HbA1c Strata Research Articles

Preoperative Risk Assessment for Lumbar Fusion in Patients With Diabetes: Data-Driven Stratification of HbA1c and Same Day Glucose Levels that Predict 90-Day Complication Rates.

Retrospective Database Analysis. Pre-operative glycemic control in diabetic patients undergoing lumbar fusion (LF) is essential for evaluating complication risk. However, current thresholds for preoperative HbA1c and same-day-glucose (SDG) are either non-specific or have low predictive power. This study uses HbA1c and SDG to provide data-driven risk stratification for 90-day major and wound complications in LF patients. Using a national database, patients undergoing LF from 2013-2022 with a recorded preoperative HbA1c and SDG level were included for analysis. Multiple HbA1c and SDG strata were identified using stratum specific likelihood ratio analysis (SSLR). Each stratum was then propensity-score matched to the lowest strata and compared using risk ratios. Significance level was set at a P-value <0.05. 12,026 patients met inclusion criteria. For 90-day major complications, SSLR identified 3 predictive HbA1c (4.5-5.4, 5.5-7.9, and 8.0+) and SDG strata (60-159, 160-239, and 240+). Following propensity-matching, the 90-day major complication risk sequentially increased for HbA1c: 5.5-7.9 (1.69; P = 0.001; 95% CI 1.24-2.30), 8.0+(2.31; P < 0.001; 95% CI 1.56-3.43). Following propensity-matching, the SDG strata similarly demonstrated sequentially increasing 90-day major complication risk: 160-239 (1.34; P < 0.001; 95% CI 1.18-1.54), 240+ (1.64; P < 0.001; 95% CI 1.31-2.05). Matched analysis demonstrated a higher relative-risk of 90-day wound complications for the 8.0+ HbA1c strata (2.23; P = 0.001; 95% CI 1.37-3.63) compared to the HbA1c 4.5-5.4 strata. No other strata were identified that predicted differences in 90-day wound complications. This study identified data-driven HbA1c and SDG strata that better risk-stratify 90-day major complications following LF. Instead of current single-value thresholds, these multiple strata may be utilized for better preoperative guidance.

Survival and hemoglobin A1c in metastatic castrate resistant prostate cancer.

75 Background: The two common therapies for metastatic castrate resistant prostate cancer (mCRPC), enzalutamide (ENZ) and abiraterone (AA), have different effectiveness in patients with diabetes mellitus and obesity due to different mechanisms of action, along with AA requiring the co-administration of prednisone. However, no prior study has assessed responses to treatment based on glycated hemoglobin (HbA1c) while accounting for body-mass index (BMI). Methods: Patients treated with AA or ENZ from September 10, 2014 to June 2, 2017 were identified within the Veterans Health Administration. The patients were classified by most recent HbA1c values (&lt;5.6%, 5.6%-6.4%, 6.5%-7.1%, ≥7.2%) collected prior to the start of AA or ENZ. Kaplan Meier and Cox proportional hazards modeling was performed to assess the association between overall survival and covariates including age, Charlson Comorbidity Index, BMI, baseline PSA, and HbA1c. Results: 3421 veterans treated with AA or ENZ had HbA1c data available. 658 patients with HbA1c &lt;5.6%, 1430 with 5.6-6.4%, 667 with 6.5%-7.1%, and 666 with HbA1c ≥7.2. Kaplan Meier analysis showed the following median survival in months with ENZ vs AA: &lt;5.6% = 22.1 vs 24.5 (p = 0.04 by log-rank), 5.6%-6.4% = 27.7 vs 22.6 (p = 0.01), 6.5%-7.1% = 23.0 vs 19.8 (p = 0.005), ≥7.2% = 26.0 vs 21.0 (p = 0.04). Cox models showed no difference in median survival between ENZ vs AA in patients with HbA1c &lt;5.6%, adjusted hazard ratio (aHR) 1.15 (95% CI, 0.960-1.370). However, there was significantly longer survival in patients who received ENZ compared to AA in all other groups as follows: 5.6%-6.4% aHR 0.86 (95% CI, 0.759-0.965), 6.5%-7.1% aHR 0.74 (0.623-0.879) and ≥7.2% aHR 0.80 (0.669-0.948). Additionally, in patients treated with AA, higher HbA1c values were associated with inferior survival compared to HbA1c &lt;5.6%, aHR 1.40 (1.19-1.65) for 6.5-7.1% and aHR 1.25 (1.05-1.48) for ≥7.2%. Conclusions: In patients with HbA1c ≥5.6%, ENZ was associated with longer overall survival compared to AA, even when including baseline BMI. Additionally, in patients treated with AA, higher HbA1c values had inferior survivals compared to patients with HbA1c &lt;5.6%. No difference in survival was observed across the HbA1c strata with ENZ. Further studies of interactions between patient factors and treatments are warranted to guide treatment selection for prostate cancer therapy.

Characteristics of newly diagnosed adults with type 1 diabetes in the UK and evolution of glycaemic control, body mass index and Charlson comorbidity index over the first 5 years after diagnosis

AimsThis retrospective, longitudinal study characterised 2430 adults (mean age 40.8±16.1years) with newly diagnosed type 1 diabetes (T1D) over the first 5years of insulin treatment. MethodsData from 1year pre- and up to 5 years post-insulin initiation were extracted from the UK Clinical Practice Research Datalink (1990–2013). Baseline HbA1c, BMI and Charlson comorbidity index (CCI) score were compared with data at 1, 2, 3 and 5 years. ResultsMean HbA1c decreased significantly from baseline 95±32.8mmol/mol (10.8±3.0%) to 61±21.9mmol/mol (7.7±2.0%) at 1year, remaining significantly lower at 2, 3 and 5 years (p<0.0001). One year after initiating insulin, only 6.3% of patients had HbA1c <48mmol/mol (<6.5%). There was no further improvement in HbA1c after 1year. Mean BMI increased significantly from baseline 25.3±5.5kg/m2 to 27.2±5.8kg/m2 at 1year; p<0.0001), remaining significantly higher thereafter, with over two-thirds having overweight/obesity by year 5. Mean CCI score increased significantly (1.32, baseline; 1.46, year 1; 1.75, year 5). CCI patterns were similar within BMI and HbA1c strata. ConclusionsMore intensive support to reach and maintain glycaemic targets soon post-diagnosis, while avoiding weight gain, and prevention and optimal management of comorbidities are warranted.

The Importance and Utility of Hemoglobin A1c Levels in the Assessment of Donor Pancreas Allografts.

Hemoglobin A1C (HbA1c) levels are often obtained in potential pancreas graft donors to assess the overall long-term functional glycemic control or the possibility of unrecognized diabetes. Although routinely measured, the impact of donor HbA1c levels on pancreas graft outcomes has not been reported. Here, we researched the relationship between donor HbA1c levels and postoperative pancreas graft survival. Data from 266 pancreas transplant patients including 182 simultaneous kidney-pancreas and 84 pancreas alone transplants were reviewed for the study. The patients were separated into groups according to their HbA1c levels (5 groups: HbA1c < 5.0, 5.0-5.4, 5.5-5.9, ≥6.0 % and not available, or 2 groups: HbA1c <5.7, ≥5.7%). Overall, death-censored and technically successful pancreas graft survival and rejection rates of each group were compared. In the case of technically successful graft survival, graft losses due to technical problems in the first 60 days were excluded. All groups were similar with regard to donor variables including age, sex, ABO blood type, ethnicity, donor type and recipient variables including recipient age, sex, induction agents and maintenance treatment. Mean follow-up time was 4.2 ± 1.97 years. The overall graft survivals and death censored graft survivals among groups were not statistically different from one other (P > 0.05). Additionally, excluding early technical losses in 18 patients did not reveal any differences in graft survivals. Patient survival and biopsy-proven acute rejections were statistically similar among HbA1c strata. This univariate retrospective analysis of a single center/organ procurement organization use of HbA1c shows that donor HbA1c levels between 3.5 and 6.2 in otherwise transplantable pancreata are not associated with different short-term outcomes.

Treatment Deintensification Is Uncommon in Adults With Type 2 Diabetes Mellitus: A Retrospective Cohort Study.

Whether treatment deintensification in Americans with diabetes mellitus varies by glycemic control, health status, and calendar year (before/after February 2008 when safety concerns about intensive glucose control were reported in the ACCORD trial [Action to Control Cardiovascular Risk in Diabetes]) is unclear. We defined deintensification as discontinuation or dosage decrease of at least 1 glycemic medication without addition of, or uptitration of, another agent in the 120 days after the index glycosylated hemoglobin (HbA1C) measurement. Of 99 694 individuals (mean age 54 years) in this retrospective cohort study being actively treated for new diabetes mellitus (50% 1 drug, 33% 2 drugs, and 17% ≥3 drugs), 12 921 (13.0%) had HbA1C <6% after 1 year, 19 670 (19.7%) had HbA1C 6.0% to 6.4%, 35 012 (35.1%) had HbA1C 6.5% to 7.5%, and 32 091 (32.2%) had HbA1C >7.5%. Glycemic therapy was deintensified in 18.3% of patients (21.2% of frail patients, 19.4% of those with multiple comorbidities, and 17.7% of otherwise healthy patients) with no gradient across glycemia levels (20.6% of those with HbA1C<6%, 17.3% of those with HbA1C 6.0%-6.4%, 17.7% of those with HbA1C 6.5%-7.5%, and 18.6% of those with HbA1C>7.5%). Similar proportions were seen even after exclusion of 26 985 patients being treated with metformin monotherapy: 23.3%, 20.4%, 20.3%, and 20% across the HbA1C strata. Therapy was deintensified in 22.5% of patients with index HbA1C <6.0% before February 2008 compared with 19.5% after (P<0.001). Among frail patients or those with multiple comorbidities, over three quarters with low HbA1C did not have their glycemic therapy deintensified, even after safety concerns were raised in the ACCORD trial.

Dental Implant Survival and Complication Rate over 2 Years for Individuals with Poorly Controlled Type 2 Diabetes Mellitus.

Emerging evidence suggests that implant therapy may be a viable option for diabetic individuals with elevated glycemic levels. The purpose of this 2 year observational study was to evaluate survival and clinical complications of dental implants following placement in type 2 diabetes individuals having poor glycemic control. Adult participants (n = 24) with poorly controlled type 2 diabetes (8.0% ≤ HbA1c ≤ 12.0%) received two or more transgingival dental implants. Survival was evaluated after 1 (23 participants, 72 implants) and 2 (20 participants, 59 implants) years. Clinical complications were evaluated in 18 participants (52 implants) after 21-34 months. Relationships between complications and stratified HbA1c levels were assessed using Pearson's correlation test. Survival rates were 98.6% (71/72 implants) after 1 year and 96.6% (57/59 implants) after 2 years. Complications were identified in 29% of participants with peri-implant mucositis, the most common event. Complications correlated directly with number of implants across HbA1c strata (0.42, R2 = 0.66). There was no correlation between HbA1c and the occurrences of complications or mucositis. This 2-year evaluation supports the broader application of implant therapy in type 2 diabetes individuals with poor glycemic control in demonstrating high survival rates with limited complications.

Influence of Baseline Glycemia on Outcomes With Insulin Glargine Use in Patients Uncontrolled on Oral Agents

Purpose: Optimizing glycemic control in patients with type 2 diabetes mellitus (T2DM) not controlled with ≥ 1 oral antidiabetes drugs (OADs) is challenging. Many therapeutic options exist; however, data comparing the effectiveness of different strategies are lacking for the management of patients with T2DM. Our study aim was to provide comparative data on efficacy and hypoglycemia when initiating insulin glargine (glargine) versus alternative treatment options (not including the newest antidiabetes agents, glucagon-like peptide [GLP]-1 receptor agonists, dipeptidyl peptidase [DPP]-4 inhibitors or sodium-glucose linked transporter [SGLT]-2 inhibitors) in insulin-naive patients with T2DM who remained uncontrolled with OADs. Methods: Patient-level data were pooled from 9 randomized controlled trials of ≥ 24 weeks duration with comparable patient populations. The effect of adding glargine was compared with intensification of lifestyle interventions or OADs, addition of neutral protamine Hagedorn (NPH) insulin, insulin lispro, premixed insulin, or all comparators pooled, on patient glycated hemoglobin (HbA1c) level, fasting plasma glucose level, weight, and hypoglycemia. Results: A greater proportion of patients achieved a target HbA1c level ≤ 7.0% with glargine treatment than with pooled comparators, intensification of OADs, or lifestyle interventions; there was no difference when compared with NPH, premixed, or insulin lispro use. The rate for reported hypoglycemic events was lower for glargine use than for pooled comparators or other insulins, but higher compared with intensification of lifestyle interventions or OADs. When stratified by baseline HbA1c level, efficacy/target attainment with glargine use was better than for pooled comparators across all HbA1c strata; OAD intensification, when baseline HbA1c level was ≥ 8.0%; and premixed insulin if baseline HbA1c level was < 8.0%; but similar to other insulins for all other categories. The incidence of reported hypoglycemia was less frequent with glargine use than other insulins, but more frequent than intensification of lifestyle interventions or OADs. Conclusion: When adequate glycemic control is not achieved using OADs in patients with T2DM, initiating insulin glargine is generally less likely to elicit hypoglycemia than initiating NPH, premixed, or prandial insulins, and the benefit–risk balance supports initiating insulin rather than intensification of OAD therapy when baseline HbA1c level is ≥ 8.0%.

Stratified Patient-Centered Care in Type 2 Diabetes

OBJECTIVEDiabetes treatment should be effective and cost-effective. HbA1c-associated complications are costly. Would patient-centered care be more (cost-) effective if it was targeted to patients within specific HbA1c ranges?RESEARCH DESIGN AND METHODSThis prospective, cluster-randomized, controlled trial involved 13 hospitals (clusters) in the Netherlands and 506 patients with type 2 diabetes randomized to patient-centered (n = 237) or usual care (controls) (n = 269). Primary outcomes were change in HbA1c and quality-adjusted life years (QALYs); costs and incremental costs (USD) after 1 year were secondary outcomes. We applied nonparametric bootstrapping and probabilistic modeling over a lifetime using a validated Dutch model. The baseline HbA1c strata were <7.0% (53 mmol/mol), 7.0–8.5%, and >8.5% (69 mmol/mol).RESULTSPatient-centered care was most effective and cost-effective in those with baseline HbA1c >8.5% (69 mmol/mol). After 1 year, the HbA1c reduction was 0.83% (95% CI 0.81–0.84%) (6.7 mmol/mol [6.5–6.8]), and the incremental cost-effectiveness ratio (ICER) was 261 USD (235–288) per QALY. Over a lifetime, 0.54 QALYs (0.30–0.78) were gained at a cost of 3,482 USD (2,706–4,258); ICER 6,443 USD/QALY (3,199–9,686). For baseline HbA1c 7.0–8.5% (53–69 mmol/mol), 0.24 QALY (0.07–0.41) was gained at a cost of 4,731 USD (4,259–5,205); ICER 20,086 USD (5,979–34,193). Care was not cost-effective for patients at a baseline HbA1c <7.0% (53 mmol/mol).CONCLUSIONSPatient-centered care is more valuable when targeted to patients with HbA1c >8.5% (69 mmol/mol), confirming clinical intuition. The findings support treatment in those with baseline HbA1c 7–8.5% (53–69 mmol/mol) and demonstrate little to no benefit among those with HbA1c <7% (53 mmol/mol). Further studies should assess different HbA1c strata and additional risk profiles to account for heterogeneity among patients.

Abstract 84: The Effect of Hyperglycemia on Stroke Outcome Depends on Baseline Glycosylated Hemoglobin Levels

Background and hypothesis: Patients with diabetes mellitus (DM) are less likely to develop adverse outcomes than are those without DM in response to acute elevations in plasma glucose after stroke. We hypothesized that baseline glycosylated hemoglobin (HbA1c) level, which provides an estimate of long-term plasma glucose concentration, inversely correlated with clinical and tissue outcome in acute ischemic stroke patients presenting with hyperglycemia. Methods: Within the context of an ongoing prospective study (Heart-Brain Interactions Study), we measured plasma glucose and HbA1c levels in 1080 patients with acute ischemic stroke within 72 hours of symptom onset. We classified patients into 3 HbA1c strata based on the American Diabetes Association criteria: group-I (HbA1c &lt;5.7%, n=439), group-II (HbA1c: 5.7 to 6.4%, n=290), group-III (known DM or HbA1c &gt;6.4, n=351). We examined the relationship between admission blood glucose level, acute infarct volume on DWI, and unfavorable outcome (mRS≥3) at 3 months in each HbA1c stratum. Results: The probability of unfavorable outcome decreased by increasing baseline HbA1c level; the OR (95% CI) for unfavorable outcome for every 10 mg/dl increase in glucose level was 1.42 (1.25-1.62) in group-I, 1.19 (1.07-1.33) in group-II, and 1.02 (0.99-1.05) in group-III. When hyperglycemia was defined as ≥144 mg/dl, OR (95% CI) for unfavorable outcome was 6.53 (2.65-16.14) in group-I, 1.56 (0.77-3.15) in group-II, and 1.35 (0.78-2.33) in group-III. Adjusting for age and sex did not change the results. For every 10 ml elevation in plasma glucose, the mean infarct volume increased by 7.45 ml (5.04-9.85) in group-I, 4.96 ml (2.82-7.09) in group-II, and 0.73 ml (-0.24-1.70) in group-III. Conclusions: Chronic hyperglycemia appears to protect from deleterious effects of acute elevations in blood glucose after ischemic stroke. Further research is warranted examining whether baseline HbA1c concentration predicts benefit from interventions for glycemic control in acute stroke.

Complexity of the Relation Between Hemoglobin A1C, Diabetes Mellitus, and Progression of Coronary Narrowing in Postmenopausal Women

The aim of this study was to assess the effect of diabetes mellitus (DM) and glycosylated hemoglobin (HbA1c) on the progression of atherosclerosis in postmenopausal women. A retrospective analysis of the Women's Angiographic and Vitamin and Estrogen (WAVE) trial, a multicenter randomized trial on progression of atherosclerosis in postmenopausal women, was performed. Baseline and follow-up angiography was performed in 320 women. Minimum luminal diameter and average luminal diameter at baseline and follow-up were measured in 1,735 coronary segments. Measurements and adverse events were grouped on the basis of history of DM and HbA1c. DM was associated with more total cardiac events but with similar rates of death or myocardial infarction. There were greater reductions in minimum luminal diameter and average luminal diameter in segments from patients with known DM (p <0.001) and with a baseline HbA1c ≥6.5% (p= 0.002 and p= 0.004, respectively). The greater reductions in minimum luminal diameter and average luminal diameter in the higher HbA1c strata were only in patients with known DM. More new lesions, however, appeared with baseline HbA1c ≥5.7%, irrespective of a history of DM. In conclusion, the relation between DM and the progression of coronary narrowing in postmenopausal women is complex. Clinically apparent DM, not elevated HbA1c alone, appears to promote the progression of established coronary lesions even in HbA1c ranges diagnostic of pre-DM and DM. This raises the possibility that coronary narrowing of existing stenosis in women with DM may be due to negative remodeling, a complex process that might be less dependent on hyperglycemia than new lesion formation.