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PubMed1999

Effect of glycemic control on heart rate variability in type I diabetic patients with cardiac autonomic neuropathy.

Diabetic cardiac autonomic neuropathy (CAN) is associated with a high risk of cardiovascular events. Previous studies have shown that strict glycemic control slows the deterioration of CAN as assessed by standard autonomic function tests but fails to show reversibility. The aim of this study was to evaluate the effect of glycemic control on early and advanced CAN in type I diabetic patients using power spectral analysis of heart rate variability (HRV). Ten patients with early and 13 patients with advanced CAN were enrolled in a program of intensified insulin treatment. Standard autonomic function tests and 24-hour time and frequency domain HRV parameters were obtained at baseline, 3, 6, and 12 months. Hemoglobin A1C decreased from 9.5 +/- 0.4% to 8.4 +/- 0.5% (p = 0.02) in the early CAN group, and from 9.3 +/- 0.4% to 8.2 +/- 0.5% (p = 0.006) in the advanced CAN group. In general, both time and frequency domain HRV indexes tended to improve in patients with early CAN but continued to deteriorate in patients with advanced CAN. The low- and high-frequency power increased in patients with early CAN (229 +/- 95 to 626 +/- 563 ms2 and 62 +/- 30 to 183 +/- 168 ms2, respectively). The high-frequency power significantly improved at 12 months over baseline (p = 0.04), indicating increased parasympathetic tone. By contrast, these parameters continued to deteriorate in patients with advanced CAN (65 +/- 32 to 46 +/- 8 ms2 and 193 +/- 75 to 144 +/- 33 ms2, respectively). Autonomic function tests showed no significant change in both groups. These data show that a reversible metabolic component of CAN exists in patients with early CAN. Power spectral analysis of HRV allows early identification of potential reversibility as early as 1 year after the institution of strict glycemic control.

Adult↗

PubMedDate not supplied

Predictors of glycemic control in children with type 1 diabetes: the importance of race.

Diabetes is a common cause of kidney failure and blindness among young adults, particularly of African-American descent. Since glycemic control is a predictor of diabetes complications, we evaluated the impact of multiple factors including a special multidisciplinary management program on glycosylated hemoglobin in children with Type 1 diabetes. Data was collected from pediatric diabetes clinics in New Orleans, LA and Baltimore, MD. In New Orleans, hemoglobin A(1c) was higher in African-American patients 12. 5+/-3.3% (n=71) vs. 10.7+/-2.1% (n=80) in Caucasian children, p<0. 0001. Longer duration of diabetes was also associated with higher hemoglobin A(1c) in both races. The effect of race on hemoglobin A(1c) was independent of the influence of sex, insurance status, body mass index (BMI) z-score, and number of clinic visits. Covariate analysis with mean blood glucose levels indicated that higher hemoglobin A(1c) was attributable to higher mean blood glucose levels in African-American children. From the Baltimore data, a multidisciplinary intervention program led to improved total glycosylated hemoglobin for Caucasian patients but not for African-American children. Poorer glycemic control of African-American children is likely to predispose them to a higher likelihood of developing microvascular complications as they mature. Standard hospital-based multidisciplinary programming for diabetes management may have limited effectiveness in improving glycemic control of African-American children with diabetes. Innovative intervention programs are needed for these high-risk patients.

Adolescent↗

PubMed2001

Glycemic control with Humalog Mix25 in type 2 diabetes inadequately controlled with glyburide.

BACKGROUND: Humalog Mix25 (Mix25) is a premixed insulin mixture of 25% insulin lispro and 75% neutral protamine lispro. OBJECTIVE: The aim of this study was to quantitate the improvement in glycemic control achieved with Mix25 versus the maximum dose of glyburide (GB) in patients with type 2 diabetes inadequately controlled with GB. METHODS: In this randomized, parallel, open-label comparative study, patients with type 2 diabetes received either Mix25 before the morning and evening meals for 4 months or GB 15 mg daily for 4 months. Glycemic control was assessed by glycosylated hemoglobin (HbA1c) measurements, 4-point self-monitored blood glucose profiles, and patient-reported hypoglycemia. Patients also completed a treatment satisfaction questionnaire at the end of the study. RESULTS: All 172 patients were white; 85 were randomized to receive Mix25. The mean age was 59.5 +/- 8.2 years, and 35.5% (61/172) were men. The mean body mass index was 27.2 kg/m2. The mean duration of type 2 diabetes was 10.2 +/- 6.6 years, and the mean duration of sulfonylurea treatment was 5.8 +/- 5.9 years. The mean HbA1c and fasting blood glucose levels were 10.07% +/- 1.4% and 11.6 +/- 2.8 mmol/L, respectively, in the glyburide group and 9.85% +/- 1.2% and 12.2 +/- 2.9 mmol/L, respectively, in the Mix25 group. There were no statistically significant differences between the treatment groups at baseline for any of the demographic or efficacy variables. At end point, mean HbA1c was significantly lower in the Mix25 group than in the GB group (Mix25, 8.5% +/- 1.3%; GB, 9.4% +/- 1.8%; P = 0.001). A larger decrease from baseline in HbA1c and in all self-monitored blood glucose values was observed in the Mix25 group: -1.4% versus -0.7% for HbA1c, P = 0.004; -2.8 mmol/L versus -1.1 mmol/L for fasting blood glucose, P < 0.01; -5.1 mmol/L versus -1.7 mmol/L for the morning 2-hour postprandial blood glucose, P < 0.001; -2.2 mmol/L versus -0.8 mmol/L for the evening preprandial blood glucose, P < 0.05; and -4.4 mmol/L versus -1.5 mmol/L for the evening 2-hour postprandial blood glucose, P < 0.001. Patients expressed more satisfaction with Mix25 than with GB, as measured by the weighted combined score on a treatment satisfaction questionnaire (2.0 +/- 1.3 vs 0.7 +/- 1.3). The mean hypoglycemia rate (events per patient per 30 days) was significantly higher in the Mix25 group at end point (Mix25, 0.30 +/- 0.53; GB, 0.05 +/- 0.20; P < 0.001). CONCLUSIONS: Compared with maximum-dose GB, twice-daily injections of Mix25 resulted in improved glycemic control and treatment satisfaction, and were associated with a predictably higher rate of hypoglycemia in this group of patients with type 2 diabetes who were inadequately controlled with maximum-dose GB. Although the inclusion of patients who were inadequately controlled with GB was intended to allow a comparison of the 2 treatments with respect to efficacy and tolerability in a real-life setting, a double-blind comparison in treatment-naive individuals may have resulted in a different outcome.

Aged↗

PubMed2003

How well do patients' assessments of their diabetes self-management correlate with actual glycemic control and receipt of recommended diabetes services?

OBJECTIVE: Although patient diabetes self-management is a key determinant of health outcomes, there is little evidence on whether patients' own assessments of their self-management correlates with glycemic control and key aspects of high-quality diabetes care. We explored these associations in a nationwide sample of Veterans' Affairs (VA) patients with diabetes. RESEARCH DESIGN AND METHODS: We abstracted information on achieved level of glycemic control (HbA(1c)) and diabetes processes of care (receipt of HbA(1c) test, eye examination, and nephropathy screen) from medical records of 1032 diabetic patients who received care from 21 VA facilities and had answered the Diabetes Quality Improvement Program survey in 2000. The survey included sociodemographic measures and a five-item scale assessing the patients' diabetes self-management (medication use, blood glucose monitoring, diet, exercise, and foot care [alpha = 0.68]). Using multivariable regression, we examined the associations of patients' reported self-management with HbA(1c) level and receipt of each diabetes process of care. We adjusted for diabetes severity and comorbidities, insulin use, age, ethnicity, income, education, use of VA services, and clustering at the facility level. RESULTS: Higher patient evaluations of their diabetes self-management were significantly associated with lower HbA(1c) levels (P < 0.01) and receipt of diabetes services. Those in the 95th percentile for self-management had a mean HbA(1c) level of 7.3 (95% CI 6.4-8.3), whereas those in the 5th percentile had mean levels of 8.3 (7.4-9.2). For every 10-point increase in patients' ratings of their diabetes self-management, even after adjusting for number of outpatient visits, the odds of receiving an HbA(1c) test in the past year increased by 15% (4-27%), of receiving an eye examination increased by 16% (7-27%), and of receiving a nephropathy screen increased by 13% (2-26%). CONCLUSIONS: In this sample, patients' assessments of their diabetes self-care using a simple five-question instrument were significantly associated both with actual HbA(1c) control and with receiving recommended diabetes services. These findings reinforce the usefulness of patient evaluations of their own self-management for understanding and improving glycemic control. The mechanisms by which those patients who are more actively engaged in their diabetes self-care are also more likely to receive necessary services warrant further study.

Aged↗

PubMed1996

Evidence for a hypothalamic-pituitary versus adrenal cortical effect of glycemic control on counterregulatory hormone responses to hypoglycemia in insulin-dependent diabetes mellitus.

The epinephrine and cortisol responses to hypoglycemia are reduced in insulin-dependent diabetes mellitus (IDDM) patients in strict glycemic control. However, it is not known whether these abnormalities are mediated at a central (hypothalamic-pituitary) or peripheral (adrenal) level. To examine this question, we measured counterregulatory hormone secretion during a 3-h hypoglycemic hyperinsulinemic clamp (12 pmol/kg.min) that lowered glucose from 5.0 to 2.2 mmol/L in steps of 0.55 mmol/L every 30 min in 13 well controlled IDDM subjects (hemoglobin A1, 7.8 +/- 0.2%), 14 poorly controlled IDDM subjects (hemoglobin A1, 12.3 +/- 1.5%), and 20 healthy volunteers. Basal levels of ACTH, cortisol, and epinephrine were similar in all 3 groups before hypoglycemia. At the nadir glucose level (2.2 mmol/L), ACTH, cortisol, and epinephrine levels were significantly lower in well controlled IDDM compared to healthy controls, and the glucose levels required for significant secretion of ACTH, cortisol, and epinephrine also were lower in well controlled IDDM compared to those in both poorly controlled IDDM and healthy volunteers (P < 0.05). During hypoglycemia, ACTH levels were significantly correlated with cortisol levels (r = 0.43; P < 0.05). Because adrenomedullary epinephrine synthesis is partially dependent on adequate adrenocortical function, we also determined whether the blunted epinephrine response might result from the reduced cortisol secretion. Eleven of the control subjects underwent a second identical insulin clamp study during which metyrapone was administered to produce adrenal cortical blockade. Despite higher basal ACTH levels after metyrapone and sustained elevations in ACTH during hypoglycemia, the cortisol response was abolished during metyrapone treatment, indicating effective blockade. However, epinephrine responses did not differ during hypoglycemia with or without metyrapone treatment. We conclude that 1) ACTH, cortisol, and epinephrine responses during hypoglycemia are reduced in IDDM patients in strict glycemic control; 2) the lower cortisol response is correlated with reduced ACTH levels; and 3) in healthy subjects, the cortisol response to hypoglycemia is abolished by adrenocortical blockade with metyrapone, whereas the epinephrine response to hypoglycemia remains intact. These data suggest that central adaptations in hypothalamic-pituitary responses to hypoglycemia rather than alterations in adrenal gland function per se underlie the reduced counterregulatory responses seen in IDDM subjects in strict glycemic control.

Adrenal Cortex↗

PubMed1988

The effect of asymptomatic nocturnal hypoglycemia on glycemic control in diabetes mellitus.

To assess the effect of asymptomatic nocturnal hypoglycemia on glycemic control in insulin-dependent diabetes mellitus, we studied, on three nights, 10 patients receiving their usual regimens of continuous subcutaneous insulin infusion. During a control night, the patients' mean (+/- SE) plasma glucose level reached a nadir of 4.5 +/- 0.2 mmol per liter at 3 a.m.; the fasting glucose level was 5.9 +/- 0.3 mmol per liter at 7:30 a.m., and a peak glucose level of 8.6 +/- 0.3 mmol per liter was reached at 10 a.m., after breakfast. During nights two and three, supplemental insulin was infused intravenously from 10 p.m. to 2 a.m. to simulate a clinical overdose of insulin. On these nights, either hypoglycemia (2.4 +/- 0.2 mmol per liter) was permitted to occur or a nearly normal glucose level (5.5 mmol per liter) was maintained by infusion of glucose. The subjects were asymptomatic on all three nights. Despite comparable plasma free insulin levels from 4 to 11 a.m., both fasting (7.3 +/- 0.2 mmol per liter) and postbreakfast (12.5 +/- 0.4 mmol per liter) plasma glucose levels were significantly higher after hypoglycemia than when hypoglycemia was prevented (6.2 +/- 0.2 mmol per liter and 8.7 +/- 0.4 mmol per liter, respectively; P less than 0.001 in both cases). Fasting levels of plasma glucose correlated directly with overnight plasma levels of epinephrine (r = 0.78, P less than 0.001), growth hormone (r = 0.57, P less than 0.009), and cortisol (r = 0.52, P less than 0.02) but correlated inversely with the overnight nadir of plasma glucose (r = -0.62, P less than 0.005). We conclude that asymptomatic nocturnal hypoglycemia can cause clinically important deterioration in glycemic control (the Somogyi phenomenon) in patients receiving intensive insulin therapy, and should therefore be considered in the differential diagnosis of unexplained morning hyperglycemia.

Adult↗

PubMedDate not supplied

The effect of short-term basal insulin supplementation with human ultralente insulin on diurnal glycemic control in NIDDM patients.

The effect of short-term insulin treatment with a long-acting insulin preparation, Ultratard HM (U-HM) was investigated in eight non-insulin-dependent diabetes mellitus (NIDDM) patients whose previous glycemic control using diet was judged unsatisfactory. The treatment consisted of one daily pre-breakfast injection of U-HM (0.3 IU/kg) for 8 days. Glycemic control, assessed by mean plasma glucose (PG) daily profile and M-value, was improved significantly after U-HM treatment (mean PG and M-value, before: 223 +/- 19 mg/dl, 38.2; on the last day of U-HM: 151 +/- 11 mg/dl, 16.3; P less than 0.001; P less than 0.05). Serum insulin (IRI) reached a peak at 14:30 h during U-HM treatment, and mean IRI level increased during U-HM treatment (before: 14.0 +/- 2.8; during U-HM: 19.9 +/- 2.7 microU/ml). The mean C-peptide (CP) level decreased during U-HM treatment. Daily urinary CP excretion also decreased during U-HM treatment (before: 52.7 +/- 4.2; during U-HM: 34.8 +/- 4.2 micrograms/24 h). The data indicated that a single daily injection of U-HM was effective to improve whole-day glycemic control in NIDDM patients.

Adult↗

PubMed2000

Dual test diabetes screening project: screening for poor glycemic control in a large workplace population.

The objective of this study was to assess the efficacy of a dual test blood glucose/fructosamine home monitoring system to screen individuals in the workplace for poor glycemic control. Screening values qualifying individuals for 90 days of additional monitoring were as follows: fasting blood glucose > or =126 mg/dL, casual blood glucose > or =140 mg/dL, and/or fructosamine <310 micromol/L. Subjects with positive values were provided access to classroom instruction by a Certified Diabetes Educator. The population consisted of 100 males and 177 females, ages 22-71 years, mean 49.7 years, with 12 males and 22 females reporting diabetes. Their ethnic backgrounds were 17.7% African American, 0.4% Asian, 1.8% Hispanic, 0.4% mixed, and 79.8% Caucasian reflecting the general United States population. A total of 26 males and 27 females had results indicating poor glycemic control. Of the known individuals with diabetes, seven of 12 males and 15 of 22 females had positive results. More males than females were unaware of their potential for diabetes but of those previously diagnosed with diabetes more females than males had poor glycemic control. A total of 31 subjects tested positive for blood glucose, 39 tested positive for fructosamine, indicating a 15.1% (p < 0.005) improvement in detection chances with fructosamine. Cost per subject including equipment, supplies, and labor was $18.13. Study results indicate that the addition of a fructosamine test improves screening accuracy for large groups of people while retaining ease of use and affordability.

Adult↗

PubMed1997

Comparison of a carbohydrate-rich diet and diets rich in stearic or palmitic acid in NIDDM patients. Effects on lipids, glycemic control, and diurnal blood pressure.

OBJECTIVE: To compare the effects on lipid levels, glycemic control, and diurnal blood pressure of two diets rich in one of the two quantitatively most important saturated fatty acids, stearic and palmitic acid, with a carbohydrate-rich diet in NIDDM patients. RESEARCH DESIGN AND METHODS: A total of 15 NIDDM patients participated in a randomized crossover study with three 3-week diet interventions separated by 2-week washout periods. Patients started with a diet rich in stearic acid (44 E% [percent of total energy] fat [13 E% stearic acid], 40 E% carbohydrate, 15 E% protein), palmitic acid (45 E% fat [16 E% palmitic acid], 40 E% carbohydrate, 15 E% protein), or carbohydrate (29 E% fat, 51 E% carbohydrate, and 18 E% protein), then were shifted to the other two diets in a randomized block design. At the start and end of each intervention period, fasting blood samples were drawn for analysis of lipids and blood glucose. In addition, diurnal blood pressure was measured. RESULTS: At the end of the 3-week interventions, total cholesterol was significantly higher after the palmitic acid-rich diet than after the stearic acid-rich or carbohydrate-rich diets (5.3 +/- 1.3 vs. 5.0 +/- 1.2 and 4.9 +/- 1.2 mmol/l, respectively; P = 0.03). No significant differences in triglyceride, LDL, or HDL cholesterol levels were seen after the three intervention diets. No difference in effects between the diet periods were seen for fructosamine, HbA1c, fasting blood glucose, or diurnal blood pressure. CONCLUSIONS: For the first time, it has been demonstrated that a diet rich in palmitic acid was not as effective in lowering cholesterol levels as carbohydrate-rich and stearic acid-rich diets in NIDDM patients. No deleterious effects were seen on diurnal blood pressure, triglyceride levels, and glycemic control. Development of foods containing stearic acid rather than the more atherogenic saturated fatty acids may allow a wider choice of acceptable foods to NIDDM patients.

Adult↗

PubMed1994

Long-term glycemic control has a nonlinear association to the frequency of background retinopathy in adolescents with diabetes. Follow-up of the Berlin Retinopathy Study.

OBJECTIVE: To assess the influence of long-term glycemic control on the development of background retinopathy in adolescents followed longitudinally from the onset of insulin-dependent diabetes mellitus (IDDM). RESEARCH DESIGN AND METHODS: Repeated retinal fluorescein angiographies, in intervals of 1-2 years, were evaluated prospectively in 346 patients (190 males, 156 females; 19.8 [8.8-35.4] years of age; diabetes duration of 10.4 [1.1-27.4] years at their latest eye examination, median [range]). The influences of long-term HbA1c (mean of 18 [1-95] determinations per person) and microalbuminuria (> or = 2 of > or = 3 measurements > or = 15 micrograms/min x 1.73 m2) were studied by multiple linear regression, life-table analysis, and trend analyses. RESULTS: The rate of background retinopathy per 100 patient-years increased with poorer glycemic control from 0.7 (long-term HbA1c < 7% to 7.3 (HbA1c > 11%) following an exponential function. Life-table analysis after subdivision in HbA1c quartiles of equal sizes (HbA1c < 8, 8-9, 9-10, and > 10%) revealed an individual median expectation of background retinopathy after more than 25, 16.2, 12.7, or 12.0 years of diabetes, respectively. However, significant differences were found only between 8-9% and 9-10%, calculated either as prevalence, life-table analysis, or relative incidence, thus suggesting that a threshold model may also fit the data. After 12 years of diabetes, < 25% of those patients exhibiting microalbuminuria (n = 18) were expected to be free from retinopathy compared with 81% of those with normoalbuminuria (n = 86). CONCLUSIONS: Two statistical models are appropriate to explain the relationship between glycemic control and risk for background retinopathy: 1) a continuous exponential relationship as described by the DCCT or 2) the presence of a threshold HbA1c level at 9%. Thus, diabetes treatment in children should aim at long-term HbA1c levels < 9.0%, but every progress closer to normal may further reduce the risk.

Adolescent↗

PubMed2000

Glycemic control of older adults with type 2 diabetes: findings from the Third National Health and Nutrition Examination Survey, 1988-1994.

BACKGROUND: Although nearly half of all people who have diabetes are aged 65 or older, glycemic control of older adults with diabetes has not been well described. METHODS: We conducted a cross-sectional study of 1,482 participants with self-reported type 2 diabetes in the Third National Health and Nutrition Examination Survey, 1988-1994 (NHANES III), a nationally representative sample of the US noninstitutionalized civilian population. Variables included in this analysis included age, sociodemographic factors, drug treatment, and level of glycemic control. RESULTS: The mean % (+/-SE) HbA1c was 7.78 +/- 0.21, 7.64 +/- 0.18, 7.71 +/- 0.14, and 7.27 +/- 0.14 in persons aged 20 to 54, 55 to 64, 65 to 74 and > or = 75 years, respectively. The mean mg/dL (+/-SE) fasting plasma glucose (FPG) was 175.9 +/- 7.6, 164.5 +/- 6.1, 183.3 +/- 5.3, and 158.5 +/- 5.5 in the four age groups and older, respectively. When controlling for race, gender, education, and duration of diabetes, age was not significantly associated with levels of HbA1c [P (trend) =0.17] or FPG [P (trend) =0.19]. Among NHANES III participants aged 65 or older, ADA guidelines for glycemic control (HbA1c < 7%) were achieved by 71%, 44%, and 27% of persons using no drug therapy, oral hypoglycemic agents, and insulin, respectively. CONCLUSIONS: Although many older adults with type 2 diabetes do not achieve targets for glucose control, there is no evidence to suggest that community-dwelling older adults with diabetes are treated less vigorously than younger persons with diabetes.

Age Factors↗

PubMed2001

Factors influencing glycemic control in young people with type 1 diabetes in Scotland: a population-based study (DIABAUD2).

OBJECTIVE: To evaluate differences in HbA1c concentrations between centers and to assess the factors associated with glycemic control in young people with type 1 diabetes in Scotland. RESEARCH DESIGN AND METHODS: Data on 1,755 patients (94% of those registered) were collected from 18 centers providing care to children <15 years of age. At every clinic visit, a duplicate HbA1c sample was measured in a reference laboratory, and clinical information was collected prospectively. RESULTS: Average HbA1c concentration was 9.1% (range 5.0-15.0). The following significant associations with HbA1c level were identified: age, insulin regimen, BMI, season, social circumstances, and family history. HbA1c concentrations were significantly worse in older children (age 10-15 years 9.5% vs. other ages 8.8%, P < 0.001), those using two injections per day (2/day 9.1% vs. 3/day 8.8%, P < 0.01), children without both parents at home (9.4 vs. 9.0%, P < 0.001), a sibling with diabetes (9.7% vs. no family history 9.1%, P < 0.001). HbA1c concentration ranged from 8.1 to 10.2% between centers, after adjustment for factors associated with poor HbA1c (P < 0.001). CONCLUSIONS: The overall glycemic control of diabetic young people in Scotland is equivalent to a Diabetes Control and Complications Trial HbA1c concentration of 8.7%, placing the majority at a high risk of the complications of diabetes in adulthood. Although factors were significantly associated with poor HbA1c adjustment for these did not explain the differences between centers. We suggest that factors not analyzed in DIABAUD2 (e.g., deployment of resources, organization of the clinical structure, strategies of care, and clinic philosophy) are the determinants of HbA1c. We speculate that the style of utilization of optimum resources is the key to achieving good glycemic control.

Adolescent↗

PubMed2004

Glycemic control with glyburide/metformin tablets in combination with rosiglitazone in patients with type 2 diabetes: a randomized, double-blind trial.

PURPOSE: To assess the efficacy and safety of adding rosiglitazone to an established regimen of glyburide/metformin in patients with type 2 diabetes who had not achieved adequate glycemic control (glycosylated hemoglobin [HbA1C] levels >7.0% and < or =10.0%). METHODS: Following an open-label, lead-in phase to optimize the dosing of glyburide/metformin tablets, 365 patients randomly received additive therapy comprising rosiglitazone (4 mg once daily) or placebo for 24 weeks. Based on glycemic response, rosiglitazone dose was maintained or increased to 4 mg twice daily. Glyburide/metformin dose was maintained or reduced by 2.5/500 mg for symptomatic hypoglycemia. The primary endpoint was the change in HbA1C level from baseline to week 24. The proportions of patients achieving HbA1C levels <7% and a fasting plasma glucose level <126 mg/dL were also assessed. RESULTS: After 24 weeks, therapy with glyburide/metformin plus rosiglitazone resulted in a greater reduction in HbA1C levels (-1.0%, P<0.001) compared with combination therapy that included placebo, and in a larger proportion of patients (42% vs. 14%) who attained levels <7%. The difference in fasting plasma glucose levels between groups was -48 mg/dL (P<0.001), favoring glyburide/metformin plus rosiglitazone. The adverse event profile in the rosiglitazone-treated group included mild-to-moderate edema (8%), hypoglycemia (22%), and weight gain of 3 kg. No patient experienced hypoglycemia requiring third-party assistance. CONCLUSION: In patients with inadequate glycemic control despite established glyburide/metformin therapy, the addition of rosiglitazone improves glycemic control, allowing more patients to achieve an HbA1C level <7% and perhaps delaying the need for insulin treatment.

Adult↗

PubMed2003

Intensified blood glucose monitoring improves glycemic control in stable, insulin-treated veterans with type 2 diabetes: the Diabetes Outcomes in Veterans Study (DOVES).

OBJECTIVE: To examine the effect of intensified self-monitored blood glucose (SMBG) testing on glycemic control. RESEARCH DESIGN AND METHODS: Subjects with stable, insulin-treated type 2 diabetes performed SMBG using an electronic blood glucose meter before all meals and at bedtime for 8 weeks. Baseline data were collected on demographics, clinical characteristics, diet, and exercise. HbA(1c) was measured at baseline, at 4 weeks, and at 8 weeks. After the intensified monitoring period, subjects resumed their usual monitoring. HbA(1c) was then measured at 24, 37, and 52 weeks. Multivariate linear regression was used to determine the effect of monitoring on glycemic control. RESULTS: A total of 201 subjects completed the monitoring period. The baseline HbA(1c) (8.10 +/- 1.67%) decreased during the monitoring period by 0.30 +/- 0.68% (P < 0.001) at 4 weeks and by 0.36 +/- 0.88% (P < 0.001) at 8 weeks. Although entry HbA(1c) and compliance independently predicted the week 8 HbA(1c) (r = 0.862, P < 0.001), standardized regression analysis found that compliance with the SMBG protocol influenced the week 8 HbA(1c) more than age, sex, BMI, exercise level, carbohydrate consumption, or treatment intensity at baseline. However, SMBG benefited only subjects whose testing compliance exceeded 75% or with an entry HbA(1c) >8.0%. Decreases in HbA(1c) (-0.31 +/- 1.17%, P = 0.001) persisted in the 159 subjects followed for 52 weeks. CONCLUSIONS: Intensified blood glucose monitoring improved glycemic control in a large cohort of stable, insulin-treated veterans with type 2 diabetes. SMBG provided a strong stimulus for improved self-care resulting in clinically important and sustained reductions in HbA(1c).

Biomarkers↗

PubMed2004

Assessment of glycemic control by continuous glucose monitoring system in 50 children with type 1 diabetes starting on insulin pump therapy.

OBJECTIVE: To report experience with a continuous glucose monitoring system (CGMS) and to identify factors influencing glycemic control in a large cohort of children and adolescents with type 1 diabetes and change to insulin pump therapy via continuous subcutaneous insulin infusion (CSII). RESEARCH DESIGN AND METHODS: In 50 patients [21 boys, 29 girls; median age 12.6 yr (range: 1.3-16.4 yr); diabetes duration 5.0 yr (0.2-13.3)], hemoglobin A1c (HbA1c) and ambulatory CGMS were performed before and 6 wk after starting CSII. Average glucose concentration per 24 h, during day and night time as well as number of excursions, duration, and area under the curve (AUC) of glucose values above 180 mg/dL and below 60 mg/dL were calculated from CGMS data. Simultaneously, metabolic control was documented by standardized self-monitoring of blood glucose (SMBG). RESULTS: In the total cohort, HbA1c improved from 8.1 +/- 1.2% at baseline to 7.7 +/- 0.9% after 6 wk of CSII (p <0.001). This effect was more distinct in boys (8.0 +/- 1.4 vs. 7.5 +/- 1.1%, p=0.007) than in girls (8.1 +/- 1.1 vs. 7.8 +/- 0.7%, p=0.039) as well as in patients with poor glycemic control (HbA1c >8.0%) at baseline (8.9 +/- 0.6 vs. 8.1 +/- 0.8%, p <0.001) and in those older than 12 yr (8.2 +/- 1.2 vs. 7.7 +/- 1.0%, p <0.001). At 6 wk of CSII, the values of glucose average per 24 h, AUC and time above 180 mg/dL, particularly during the day, improved. HbA1c was correlated with AUC above 180 mg/dL (r=0.742, p <0.001) and CGMS average glucose per 24 h (r=0.628, p=0.002), but to a lesser extent with SMBG values (r=0.418, p=0.054). CONCLUSION: With the change to CSII, HbA1c improved significantly after 6 wk of therapy. CGMS usage provided additional information about glycemic control in these patients.

Adolescent↗

PubMed2006

Glycemic control after coronary bypass graft: using intravenous insulin regulated by a computerized system.

Hyperglycemia is a risk factor for poor outcomes in patients who undergo coronary artery bypass grafting. Poor outcomes led a multidisciplinary team to formulate a protocol to improve glycemic control of inpatients who had diabetes or hyperglycemia. This protocol initiated an intravenous (i.v.) insulin infusion that is regulated by a computerized system that is known as a Glucommander, and guides the surgeon and nurses to an easy transition to subcutaneous insulin. As a result of implementing the computerized system which regulated i.v. insulin, glycemic control improved during surgery and postoperatively. Additionally, physician and nurse satisfaction increased because of better glycemic control using a reliable, safe, and easy tool for the management of insulin infusions and there were fewer interruptive phone calls to physicians.

Algorithms↗

PubMed2005

Effects of exenatide (exendin-4) on glycemic control over 30 weeks in patients with type 2 diabetes treated with metformin and a sulfonylurea.

OBJECTIVE: This study evaluated the effects of exenatide, a novel incretin mimetic, in hyperglycemic patients with type 2 diabetes unable to achieve glycemic control with metformin-sulfonylurea combination therapy. RESEARCH DESIGN AND METHODS: A 30-week, double-blind, placebo-controlled study was performed in 733 subjects (aged 55 +/- 10 years, BMI 33.6 +/- 5.7 kg/m(2), A1C 8.5 +/- 1.0%; means +/- SD) randomized to 5 microg subcutaneous exenatide b.i.d. (arms A and B) or placebo for 4 weeks. Thereafter, arm A remained at 5 microg b.i.d. and arm B escalated to 10 microg b.i.d. Subjects continued taking their dose of metformin and were randomized to either maximally effective (MAX) or minimum recommended (MIN) doses of sulfonylurea. RESULTS: Week 30 A1C changes from baseline (+/-SE) were -0.8 +/- 0.1% (10 microg), -0.6 +/- 0.1% (5 microg), and +0.2 +/- 0.1% (placebo; adjusted P < 0.0001 vs. placebo), yielding placebo-adjusted reductions of -1.0% (10 microg) and -0.8% (5 microg). In the evaluable population, exenatide-treated subjects were more likely to achieve A1C < or =7% than placebo-treated subjects (34% [10 microg], 27% [5 microg], and 9% [placebo]; P < 0.0001). Both exenatide arms demonstrated significant weight loss (-1.6 +/- 0.2 kg from baseline each exenatide arm, -0.9 +/- 0.2 kg placebo; P < or = 0.01 vs. placebo). Mild or moderate nausea was the most frequent adverse event. The incidence of mild/moderate hypoglycemia was 28% (10 microg), 19% (5 microg), and 13% (placebo) and appeared lower with MIN than with MAX sulfonylurea treatment. CONCLUSIONS: Exenatide significantly reduced A1C in patients with type 2 diabetes unable to achieve adequate glycemic control with maximally effective doses of combined metformin-sulfonylurea therapy. This improvement in glycemic control was associated with no weight gain and was generally well tolerated.

Adult↗

PubMed1998

Improvement of glycemic control by CAPD with intraperitoneal insulin in a child with IDDM and ESRD.

Use of intraperitoneal insulin in diabetic end-stage renal disease (ESRD) patients receiving continuous ambulatory peritoneal dialysis (CAPD) is known to result in improved glycemic control. This route of insulin administration, although standard in adult diabetic CAPD patients, has not previously been reported in children. A 12-year old boy with ESRD from renal dysplasia who also had insulin-dependent diabetes mellitus (IDDM) was treated with CAPD and intraperitoneal insulin prior to renal transplantation. Diabetes and renal dysplasia were both diagnosed at 11 weeks of age. When he reached end-stage he was initially started on hemodialysis via a central line but was switched to CAPD because of recurrent line sepsis. His IDDM had been poorly controlled up to that time. CAPD was performed using 4 exchanges per day of 1.5% dialysate with a fixed dose of insulin added to each bag and with adjustments made based on blood glucose. His glycemic control markedly improved, with a fall in his glycosylated hemoglobin from 13.6% to 6%. CAPD was continued for 7 months until a living-related renal transplant was performed. Two episodes of peritonitis occurred while the patient received CAPD (1 episode/3.5 patient-months). We conclude that the use of intraperitoneal insulin in children with IDDM and ESRD leads to improved glycemic control. The rate of peritonitis, however, may be increased in these children.

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