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Progression of incipient diabetic retinopathy during good glycemic control.

To assess the extent to which the progression of diabetic retinopathy can be arrested by improved glycemic control, 35 normal dogs were randomly divided into a nondiabetic and three alloxan-induced diabetic groups prospectively identified according to glycemic control: poor control for 5 yr (PC), good control for 5 yr (GC), and poor control for 2.5 yr followed by good control for 2.5 yr (PGC). To achieve good control, insulin was given twice daily together with a measured diet so that hyperglycemia and glucosuria were mild and infrequent, and HbA1 was comparable to normal. Retinal capillary aneurysms and other lesions developed during 60 mo of poor control (group PC) and were inhibited if good control was begun promptly within 2 mo (group GC). In group PGC, retinopathy was absent or equivocal at 2.5 yr of poor control and, surprisingly, was found to develop subsequently despite good glycemic control. Retinopathy in group PGC was greater at autopsy than at 2.5 yr and was greater than in group GC. The results indicate that retinopathy may be preventable but tends to resist arrest even in its incipient stages, before more than the first few aneurysms have appeared.

Aneurysm↗

The cost to health plans of poor glycemic control.

OBJECTIVE: We tested the hypothesis that level of glycemic control is related to medical care costs in adults with diabetes. RESEARCH DESIGN AND METHODS: Regression analysis was used to estimate the relationship between glycemic control and medical care charges for 3,017 adults with diabetes who were continuously enrolled in a large health maintenance organization (HMO) over a 4-year period. Diagnosis of diabetes was ascertained from diagnostic and pharmaceutical databases using a method with an estimated sensitivity of 0.91 and an estimated specificity of 0.99. Charges for care included defined outpatient and inpatient services. Patients who disenrolled or who died during the 4-year period were excluded from the main analysis. RESULTS: Charges for medical care for patients with diabetes from 1993 to 1995 were closely related to HbA1c level in 1992 before and after adjustment for age, sex, coronary heart disease, and hypertension. Standardized 3-year estimates of charges ranged from $10,439 for patients without comorbid conditions to $44,417 for those with heart disease and hypertension. Medical care charges increased significantly for every 1% increase above HbA1c of 7%. For a person with an HbA1c value of 6%, successive 1% increases in HbA1c resulted in cumulative increases in charges of approximately 4, 10, 20, and 30%. The increase in charges accelerated as the HbA1c value increased. For patients with diabetes only, or with diabetes plus other chronic conditions, the rate of increase in charges with HbA1c was consistent. CONCLUSIONS: HbA1c provides useful information to providers and patients regarding both health status and future medical care charges. Economic data suggest that clinicians should assign high importance to low HbA1c results and aggressively maintain the HbA1c status of patients who have low HbA1c values. For economic as well as clinical reasons, it may be beneficial to lower HbA1c when it is > 8% and to reduce cardiovascular risk factors. The medical charge data suggest that investment in clinical systems to improve diabetes care may benefit both payers and patients.

Adult↗

Longitudinal study of a diabetes education and care intervention: predictors of improved glycemic control.

BACKGROUND: This study prospectively identifies those characteristics of office patients with diabetes that predict subsequent improvement in glycemic control in response to an educational intervention. METHODS: Data on demographic factors, disease characteristics, and glycemic control were obtained on a consecutive series of patients referred by their primary physician to a 4-day outpatient diabetes education and care program. Follow-up measurement of glycosylated hemoglobin (HbA1C) was obtained from the same laboratory 2 months later. Analysis using logistic response models identified baseline characteristics associated with improved HbA1C. RESULTS: Among the 169 study subjects, 74 (44 percent) had at least a 20 percent improvement in HbA1C levels 2 months after the program. Among these subjects, mean HbA1C level was 10.6 percent before and 7.4 percent 2 months after the program. Factors associated with improvement in HbA1C values in bivariate and multivariate logistic models included duration of diabetes less than 2 years (risk ratio = 1.90, 95 percent confidence interval (CI) 1.30-2.76) and initial HbA1C level greater than 10 percent (risk ratio = 2.75, 95 percent CI 2.08-4.01). Baseline functional status, health locus of control, social support, knowledge of diabetes self-care, age, weight as percentage of ideal body weight, age at diagnosis, race, sex, family history of diabetes, type of diabetes, and mode of treatment were not significant predictors of improved HbA1C. CONCLUSIONS: Patients with shorter duration of diabetes and poor baseline glycemic control were most likely to have clinically significant glycemic responses to this program. Severity of disease and regression to the mean were unable to account for this association, leaving unanswered the question of the mechanism of this association. The data also identified a group of patients who do not respond well to this educational approach and for whom novel approaches to behavior change should be considered.

Connecticut↗

Influence of glycemic control on viscosity and density of plasma and whole blood in type-1 diabetic patients.

The hemorheological properties of blood play an important role in determining blood flow. Blood inertia, as characterized by blood density, controls blood flow in the large arteries, whereas blood viscosity becomes increasingly important with decreasing vessel diameter. In order to evaluate the impact of glycemic control on the rheological properties of blood, we examined viscosity (shear range: 600-0.2 s-1) and density of plasma and whole blood in 26 Type-1 diabetic patients and in 24 healthy controls, matched for age and sex. The diabetic subjects were subdivided into two groups according to their degree of glycemic control: 14 patients with good (HbA1c = 7.1 +/- 0.6%), and 12 patients with poor control (HbA1c = 8.7 +/- 0.7%). Diabetic patients as a whole did not differ from healthy controls in any of the rheological parameters. Subdivision of the patients due to their degree of glycemic control led to a marked rheological separation of Type-1 diabetic subjects with significantly lower plasma (P < 0.008) and whole blood viscosity (P < 0.03 at 10 and 25 s-1), and plasma density (P < 0.05) in well controlled patients. Compared with healthy controls, well controlled diabetic patients had significantly lower values of viscosity (P < 0.005) and density (P < 0.05) of plasma. Poorly controlled patients, on the other hand, did not differ from healthy controls in the examined rheological parameters. There seems to be a positive influence of good glycemic control on hemorheology in Type-1 diabetic patients.

Adult↗

Spontaneous abortions in repeat diabetic pregnancies: a relationship with glycemic control.

In previous studies, we reported a high rate of spontaneous abortions in insulin-dependent diabetic pregnancies. Abortions were associated with poor first-trimester glycemic control. We hypothesized that improvement of glycemic control from one pregnancy to the other would improve fetal outcome and that deterioration of glycemic control would increase the likelihood of abortion. We studied prospectively 43 insulin-dependent diabetic women (White class B-RF) with two consecutive pregnancies, recruited before 9 weeks' gestation. Preprandial and 90-minute postprandial blood glucose concentrations were measured at each weekly visit. Glycohemoglobin A1 was measured at 9 weeks' gestation. Twenty women had two successful pregnancies and 15 had an abortion followed by a successful pregnancy (abortion-no abortion); the sample sizes for other sequences (no abortion-abortion, N = 5; and abortion-abortion, N = 3) were too small to allow for analysis. Glycohemoglobin A1 concentrations were stable in the sequence no abortion-no abortion (9.7 +/- 0.5 versus 9.8 +/- 0.4%, mean +/- SEM; not significant), whereas in the sequence abortion-no abortion, there was a significant decrease in glycohemoglobin A1 values from the nonsuccessful to the successful pregnancy (10.7 +/- 0.6 versus 9.3 +/- 0.4%; P = .01). Similarly, in the sequence abortion-no abortion, there was a significant decrease in mean postprandial blood glucose from first to second pregnancy (166 +/- 13 versus 135 +/- 11 mg/dL; P = .04), whereas in the sequence no abortion-no abortion, mean postprandial blood glucose did not change significantly (160 +/- 14 versus 144 +/- 11 mg/dL; not significant).(ABSTRACT TRUNCATED AT 250 WORDS)

Abortion, Spontaneous↗

The effect of chromium picolinate and biotin supplementation on glycemic control in poorly controlled patients with type 2 diabetes mellitus: a placebo-controlled, double-blinded, randomized trial.

BACKGROUND: Preclinical studies have shown that the combination of chromium picolinate and biotin significantly enhances glucose uptake in skeletal muscle cells and enhances glucose disposal. The present pilot study was conducted to determine if supplementation with chromium picolinate and biotin can improve glycemic control in patients with type 2 diabetes mellitus with suboptimal glycemic control despite use of oral antihyperglycemic agents. METHODS: Forty-three subjects with impaired glycemic control (2-h glucose >200 mg/dL; glycated hemoglobin >or=7%), despite treatments with oral antihyperglycemic agents, were randomized to receive 600 microg of chromium as chromium picolinate and biotin (2 mg/day) (Diachrome(, Nutrition 21, Inc., Purchase, NY) in addition to their prestudy oral antihyperglycemic agent therapy. Measurements of glycemic control and blood lipids were taken at baseline and after 4 weeks. RESULTS: After 4 weeks, there was a significantly greater reduction in the total area under the curve for glucose during the 2-h oral glucose tolerance test for the treatment group (mean change -9.7%) compared with the placebo group (mean change +5.1%, P < 0.03). Significantly greater reductions were also seen in fructosamine (P < 0.03), triglycerides (P < 0.02), and triglycerides/ high-density lipoprotein cholesterol ratio (P < 0.05) in the treatment group. No significant adverse events were attributed to chromium picolinate and biotin supplementation. CONCLUSIONS: This pilot study demonstrates that supplementation with a combination of chromium picolinate and biotin in poorly controlled patients with diabetes receiving antidiabetic therapy improved glucose management and several lipid measurements. Chromium picolinate/ biotin supplementation may represent an effective adjunctive nutritional therapy to people with poorly controlled diabetes with the potential for improving lipid metabolism.

Adult↗

The effect of stress on glycemic control in patients with type II diabetes during glyburide and glipizide therapy.

Stress adversely affects glycemic control in patients with type II diabetes mellitus. In addition, stress reduction with relaxation techniques or medication use in the management of hyperglycemia has been recommended. This study examined the relationship of glycemic control to self-reported stress in 19 patients with type II diabetes mellitus who were randomly allocated to receive either glyburide or glipizide for 16 weeks in a double-blind crossover design. Each treatment phase was preceded by a 2-week washout period. A previously designed and validated nine-item stress questionnaire was used to assess areas such as safety, financial wellbeing, energy level, health, etc. These areas were evaluated as more/less, better/worse, or no change. The stress questionnaire, fasting blood glucose (FBG), and glycosylated hemoglobin (GHb) concentrations were completed or measured at the end of glyburide and glipizide treatment periods. By assigning a value of 1, 2, or 3 to a positive, no change, or negative response, respectively, a composite stress score was computed and compared with glycemic control as assessed by FBG and GHb. Regression analysis showed highly significant correlations (P < .05) between stress scores and FBG (r = .70) as well as GHb (r = 0.84) with glipizide therapy. No such correlation was noted with glyburide (FBG: r = 0.29; GHb: r = 0.29). These findings suggest that during glyburide treatment, in contrast to glipizide, an increase in stress was not associated with a corresponding rise in blood glucose or worsening of metabolic control.(ABSTRACT TRUNCATED AT 250 WORDS)

Adult↗

Glycosylated serum proteins and glycosylated hemoglobin in the assessment of glycemic control in insulin-dependent and non-insulin-dependent diabetes mellitus.

To evaluate the relative value of glycosylated serum proteins (GSPs) versus glycosylated hemoglobin (HbA1c) in assessing glycemic control in diabetes mellitus, we performed regular monitoring of GSPs and HbA1c in 30 subjects with insulin-dependent diabetes mellitus (IDDM) or non-insulin-dependent diabetes mellitus (NIDDM) who performed frequent self-glucose monitoring. Analysis of the relationship between patterns of glycemic control and GSPs and HbA1c demonstrated that subjects with IDDM and NIDDM appeared similar when the more traditional indicators of glycemic control such as mean blood glucose level (166.9 +/- 20.9 v 177.4 +/- 39.6 mg/dL) or HbA1c (83.57 +/- 12.8 v 80.24 +/- 15.7 mmol hydroxymethyl furfuraldehyde [HMF]/mol hemoglobin [Hgb]) were used. However, when GSP levels or the standard deviation of mean glucose levels (SDMG) were used to assess glycemic control, higher levels were found in subjects with IDDM (52 +/- 10.3 mg/g protein and 28.59 +/- 7.60 mg/dL) versus NIDDM (44.6 +/- 15.2 mg/g protein and 21.6 +/- 15.9 mg/dL). Using multivariate analysis, GSPs were predictive of SDMG (P = .046), whereas HbA1c added no significant further information (P = .27). Our results suggest that GSPs may be more sensitive than HbA1c assay to the greater fluctuations in blood glucose levels generally associated with IDDM.

Adult↗

Effect of glycemic control on the overnight dexamethasone suppression test in patients with diabetes mellitus.

Because many of the clinical features associated with Cushing's syndrome are frequently found in patients with diabetes mellitus, diabetic patients are often evaluated for Cushing's syndrome. The initial test for Cushing's syndrome is the 1 mg overnight dexamethasone suppression test (DST), but its value as a screening test in diabetic subjects, especially those with poor glycemic control, has been questioned. To address this issue, an overnight DST was administered to 100 subjects with diabetes. Only 7 patients failed to suppress their plasma cortisol to less than 140 nmol/L (5.0 micrograms/dL), achieving a specificity of 93%. There was no relation between acute glycemic control (as measured by the mean of 4 serum glucose values obtained before receiving dexamethasone) or chronic glycemic control (as measured by glycohemoglobin) and false positive responses to the 1 mg overnight DST. The mean of the measures of acute glycemic control of the 7 subjects who had false positive results, 14.4 +/- 2.8 mmol/L, was not significantly different than that of the 93 subjects with normal responses, 13.2 +/- 3.3 mmol/L. Similarly, the mean glycohemoglobin of the subjects with false positive results, 12.8 +/- 2.4%, was not significantly different than that of the subjects with normal responses, 12.9 +/- 2.5%. There was no correlation between plasma cortisol after dexamethasone and glycohemoglobin (r = 0.05), and only a weak correlation with the mean serum glucose (r = 0.21). We conclude that the 1 mg overnight DST is a valid screening test for Cushing's syndrome in patients with diabetes, regardless of glycemic control.

Adult↗

Induction of long-term glycemic control in newly diagnosed type 2 diabetic patients is associated with improvement of beta-cell function.

OBJECTIVE: To investigate whether long-term optimal glycemic control can be achieved without medication by transient continuous subcutaneous insulin infusion (CSII) and the possible mechanisms responsible for this remission. RESEARCH DESIGN AND METHODS: Newly diagnosed type 2 diabetic patients (n = 138, fasting glucose >11.1mmol/l) were hospitalized and treated with CSII for 2 weeks. Intravenous glucose tolerance tests (IVGTTs) were performed, and blood glucose, HbA(1c), lipid profiles, proinsulin, insulin, and C-peptide were measured before and after CSII. Patients were followed longitudinally on diet alone after withdrawal of insulin. RESULTS: Optimal glycemic control was achieved within 6.3 +/- 3.9 days by CSII in 126 patients. The remission rates (percentages maintaining near euglycemia) at the third, sixth, twelfth, and twenty-fourth month were 72.6, 67.0, 47.1, and 42.3%, respectively. Patients who maintained glycemic control >12 months (remission group) had greater recovery of beta-cell function than those who did not (nonremission group) when assessed immediately after CSII. Homeostasis model assessment of beta-cell function (HOMA-B) and the area under the curve (AUC) of insulin during IVGTT were higher in the remission group (145.4 +/- 89.6 vs. 78.5 +/- 68.5, P = 0.002, and 1,423.4 +/- 523.2 vs. 1,159.5 +/- 476.8 pmol x l(-1) x min(-1), P = 0.044). Change in acute insulin response was also greater in the remission group than that in the nonremission group (621.8 +/- 430.4 vs. 387.3 +/- 428.8 pmol x l(-1) x min(-1), P = 0.033). CONCLUSIONS: Short-term intensive insulin therapy can induce long-term glycemic control in newly diagnosed type 2 diabetic patients with severe hyperglycemia. The improvement of beta-cell function, especially the restoration of first-phase insulin secretion, could be responsible for the remission.

Adult↗

Health economic benefits and quality of life during improved glycemic control in patients with type 2 diabetes mellitus: a randomized, controlled, double-blind trial.

CONTEXT: Although the long-term health benefits of good glycemic control in patients with diabetes are well documented, shorter-term quality of life (QOL) and economic savings generally have been reported to be minimal or absent. OBJECTIVE: To examine short-term outcomes of glycemic control in type 2 diabetes mellitus (DM). DESIGN: Double-blind, randomized, placebo-controlled, parallel trial. SETTING: Sixty-two sites in the United States. PARTICIPANTS: A total of 569 male and female volunteers with type 2 DM. INTERVENTION: After a 3-week, single-blind placebo-washout period, participants were randomized to diet and titration with either 5 to 20 mg of glipizide gastrointestinal therapeutic system (GITS) (n = 377) or placebo (n = 192) for 12 weeks. MAIN OUTCOME MEASURES: Change from baseline in glucose and hemoglobin A1c (HbA1c) levels and symptom distress, QOL, and health economic indicators by questionnaires and diaries. RESULTS: After 12 weeks, mean (+/-SE) HbA1c and fasting blood glucose levels decreased with active therapy (glipizide GITS) vs placebo (7.5% 0.1% vs 9.3%+/-0.1% and 7.0+/-0.1 mmol/L [126+/-2 mg/dL] vs 9.3+/-0.2 mmol/L [168+/-4 mg/ dL], respectively; P<.001). Quality-of-life treatment differences (SD units) for symptom distress (+0.59; P<.001), general perceived health (+0.36; P= .004), cognitive functioning (+0.34; P=.005), and the overall visual analog scale (VAS) (+0.24; P=.04) were significantly more favorable for active therapy. Subscales of acuity (+0.38; P=.002), VAS emotional health (+0.35; P=.003), general health (+0.27; P=.01), sleep (+0.26; P=.04), depression (+0.25; P=.05), disorientation and detachment (+0.23; P= .05), and vitality (+0.22; P=.04) were most affected. Favorable health economic outcomes for glipizide GITS included higher retained employment (97% vs 85%; P<.001), greater productive capacity (99% vs 87%; P<.001), less absenteeism (losses = $24 vs $115 per worker per month; P<.001), fewer bed-days (losses = $1539 vs $1843 per 1000 person-days; P=.05), and fewer restricted-activity days (losses = $2660 vs $4275 per 1000 person-days; P=.01). CONCLUSIONS: Improved glycemic control of type 2 DM is associated with substantial short-term symptomatic, QOL, and health economic benefits.

Absenteeism↗

Glycemic control, hypertension and chronic complications in type 2 diabetic subjects attending a tertiary care centre.

BACKGROUND: This study was carried out to assess the association of glycemic control and hypertension with chronic complications in type 2 diabetic subjects attending a tertiary care centre in Karachi, Pakistan. METHODS: This was a cross sectional analytical study. First visit of type 2 diabetic subjects to the outpatient department of Baqai Institute of Diabetology and Endocrinology, from September 1996 to December 2001, were analyzed for this study. Sociodemographic attributes and clinical profiles were obtained from the computerized records of these patients retrospectively. Odds ratio with 95% confidence interval were reported for independent variables associated with outcome variables. RESULTS: Records of 2199 subjects (48.5% males, 51.5% females) were analyzed. Mean age of the male and female subjects was 52.2 and 50.6 years respectively. Hypertriglyceridemia [OR: 1.74; 95% CI (1.18-2.57)] and diabetic foot ulcers [OR: 2.32; 95% CI (1.14-4.01)] were significantly associated with poor glycemic control according to HbA1c. Whereas hypertriglyceridemia [OR: 2.39; 95% CI (1.42-4.03)] and hypertension [OR: 1.65; 95% CI (1.13-2.41)] were significantly associated with poor glycemic control according to FPG. Obesity [OR: 1.44; 95% CI (1.18-1.75)], Retinopathy [OR: 1.95; 95% CI (1.49-2.53)], nephropathy [OR: 1.99; 95% CI (1.45-2.75)], neuropathy [OR:1.40; 95% CI (1.15-1.71)] and presence of coronary arterial disease [OR: 1.33; 95% CI (1.02-1.72)] were found to be significantly associated with systolic blood pressure. Obesity [OR:2.07; 95% CI (1.69-2.54)], hyperglycemia [OR: 1.40; 95% CI (1.04-1.90)] and nephropathy [OR: 1.92; 95% CI (1.39-2.64)] had significant association with high diastolic blood pressure. CONCLUSION: In conclusion this study shows the association of chronic complications with glycemic control and hypertension amongst type 2 diabetics in Karachi. This information needs to be verified by multicentred large scale studies in order to be helpful in planning healthcare and treatment strategies.

Blood Glucose↗

Relative clinical usefulness of glycosylated serum albumin and fructosamine during short-term changes in glycemic control in IDDM.

Serial changes in glycosylated blood proteins and direct measures of glycemia were studied in 100 subjects with insulin-dependent diabetes mellitus (IDDM) over a 6-wk period while attempts were made to improve glycemic control. All measures of glycemic control improved significantly (P less than .001). Mean +/- SE glycosylated hemoglobin (HbA1) fell from 9.1 +/- 0.2 to 8.0 +/- 0.1%, glycosylated serum albumin (GSA) from 9.8 +/- 0.4 to 7.3 +/- 0.3%, and fructosamine from 3.92 +/- 0.08 to 3.42 +/- 0.07 mM. Fasting blood glucose levels fell from 11.1 +/- 0.6 to 8.1 +/- 0.7 mM mean blood glucose levels from 12.5 +/- 0.3 to 8.8 +/- 0.03 mM, and the M value from 118 +/- 7 to 40 +/- 3 U. Mean percentage changes in direct measures of glycemia (32-66%) and GSA (29%) were greater than for fructosamine (11%) or HbA, (12%) levels (P less than .001). Furthermore, the correlation between the change in GSA and changes in direct measures of glycemia over the initial 2-wk period was significantly different from the corresponding correlations between direct measures of glycemia and fructosamine over this period (P less than .05-.01). Changes in GSA also correlated more closely than HbA1 or fructosamine did with direct measures of glycemia after 4 and 6 wk. The Spearman rank-correlation coefficient (rs) of absolute changes in GSA, fructosamine, and HbA1 after 2-6 wk ranged from 0.27 to 0.57, confirming that the three measures responded differently to changing glycemic control.(ABSTRACT TRUNCATED AT 250 WORDS)

Adult↗

Effect of long term glycemic control on the onset of retinopathy in iddm subjects. A longitudinal and retrospective study.

A random sample of 78 IDDM patients were studied retrospectively with regard to longitudinal glycemic control from onset of diabetes in relation to onset of retinopathy from 10-20 years of the disease. During the latter period 40 patients developed retinopathy (retinopathy group) whereas 38 did not (no retinopathy group). Sex ratio as well as age at onset of diabetes was similar between the two groups. Also glycemic control was similar during the first five years of diabetes as assessed from glucose determinations in urine and blood. However, during the period from 5-10 years of diabetes duration glycemic control of the retinopathy group deteriorated significantly in comparison to previous years and in comparison with the non-retinopathy group. The frequency of control visits did not differ between groups; however patients in the retinopathy group more frequently changed from one institution of treatment to another than did the other patients. This study demonstrates that glycemic control deteriorates with time in a sub-group of IDDM subjects and supports the concept that onset of retinopathy depends on cumulative exposure to hyperglycemia.

Adolescent↗

Lipid effects of glyburide/metformin tablets in patients with type 2 diabetes mellitus with poor glycemic control and dyslipidemia in an open-label extension study.

BACKGROUND: Because both type 2 diabetes and elevated plasma lipid levels are important independent risk factors for cardiovascular disease and coronary heart disease, the choice of an antihyperglycemic agent for patients with type 2 diabetes--in whom abnormal plasma lipid levels are often seen-should take into account effects on lipids as well as on markers of glycemic control. OBJECTIVE: This study assessed the effects on lipid levels of glyburide/metformin tablets in the treatment of type 2 diabetes, particularly in a group of patients who had poor glycemic control and dyslipidemia at baseline. METHODS: This 52-week, open-label study was an extension of a 32-week, double-blind, placebo-controlled study. The patient population was drawn from 3 groups: those who completed the double-blind study, those who were discontinued from the double-blind study, and those who were ineligible for the double-blind study based on predefined measures of glycemic control (screening fasting plasma glucose > 240 mg/dL and glycosylated hemoglobin [HbA1c] < or = 12%, or HbA1c 11%-12%) and were directly enrolled in the open-label extension study. Patients with an HbA1c of < 9% received glyburide/ metformin tablets 1.25 mg/250 mg BID; those with an HbA1c > or = 9% received glyburide/ metformin tablets 2.5 mg/500 mg BID. Changes in total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), and triglyceride (TG) levels were assessed for 52 weeks. RESULTS: The study population included 828 patients: 515 who completed the double-blind study, 138 who were discontinued from the double-blind study, and 175 who were enrolled directly. Direct enrollees had poor glycemic control and dyslipidemia at baseline. Improvements in plasma lipid levels were seen as early as week 13. At week 52, the mean change in TC from baseline was -8.0 mg/dL for the total population (95% CI, -10.9 to -5.2; P < 0.05) and -23.2 mg/dL for direct enrollees (95% CI, -30.1 to -16.4; P < 0.05). The mean decrease in LDL-C from baseline for the total population was 2.86 mg/dL (95% CI, -5.3 to -0.4; P < 0.05), compared with a reduction of 13.3 mg/dL for direct enrollees (95% CI, -18.5 to -8.1; P < 0.05). Mean HDL-C levels were minimally affected. Mean TG levels decreased by 27.8 mg/dL for the entire population (95% CI, -42.9 to -12.8; P < 0.05) and by 99.7 mg/dL for direct enrollees (95% CI, -152.5 to -46.8; P < 0.05). CONCLUSION: In this open-label extension study, treatment with glyburide/ metformin tablets for type 2 diabetes had a durable, favorable effect on lipid levels, particularly in those with poor glycemic control and dyslipidemia at baseline.

Blood Glucose↗

Long-term randomized placebo-controlled double-blind therapeutic comparison of glipizide and glyburide. Glycemic control and insulin secretion during 15 months.

OBJECTIVE: To examine the long-term (15 months) effects on glycemic control and insulin secretion of glipizide and glyburide treatment in patients with non-insulin-dependent diabetes mellitus (NIDDM). RESEARCH DESIGN AND METHODS: Prospective, randomized, double-blind, placebo-controlled study on 46 NIDDM patients comparing fasting levels and test-meal responses of glucose and insulin during 15 months of follow-up. RESULTS: A comparable reduction in HbA1c levels by both agents versus placebo was observed throughout the study period, but after a marked initial reduction in both sulfonylurea groups, all three groups showed gradually increasing HbA1c levels. However, both glipizide and glyburide achieved and maintained lowered postprandial glucose levels and increased fasting and postprandial insulin levels compared with placebo. CONCLUSIONS: Both glipizide and glyburide may achieve and maintain glycemic reduction and stimulation of insulin secretion during long-term treatment. However, these agents do not prevent the gradual increase in overall glycemia that develops over time in NIDDM patients.

Blood Glucose↗

Comparing easy and accessible parameters of glycemic control in type 2 diabetes.

BACKGROUND: HbA1c is considered the gold standard of long-term glycemic control and is recommended as a routine test for every diabetic patient. However, its common use in clinical practice has some problems related to lack of standardization and its relative cost. Recent studies have suggested, that postprandial blood glucose could be better than a fasting sample, as a marker of diabetes control. The objective of the present study was to evaluate the relative value of plasma glucose samples at different times of the day, and easy and accessible programs for home blood and urinary glucose measurements compared with HbA1c in assessing the mean glycemic control of type 2 diabetic patients. METHODS: Sixty type 2 diabetic patients were instructed to do home blood and urine glucose monitoring for two months, at the end, plasma glucose profiles were obtained. RESULTS: The mean of all the capillary BG measurements had the best correlation with the HbA1c (r = 0.84, p < 0.001), followed by the mean of the capillary BG measurements before breakfast and supper (r = 0.82, p < 0.001), and the 2 hr. postbreakfast plasma glucose (r = 0.79 p < 0.001). The fasting PG had a low correlation (r = 0.65, p < 0.001), but a good sensitivity to predict a fair or a poor metabolic control. Diabetes duration and type of treatment explained 17% and 28% of variance in HbA1c levels. CONCLUSIONS: A bimonthly fasting PG correlated well with the glycosylated hemoglobin and is the easiest and cheapest way of monitoring glycemic control in type 2 diabetic patients with some preserved insulin reserve (diabetes for less than 10 years and on treatment with only one hypoglycemic agent). A sample of capillary BG, fasting, once per week correlates better with the HbA1c than a fasting PG every 2-3 months. The 2 hr and 5 hr postbreakfast PG have a good correlation with the HbA1c, but are not a substitute for doing BG monitoring. Glycosuria may be a useful parameter to rule out a fair or poor metabolic control in some patients.

Adult↗

High variability of glycated hemoglobin concentrations in patients with IDDM followed over 9 years. What is the best index of long-term glycemic control?

OBJECTIVE: To determine variability of long-term glycemic control in patients with IDDM. RESEARCH DESIGN AND METHODS: A retrospective analysis of HbA1 among 122 IDDM patients followed over 9 years. RESULTS: Annual group mean HbA1 ranged from 8.4 to 9.3% with large standard deviations (1.7-2.0%), indicating marked variability among individuals. Fluctuations of more than +/- 1% HbA1 occurred in 50% of the patients year to year, and over 9 years the minimum-maximum range was > 3 and > 5% HbA1 in 55 and 11% of patients, respectively. In any one year, 22-43% of patients had HbA1 < 8%, but over 9 years only 3.3% were consistently < 8%. Groups divided according to baseline HbA1 of < 8, 8-10, and > 10% were significantly separated over 9 years by frequency distribution analysis of individual mean HbA1 but were indistinguishable when analyzed by individual HbA1 interquartile range (measure of variability). CONCLUSIONS: High variability of long-term glycemic control is a marked feature of IDDM, the extent of which may be relevant to microvascular risk.

Adult↗