Proportion Of HbA1c Research Articles

IDF21-0072 Safety and Efficacy of Insulin IGlarLixi versus IDegLira: A Meta-Analysis of Fifteen studies

Background: Combination of insulin and a GLP-1 analogue in a fixed-ratio, the once-daily injection has a promising beneficial clinical base on efficacy and safety, besides GLP-1 affects weight loss and cardiovascular protection. Up to now, there is no head-to-head comparison between IDeglira and IGlarLixi. Aim: This meta-analysis intends to evaluate clinical studies regarding assess efficacy and safety between IGlarLixi versus IDegLira indirectly comparative. Method: The eligible publication was screened using inclusion criteria such as 1) the study included minimal one month follow up; 2) be compared to a control group; 3) carried by the English language; 4) published at least from 2010, and; 5) clinical study that reached phase 1 until phase 3. Any situation which altered endocrinologic status, abstracts only, case reports, letters, comments, or reviews; animal studies; duplicate studies; no surgical intervention; and no population of interest, and receipt of any investigational product within 30 days before screening was set as exclusion criteria. Studies were searched using keywords: (IGlarLixi) OR (IDegLira) AND (Diabetes Mellitus) in several databases of Cochrane Central Register of Controlled Trials (CENTRAL), Pubmed, ClinicalTrials.gov, EMBASE. All papers were reviewed using critical appraisal for clinical trials by Centre for Evidence-Based Medicine Oxford University. The risk of bias was determined by the Cochrane Handbook by Cochrane Handbook for a randomized trial. Seventy papers were initially collected using PICO in advanced search, 20 are duplicated, and 35 articles did not fulfil the criteria. Fifteen clinical trials (Lixilan and DUAL trial) were pooled and entered into review manager 5.4 and Graph Prism 8. [1,2,11–15,3–10] The primary endpoint was the mean difference in HbA1c and Fasting plasma glucose from baseline in each group; secondary efficacy endpoints were risk ratio of achievement of end-of-trial HbA1c of less than 7.0% and several participants without weight gain at the end of the trial. Safety variables included severe, non-serious adverse, and hypoglycaemic events. Results: Fifteen RCTs were identified using a total of 9896 T2DM patients i.e;5509 intervention and 4389 control. The baseline data of mean age respectively Lixilan vs DUAL in each case and control group was 58.2 ±1.92;58.2 ±1.92 in Lixilan Trial, while in DUAL trial 58.2 ±1.92 and 58.2 ±1.92; duration of diabetes 9.97±1.51; 10.2± 1.34 vs 9.46±2.13; 9.6±2.08 years, HbA1C (%) 8.11± 0.108; 8.09±0.12 vs 8.24±0.06;8.25±0.31; Fasting plasma glucose (mmol/L) 8.5±1.03; 8.52±1.03 vs 9.29±0.49; 9.39±0.56. Primary endpoint such as a decrease in HbA1c, FPG level, the proportion of HbA1c < 7%, and patient without weight gain was not different as statically with p=0.32;0,29,0.34;0.95. The safety endpoint showed the same result. Severe hypoglycaemia was 1.06 (0.48, 2.34). Discussion: Limitations: The assumptions made in the indirect comparison and differences between the included trials in efficacy and safety endpoint. Conclusion: These results, either efficacy and safety endpoint showed no statistically significant differences between IGlarLixi and IDegLira, and both states promising beneficial clinically with equal evidence.

The Relationship between Oral and Dental Health Self-care and Hemoglobin A1c in Adults with Diabetes.

Statement of the Problem: Due to the mutual relationship between periodontal diseases and diabetes, it seems that adopting oral self-care in a way to prevent and control the progress of periodontal diseases, improves the oral health of diabetic patients as well as their general health.Purpose: The aim of this study was to investigate the relationship between the oral self-care behaviors and the hemoglobin A1c (Hb A1c) levels in adults with diabetes.Materials and Method: In this cross-sectional study with convenience sampling, 120 adults between 18 to 50 years old, who had at least two healthy functional teeth, were selected from private endocrinology offices in Tehran in August 2019. The exclusion criteria were illiterate individuals and pregnant women. A standard questionnaire was used which included the information about demographic, diabetes, and self-care behaviors. The outcome variable was the latest Hb A1c rate.Results: The mean age of participants was 35.8±10.5 years. The average Hb A1c was 7.4± 1.55%. 35.0% of participants brushed their teeth twice a day or more and 60.8% flossed rarely. The proportion of Hb A1c <7% was higher in three groups including the participants who had information about the effect of periodontal disease on diabetes (p= 0.032), participants who brushed twice a day or more (p= 0 .014), and those who used dental floss once a day or more (p< 0.001). The likelihood of having Hb A1c <7% in participants who had information about the effect of periodontal disease on diabetes was about three times more than those who had no information (OR= 3.05, p= 0.036). Furthermore, it was about six times higher in participants who used dental floss once a day or more than those who used rarely (OR= 5.66, p= 0.001).Conclusion: Results of the present study show that people who had better oral health self-care behaviors had better Hb A1c and diabetes control.

Correlation between the Variability of Glycosylated Hemoglobin and Cardiovascular Risk in New-Onset T2DM Patients.

Objective To investigate the relationship between glycosylated hemoglobin variant index and cardiovascular disease in patients with type 2 diabetes. Methods A total of 120 patients with type 2 diabetes who were admitted to the Department of Endocrinology in Chun'an Branch of Zhejiang Provincial People's Hospital from January 2014 to January 2017 were enrolled. The clinical data, fasting blood glucose, and glycosylated hemoglobin levels of the patients were collected, and HGI was obtained by calculating the FPG level into the formula. Follow-up for three years was performed to observe the cardiovascular disease (including coronary heart disease and ischemic stroke) in patients. The occurrence of CVD was analyzed in patients with different levels of HGI. Multivariate logistics regression analysis was used to analyze the risk factors of CVD in patients with T2DM. Results After three years of follow-up, 8 cases of 120 patients were lost to follow-up. In the end, 24 cases of CVD occurred in 112 patients, with an incidence rate of 21.43%. Comparing the clinical data of CVD patients and non-CVD patients, it was found that the proportion of age, FPG, HbA1c, HGI, and insulin control in the CVD group was higher than that of the non-CVD group, and the difference was statistically significant (P < 0.05). After grouping according to different HGI levels, it was found that with the increase of HGI level, the proportion of HbA1c, FPG, TC, CVD, and insulin use showed an upward trend (P < 0.05). Multivariate logistic regression analysis showed that high HGI level (OR = 4.660), older age (OR = 4.815), and higher FPG level (OR = 1.717) are independent risk factors that affect T2DM patients with cardiovascular disease (P < 0.05). Conclusion High HGI is independently associated with CVD events in patients with type 2 diabetes. HGI testing is helpful for clinical assessment of personalized assessment and prediction of cardiovascular risk in patients with diabetes.

Effects of occupational nickel exposure on glycemic parameters in workers

Objective: To explore the effect of occupational nickel exposure on blood glucose related indicators of workers. Methods: In March 2019, five electroplating enterprises and one plastic hardware enterprise were selected by cluster sampling method. 159 nickel plating workers were selected as the contact group, and 66 administrative personnel of the same enterprise were selected as the control group. The serum nickel concentration, fasting blood glucose (FPG) , fasting insulin (FIns) and glycosylated hemoglobin (HbA1c) were measured in the contact group and the control group. The differences of blood glucose related indexes between the two groups were compared, and the risk factors of abnormal blood glucose indexes were analyzed. Results: Compared with the control group, the blood nickel concentration and detection rate of nickel in the contact group were higher, the levels of FIns were lower, and the proportion of HbA1c was higher in the contact group (P<0.05) . Stratified analysis showed that compared with the control group, the blood glucose index of men in the contact group changed significantly (P<0.05) ; logistic regression analysis showed that male was an independent influencing factor for decreased FIns (OR=8.264, P<0.05) . Conclusion: Long term exposure to nickel can affect the blood glucose related indexes such as fins and HbA1c.

39-OR: Secular Trends in Glucose-Lowering Drug Utilization, Glycemic Control, and Severe Hypoglycemia in Adults with Diabetes between 2002 and 2016 in Hong Kong

Introduction: There has been a shift towards new classes of glucose lowering drugs (GLDs) in the past decade but no improvements in glycemic control or hospitalization rates due to severe hypoglycemia (SH) in previous surveys. We examined secular trends in GLDs utilization, glycemic control and rate of SH among people with diabetes, mainly type 2 diabetes, in Hong Kong which introduced a territory-wide, team-based diabetes care model since 2000. Methods: Using population-based data from the Hong Kong Diabetes Surveillance Database consisting mainly of Chinese living a westernized lifestyle, we estimated the annual age- and sex-standardized proportion of GLDs classes, mean hemoglobin A1c (HbA1c) levels and SH rates in 763,809 diabetes patients aged ≥20 years between 2002-2016. We used Joinpoint regression to examine secular trends over time. Results: In 2002-2016, use declined for sulfonylureas (50.7% to 28.9%) but increased for metformin (47.8% to 57.3%) and dipeptidyl peptidase-4 inhibitors (DPP-4i) (0.01% in 2007 to 7.0%). The proportion of patients with HbA1c of 6.0-7.0% increased from 25.6% to 37.2% while the rate of SH declined from 4.4 to 1.7 per 100 person-years. The main improvement in annual mean HbA1c occurred between 2007 and 2014, decreasing from mean (SD) 7.8 (1.6)% to 7.4 (1.7)% (p&amp;lt;0·001). The 20-44 age group had the highest proportion of HbA1c&amp;gt;9% with rising proportions not treated with any GLDs (from 4.3% to 10.5%). Conclusion: Prescription of GLDs has changed dramatically in Hong Kong in the past 15 years in line with treatment guidelines and introduction of new drugs. The modest but important improvement in HbA1c since 2007 coincided with widening reform of diabetes services in primary care and introduction of DPP-4i. Poor glycemic control and low utilization of GLDs in the youngest age group calls for targeted treatment strategies and ongoing surveillance. Disclosure A. Yang: None. H. Wu: None. E.S. Lau: None. R.C. Ma: Advisory Panel; Self; AstraZeneca. Stock/Shareholder; Self; GemVCare. Other Relationship; Self; AstraZeneca, Bayer Healthcare Pharmaceuticals Inc., Merck &amp; Co., Inc., Novo Nordisk A/S, Pfizer Inc., Sanofi-Aventis, Tricida Inc. A.P. Kong: Advisory Panel; Self; Eli Lilly and Company. Research Support; Self; AstraZeneca. Speaker’s Bureau; Self; Abbott, AstraZeneca, Sanofi. Other Relationship; Self; AstraZeneca, Novartis Pharmaceuticals Corporation, Sanofi. W. So: None. A. Luk: Research Support; Self; Bayer Healthcare Pharmaceuticals Inc., Roche Pharma. Other Relationship; Self; Merck Sharp &amp; Dohme Corp. J.C. Chan: None. E. Chow: None. Funding Chinese University of Hong Kong

THE EFFECT OF IRON DEFICIENCY ANEMIA ON GLYCATED HEMOGLOBIN (HBA1C) IN NON DIABETIC ADULTS

Background: Iron deficiency anemia is the most common form of anemia in India. Hemoglobin A1c (HbA1c) is used in diabetic patients as an index of glycemic control reflecting glucose levels of the previous 3 months. Like blood sugar levels, HbA1c levels are also affected by the presence of variant hemoglobins, hemolytic anemias, nutritional anemias, uremia, pregnancy, and acute blood loss. Previous studies suggest that iron deficiency anemia (IDA) affects the levels of HbA1c.&#x0D; Methods: A prospective observational study on 50 iron deficiency patient cases and 50 healthy control. Exclusion and inclusion criteria were used to recruit cases from the wards and OPDs of the hospital. Appropriate descriptive statistics was used to analyse the data.&#x0D; Results: The HbA1C was significantly higher in the iron deficiency patients as compare to the control (5.88 ± 0.41 vs 5.03 ± 0.17, respectively, P &lt; .05).&#x0D; Conclusion: Our results showed that iron deficiency was associated with higher proportions of HbA1c, which could cause problems in the diagnosis of uncontrolled diabetes mellitus in iron-deficient patients.&#x0D; Keywords: Non-Diabetic Patient, Glycosylated Haemoglobin, Iron Deficiency Anaemia.

Efficacy and safety of domestic exenatide injection in treating type 2 diabetes: A multicenter, randomized, controlled, and non-inferiority trial

Objective To investigate the efficacy and safety of domestic exenatide injection versus imported exenatide injection in type 2 diabetic patients with inadequate glycemic control on monotherapy or combination therapy of metformin and insulin secretagogues. Methods A multicenter, randomized, parallel-controlled, and non-inferiority trial was carried out. A total of 240 subjects were randomized at a 1∶1 ratio to add domestic exenatide injection(trial group)or imported exenatide injection(control group)on the background therapies. The primary endpoint of efficacy was HbA1C change from baseline to week 16. The secondary endpoints of efficacy were the proportion of HbA1C<7.0%, and the changes in fasting plasma glucose(FPG), 2 h plasma glucose after standard meal(2hPG), 7-point self monitoring of blood glucose(7P-SMBG), and body weight from baseline to week 16. Results Among subjects of per-protocol sets, adjusted mean HbA1C reduction was -1.07% in the trial group versus -1.06% in the control group after 16 weeks of treatment. The lower boundary of the two-sided 95% confidence intervals of the mean HbA1C reduction difference between the trial and control groups was -0.29%, which was more than -0.35%, suggesting that the predefined statistical criterion for non-inferiority was achieved. The proportions of subjects achieving HbA1C 0.05). The changes in FPG, 2hPG, 7P-SMBG and body weight from baseline to week 16 were comparable between the two groups(all P>0.05). Moreover, the incidences of hypoglycemia and adverse events were similar between the two groups(both P>0.05). Conclusion In type 2 diabetic patients inadequately controlled by monotherapy or combination therapy of metformin and insulin secretagogues, the efficacy of cotreatment with domestic exenatide injection is not inferior to that of imported product ones, with a similar safety profile. (Chin J Endocrinol Metab, 2017, 33: 301-306) Key words: Diabetes mellitus, type 2; Exenatide; Non-inferiority trial

Twelve-year follow-up of a population-based primary care diabetes program in Israel

To describe the effects of a long-term intervention including 72% of Israeli diabetes patients, aimed at improving diabetes care in a primary care setting. A retrospective periodic population-based cross-sectional study. Two health maintenance organizations (HMOs) in Israel-intervention and control. All diagnosed diabetes patients enrolled in both HMOs. Multifaceted interventions directed toward primary care providers, including educational strategies, registries, clinical pathways, care quality indicators, computerized reminders and feedback. Performance in quality indicators, compared with an HMO that did not implement an intervention program. The prevalence of diabetes increased from 20.2/1000 in 1995 to 63.7/1000 in 2007. Annual testing of hemoglobin A1c (HbA1c) rose from 22% in 1995 to 88% in 2007. The corresponding figures for low-density lipoprotein (LDL) were 23 and 89%, and for microalbumin 10 and 69%, respectively (P< 0.0001 for all comparisons). The proportion of HbA1c ≤7% increased from 10 to 53%, while HbA1c >9% decreased from 40 to 13% (P< 0.0001). Good control of LDL ≤100 mg/dl increased from 26 to 59% (P< 0.0001). In the comparison HMO, subtle increases in the performance of HbA1c (55.8-63.4%), LDL (59.7-67.0%) and microalbumin (55.1-67.6%) were noted between 2005 and 2007, respectively. HbA1c ≤7 and >9% remained stable (36 and 13%, respectively), while LDL ≤100 mg/dl rose from 38 to 44% in the control HMO. A community-oriented program for diabetes care led to improvements in performance of tests, as well as control of HbA1c and LDL among 72% of diabetes patients in Israel.

Hemoglobin A1c proportion, mortality rate, and risk factors for death in diabetic patients with severe hypoglycemia: A multicenter retrospective survey over ten years

ObjectiveTo investigate the HbA1c proportion and mortality rate across diabetic patients with severe hypoglycemia and the risk factors for death. MethodsAll the diabetic patients with severe hypoglycemia were divided into HbA1c<6.5% group and HbA1c≥6.5% group. The proportion of HbA1c, mortality rate and the risk factors for death were analyzed. Common causes for severe hypoglycemia were also analyzed. ResultsThe percentages of HbA1c in the HbA1c<6.5% and HbA1c≥6.5% groups were 51.2% and 48.8%, respectively. The mortality rates were not significantly different between the 2 groups (5.3% vs. 5.1%, χ2=0.01, p=0.17). Binary logistic regression analysis revealed that in both groups, creatinine, aspartate aminotransferase, and uric acid levels were the risk factors for death. In the HbA1c<6.5% and HbA1c≥6.5% groups, 65.0% and 64.2% showed common causes of severe hypoglycemia, respectively. ConclusionsWith respect to severe hypoglycemia, equal attention should be paid to patients with an HbA1c level of ≥6.5% and those with an HbA1c level of <6.5%. The mortality rate is approximately 5% in severe hypoglycemia no matter how the HbA1c level is. Creatinine, aspartate aminotransferase, and uric acid are the main risk factors in both groups. Two-thirds of severe hypoglycemia cases could be prevented.

Standardization of Hemoglobin A1c

Kobold et al. (1) describe candidate reference methods for hemoglobin A1c (HbA1c) that are based on the identification of hexapeptides from the N-terminus of the β-chains by both a mass spectrometry technique and capillary electrophoresis. Although they are to be congratulated on their efforts in this regard, I wonder whether the (IFCC) definition of HbA1c as hemoglobin modified irreversibly by glucose at one or both N-terminal valines of the β-chains might be a source of difficulty when applied to routine methods. For example, if a patient’s specimen contains, as seems probable, a mixture of modified hemoglobin species such that 10% have both N-terminal valines glycated (β2-G2) and 5% have only one valine glycated (β2-G), the candidate reference methods will determine a HbA1c proportion of 12.5% because this represents the proportion of N-terminal valines that are glycated. It appears unlikely that any routine method will duplicate this result other … aAuthor for correspondence. Fax 49 8158 22 4055; e-mail uwe_kobold{at}bmg.boehringer-mannheim.com

Quantitation of hemoglobin A1a+b and hemoglobin A1c by automated "high-performance" liquid chromatography.

The glycosylated hemoglobins A1a+b and A1c have been rapidly and precisely quantitated in 5-micro L samples of human blood hemolysate (approximately 240 micrograms of hemoglobin) by cation-exchange column chromatography. Total chromatographic is 22.0 min. Proportions of Hb A1c range from 3.85 to 6.71% in normal individuals and from 4.23 to 19.90% in diabetic subjects. Within-day variation was 1.58 and 1.10% for mean Hb A1c proportions of 4.92 and 10.32%, respectively. Hb A1c and Hb A1 are stable in hemolysates stored at 4 degrees C for as long as seven days, and indefinitely under liquid nitrogen.