Incidence of lower-extremity amputation in American Indians: the Strong Heart Study

OBJECTIVE: To define incidence and predictors of nontraumatic lower-extremity amputation (LEA) in a diverse cohort of American Indians with diabetes. RESEARCH DESIGN AND METHODS: The Strong Heart Study is a study of cardiovascular disease and its risk factors in 13 American-Indian communities. Data on the presence/absence of amputations were collected at each of three serial examinations (1989-1992, 1993-1995, and 1997-1999) by direct examination of the lower extremity. The logistic regression model was used to quantify the relationship between risk of LEA and potential risk factors, including diabetes duration, HbA(1c), peripheral arterial disease, and renal function. RESULTS: Of the 1,974 individuals with diabetes and without prevalent LEA at baseline, 87 (4.4%) experienced an LEA during 8 years of follow-up, and a total of 157 anatomical sites were amputated among these individuals. Amputation of toes was most common, followed by below-the-knee and above-the-knee amputations. Age-adjusted odds of LEA were higher among individuals with unfavorable combinations of risk factors, such as albuminuria and elevated HbA(1c). Multivariable modeling indicated that male sex, renal dysfunction, high ankle-brachial index, longer duration of diabetes, less than a high school education, increasing systolic blood pressure, and HbA(1c) predicted LEA risk. CONCLUSIONS: The 8-year cumulative incidence of LEA in American Indians with diabetes is 4.4%, with marked differences in risk by sex, educational attainment, renal function, and glycemic control.     

Glycemic control with insulin glargine as part of an ethnically diverse, community-based diabetes management program

OBJECTIVE: To evaluate the contribution of long-acting basal insulin therapy (insulin glargine) to glycemic control in a predominantly Hispanic population participating in a community-based diabetes management program, Project Dulce. RESEARCH DESIGN AND METHODS: This retrospective analysis included 3122 adult patients with diabetes from 17 community clinics in San Diego County, California who participated in Project Dulce between July 2000 and March 2003. A subset of 180 patients received insulin glargine because of ongoing, inadequate glycemic control (ie, elevated HbA1c). Glycemic control was evaluated by mean adjusted HbA1c during follow-up clinical visits using hierarchical linear modeling, with values determined separately before and after initiation of insulin glargine. RESULTS: At baseline, the mean number of individuals with hypoglycemia, presence of diabetic complications, and duration of diabetes were greater in the glargine group that in the reference group. HbA1c at baseline was 8.79 and 9.44 (P = 0.019) in the reference and glargine groups, respectively. Mean adjusted HbA1c in the glargine group was 8.80 at baseline, 7.89 before initiation of insulin glargine (P < 0.001 vs baseline), and 7.34 after adding insulin glargine (P < 0.001 vs pre-glargine). In the reference group, mean adjusted HbA1c decreased from 8.81 at baseline to 7.40 during follow-up (P < 0.001 vs baseline). CONCLUSIONS: A comprehensive program of diabetes care in Project Dulce improved HbA1c significantly in a predominantly Hispanic population. Adding long-acting basal insulin therapy with insulin glargine produced significant incremental improvement in HbA1c.     

Progression of retinopathy after improved metabolic control in type 2 diabetic patients. Relation to IGF-1 and hemostatic variables

OBJECTIVE: To determine the impact of improved glycemic control on the development and progression of retinopathy after the institution of insulin therapy in patients with type 2 diabetes and to assess the relation to IGF-1 and hemostatic variables. RESEARCH DESIGN AND METHODS: In a prospective observational study, 45 type 2 diabetic patients were examined at baseline and 1, 3, 6, 12, and 24 months after change to insulin therapy. Retinopathy was graded on fundus photographs using the Wisconsin scale; HbA1c, IGF-1, and hemostatic variables were measured. RESULTS: During the observation period of 2 years, 23 patients progressed in the retinopathy scale; 8 progressed > or = 3 levels. After 2 years of insulin treatment, HbA1c and IGF-1 were significantly lower than at baseline, whereas the hemostatic variables had not changed significantly. Progression of retinopathy > or = 3 levels was related to the degree of HbA1c reduction, the duration of diabetes, a higher prothrombin fragment 1 + 2 levels (F1 + 2), but not to other hemostatic variables or IGF-1. The relative risk for progression > or = 3 levels was 2.6 when HbA1c had been reduced > or = 3 percent units (95% CI 1.1-6.1). CONCLUSIONS: The magnitude of improvement of HbA1c by the institution of insulin treatment over a 2-year period may be associated with progression of retinopathy in patients with type 2 diabetes.     

Telecare for patients with type 1 diabetes and inadequate glycemic control: a randomized controlled trial and meta-analysis

OBJECTIVE: To determine the efficacy of telecare (modem transmission of glucometer data and clinician feedback) to support intensive insulin therapy in patients with type 1 diabetes and inadequate glycemic control. RESEARCH DESIGN AND METHODS: Thirty-one patients with type 1 diabetes on intensive insulin therapy and with HbA1c >7.8% were randomized to telecare (glucometer transmission with feedback) or control (glucometer transmission without feedback) for 6 months. The primary end point was 6-month HbA1c. To place our findings in context, we pooled HbA1c change from baseline reported in randomized trials of telecare identified in a systematic review of the literature. RESULTS: Compared with the control group, telecare patients had a significantly lower 6-month HbA1c (8.2 vs. 7.8%, P = 0.03, after accounting for HbA1c at baseline) and a nonsignificant fourfold greater chance of achieving 6-month HbA1c < or =7% (29 vs. 7%; risk difference 21.9%, 95% CI -4.7 to 50.5). Nurses spent 50 more min/patient giving feedback on the phone with telecare patients than with control patients. Meta-analysis of seven randomized trials of adult patients with type 1 diabetes found a 0.4% difference (95% CI 0-0.8) in HbA1c mean change from baseline between the telecare and control groups. CONCLUSIONS: Telecare is associated with small effects on glycemic control in patients with type 1 diabetes on intensive insulin therapy but with inadequate glycemic control.     

Immediate feedback of HbA1c levels improves glycemic control in type 1 and insulin-treated type 2 diabetic patients.

OBJECTIVE: Accurate and reliable HbA1c results can be obtained at the time of the office visit by using benchtop analyzers. We tested the hypothesis that immediately available HbA1c results could improve glycemic control by changing physician or patient behavior or both. RESEARCH DESIGN AND METHODS: A randomized controlled trial was conducted in 201 type 1 and insulin-treated type 2 diabetic patients attending an academic diabetes center. HbA1c levels, changes in insulin therapy, and use of health care resources were assessed during a 12-month follow-up period. RESULTS: HbA1c levels decreased significantly at 6 and 12 months in the immediate assay group (-0.57 +/- 1.44 and -0.40 +/- 1.65%, respectively; P < 0.01) but did not change in the control group (-0.11 +/- 0.79 and -0.19 +/- 1.16%, respectively; NS). The changes were similar for both type 1 and type 2 diabetic patients. There were no differences in the rates of hypoglycemic events or use of health care resources. CONCLUSIONS: In the setting of a controlled randomized trial, the immediate feedback of HbA1c results at the time of patient encounters resulted in a significant improvement of glycemic control at 6-month follow-up and persisted for the 12-month study. The introduction of this assay was positively received by both patients and physicians.     

Circulating 1,5-anhydroglucitol levels in adult patients with diabetes reflect longitudinal changes of glycemia: a U.S. trial of the GlycoMark assay

OBJECTIVE: 1,5-Anhydroglucitol (1,5AG) is a major circulating polyol arising primarily from ingestion and excreted competitively with glucose. Japanese studies have demonstrated reduced concentrations of 1,5AG in serum in hyperglycemic patients in comparison with euglycemic subjects and a gradual normalization of 1,5AG values for patients responding to antihyperglycemic therapies. In this first U.S. study, we assessed the ability of 1,5AG measurements to monitor glycemic control in a cohort of 77 patients with diabetes (22 with type 1 diabetes, 55 with type 2 diabetes) who presented with suboptimal glycemic control at baseline (defined as HbA(1c) >or=7%). RESEARCH DESIGN AND METHODS: Each patient received therapies consisting of combinations of diabetes education, nutritional counseling, and addition or dose adjustment of various insulins or oral antihyperglycemic medications. Therapy was targeted to reduce mean HbA(1c) by >or=1.0% over the monitoring period. 1,5AG, HbA(1c), fructosamine, and random glucose measurements were performed at baseline and at 2, 4, and 8 weeks after the initiation of therapy. RESULTS: 1,5AG, fructosamine, and glucose values progressed significantly toward euglycemia by week 2 of monitoring (Wilcoxon's signed-rank test, P < 0.05), with median changes of 93, -7, and -13% for 1,5AG, fructosamine, and glucose, respectively. In contrast, HbA(1c) values did not respond significantly to therapy until week 4. On an individual patient basis, 89.6% of patients displayed longitudinal changes of 1,5AG from baseline to week 8 in concordance with HbA(1c). 1,5AG was also highly correlated with HbA(1c) and fructosamine (Spearman rho = -0.6459 and -0.6751, respectively; both P < 0.0001). CONCLUSIONS: We conclude that 1,5AG responds sensitively and rapidly to changes in glycemia and monitors glycemic control in accordance with established markers.     

A randomized trial of rosiglitazone therapy in patients with inadequately controlled insulin-treated type 2 diabetes.

OBJECTIVE: To determine the efficacy and safety of rosiglitazone (RSG) when added to insulin in the treatment of type 2 diabetic patients who are inadequately controlled on insulin monotherapy. RESEARCH DESIGN AND METHODS: After 8 weeks of insulin standardization and placebo (PBO) run-in, 319 type 2 diabetic patients with mean baseline HbA(1c) > or = 7.5% (8.9 +/- 1.1 to 9.1 +/- 1.3) on twice-daily insulin therapy (total daily dose > or = 30 U) were randomized to 26 weeks of additional treatment with RSG (4 or 8 mg daily) or PBO. Insulin dose could be down- titrated only for safety reasons. The primary end point was reduction of HbA(1c) from baseline. RESULTS: RSG 4 and 8 mg daily significantly improved glycemic control, which was unchanged on PBO. By intent-to-treat analysis, treatment with RSG 8 mg plus insulin resulted in a mean reduction from baseline in HbA(1c) of 1.2% (P < 0.0001), despite a 12% mean reduction of insulin dosage. Over 50% of subjects treated daily with RSG 8 mg plus insulin had a reduction of HbA(1c) > or = 1.0%. Neither total:HDL cholesterol nor LDL:HDL cholesterol ratios significantly changed with RSG treatment. Serious adverse events did not differ among groups. CONCLUSIONS: The addition of RSG to insulin treatment results in significant improvement in glycemic control and is generally well tolerated.     

Indication of intensive insulin therapy and its practice

DCCT and Kumamoto Study demonstrated that optimal glycemic control with intensive insulin therapy could delay the onset and progression of the early stages of diabetic microvascular complications in Japanese patients with noninsulin dependent diabetes as well as in patients with insulin dependent diabetes mellitus. To obtain optimal glycemic control, the prandial insulin supplements before each meal are recommended for insulin requiring patients with noninsulin dependent diabetes mellitus whose residual B cell functions are retained to some extent, whereas the combined basal at bedtime plus prandial insulin supplements are essential for the patients with noninsulin dependent diabetes mellitus whose residual B cell functions are severely exhausted as well as in the patients with insulin dependent diabetes mellitus. The glycemic threshold to prevent the onset and progression of diabetic microvascular complications in the Kumamoto Study was indicated as follows; HbA1c < 6.5%, fasting blood glucose concentration < 110 mg/dl, and 2-hour postprandial blood glucose concentration < 180 mg/dl.     

Fasting plasma glucose and hemoglobin A1c in identifying and predicting diabetes: the strong heart study

OBJECTIVE: To compare fasting plasma glucose (FPG) and HbA(1c) in identifying and predicting type 2 diabetes in a population with high rates of diabetes. RESEARCH DESIGN AND METHODS: Diabetes was defined as an FPG level ≥ 126 mg/dL or an HbA(1c) level ≥ 6.5%. Data collected from the baseline and second exams (1989-1995) of the Strong Heart Study were used. RESULTS For cases of diabetes identified by FPG ≥ 126 mg/dL, using HbA(1c) ≥ 6.5% at the initial and 4-year follow-up diabetes screenings (or in identifying incident cases in 4 years) among undiagnosed participants left 46% and 59% of cases of diabetes undetected, respectively, whereas for cases identified by HbA(1c) ≥ 6.5%, using FPG ≥ 126 mg/dL left 11% and 59% unidentified, respectively. Age, waist circumference, urinary albumin-to-creatinine ratio, and baseline FPG and HbA(1c) levels were common significant risk factors for incident diabetes defined by either FPG or HbA(1c); triglyceride levels were significant for diabetes defined by HbA(1c) alone, and blood pressure and sibling history of diabetes were significant for diabetes defined by FPG alone. Using both the baseline FPG and HbA(1c) in diabetes prediction identified more people at risk than using either measure alone. CONCLUSIONS Among undiagnosed participants, using HbA(1c) alone in initial diabetes screening identifies fewer cases of diabetes than FPG, and using either FPG or HbA(1c) alone cannot effectively identify diabetes in a 4-year periodic successive diabetes screening or incident cases of diabetes in 4 years. Using both criteria may identify more people at risk. The proposed models using the commonly available clinical measures can be applied to assessing the risk of incident diabetes using either criterion.     

Markers of insulin resistance are strong risk factors for retinopathy incidence in type 1 diabetes

OBJECTIVE: To determine the incidence of retinopathy and the relative importance of its risk factors in type 1 diabetes. RESEARCH DESIGN AND METHODS: This is a 7.3-year follow-up of 764 of 1,215 (63%) people with type 1 diabetes across Europe, aged 15-60 years at baseline with no retinopathy (the EURODIAB Prospective Complications Study). Retinal photographs were taken at baseline and follow-up and risk factors were assessed to a standard protocol. RESULTS: Retinopathy incidence was 56% (429/764, 95% CI 52-59%). Key risk factors included diabetes duration and glycemic control. We found no evidence of a threshold effect for HbA1c on retinopathy incidence. Univariate associations were observed between incidence and albumin excretion rate, cholesterol, triglyceride, fibrinogen, von Willebrand factor, gamma-glutamyltransferase, waist-to-hip ratio, and insulin dose. No associations were observed for blood pressure, cardiovascular disease, or smoking. Independent risk factors, as assessed by standardized regression effects, were HbA1C (1.93, P = 0.0001), duration (1.32, P = 0.008), waist-to-hip ratio (1.32, P = 0.01), and fasting triglyceride (1.24, P = 0.04). CONCLUSIONS: Retinopathy incidence in type 1 diabetes remains high. Key risk factors include diabetes duration and glycemic control, with no evidence of a threshold for the latter. Other independent risk factors, such as waist-to-hip ratio and triglyceride levels, both markers of insulin resistance, were strongly related to incidence.     

The potentially poor response to outpatient diabetes care in urban African-Americans

OBJECTIVE: HbA1c levels can be reduced in populations of diabetic patients, but some individuals may exhibit little improvement. To search for reasons underlying differences in HbA1c outcome, we analyzed patients managed in an outpatient diabetes clinic. RESEARCH DESIGN AND METHODS: African-Americans with type 2 diabetes were categorized as responders, intermediate responders or poor responders according to their HbA1c level after 1 year of care. Logistical regression was used to determine baseline characteristics that distinguished poor responders from responders. Therapeutic strategies were examined for each of the response categories. RESULTS: The 447 patients had a mean age and disease duration of 58 and 5 years, respectively, and BMI of 32 kg/m2. Overall, the mean HbA1c level fell from 9.6 to 8.1% after 12 months. Mean HbA1c levels improved from 8.8 to 6.2% in responders, and from 9.5 to 7.9% in intermediate responders. In poor responders, the average HbA1c level was 10.8% on presentation and 10.9% at 1 year. The odds of being a poor responder were significantly increased with longer disease duration, higher initial HbA1c level, and greater BMI. Although doses of oral agents and insulin were significantly higher among poor responders at most visits, the acceleration of insulin therapy did not occur until late in the follow-up period. CONCLUSIONS: Clinical diabetes programs need to devise methods to identify patients who are at risk for persistent hyperglycemia. Whereas patient characteristics explain some heterogeneity of HbA1c outcome (and may aid in earlier identification of patients who potentially may not respond to conventional treatment), insufficient intensification of therapy may also be a component underlying the failure to achieve glycemic goals.     

Addition of nateglinide to rosiglitazone monotherapy suppresses mealtime hyperglycemia and improves overall glycemic control

OBJECTIVE: To determine the effects of nateglinide added to rosiglitazone monotherapy on glycemic control and on postprandial glucose and insulin levels in patients with type 2 diabetes. RESEARCH DESIGN AND METHODS: This 24-week, multicenter, double-blind, randomized study compared the efficacy of nateglinide (120 mg a.c.) and placebo added to rosiglitazone monotherapy (8 mg q.d.) in 402 patients with type 2 diabetes with HbA(1c) between 7 and 11% (inclusive). Efficacy parameters tested included HbA(1c) and plasma glucose and insulin levels in the fasting state and after a standardized meal challenge. Safety data were also collected. RESULTS: In placebo-treated patients, HbA(1c) did not change (Delta = 0.0 +/- 0.1%). In patients randomized to nateglinide, HbA(1c) decreased from 8.3 to 7.5% (Delta = -0.8 +/- 0.1%, P < 0.0001 vs. placebo). Target HbA(1c) (<7.0%) was achieved by 38% of patients treated with combination therapy and by 9% of patients remaining on rosiglitazone monotherapy. In nateglinide-treated patients, fasting plasma glucose levels decreased by 0.7 mmol/l, 2-h postprandial glucose levels decreased by 2.7 mmol/l, and 30-min insulin levels increased by 165 pmol/l compared with no changes from baseline of these parameters with placebo added to rosiglitazone (P < 0.001). CONCLUSIONS: By selectively augmenting early insulin release and decreasing prandial glucose excursions, nateglinide produced a clinically meaningful improvement in overall glycemic exposure in patients with type 2 diabetes inadequately controlled with rosiglitazone. Therefore, nateglinide substantially improves the likelihood of achieving a therapeutic target of HbA(1c) <7.0%.     

Implementing practice guidelines for diabetes care using problem-based learning. A prospective controlled trial using firm systems.

OBJECTIVE: A controlled trial with 15-month follow-up was conducted in two outpatient clinics to study the effects of using the problem-based learning technique to implement a diabetes clinical practice guideline. RESEARCH DESIGN AND METHODS: A total of 144 patients with type 2 diabetes aged 25-65 years in two internal medicine outpatient clinics were enrolled in the study. African-Americans and Hispanics made up > 75% of the patients. Doctors and staff in one of the clinics were trained in the use of a clinical practice guideline based on Staged Diabetes Management. A problem-based learning educational program was instituted to reach consensus on a stepped intensification scheme for glycemic control and to determine the standards of care used in the clinic. HbA1c was obtained at baseline and at 9 and 15 months after enrollment. RESULTS: At 9 months, there was a mean -0.90% within-subject change in HbA1c in the intervention group, with no significant changes in the control group. The 15-month mean within-subject change in HbA1c of -0.62% in the intervention group was also significant. Among intervention patients, those with the poorest glycemic control at baseline realized the greatest benefit in improvement of HbA1c. The intervention group also exhibited significant changes in physician adherence with American Diabetes Association standards of care. CONCLUSIONS: Clinical practice guidelines are an effective way of improving the processes and outcomes of care for patients with diabetes. Problem-based learning is a useful strategy to gain physician support for clinical practice guidelines. More intensive interventions are needed to maintain treatment gains.     

Incidence of diabetes in American Indians of three geographic areas: the Strong Heart Study.

OBJECTIVE: To estimate incidence rates of diabetes and associated risk factors among participants of the Strong Heart Study. RESEARCH DESIGN AND METHODS: Of the 4,549 Strong Heart Study participants examined at baseline, 3,638 returned for a similar examination after an average of 4 years. The 1985 World Health Organization criteria for diabetes were used to identify new diabetes cases. Rates of diabetes among participants who did not have diabetes at baseline examination were determined. The relationships between the incidence rates of diabetes and a number of risk factors measured at baseline examination were studied. RESULTS: Significant variables associated with the development of diabetes included triglycerides, obesity, fasting plasma glucose, insulin, and degree of American Indian blood among participants with NGT at baseline. For those with IGT at baseline, significant predictors included fasting plasma glucose, 2-h glucose, BMI, degree of American Indian blood, and albuminuria. CONCLUSIONS: The high incidence rates found in this study were alarming. To slow down the rapid increase of this disease in the American Indian population, preventive programs must be designed and implemented. Patients with IGT should be treated with diabetes medication or put on a rigid weight-reduction program to reduce the risk of progression to diabetes.     

Effects of multiple daily insulin injections on peripheral glucose disposal in Latin Americans with type 2 diabetes mellitus.

OBJECTIVE: To evaluate the effects of insulin in multiple daily injections (MDI) on peripheral glucose disposal in Latin American patients with type 2 diabetes. METHODS AND RESULTS: Ten Latin American patients (four men and six women) with type 2 diabetes between the ages of 32 and 45 years were evaluated. All women were premenopausal and had regular menstrual periods. A hyperinsulinemic-euglycemic clamp procedure was performed at baseline and was repeated approximately 2 years after insulin monotherapy on MDI was initiated. Both genders had comparable baseline anthropometric and laboratory features, including a mean body mass index > 30 kg/m2 and percent body fat > 30%. Baseline percent hemoglobin A1c (HbA1c%) was 9.5 +/- 1.5%, and post-intervention HbA1c% was 7.0 +/- 1.2%. The peripheral glucose disposal rate at baseline was 4.5 +/- 2.2 mg/kg/min fat-free mass and at postintervention was 3.6 +/- 2.3 mg/kg/min fat-free mass. CONCLUSIONS: Despite a significant improvement in glycemic control, MDI did not seem to increase the insulin-mediated glucose disposal rate. Underlying obesity and increased percent body fat may have been the most counteracting factors on the potential improvement in insulin sensitivity expected with insulin monotherapy.     

Maintenance of sulfonylurea responsiveness in NIDDM. Randomized double-blind study of intermittent glyburide therapy.

OBJECTIVE--To assess the effectiveness of intermittent administration of sulfonylurea (glyburide) to patients with non-insulin-dependent diabetes mellitus (NIDDM). RESEARCH DESIGN AND METHODS--A randomized, double-blind, prospective trial compared daily administration with intermittent administration of glyburide to patients who initially responded to the drug. Twenty-eight of 60 patients with NIDDM achieved the predetermined improvement in plasma glucose concentration on glyburide therapy. These 28 responders were enrolled into a 16-wk trial of daily versus intermittent (2 wk on, 2 wk off) glyburide treatment. Laboratory assessment of glycemic control and insulin secretion in fasting and 2-h postprandial states was done every 2 wk. RESULTS--Patients on continuous glyburide therapy maintained their glycemic control throughout the study. In contrast, patients on the intermittent schedule lost their glycemic control immediately after being placed on placebo. Despite a significant response to each sulfonylurea pulse, these subjects never regained their baseline glycemic levels. Their fructosamine and HbA1c concentrations deteriorated and remained significantly higher than those of the continuously treated subjects. CONCLUSIONS--Results suggest that administration of glyburide on an intermittent basis after a 2-wk drug-free period to patients initially rendered responsive to sulfonylurea therapy is without clinical merit.     

Diabetes in urban African-Americans. XVI. Overcoming clinical inertia improves glycemic control in patients with type 2 diabetes.

OBJECTIVE: Diabetes care can be limited by clinical inertia-failure of the provider to intensify therapy when glucose levels are high. Although disease management programs have been proposed as a means to improve diabetes care, there are few studies examining their effectiveness in patient populations that have traditionally been underserved. We examined the impact of our management program in the Grady Diabetes Unit, which provides care primarily to urban African-American patients with type 2 diabetes. RESEARCH DESIGN AND METHODS: We assessed glycemic outcomes in patients with type 2 diabetes who had an intake evaluation between 1992 and 1996 and who were identified on the basis of compliance with keeping the recommended number of return visits. For 698 patients, we analyzed changes in HbA1c values between baseline and follow-up visits at 6 and 12 months, and the proportion of patients achieving a target value of < or =7.0% at 12 months. Since a greater emphasis on therapeutic intensification began in 1995, we also compared HbA1c values and clinical management in 1995-1996 with that of 1992-1994. RESULTS: HbA1c averaged 9.3% on presentation. After 12 months of care, HbA1c values averaged 8.2, 8.4, 8.5, 7.7, and 7.3% for the 1992-1996 cohorts, respectively, and were significantly lower compared with values on presentation (P < 0.0025); the average fall in HbA1c was 1.4%. The percentage of patients achieving a target HbA1c < or =7.0% improved progressively from 1993 to 1996, with 57% of the patients attaining this goal in 1996. Mean HbA1c after 12 months was 7.6% in 1995-1996, significantly improved over the level of 8.4% in 1992-1994 (P < 0.0001). HbA1c levels after 12 months of care were lower in 1995-1996 versus 1992-1994, whether patients were managed with diet alone, oral agents, or insulin (P < 0.02). Improved HbA1c in 1995-1996 versus 1992-1994 was associated with increased use of pharmacologic therapy CONCLUSIONS: Structured programs can improve glycemic control in urban African-Americans with diabetes. Self-examination of performance focused on overcoming clinical inertia is essential to progressive upgrading of care.     

Insulin as initial therapy in type 2 diabetes: effective, safe, and well accepted.

BACKGROUND: To achieve glycemic control in type 2 diabetes mellitus (T2DM), multiple oral agents are used in a stepwise approach, but long-term maintenance of normoglycemia is difficult to achieve, and, eventually, most patients require insulin. The aim of this study was to evaluate the feasibility, acceptability, and efficacy of insulin with metformin for newly diagnosed, treatment-naive patients with T2DM. METHODS: Eligible patients were started on insulin NovoLog 70/30 and metformin 1,000 mg twice daily. Biochemical evaluation was performed at baseline and at the end of the 3-month study. Patients were seen monthly to assess side effects and compliance and make insulin dose adjustments. Patient treatment satisfaction was evaluated at the end of the study. RESULTS: Of 63 patients, 92% completed the study. The hemoglobin A(1c) (HbA(1c)) decreased from 10.8 to 5.9% (p < .0001), and 100% of subjects achieved an HbA(1)c < 7%. Weight increased from 100.0 to 101.6 kg (p = .004) but was less than expected given that patients lost an average of 7.2 kg prior to diagnosis and achieved a reduction in HbA(1c) of 5%. The rate of hypoglycemia was low (1.5 episodes/patient-month). Ninety-seven percent of the patients were satisfied with their insulin treatment, and 88% were willing to continue insulin. Compliance was 96.5% with insulin and 95.1% with metformin. CONCLUSION: Outpatient initiation of insulin therapy at the time of diagnosis of T2DM is an effective, safe, and feasible strategy for rapidly lowering HbA(1c) levels to targets. Insulin was very well accepted by the patients, refuting the misconception of low satisfaction and acceptance of such treatment.     

Diabetes in urban African-Americans. XVII. Availability of rapid HbA1c measurements enhances clinical decision-making.

OBJECTIVE: To assess the impact of rapid-turnaround HbA1c results on providers' clinical decision-making and on follow-up HbA1c levels. RESEARCH DESIGN AND METHODS: The research design was a randomized clinical trial in which rapid HbA1c results were made available to providers on even days of the month (rapid, n = 575), but delayed by 24 h on odd days (conventional, n = 563). Adjustment of therapy for patients with type 2 diabetes was considered appropriate if therapy was intensified for HbA1c values >7% or not intensified for HbA1c values < or =7%. A post-hoc analysis was also performed using patients (n = 574) who returned for follow-up 2-7 months later to ascertain the effect of rapid HbA1c availability on subsequent glycemic control. RESULTS: Rapid HbA1c availability resulted in more appropriate management compared with conventional HbA1c availability (79 vs. 71%, P = 0.003). This difference was due mainly to less frequent intensification when HbA1c levels were < or =7% (10 vs. 22%, P < 0.0001) and slightly to more frequent intensification for patients with HbA1c values >7% (67 vs. 63%, P = 0.33). For both groups, intensification was greatest for patients on insulin (51%) compared with patients on oral agents (35%) and diet alone (14%) (P < 0.0001). Regression analysis confirmed that providers receiving conventional HbA1c results were more likely to intensify therapy in patients who already had HbA1c levels < or =7%. Over 2-7 months of follow-up, HbA1c rose more in patients with conventional HbA1c results compared with rapid results (0.8 vs. 0.4%, P = 0.02). In patients with initial HbA1c >7%, rapid HbA1c results had a favorable impact on follow-up HbA1c independent of the decision to intensify therapy (P = 0.03). CONCLUSIONS: Availability of rapid HbA1c determinations appears to facilitate diabetes management. The more favorable follow-up HbA1c profile in the rapid HbA1c group occurs independently of the decision to intensify therapy, suggesting the involvement of other factors such as enhanced provider and/or patient motivation.