves, and associated mobile applications. 1,898 publications/abstracts were identified. Following screening, 11 unique studies were retained for analysis: 6 observational studies, three RCTs and two economic studies. The small size and observational design of many studies, as well as heterogeneity of outcomes, precludes drawing firm overall conclusions. However, the emerging data show a positive trend for the impact of connected insulin pens on PwD. Specifically, use of connected technologies resulted in fewer missed bolus doses, better time in range and blood glucose levels, lower incidence of hypoglycaemia, higher patient satisfaction, and lower costs. This SLR documented that connected insulin pen systems may help to reduce suboptimal insulin dosing. Studies demonstrate that these systems may help type 1 and type 2 PwDs to relieve the burden of insulin-treatment and to reduce the number of missed bolus injections, which leads to better glycaemic control. Although evidence in this field is still in its early stages, early indications suggest that connected insulin pen systems could be increasingly considered as part of routine clinical care for insulin-treated PwD who are faced with the complexity of their daily insulin routine.

Tirzepatide versus insulin glargine in type 2 diabetes and increased cardiovascular risk (SURPASS-4): a randomised, open-label, parallel-group, multicentre, phase 3 trial

We aimed to assess efficacy and safety, with a special focus on cardiovascular safety, of the novel dual GIP and GLP-1 receptor agonist tirzepatide versus insulin glargine in adults with type 2 diabetes and high cardiovascular risk inadequately controlled on oral glucose-lowering medications. This open-label, parallel-group, phase 3 study was done in 187 sites in 14 countries on five continents. Eligible participants, aged 18 years or older, had type 2 diabetes treated with any combination of metformin, sulfonylurea, or sodium-glucose co-transporter-2 inhibitor, a baseline glycated haemoglobin (HbA1c) of 7·5-10·5% (58-91 mmol/mol), body-mass index of 25 kg/m2 or greater, and established cardiovascular disease or a high risk of cardiovascular events. Participants were randomly assigned (1:1:1:3) via an interactive web-response system to subcutaneous injection of either once-per-week tirzepatide (5 mg, 10 mg, or 15 mg) or glargine (100 U/mL), titrated to reach fasting blood glucose of less than 100 mg/dL. The primary endpoint was non-inferiority (0·3% non-inferiority boundary) of tirzepatide 10 mg or 15 mg, or both, versus glargine in HbA1c change from baseline to 52 weeks. All participants were treated for at least 52 weeks, with treatment continued for a maximum of 104 weeks or until study completion to collect and adjudicate major adverse cardiovascular events (MACE). Safety measures were assessed over the full study period. This study was registered with ClinicalTrials.gov, NCT03730662. Patients were recruited between Nov 20, 2018, and Dec 30, 2019. 3045 participants were screened, with 2002 participants randomly assigned to tirzepatide or glargine. 1995 received at least one dose of tirzepatide 5 mg (n=329, 17%), 10 mg (n=328, 16%), or 15 mg (n=338, 17%), or glargine (n=1000, 50%), and were included in the modified intention-to-treat population. At 52 weeks, mean HbA1c changes with tirzepatide were -2·43% (SD 0·05) with 10 mg and -2·58% (0·05) with 15 mg, versus -1·44% (0·03) with glargine. The estimated treatment difference versus glargine was -0·99% (multiplicity adjusted 97·5% CI -1·13 to -0·86) for tirzepatide 10 mg and -1·14% (-1·28 to -1·00) for 15 mg, and the non-inferiority margin of 0·3% was met for both doses. Nausea (12-23%), diarrhoea (13-22%), decreased appetite (9-11%), and vomiting (5-9%) were more frequent with tirzepatide than glargine (nausea 2%, diarrhoea 4%, decreased appetite <1%, and vomiting 2%, respectively); most cases were mild to moderate and occurred during the dose-escalation phase. The percentage of participants with hypoglycaemia (glucose <54 mg/dL or severe) was lower with tirzepatide (6-9%) versus glargine (19%), particularly in participants not on sulfonylureas (tirzepatide 1-3% vs glargine 16%). Adjudicated MACE-4 events (cardiovascular death, myocardial infarction, stroke, hospitalisation for unstable angina) occurred in 109 participants and were not increased on tirzepatide compared with glargine (hazard ratio 0·74, 95% CI 0·51-1·08). 60 deaths (n=25 [3%] tirzepatide; n=35 [4%] glargine) occurred during the study. In people with type 2 diabetes and elevated cardiovascular risk, tirzepatide, compared with glargine, demonstrated greater and clinically meaningful HbA1c reduction with a lower incidence of hypoglycaemia at week 52. Tirzepatide treatment was not associated with excess cardiovascular risk. Eli Lilly and Company.

Treatment Patterns, Effectiveness, and Satisfaction Among Patients with Type2 Diabetes Treated with Insulin in Saudi Arabia: Results of the RIMODIS Study.

IntroductionThe alarming increase in type 2 diabetes mellitus (T2DM) in Saudi Arabia is aggravated by increasing obesity, sedentary lifestyle, and population aging. The RIMODIS study aimed at describing the practices in the therapeutic management of patients with T2DM treated with different insulin regimens. MethodsThis national, multicenter, non-interventional, cross-sectional disease registry on the real-life therapeutic management of insulin-treated patients with T2DM in Saudi Arabia enrolled 3010 patients. It primarily aimed at describing treatment patterns, complications, and glycemia levels. Patients completed the diabetes treatment satisfaction questionnaire (DTSQ). Data on different treatment patterns were analyzed using chi-square or Fisher’s exact test. Outcomes were analyzed according to the different insulin regimen subgroups (basal versus premixed).ResultsOver 60% of patients were treated with premixed insulin and most patients were also prescribed oral antidiabetics (OADs). Patients on insulin alone seemed to achieve better glycated hemoglobin (HbA1c) control. Adding OADs to insulin slightly increased treatment satisfaction scores, with scores higher in patients on basal insulin compared to premixed insulin. Hypoglycemia was lower when adding OADs to insulin. Most patients showed high treatment adherence; however, two-thirds of study patients failed to achieve glycemic target levels. ConclusionMost patients are treated with a combination of insulin and OADs, associated with glycemic control and low incidence of hypoglycemia. However, we highlight suboptimal glycemic target achievement, underscoring the need to improve T2DM clinical management and promote healthier lifestyle among patients in Saudi Arabia.

61-LB: Continuous Glucose Monitoring (CGM) in ICU Patients during COVID-19: A Pilot Study

Objective: During the COVID 19 pandemic, the FDA approved emergency authorization of Real Time Continuous Glucose Monitoring (RT-CGM) for inpatient use. The objective of this study was to evaluate the safety of RT-CGM use. Methods: Blood Glucose (BG) data were collected from the electronic medical record and the Dexcom system on 165 patients treated on DEXCOM CGM from June to December using a preapproved protocol. Retrospective chart review was performed on 60 patients on vasopressors and dialysis. Analysis included glycemic control, hypoglycemia rate, and correlation between finger stick (FS) and RT-CGM BG. Pearson's correlation coefficients (PCC) and MARD were calculated. Strong correlation was defined as a PCC value of > 0.7. Results: Of the > 300,000 BG readings from DEXCOM, 81 % were between 70-180 mg/dl;12 % between 180-250mg/dl;and 5% were > 250 mg/dl. The incidence of hypoglycemia was low, 0.8% values being between 55 - 69 mg/dL and 0.5% being < 55 mg/dL. Of the 2016 readings used for correlation, the PCC between FS and RT-CGM glucose was 0.838 with a MARD of 14%. PCC was 0.798 for patients on vasopressors and 0.79 for dialysis Patients. Conclusions: In this preliminary study, Dexcom CGM utilization was safe with a low incidence of hypoglycemia and good correlation to FS blood glucose. CGM utilization decreased the frequency of FS for most patients, and was well accepted by the clinical team.

800-P: Phase 3 Results of Fixed-Dose Combination of Remogliflozin Etabonate and Vildagliptin in Indian T2DM Patients

Introduction: Remogliflozin Etabonate (RE) and Vildagliptin are approved in India for management of type 2 diabetes mellitus (T2DM), which were evaluated as a fixed dose combination (FDC) in this pivotal phase III study. Methods: This 16 week, multi-centric, prospective, double blind, double dummy, parallel group, randomized controlled study compared efficacy and safety of FDC of RE 100mg + Vildagliptin 50mg (RV) given twice daily to active comparator of Empagliflozin 25mg + Linagliptin 5mg (EL) given once daily. Adult T2DM patients with HbA1c 8-11% on Metformin stable dose of ≥1500mg for ≥8 weeks before screening were randomized to either of treatment arms. The study endpoints were mean changes from baseline (CFB) in HbA1c (primary), fasting plasma glucose (FPG), post-prandial plasma glucose (PPG), body weight (BW) and blood pressure (BP) for efficacy and adverse events (AE) monitoring for safety assessments. Results: Of 182 eligible subjects (91 in each arm), 157 (86.3%) subjects completed the study. The baseline demographic characteristics were well balanced between 2 treatment arms. Adjusted mean (SE) change from baseline in HbA1c (%) at week 16 viz. EL arm -1.36 (0.15) vs. RV arm -1.41(0.16); (mITT population; p&amp;lt;0.001 in each arm) was comparable between the two treatment arms (p=0.82). The mean difference of -0.05% (95%CI: -0.46, 0.36) in HbA1c demonstrated non-inferiority (NI) of RV compared to EL (p=0.016 for NI test). Similarly, significant reduction was observed in FPG, PPG, BW and BP which was found to be comparable between the two treatment arms. Drug related AEs were observed in 8.8% and 6.6% subjects of EL and RV arm respectively, with low incidence of hypoglycemia, genital and urinary tract infections (1-3%). Conclusion: Overall, FDC of Remogliflozin Etabonate + Vildagliptin was found to be efficacious, safe and well tolerated in the treatment of patients with T2DM, and demonstrated non-inferiority to Empagliflozin 25mg + Linagliptin 5mg treatment. Disclosure B. Mohan: None. M. S. Chawla: Speaker’s Bureau; Self; Abbott Diabetes, Boehringer Ingelheim Pharmaceuticals, Inc., Colgate-Palmolive, Eli Lilly and Company, Glenmark Pharmaceuticals Limited, Novo Nordisk. R. R. Kodgule: Employee; Self; Glenmark Pharmaceuticals Limited. M. Tandon: Employee; Self; Glenmark Pharmaceuticals Limited. S. Katare: Employee; Self; Glenmark Pharmaceuticals Limited. S. Suryawanshi: Employee; Self; Glenmark Pharmaceuticals Limited. H. V. Barkate: None.

Dapagliflozin in the management of type 2 diabetes mellitus: a real-life experience in Bangladesh

Background: Dapagliflozin, a selective renal sodium-glucose cotransporter-2 inhibitor (SGLT2i), lowers plasma glucose by increasing urinary excretion of glucose. This study evaluated the efficacy and safety of dapagliflozin as add on therapy for a selected group of Bangladeshi type 2 diabetic patients.&#x0D; Methods: This was a 24-week, open-label, prospective, real-life study including type 2 diabetic patients with glycated hemoglobin (HbA1c) 7.0–10% (N =53). Study subjects were selectively assigned to dapagliflozin 5 mg once-daily in the morning along with ongoing oral anti-diabetic drug (OAD). The primary end point was to see the safety (adverse events) and efficacy (reduction of fasting and post-prandial blood glucose, HbA1c) of dapagliflozin.&#x0D; Results: Mean HbA1c changes from baseline to week 24 was – 1.15 ± 0.82 % (P = 0.000) and weight reduction was – 2.49 ± 0.32 kg from base line (P=0.000). Among total study subjects, 6 (11.3 %) had developed urinary tract infection (UTI). There were no major episodes of hypoglycemia or renal function deterioration.&#x0D; Conclusion: Dapagliflozin showed significant reduction of HbA1c as add on therapy. The low incidence of hypoglycemia and UTI make dapagliflozin as an acceptable addition to existing treatment option for type 2 diabetes in Bangladeshi population.&#x0D; Birdem Med J 2021; 11(1): 57-62

Indirect comparison of efficacy and safety of insulin glargine/lixisenatide and insulin degludec/insulin aspart in type 2 diabetes patients not controlled on basal insulin

BackgroundFixed-dose combinations of insulin glargine/lixisenatide (IGlarLixi) or insulin degludec/insulin aspart (IDegAsp) constitute treatment intensification in type 2 diabetes mellitus (T2D). ObjectivesCompare efficacy and safety of IGlarLixi and IDegAsp (as intensification from basal insulin), by indirect comparison of phase III trials, in the absence of head-to-head trials. Study eligibility criteriaStudies comparing treatment intensification by once-daily IDegAsp or IGlarLixi to basal insulin. Data were extracted from two trials (BOOST: Intensify-Basal and LixiLan-L) retained for analysis. Synthesis methodsTreatments were compared in terms of estimated treatment difference (ETD) in glycated haemoglobin (HbA1c), fasting and postprandial plasma glucose (FPG and PPG) change from baseline; in addition to hypoglycaemia incidence and weight changes. ResultsIn a fixed-effect model examining HbA1c control, IGlarLixi was more effective than IDegAsp in reducing HbA1c (ETD 0.53%, P<0.0001]), PPG (ETD 2.65%, P<0.0001), and body weight (ETD 1.73kg, P<0.0001). Patients on IGlarLixi were more likely to achieve HbA1c<7% than patients on IDegAsp (odds ratio [OR]=0.40, P<0.0001), with lower incidence of hypoglycaemia (OR=1.33, P<0.001). LimitationsLimited number of studies; different baseline HbA1c and FPG. ConclusionOnce-daily IGlarLixi is more efficient than once-daily IDegAsp in controlling HbA1c and PPG and associates with greater weight loss and lower hypoglycaemia incidence.