Health status after treatment for coronary artery disease and type 2 diabetes mellitus in the Bypass Angioplasty Revascularization Investigation 2 Diabetes trial.

BACKGROUND: Health status is a key outcome for comparing treatments, particularly when mortality does not differ significantly. METHODS AND RESULTS: Bypass Angioplasty Revascularization Investigation 2 Diabetes (BARI 2D) randomized 2368 patients with type 2 diabetes mellitus and stable ischemic heart disease to (1) prompt revascularization versus medical therapy and (2) insulin sensitization versus insulin provision. Randomization was stratified by the intended method of revascularization, coronary artery bypass graft surgery or percutaneous coronary intervention. The Duke Activity Status Index and RAND Energy, Health Distress, and Self-Rated Health scales were assessed at study entry and annually thereafter; linear mixed models were used to evaluate the effect of randomized treatment on these measures. Health status improved significantly from baseline to 1 year (P<0.001) in each randomized treatment group. Compared with medical therapy, prompt revascularization was associated with significantly greater improvements in Duke Activity Status Index (1.32 points; P<0.001), Energy (1.36 points; P=0.02), and Self-rated Health (1.77 points; P=0.007) but not Health Distress (-0.47; P=0.46). These treatment effects were largely maintained over 4 years of follow-up. The effect of revascularization on the Duke Activity Status Index was significantly larger in the subgroup of patients intended for coronary artery bypass graft surgery compared with the subgroup intended for percutaneous coronary intervention. Health status did not differ significantly on any of the 4 measures between the insulin provision and insulin sensitization strategies. CONCLUSIONS: Prompt coronary revascularization was associated with small yet statistically significant improvements in health status compared with initial medical therapy among patients with diabetes mellitus and stable ischemic heart disease. CLINICAL TRIAL REGISTRATION: http://www.clinicaltrials.gov. Unique identifier: NCT00006305.

The impact of race/ethnicity on baseline characteristics and the burden of coronary atherosclerosis in the Bypass Angioplasty Revascularization Investigation 2 Diabetes trial.

OBJECTIVES: We aimed to test the impact of race/ethnicity on coronary artery disease (CAD) after adjusting for baseline risk factors. BACKGROUND: Whether race/ethnicity remains an important determinant of the burden of CAD even among patients with long-standing type 2 diabetes (diabetes mellitus) and established CAD is unknown. METHODS: Analysis of baseline data from the BARI 2D trial (January 1, 2001, to March 31, 2005) was performed. Myocardial jeopardy index (MJI) was evaluated by a blinded core angiographic laboratory. Multivariate regression analysis was performed to determine the independent association of race/ethnicity on the burden of CAD after adjusting for baseline risk factors. Data were collected from US and Canadian academic and community hospitals. The baseline analysis was performed on patients with long-standing diabetes and documented CAD with no prior revascularization at study entry (n = 1,331). The main outcome measure was MJI, which represents the percentage of myocardium jeopardized by significant lesions (≥50%). The secondary outcome measure was ≥2 lesions with ≥50% stenosis. RESULTS: Risk factors varied significantly among racial/ethnic groups. Blacks were significantly more likely to be women, have no health insurance, be current smokers, have higher body mass index, have hypertension, have a longer duration of diabetes, a higher hemoglobin A(1c) level, and were more likely to be taking insulin. Their mean total, low-density lipid, and high-density lipid cholesterol levels were higher, whereas their triglycerides were lower than others. After controlling for baseline risk factors, blacks had a significantly lower burden of CAD; the adjusted MJI was 5.43 U lower (95% CI -9.13 to -1.72), and the adjusted number of lesions was 0.53 fewer (95% CI -0.88 to -0.18) in blacks compared to whites. CONCLUSIONS: In the BARI 2D trial, self-reported race/ethnicity is associated with important differences in baseline risk factors and is a powerful predictor of the burden of CAD adjusting for such baseline differences. These findings may help direct medical intervention and resources and further investigation into the basis of racial/ethnic differences in CAD burden.

Hypoglycemia in Older Adults with Type 1 Diabetes.

BACKGROUND: Hypoglycemia is a major concern in older adults with type 1 diabetes (T1D) and there is limited knowledge in this population. We examined data from 199 adults, ≥60 years of age, who participated in a T1D Exchange study assessing factors associated with severe hypoglycemia (SH) in older adults with T1D: 100 with SH in the prior year and 99 with no SH in prior 3 years (mean age 68; mean diabetes duration 40 years; 47% female; 92% non-Hispanic white). Hypoglycemia was assessed with up to 14 days of blinded continuous glucose monitoring (CGM). Linear regression models were performed to assess the association between biochemical hypoglycemia [defined as percentage of time below specific cutoffs (<70/60/50 mg/dL)] and various factors. RESULTS: Overall, participants had CGM values <70 mg/dL for a median of 91 min per day. On 53% of days, glucose levels continuously were <70 mg/dL for ≥20 min. Hypoglycemia was found to be strongly associated with glucose variability (r = 0.76; P < 0.001). Time spent in hypoglycemia was greater in those who were younger (P = 0.004), had shorter diabetes duration (P = 0.008), lower HbA1c (P < 0.001), and undetectable C-peptide (P = 0.001), but did not differ by insulin method, education level, number of blood glucose checks per day, cognition, activities of daily living, or fear of hypoglycemia. INNOVATION: This study adds valuable data on the frequency of hypoglycemia in older adults with T1D. CONCLUSION: Future studies need to focus on how to prevent hypoglycemia in this vulnerable population of older adults with long-standing T1D.

Differences in the management of type 1 diabetes among adults under excellent control compared with those under poor control in the T1D Exchange Clinic Registry.

OBJECTIVE: Optimizing glycemic control in type 1 diabetes is important to minimize the risk of complications. We used the large T1D Exchange clinic registry database to identify characteristics and diabetes management techniques in adults with type 1 diabetes, differentiating those under excellent glycemic control from those with poorer control. RESEARCH DESIGN AND METHODS: The cross-sectional analysis included 627 participants with HbA1c <6.5% (excellent control) and 1,267 with HbA1c ≥8.5% (fair/poor control) at enrollment who were ≥26 years of age (mean ± SD 45.9 ± 13.2 years), were not using continuous glucose monitoring, and had type 1 diabetes for ≥2 years (22.8 ± 13.0 years). RESULTS: Compared with the fair/poor control group, participants in the excellent control group had higher socioeconomic status, were more likely to be older and married, were less likely to be overweight, were more likely to exercise frequently, and had lower total daily insulin dose per kilogram (P < 0.0001 for each). Excellent control was associated with more frequent self-monitoring of blood glucose (SMBG), giving mealtime boluses before a meal rather than at the time of or after a meal, performing SMBG before giving a bolus, and missing an insulin dose less frequently (P < 0.0001 for each). Frequency of severe hypoglycemia was similar between groups, whereas diabetic ketoacidosis was more common in the fair/poor control group. CONCLUSIONS: Diabetes self-management related to insulin delivery, glucose monitoring, and lifestyle tends to differ among adults with type 1 diabetes under excellent control compared with those under poorer control. Future studies should focus on modifying diabetes management skills in adult type 1 diabetes patients with suboptimal glycemic control.