Mean HbA1c Level Research Articles

Clinical and Economic Assessment of MyDiaCare, Digital Tools Combined With Diabetes Nurse Educator Support, for Managing Diabetes in South Africa: Observational Multicenter, Retrospective Study Associated With a Budget Impact Model.

In South Africa, diabetes prevalence is expected to reach 5.4 million by 2030. In South Africa, diabetes-related complications severely impact not only patient health and quality of life but also the economy. The Diabetes Nurse Educator (DNE) study assessed the benefit of adding the MyDiaCare program to standard of care for managing patients with type 1 and type 2 diabetes in South Africa. An economic study was also performed to estimate the budget impact of adding MyDiaCare to standard of care for patients with type 2 diabetes older than 19 years treated in the South African private health care sector. The real-world DNE study was designed as an observational, retrospective, multicenter, single-group study. Eligible patients were older than 18 years and had at least 6 months of participation in the MyDiaCare program. The MyDiaCare program combines a patient mobile app and a health care professional platform with face-to-face visits with a DNE. The benefit of MyDiaCare was assessed by the changes in glycated hemoglobin (HbA1c) levels, the proportion of patients achieving clinical and biological targets, adherence to care plans, and satisfaction after 6 months of participating in the MyDiaCare program. A budget impact model was performed using data from the DNE study and another South African cohort of the DISCOVERY study to estimate the economic impact of MyDiaCare. Between November 25, 2019, and June 30, 2020, a total of 117 patients (8 with type 1 diabetes and 109 with type 2 diabetes) were enrolled in 2 centers. After 6 months of MyDiaCare, a clinically relevant decrease in mean HbA1c levels of 0.6% from 7.8% to 7.2% was observed. Furthermore, 54% (43/79) of patients reached or maintained their HbA1c targets at 6 months. Most patients achieved their targets for blood pressure (53/79, 67% for systolic and 70/79, 89% for diastolic blood pressure) and lipid parameters (49/71, 69% for low-density-lipoprotein [LDL] cholesterol, 41/71, 58% for high-density-lipoprotein [HDL] cholesterol, and 59/71, 83% for total cholesterol), but fewer patients achieved their targets for triglycerides (32/70, 46%), waist circumference (12/68, 18%), and body weight (13/76, 17%). The mean overall adherence to the MyDiaCare care plan was 93%. Most patients (87/117, 74%) were satisfied with the MyDiaCare program. The net budget impact per patient with type 2 diabetes, older than 19 years, treated in the private sector using MyDiaCare was estimated to be approximately South African Rands (ZAR) 71,023 (US $4089) during the first year of introducing MyDiaCare. The results of using MyDiaCare program, which combines digital tools for patients and health care professionals with DNE support, suggest that it may be a clinically effective and cost-saving solution for diabetes management in the South African private health care sector.

Glycaemic control, risk of hypoglycaemia and all-cause mortality in new users of second-generation basal insulin with type 2 diabetes and chronic kidney disease: a nationwide register-based cohort study.

The aim of this study was to compare the performance of the second-generation basal insulins, insulin degludec 100 U/ml (Deg-100) and insulin glargine 300 U/ml (Gla-300), in terms of change in HbA1c, hospitalisation for hypoglycaemia and all-cause mortality among individuals with type 2 diabetes and concurrent chronic kidney disease. This register-based cohort study, based on the entire Danish diabetes population, included 6519 new users of Deg-100 and Gla-300 with type 2 diabetes and moderate to end-stage chronic kidney disease. HbA1c trajectories, from initiation of either Deg-100 (2013) or Gla-300 (2015) to end of follow-up (2020), were modelled with mixed-effect models while rates of hospitalisation for hypoglycaemia and all-cause mortality were modelled in separate models using Poisson likelihood. Of the 6519 (44% women) individuals included in the study, 3747 were exposed to Deg-100 and 2772 to Gla-300. Both mean (SD) type 2 diabetes duration (14.4 [6.6] years vs 15.2 [6.7] years) and median (IQR) chronic kidney disease duration (2.3 [1.3, 3.9] years vs 2.8 [1.6, 4.6] years) were significantly shorter in the Gla-300 group. The median (IQR) follow-up time was similar between groups: 1.0 (0.5-1.6) year for Gla-300 and 1.0 (0.3-1.5) year for Deg-100. In both groups mean HbA1c levels were reduced by 13-14 mmol/mol (1.2-1.3%) from initiation to end of follow-up, with the largest reduction (of 8-9 mmol/mol [0.7-0.8%]) occurring during the first year. There was no significant difference in HbA1c reduction between Deg-100 and Gla-300. Both the rate of hospitalisation for hypoglycaemia (rate ratio 1.02 [95% CI 0.70, 1.49], Deg-100 vs Gla-300) and the rate of all-cause mortality (rate ratio 0.98 [95% CI 0.84, 1.15], Deg-100 vs Gla-300) were similar between the groups. We found no difference in HbA1c reduction, hospitalisation for hypoglycaemia or all-cause mortality between Gla-300 and Deg-100 in a real-world population of new users with type 2 diabetes and moderate to end-stage chronic kidney disease. Therefore, we conclude that these two treatment options are equally effective and safe in this vulnerable population.

Add-On Therapy of Dapagliflozin to Metformin in Patients with Diabetes Mellitus Type-2; Efficacy and Renal Safety

Objective: To study efficacy of Dapagliflozin in treatment of diabetes mellitus type-2. Study Design: Quasi-experimental study. Place and Duration of Study: Medical unit, Benazir Bhutto Shaheed Hospital, Rawalpindi Pakistan from Jan to Dec 2019. Patients & methods: Patients taking Dapagliflozin in combination with Metformin (MET+DAPA) (n=45) were compared to those taking other glucose lowering agent in combination with Metformin (MET+ other drug) (n=45) for the control of diabetes mellitus type-II. Efficacy of treatment was assessed by the level of glycosylated hemoglobin HbA1c, and renal safety assessed by serum creatinine level done at 6 and 12 months of treatment. Results: Total 90 cases were studied including 60% male and 40% female cases with mean age 50.8±7.4 years. Patients taking Dapagliflozin + Metformin (n=45), and others taking Metformin+ other glucose lowering drug (n=45) were having mean values of BMI 32.8±5.9 kg/m2 & 33.4±7.2 kg/m2, HbA1c 8.4±1.2% & 9.1±1.6 % and blood urea nitrogen 6.7±1.4 & 6.5±1.8 mmol/L respectively. After 12 months treatment mean HbA1c level was reduced from 8.7 ± 1.4% to 6.6 ± 0.3%, BMI reduced significantly and no detrimental effects reported on renal function. Conclusion: Patients with type-II diabetes mellitus taking Dapagliflozin in combination with Metformin showed good glycemic control and renal safety.

Fast-Acting Insulin Aspart in Patients with Type1 Diabetes in Real-World Clinical Practice: A Noninterventional, Retrospective Chart and Database Study.

This study utilized continuous glucose monitoring data to analyze the effects of switching to treatment with fast-acting insulin aspart (faster aspart) in adults with type1 diabetes (T1D) in clinical practice. A noninterventional database review was conducted in Sweden among adults with T1D using multiple daily injection (MDI) regimens who had switched to treatment with faster aspart as part of basal-bolus treatment. Glycemic data were retrospectively collected during the 26weeks before switching (baseline) and up to 32weeks after switching (follow-up) to assess changes in time in glycemic range (TIR; 70-180mg/dL), mean sensor glucose, glycated hemoglobin (HbA1c) levels, coefficient of variation, time in hyperglycemia (level1, > 180 to ≤ 250mg/dL; level2, > 250mg/dL), and time in hypoglycemia (level1, ≥ 54 to < 70mg/dL; level2, < 54mg/dL) (ClinicalTrials.gov Identifier NCT03895515). Overall, 178 participants were included in the study cohort. The analysis population included 82 individuals (mean age 48.5years) with adequate glucose sensor data. From baseline to follow-up, statistically significant improvements were reported for TIR (mean increase 3.3%-points [approximately 48min/day]; p = 0.006) with clinically relevant improvement (≥ 5%) in 43% of participants. Statistically significant improvements from baseline were observed for mean sensor glucose levels, HbA1c levels, and time in hyperglycemia (levels1 and 2), with no statistically significant changes in time spent in hypoglycemia. Switching to faster aspart was associated with improvements in glycemic control without increasing hypoglycemia in adults with T1D using MDI in this real-world setting.

Impact of glycemic control on the progression of aortic stenosis: a single-center cohort study using a common data model

BackgroundDiabetes mellitus (DM) is a well-established risk factor for the progression of degenerative aortic stenosis (AS). However, no study has investigated the impact of glycemic control on the rate of AS progression. We aimed to assess the association between the degree of glycemic control and the AS progression, using an electronic health record-based common data model (CDM).MethodsWe identified patients with mild AS (aortic valve [AV] maximal velocity [Vpeak] 2.0–3.0 m/sec) or moderate AS (Vpeak 3.0–4.0 m/sec) at baseline, and follow-up echocardiography performed at an interval of ≥ 6 months, using the CDM of a tertiary hospital database. Patients were divided into 3 groups: no DM (n = 1,027), well-controlled DM (mean glycated hemoglobin [HbA1c] < 7.0% during the study period; n = 193), and poorly controlled DM (mean HbA1c ≥ 7.0% during the study period; n = 144). The primary outcome was the AS progression rate, calculated as the annualized change in the Vpeak (△Vpeak/year).ResultsAmong the total study population (n = 1,364), the median age was 74 (IQR 65–80) years, 47% were male, the median HbA1c was 6.1% (IQR 5.6–6.9), and the median Vpeak was 2.5 m/sec (IQR 2.2–2.9). During follow-up (median 18.4 months), 16.1% of the 1,031 patients with mild AS at baseline progressed to moderate AS, and 1.8% progressed to severe AS. Among the 333 patients with moderate AS, 36.3% progressed to severe AS. The mean HbA1c level during follow-up showed a positive relationship with the AS progression rate (β = 2.620; 95% confidence interval [CI] 0.732–4.507; p = 0.007); a 1%-unit increase in HbA1c was associated with a 27% higher risk of accelerated AS progression defined as △Vpeak/year values > 0.2 m/sec/year (adjusted OR = 1.267 per 1%-unit increase in HbA1c; 95% CI 1.106–1.453; p < 0.001), and HbA1c ≥ 7.0% was significantly associated with an accelerated AS progression (adjusted odds ratio = 1.524; 95% CI 1.010–2.285; p = 0.043). This association between the degree of glycemic control and AS progression rate was observed regardless of the baseline AS severity.ConclusionIn patients with mild to moderate AS, the presence of DM, as well as the degree of glycemic control, is significantly associated with accelerated AS progression.

Geographic variation in diabetic retinopathy screening within the Veterans Health Administration

AimsDiabetic retinopathy (DR) remains the leading cause of vision impairment among working-age adults in the United States. The Veterans Health Administration (VA) supplemented its DR screening efforts with teleretinal imaging in 2006. Despite its scale and longevity, no national data on the VA’s screening program exists since 1998. Our objective was to determine the influence of geography on diabetic retinopathy screening adherence. MethodsSetting: VA national electronic medical records. Study Population: A national cohort of 940,654 veterans with diabetes (defined as two or more diabetes ICD-9 codes (250.xx)) without a history of DR. Exposures: 125 VA Medical Center catchment areas, demographics, comorbidity burden, mean HbA1c levels, medication use and adherence, as well as utilization and access metrics. Main Outcome Measure: Screening for diabetic retinopathy within the VA medical system within a 2-year period. ResultsWithin a 2-year time frame 74 % of veterans without a history of DR received retinal screenings within the VA system. After adjustment for age, gender, race-ethnic group, service-connected disability, marital status, and the van Walraven Elixhauser comorbidity score, the prevalence of DR screening varied by VA catchment area with values ranging from 27 % to 86 %. These differences persisted after further adjusting for mean HbA1c level, medication use and adherence as well as utilization and access metrics. ConclusionsThe wide variability in DR screening across 125 VA catchment areas indicates the presence of unmeasured determinants of DR screening. These results are relevant to clinical decision making in DR screening resource allocation.

Association of Glycosylated Hemoglobin with Left Ventricular Diastolic Dysfunction in Type 2 Diabetes Mellitus

Abstract Background: Diabetes is the leading cause of death and disability among cardiovascular disease patients. By 2025, India will have people with diabetes to one in every five diabetics worldwide. Aim: The study examines the relationship between glycosylated hemoglobin (HbA1c) levels and left ventricular diastolic dysfunction (LVDD) in type 2 diabetes patients. Settings and Design: This was a cross-sectional observational study. Materials and Methods: Over 2 years, 345 subjects with type 2 diabetes mellitus who gave informed consent and met the inclusion criteria were studied. The HbA1c test was performed using ion-exchange high-performance liquid chromatography. Electrocardiogram and two-dimensional echocardiography were used to evaluate cardiac dysfunctions. The relationship between potential variables and outcomes was determined using logistic regression. Statistical Analysis: All statistical analyses were carried out using STATA version 13 (College Station, TX: Stata Corp LP). Results: Mean HbA1c levels were found to be higher in patients with LVDD (10.40% ± 4.25%) compared to normal LVDD (7.51% ±3.18%) (P = 0.004) in the current study. The predicted left ventricular (LV) function with an area under the receiver operating characteristic curve of 0.883. Conclusions: LVDD is a common finding in people with type 2 diabetes. LVDD causes various cardiac complications, including LV hypertrophy, which is concerning. The current findings suggest that HbA1c is a reliable predictor of LVDD that can be used for screening in resource-limited areas where echocardiography is unavailable. In addition, regular HbA1c screening and blood sugar control can help prevent cardiovascular complications caused by LVDD in type 2 diabetic patients.

GLYCAEMIC CONTROL AMONG SAUDI PATIENTS WITH TYPE 2 DIABETES MELLITUS AT FIRST TIME REGISTRY IN RAQEB RECORDS FROM 2018-2022

Background:Diabetes Mellitus (DM) is a major risk factor for many complications and glycaemic control prevents and delays such complications. The Raqeb registry aims toimprove diabetic patientscontrol of their diabetes by giving them glucometers. Objective:This study aims to determine the prevalence of type 2 diabetes (T2DM) glycaemic control in all regions of Saudi Arabia using Raqeb data, as well as outline the factors associated with uncontrolled T2DM. Methods:This paper conducted a registry-based cross-sectional study among all patients with T2DM who registered in Raqeb from October 16, 2018, to July 17, 2022. According to the American Diabetes Association, for non-pregnant adults, HbA1c can be used to assess glycaemic control according to the HbA1c target of &lt; 7% (control DM) and ≥7 (uncontrolled DM). To identify glycaemic control determinants, the present study used multivariate logistic regression analysis, while SPSS v26 software was used for data entry and analysis. Results: In the study, the mean level of HbA1c of the patients was 8.4 (SD1.7) and approximately 86% of the patients had uncontrolled diabetes mellitus (HbA1c ≥ 7%). Multivariate analysis revealed that being over 45 years old, using hypoglycaemic agents (OHA) and insulin, being followed up in a diabetic centre and being from the Western, Southern or Northern regions were all significant predictors of poor glycaemic control. Meanwhile, the female gender and OHA treatment were linked to a lower risk of poor glycaemic control. Conclusion:Using data from Saudi Arabias Raqeb registry of T2DM patients, this different level of care database analysis over a five-year period revealed uncontrolled DM. An increased risk of uncontrolled DM in T2DM patients was seen in those over the age of 45 years and patients using OHA and insulin treatment, as well as people from the Western, Southern or Northern regions of Saudi Arabia.

Impact of Age on HbA1c Level of Diabetic Patients Attending Ahmadu Bello University Teaching Hospital Zaria, Nigeria

The present study looked into the possibility of impact of age on HbA1c level of diabetic patients attending Ahmadu Bello University Teaching Hospital (ABUTH) Zaria, Nigeria, as there have been reports of correlation between age and HbA1c in some other parts of the world. Three hundred and fifty (350) diabetic patients were initially recruited over a period of 10 months, from March 2018 to December 2018. Subjects consisted of 200 female and 150 male diabetic patients. After 10-12 hours fast, 5mL of blood was drawn from volunteer patients. About 3mL was centrifuged in order to separate the serum after which the serum was then analysed for glucose. Two hundred and fifteen (215) subjects, comprising of 110 female and 105 male diabetic patients, with ages between 46 years and 84 years (mean age = 65±19 years) and mean blood glucose of 200±20 mg/dL were then selected for the study. The remaining 2mL whole blood was analysed immediately for HbA1c. Information about patient’s age was obtained via a well-designed questionnaire and matched with hospital record. There was no significant difference in the mean HbA1c levels of male and female participants. For the given blood glucose range, the HbA1c level increased by 0.2%, proportionally, with every decade (10 years) increase in age. It was concluded that HbA1c increases consistently – independent of blood glucose and gender – with increase in age of diabetic patients.

Once-Weekly Insulin Icodec vs Once-Daily Insulin Degludec in Adults With Insulin-Naive Type 2 Diabetes

Once-weekly insulin icodec could provide a simpler dosing alternative to daily basal insulin in people with type 2 diabetes. To evaluate the efficacy and safety of once-weekly icodec vs once-daily insulin degludec in people with insulin-naive type 2 diabetes. Randomized, double-masked, noninferiority, treat-to-target, phase 3a trial conducted from March 2021 to June 2022 at 92 sites in 11 countries in adults with type 2 diabetes treated with any noninsulin glucose-lowering agents with hemoglobin A1c (HbA1c) of 7%-11% (53-97 mmol/mol). Participants were randomly assigned in a 1:1 ratio to receive either once-weekly icodec and once-daily placebo (icodec group; n = 294) or once-daily degludec and once-weekly placebo (degludec group; n = 294). The primary end point was change in HbA1c from baseline to week 26 (noninferiority margin, 0.3% percentage points). Secondary end points included change in fasting plasma glucose from baseline to week 26, mean weekly insulin dose during the last 2 weeks of treatment, body weight change from baseline to week 26, and number of level 2 (clinically significant; glucose level <54 mg/dL) and level 3 (severe; requiring external assistance for recovery) hypoglycemic episodes. Among 588 randomized participants (mean [SD] age, 58 [10] years; 219 [37%] women), 564 (96%) completed the trial. Mean HbA1c level decreased from 8.6% (observed) to 7.0% (estimated) at 26 weeks in the icodec group and from 8.5% (observed) to 7.2% (estimated) in the degludec group (estimated treatment difference [ETD], -0.2 [95% CI, -0.3 to -0.1] percentage points), confirming noninferiority (P < .001) and superiority (P = .002). There were no significant differences between the icodec and degludec groups for fasting plasma glucose change from baseline to week 26 (ETD, 0 [95% CI, -6 to 5] mg/dL; P = .90), mean weekly insulin dose during the last 2 weeks of treatment, or body weight change from baseline to week 26 (2.8 kg vs 2.3 kg; ETD, 0.46 [95% CI, -0.19 to 1.10] kg; P = .17). Combined level 2 or 3 hypoglycemia rates were numerically higher in the icodec group than the degludec group from week 0 to 31 (0.31 vs 0.15 events per patient-year exposure; P = .11) and statistically higher in the icodec group from week 0 to 26 (0.35 vs 0.12 events per patient-year exposure; P = .01). Among people with insulin-naive type 2 diabetes, once-weekly icodec demonstrated superior HbA1c reduction to once-daily degludec after 26 weeks of treatment, with no difference in weight change and a higher rate of combined level 2 or 3 hypoglycemic events in the context of less than 1 event per patient-year exposure in both groups. ClinicalTrials.gov Identifier: NCT04795531.

818-P: Glycemic Control in Naïve Users of Second-Generation Basal Insulins with T2D and CKD—A Nationwide Register-Based Cohort Study

Objective: We aimed to compare the effectiveness and safety of second-generation basal insulins, insulin glargine 300 U/mL (Gla-300) and insulin degludec 100 U/mL (Deg-100), in terms of change in HbA1c, hospitalization for hypoglycemia and all-cause mortality. Methods: In this register-based cohort study, using real-word data on the entire Danish diabetes population in the period 2013-2020, we included 6519 naïve users of Gla-300 or Deg-100 with T2D and chronic kidney disease (CKD). Change in HbA1c, from initiation of either study drugs to end of follow-up, was modeled with mixed-effect models while rates of hospitalization for hypoglycemia and all-cause mortality were modeled in separate Poisson models. Results: Mean HbA1c levels were reduced by 13-14 mmol/mol over a four-year period in both groups with no significant difference (Figure). The rate of hospitalization for hypoglycemia was slightly but not significantly higher in the Deg-100 group (rate-ratio 1.03 (CI 95%: 0.71, 1.49) while the all-cause mortality rate was slightly but not significantly lower in the Deg-100 group (0.97 (0.83, 1.14)). Conclusion: We found no difference in HbA1c reduction, hospitalization for hypoglycemia or all-cause mortality between Gla-300 and Deg-100, in a real-world population of naïve users with T2D and CKD. Disclosure V.Kosjerina: Research Support; Sanofi-Aventis Deutschland GmbH. B.Carstensen: Stock/Shareholder; Novo Nordisk. H.Amadid: Employee; Novo Nordisk A/S. D.Vistisen: Research Support; Bayer Inc., Sanofi, Boehringer-Ingelheim, Stock/Shareholder; Novo Nordisk A/S. Funding Sanofi-Aventis Deutschland GmbH

55-OR: HSK7653, a Novel Ultralong-Acting DPP-4 Inhibitor, as Monotherapy in Patients With Type 2 Diabetes—A Randomized, Double-Blind, Placebo-Controlled Phase III Trial

Background: HSK7653 is a novel ultralong-acting DPP-4 inhibitor that maintains the average plasma DPP-4 inhibition over 80% for 14 days after 10mg or 25mg dosing. This randomized, double-blind, placebo-controlled phase III trial was conducted to evaluate the efficacy and safety of HSK7653 biweekly as monotherapy for 52 weeks in drug naive type 2 diabetes patients with inadequate glycemic control on diet and exercise. Methods: A total of 475 patients with a mean HbA1c level of 8.1% were randomized to HSK7653 10mg, 25mg or placebo biweekly at a ratio of 1:1:1 for 24 weeks of double-blind treatment, followed by 28 weeks of open-label extension treatment with HSK7653 25mg for all patients. The primary endpoint was the change in HbA1c from baseline at 24 weeks. Results: At week 24, the least-squares mean change in HbA1c from baseline was -0.96% in HSK7653 10mg, -0.92% in HSK7653 25mg and -0.33% in placebo. HSK7653 10mg and 25mg treatment resulted in significant placebo-subtracted changes in HbA1c of -0.63% (95% CI: -0.81%, -0.46%, p&amp;lt;0.0001) and -0.59% (95% CI: -0.77%, -0.42%, p&amp;lt;0.0001), respectively. The percentage of patients achieving HbA1c&amp;lt;7.0% was 44.2% in HSK7653 10mg group and 44.4% in HSK7653 25mg group versus 20.6% in placebo group (p&amp;lt;0.0001 for HSK7653 groups vs. placebo). No meaningful body weight changes were observed in all treatment groups. In the open-label extension treatment (from week 24 to week 52), the sustaining reduction of HbA1c from baseline were observed in HSK7653 10mg switched to 25mg group and HSK7653 25mg maintenance group. There were no excess hypoglycemia events in HSK7653 vs. placebo, and the incidence of adverse events was similar in all groups during the treatment. Conclusions: In people with type 2 diabetes who had inadequate glycemic control on diet and exercise, HSK7653 monotherapy significantly improved glycemic control with well tolerability and safety. Clinical trial information: NCT04556851. Disclosure L.Ji: Other Relationship; Eli Lilly and Company, Novo Nordisk, Merck &amp; Co., Inc., Bayer Inc., Sanofi-Aventis U.S., Roche Pharmaceuticals, MSD Life Science Foundation, AstraZeneca, Boehringer Ingelheim Inc., Abbott, Metronics. F.Bian: None. T.Pan: None. H.Jiang: None. C.Jiang: None. Q.Ren: None.

1086-P: Humanistic Burden of Type 1 Diabetes in U.S. Adults across Different Age Cohorts—A Qualitative Interview Study

Introduction: This study explores the perceived humanistic burden of type 1 diabetes (T1D) across different age cohorts of adults (18-35 yrs., 36-64 yrs., and 65+ yrs.) in the US who are using continuous glucose monitors (CGM). Methods: Adult CGM users (≥18 years of age) with self-reported T1D diagnosis (≥ 5 yrs.) were interviewed to evaluate the impact of T1D on quality of life (QoL). Participants ranked the ‘top 3’ negative impacts of T1D on QoL using a “Wheel of Life” visual framework, which helped participants identify and describe the multi-faceted impacts of T1D on QoL. Interview transcripts were thematically analyzed. Subgroup analyses were conducted by age cohort. Results: Overall, 31 participants (18-35 yrs., n=10; 36-64 yrs., n=12; 65+ yrs., n=9) took part in the study. Participants were mostly female (74%) and married (81%), with a mean age at diagnosis of 28 yrs. and a reported mean HbA1c level of 7.1% (range: 5.0% - 9.9%); 42% reported having ≥ 2 severe hypoglycemic events (SHEs) in the past year. Impacts on physical health, mental health, sleep, relationships, leisure activities, work/studies, and sex life were reported by participants as affecting their daily lives. Physical health impacts were most frequently ranked in “top 3” negative impacts across age cohorts. Negative impacts on physical health, mental health and sleep were ranked as “top 3” for both the 18-35 yrs. and the 36-64 yrs. age cohorts, while negative impacts on physical health, leisure activities, and relationships were top ranked by the 65+ yrs. cohort. Conclusions: Despite use of advanced diabetes technologies, the humanistic burden of T1D persists across adults of different age cohorts. Participants in all age cohorts reported physical health as the leading negative impact to QoL, while other perceived negative impacts varied in rank order across age cohorts. Disclosure P. Callahan: Employee; Vertex Pharmaceuticals Incorporated, Genesis Research. Consultant; Rhythm Pharmaceuticals, Inc., Abbott Diabetes, HealthCore Inc., BMS. A. Boateng-Kuffour: None. K. Chandarana: Employee; Vertex Pharmaceuticals Incorporated. Stock/Shareholder; Vertex Pharmaceuticals Incorporated. J.L. Gaglia: Consultant; Vertex Pharmaceuticals Incorporated. Stock/Shareholder; Vertex Pharmaceuticals Incorporated. Consultant; Abata Therapeutics, Avotres Inc. Research Support; Avotres Inc. Advisory Panel; Dompé. Research Support; Dompé, Imcyse. Consultant; Current Health. M. Phinney: None. E. Guzman Ortega: Research Support; Vertex Pharmaceuticals Incorporated. R.N. Krupnick: Consultant; Vertex Pharmaceuticals Incorporated. M. Reaney: None. W.H. Polonsky: Consultant; Abbott Diabetes, Boehringer Ingelheim and Eli Lilly Alliance, Eli Lilly and Company, Insulet Corporation, Intuity Medical, Inc., MannKind Corporation, Provention Bio, Inc., Sanofi-Aventis U.S., Vertex Pharmaceuticals Incorporated.

EVALUATION OF HBA1C IN THE DIAGNOSIS OF DIABETES MELLITUS

Diabetes mellitus is a prevalent metabolic disorder that requires early detection and effective management. Glycated hemoglobin (HbA1c) evaluation has emerged as a valu- able tool in diagnosing diabetes mellitus. This study evaluated 62 cases, with 21 diabetic and 41 non-diabetic, and found a significant p-value for HbA1c levels. The mean HbA1c level was 6.36, with a standard deviation of 1.90 and a variance of 3.6189. Comparative analysis showed an increased case detection rate in HbA1c testing. HbA1c testing improves accuracy and convenience of diabetes diagnosis, correlates with long-term glycemic control, and is a prognostic marker for cardiovascular risk. The study highlights the importance of incorporating HbA1c testing into clinical practice, monitoring treatment effectiveness and guiding therapeutic decisions. The findings support the growing recognition of HbA1c as a reliable diagnostic tool for diabetes mellitus, with its ability to reflect average blood glucose levels over a prolonged period. Further research is needed to explore its applicability across different populations and establish standardized guidelines for HbA1c interpretation and utilization. Keywords: Diabetes mellitus, HbA1c, Diagnostic tool, Glycemic control, Fasting, Post prandial

Quality of Life, Medication Adherence, and Glycemic Control in Type 1 Diabetes Mellitus Children with Basal Bolus Regimen During COVID-19 in Limited Resources Setting

Background: Type 1 Diabetes Mellitus (T1DM) is a chronic disease that requires complicated therapies. The coronavirus disease 2019 (COVID-19) pandemic has caused lockdown restrictions, compromising access to medical care, including T1DM management. Poor medication adherence may affect the quality of life (QoL) and glycemic control. Objectives: This study analyzed the association among QoL, medication adherence, and glycemic control in T1DM patients during the COVID-19 pandemic. Methods: This study recruited T1DM patients aged 5 - 18 who regularly visited the pediatric endocrinology outpatient clinic. The PedsQL 3.2 and the diabetes management questionnaire (DMQ) were used to measure QoL and medication adherence. In addition, glycemic control was measured based on HbA1c levels. All data were analyzed using SPSS version 17, and correlations between variables were analyzed using Spearman or Pearson correlation tests. Results: Twenty-five children and adolescents with a mean age of 141.1 months (± 36.7) were included in this study. The mean HbA1c level was 10.7 mg/dL (± 2.4). Around 19 (76%) participants had already experienced diabetic ketoacidosis (DKA). There was no significant correlation between QoL and medication adherence or HbA1c level (P = 0.220, r = - 0.254; P = 0.753, and r = - 0.066, respectively). Conclusions: Our study’s QoL and medication adherence of T1DM children was relatively good even though the HbA1c was still high. However, numerous factors affect QoL and medication adherence in T1DM children other than HbA1c level.

Side-to-side magnet anastomosis system duodeno-ileostomy with sleeve gastrectomy: early multi-center results

IntroductionGastrointestinal anastomoses with classical sutures and/or metal staples have resulted in significant bleeding and leak rates. This multi-site study evaluated the feasibility, safety, and preliminary effectiveness of a novel linear magnetic compression anastomosis device, the Magnet System (MS), to form a side-to-side duodeno-ileostomy (DI) diversion for weight loss and type 2 diabetes (T2D) resolution.MethodsIn patients with class II and III obesity (body mass index [BMI, kg/m2] ≥ 35.0– ≤ 50.0 with/without T2D [HbA1C > 6.5%]), two linear MS magnets were delivered endoscopically to the duodenum and ileum with laparoscopic assistance and aligned, initiating DI; sleeve gastrectomy (SG) was added. There were no bowel incisions or retained sutures/staples. Fused magnets were expelled naturally. Adverse events (AEs) were graded by Clavien-Dindo Classification (CDC).ResultsBetween November 22, 2021 and July 18, 2022, 24 patients (83.3% female, mean ± SEM weight 121.9 ± 3.3 kg, BMI 44.4 ± 0.8) in three centers underwent magnetic DI. Magnets were expelled at a median 48.5 days. Respective mean BMI, total weight loss, and excess weight loss at 6 months (n = 24): 32.0 ± 0.8, 28.1 ± 1.0%, and 66.2 ± 3.4%; at 12 months (n = 5), 29.3 ± 1.5, 34.0 ± 1.4%, and 80.2 ± 6.6%. Group mean respective mean HbA1C and glucose levels dropped to 1.1 ± 0.4% and 24.8 ± 6.6 mg/dL (6 months); 2.0 ± 1.1% and 53.8 ± 6.3 mg/dL (12 months). There were 0 device-related AEs, 3 procedure-related serious AEs. No anastomotic bleeding, leakage, stricture, or mortality.ConclusionIn a multi-center study, side-to-side Magnet System duodeno-ileostomy with SG in adults with class III obesity appeared feasible, safe, and effective for weight loss and T2D resolution in the short term.

Real-World Use of Once-Weekly Semaglutide in Thai Patients With Type 2 Diabetes Mellitus in a Private Hospital Setting.

To evaluate the real-world use of once-weekly semaglutide among Thai patients with type 2 diabetes (T2DM) in a private hospital setting. A retrospective review of Thai patients with T2DM who have initiated semaglutide for at least 1 month between June 2020 and March 2022 at Theptarin Hospital, Bangkok, Thailand. A total of 58 patients (50% female, mean age 55.6 ± 15.9 years, with duration of diabetes 12.6 ± 10.3 years, BMI 31.5 ± 4.4 kg/m2, baseline HbA1c 7.9 ± 1.9%, with prior GLP-1 RA use 24.1%, and concomitant SGLT2i intake (41.4%) were included. During a median follow-up of 6 months, the mean serum HbA1c level reduction was 1.3 ± 1.7% with weight loss of 4.7 ± 4.1 kg. The proportion of patients who achieved optimal and sustainable glycemic control (HbA1c < 7.0%) increased from 43.1% to 55.8% at the last follow-up. The proportion of patients reaching both HbA1c targets of <7.0% and 5% weight loss was 27.8%. No cases of pancreatitis, cancer, or progressive retinopathy were observed. In this single center undertaking, it was shown that in among persons with T2DM and obesity in Thailand, semaglutide was associated with short-term glycemic control and weight loss comparable with what has been observed in randomized clinical trials and other RWE.

Correlation of HbA1c with Serum Iron & Transferrin Saturation in Non-Diabetic Patients with Iron Deficiency.

To determine correlation of HbA1c with serum iron and transferrin saturation in non-diabetic patients with iron deficiency. This cross-sectional comparative study was conducted at Dr Ruth KM Pfau Civil Hospital Karachi from 15th September 2021 to 14th March 2022, on non-diabetic patients based on fasting blood sugar (FBS) of <100 mg/dl. Patients were divided into two groups. Group one included patients having iron deficiency anemia (ID), whereas group two included same number of age and sex matched healthy subjects taken as controls, without ID. Blood sample was taken for HbA1c, CBC, serum iron and total iron binding capacity. Transferrin saturation (TSAT) was calculated. Comparison of quantitative variables with ID and non-ID group was done by Student's t-test. Correlation of HbA1c with iron &TSAT was done in both groups using Kendal tau-b test, as data was not normally distributed. Out of 230 patients, 83 (36.1%) were males while 147(63.9%) were females. Mean age of patients was 43.7±13.28 years. Mean HbA1c level was significantly high in ID group (5.89±0.43) as compared to non-ID group (5.52±0.50) with a p-value <.001. The HbA1c levels correlated negatively with hemoglobin, serum iron levels and transferrin saturation with a p-value <.001. Low serum Iron and TSAT was related to elevation in HbA1c value. Iron deficiency needs to be corrected before HbA1c interpretation.

Diabetes Care Barriers, Use, and Health Outcomes in Younger Adults With Type 1 and Type 2 Diabetes

Treatment challenges exist for younger adults with type 1 (T1D) and type 2 diabetes (T2D). Health care coverage, access to, and use of diabetes care are not well delineated in these high-risk populations. To compare patterns of health care coverage, access to, and use of diabetes care and determine their associations with glycemia among younger adults with T1D and with T2D. This cohort study analyzed data from a survey that was jointly developed by 2 large, national cohort studies: the SEARCH for Diabetes in Youth (SEARCH) study, an observational study of individuals with youth-onset T1D or T2D, and the Treatment Options for Type 2 Diabetes in Adolescents and Youth (TODAY) study, a randomized clinical trial (2004-2011) followed by an observational study (2012-2020). The interviewer-directed survey was administered during in-person study visits in both studies between 2017 and 2019. Data analyses were performed between May 2021 and October 2022. Survey questions addressed health care coverage, usual sources of diabetes care, and frequency of care use. Glycated hemoglobin (HbA1c) levels were assayed in a central laboratory. Patterns of health care factors and HbA1c levels were compared by diabetes type. The analysis included 1371 participants (mean [range] age, 25 [18-36] years; 824 females [60.1%]), of whom 661 had T1D and 250 had T2D from the SEARCH study and 460 had T2D from the TODAY study. Participants had a mean (SD) diabetes duration of 11.8 (2.8) years. More participants with T1D than T2D in both the SEARCH and TODAY studies reported health care coverage (94.7%, 81.6%, and 86.7%), access to diabetes care (94.7%, 78.1%, and 73.4%), and use of diabetes care (88.1%, 80.5%, and 73.6%). Not having health care coverage was associated with significantly higher mean (SE) HbA1c levels in participants with T1D in the SEARCH study (no coverage, 10.8% [0.5%]; public, 9.4% [0.2%]; private, 8.7% [0.1%]; P < .001) and participants with T2D from the TODAY study (no coverage, 9.9% [0.3%]; public, 8.7% [0.2%]; private, 8.7% [0.2%]; P = .004). Medicaid expansion vs without expansion was associated with more health care coverage (participants with T1D: 95.8% vs 90.2%; participants with T2D in SEARCH: 86.1% vs 73.9%; participants with T2D in TODAY: 93.6% vs 74.2%) and lower HbA1c levels (participants with T1D: 9.2% vs 9.7%; participants with T2D in SEARCH: 8.4% vs 9.3%; participants with T2D in TODAY: 8.7% vs 9.3%). The T1D group incurred higher median (IQR) monthly out-of-pocket expenses than the T2D group ($74.50 [$10.00-$309.00] vs $10.00 [$0-$74.50]). Results of this study suggested that lack of health care coverage and of an established source of diabetes care were associated with significantly higher HbA1c levels for participants with T1D, but inconsistent results were found for participants with T2D. Increased access to diabetes care (eg, through Medicaid expansion) may be associated with improved health outcomes, but additional strategies are needed, particularly for individuals with T2D.

Glycemic Abnormalities in Pancreatic Cystic Lesions—A Single-Center Retrospective Analysis

Background and Objectives: Glucose metabolism alterations are very common in solid pancreatic lesions, particularly in pancreatic cancer. Similarly, diabetes and especially new-onset diabetes (NOD) have been associated with the malignant transformation of pancreatic cysts. We aimed to assess the prevalence and relevant associations of glycemic abnormalities in pancreatic cystic lesions (PCLs) in a retrospective analysis. Materials and Methods: We retrospectively recruited all patients who underwent endoscopic ultrasound for a PCL over a period of 36 months (January 2018 to December 2021). Final diagnosis was set by means of tissue acquisition, surgery, follow-up, or board decision. Demographic and clinical data, laboratory workup, and imaging features were extracted from the patients’ charts according to a predefined protocol. We considered fasting blood glucose (FBG) and HbA1c values and stratified the patients as nondiabetic (FBG ≤ 99 mg/dL, HbA1c ≤ 5.6%, no history of glycemic abnormalities), prediabetic (FBG 100–125 mg/dL, HbA1c 5.7–6.4%), or diabetic (long-lasting diabetes or NOD). Results: Altogether, 81 patients were included, with a median age of 66 years, and 54.3% of them were male. The overall prevalence of fasting hyperglycemia was 54.3%, comprising 34.6% prediabetes and 22.2% diabetes, of which 16.7% had NOD. The mean FBG and HbA1c levels were higher in malignant and premalignant PCLs (intraductal papillary mucinous neoplasm (IPMN), mucinous cystic neoplasm (MCN), cystadenocarcinoma, and cystic neuroendocrine tumor) compared to the benign lesions (pseudocysts, walled-off necrosis, and serous cystadenoma): 117.0 mg/dL vs. 108.3 mg/dL and 6.1% vs. 5.5%, respectively. Conclusions: Hyperglycemia and diabetes are common in PCLs, with a high prevalence in premalignant and malignant cysts. Screening and follow-up for glycemic abnormalities should be routinely conducted for PCLs, as they can contribute to a tailored risk assessment of cysts.