Implementation of a systematic approach to diabetes in primary care in Bahia, Brazil improves metabolic outcomes: PRODIBA-Programa de Interiorização da Assistência ao Diabetes na Bahia (Project for Dissemination of Diabetes Care in the State of Bahia).

BACKGROUND: Staged Diabetes Management (SDM) improves glycaemic control and reduces diabetes-related complications in primary care. METHODS: An 18-month randomized controlled cohort study was conducted in two municipalities in the state of Bahia, Brazil, involving 100 patients with Type 2 diabetes in each municipality. In one municipality, healthcare professionals were trained to use SDM customized protocols for clinical decisions and, in the other municipality, no protocols for diabetes care were implemented. We hypothesized that, in the municipality with SDM trained professionals, patients would have better outcomes, including a fall in glycated haemoglobin (HbA(1c)). RESULTS: Improvements in some metabolic parameters were observed in the SDM group, including a 22% decrease in mean random glucose, a significant 15% decrease in mean HbA(1c), a 6% decrease in systolic blood pressure and an 11% decrease in diastolic blood pressure. There were no differences in body mass index and lipid profile. CONCLUSIONS: SDM customized algorithms are effective, practical and easy to use in primary healthcare teams with very limited resources.

Characterizing blood pressure control in individuals with Type 2 diabetes: the relationship between clinic and self-monitored blood pressure.

AIMS: To determine the relationship between blood pressure (BP) measurement in the clinic and self-monitored blood pressure (SMBP); and to evaluate the accuracy of self-reported data in patients with Type 2 diabetes treated intensively for hypertension. METHODS: Seventy subjects had baseline and 1-week follow-up clinic BP measured using an Omron 907 automated device. During a contemporaneous 14-day period these subjects measured their BP at least four times each day using an Omron IC semiautomatic portable monitor which, unknown to them, contained an onboard memory capable of storing BP with corresponding time and date. RESULTS: There was no significant difference between mean clinic and mean self-monitored BP. Correlations between clinic BP and SMBP were r=0.61 (P<0.0001) for systolic BP and r=0.69 (P<0.0001) for diastolic BP. Clinic BP classified 56 subjects as uncontrolled hypertension (BP > or = 130/80 mmHg, adjusted for diabetes) and 14 subjects as controlled hypertension. Using World Health Organization-International Society of Hypertension criteria for SMBP (> or = 125/75 mmHg), 55 cases of clinic classified uncontrolled hypertension were confirmed, resulting in 98% sensitivity. Clinic and SMBP agreed in one case of controlled hypertension, resulting in 7% specificity. For all subjects, the median percent of values exceeding SMBP criteria for controlled hypertension was systolic 92% and diastolic 70%. Self-reporting precision averaged 89+/-10% (range 45-100%); under-reporting was 25+/-16% (ranging from 0 to 56%) and over-reporting was 12+/-15% (ranging from 0 to 46%). The overall logbook mean was not significantly different from the downloaded data from the Omron IC(R) monitors. CONCLUSIONS: SMBP was able to identify 13 patients with uncontrolled hypertension who, by clinic BP measurement, had been classified as controlled.

The effects of sevoflurane on serum creatinine and blood urea nitrogen concentrations: a retrospective, twenty-two-center, comparative evaluation of renal function in adult surgical patients.

UNLABELLED: Despite mounting clinical evidence that supports its safety, the question of the potential adverse effects of sevoflurane on renal function continues to generate some controversy. This study retrospectively evaluated pooled renal laboratory data from 22 different clinical trials that compared sevoflurane with three widely used anesthetics. The trials examined postoperative changes in serum creatinine and blood urea nitrogen levels from a total of 3, 436 ASA physical status I-IV adult surgical patients administered either sevoflurane (n = 1941) or a control drug (isoflurane, enflurane, or propofol; n = 1495) as the maintenance anesthetic. The incidences of increased serum creatinine and blood urea nitrogen concentrations were similar among patients administered sevoflurane and those administered control drugs. Additionally, no trends specific to sevoflurane were observed with respect to postoperative serum creatinine concentration and fresh gas flow rate, concurrent treatment with nephrotoxic antibiotics, or type of carbon dioxide absorbent. IMPLICATIONS: Our data for changes in serum creatinine and blood urea nitrogen indicate that, for exposures of less than 4 minimum alveolar anesthetic concentration/h, sevoflurane is not associated with an increased risk of renal toxicity compared with other commonly used anesthetics. For clinical purposes, the pre- to postoperative changes in serum creatinine and blood urea nitrogen are appropriate measures of renal function in surgical patients.

Trace nitrous oxide levels in the postanesthesia care unit.

UNLABELLED: The effect of trace levels of waste anesthetic gases on the health of postanesthesia care unit (PACU) nurses who work in an unscavenged environment has been questioned, although it seems likely that levels of trace gases in the PACU would be much lower than those in the operating room. In this study, we documented nitrous oxide levels in the ambient air of two large PACUs. Nitrous oxide levels were measured using a time-weighted average monitor worn by 33 PACU workers at two different hospitals for the duration of their shifts. On the same day, patient data were collected at the time of admission to the PACU. Data included age and weight of the patient, type of surgery, anesthetic technique, and end-tidal level of nitrous oxide immediately before the patient left the operating room. The mean time-weighted average nitrous oxide level in PACU A was 2.0 ppm (range 0-6.4); in PACU B, it was undetectable, i.e., < 2.0 ppm. Levels of nitrous oxide to which PACU patient care personnel are exposed are well below the National Institute of Occupational Safety and Health and Occupational Health and Safety Administration recommended exposure level of 25 ppm measured for the duration of anesthetic administration. IMPLICATIONS: Our results indicate that the levels of nitrous oxide in postanesthesia care units with well maintained, modern ventilation systems are very low. Previous research suggests that the health of workers exposed to these levels should not be adversely affected.

Reducing lower-extremity amputations due to diabetes. Application of the staged diabetes management approach in a primary care setting.

BACKGROUND: While lower-extremity amputation (LEA) is a frequent complication of diabetes, effective strategies for the prevention of LEA in primary care settings have not been extensively studied. METHODS: This prospective study of American Indians with diabetes in a rural primary care clinic was divided into three periods: the standard care period (1986 to 1989), during which patients received foot care at the discretion of the primary care provider; the public health period (1990 to 1993), during which patients were screened for foot problems and high-risk individuals received foot care education and protective footwear; and the Staged Diabetes Management (SDM) period (1994 to 1996), during which comprehensive guidelines for diabetic foot management were adapted by the primary care clinicians to their practices and were systematically implemented. RESULTS: A total of 639 individuals contributed 4322 diabetic person-years during the three periods of observation. Patient sex distribution, mean age, and mean duration of diabetes were similar i the three periods. The average annual LEA incidence was 29/1000 diabetic person-years for the standard care period (n = 42), 21/1000 for the public health period (n = 33), and 15/1000 for the SDM period (n = 20), an overall 48% reduction (P = .016). Overall, the incidence of a first amputation declined from 21/1000 to 6/1000 (P < .0001). CONCLUSIONS: The customization and systematic implementation of practice guidelines by local primary care providers was associated with improved diabetic foot care outcomes. SDM has relevance to primary care organizations seeking to improve outcomes for patients with diabetes.

Staged diabetes management: computerizing a disease state management program.

Recently, the Diabetes Control and Complication Trial (DCCT) and other similar studies have demonstrated that near-normalization of blood glucose in diabetes will reduce complications up to 75% but translation of these results into practice has been difficult. In an attempt to help provide the best possible control of patients with diabetes, we have produced an attempt to help provide the best possible control of patients with diabetes, we have produced a new disease state management system for diabetes, called "Staged Diabetes Management" (SDM), implemented it in over 100 sites worldwide, and developed a computer program to simplify its use. SDM, designed to change the way we deal with patients with diabetes, is based upon five principles: (1) community involvement in setting care guidelines; (2) negotiation of goals with patients; (3) appropriate timelines for therapeutic success; (4) use of flowcharts for medical decisions; and (5) evaluation of the program. SDM is designed to be altered by a community to meet its needs and resources. It encourages primary care physicians to deliver better diabetes care using a team approach and to refer patients with diabetes to specialists when appropriate. It has a complete set of materials for communities, individual health care providers and patients. SDM has been tested for changes in structure, process and outcomes. A meta-analysis of seven clinical trials with over 500 patients has shown a time-weighted average fall in hemoglobin A1c of 1.7 points (equivalent to a drop in mean blood glucose of about 3.5 mM or 60 mg/dL). Preliminary pharmacoeconomic analysis demonstrates a lifetime cost saving of over $27,000 per patient. A computer program has been developed for the Microsoft Windows environment that contains a client-server database, based upon DiabCare, for the data file structure.

Effectiveness of medical nutrition therapy provided by dietitians in the management of non-insulin-dependent diabetes mellitus: a randomized, controlled clinical trial.

OBJECTIVE: To assess the effect of medical nutrition therapy (MNT) provided by dietitians on medical and clinical outcomes for adults with non-insulin-dependent diabetes mellitus (NIDDM), and to compare MNT administered according to practice guidelines nutrition care (PGC) to MNT administered with basic nutrition care (BC). DESIGN: A prospective, randomized, controlled clinical trial of two levels of MNT on metabolic control in persons newly diagnosed with or currently under treatment for NIDDM was conducted at diabetes centers in three states (Minnesota, Florida, and Colorado). BC consisted of a single visit with a dietitian; PGC involved an initial visit with a dietitian followed by two visits during the first 6 weeks of the study period. Data were collected at entry to the study and at 3 and 6 months. SUBJECTS: Results are reported for 179 men and women aged 38 to 76 years: 85 assigned randomly to BC and 94 to PGC. This represents 72% of the 247 subjects enrolled. An additional 62 adults with NIDDM at one site who had no contact with a dietitian were identified as a nonrandom comparison group. OUTCOMES: Medical outcome measures included fasting plasma glucose (FPG), glycated hemoglobin (HbA1c), and serum lipid levels. Clinical outcomes included weight, body mass index, waist-to-hip ratio, and changes in medical therapy. STATISTICAL ANALYSES: Initial analysis of the discrete variables was done using the chi 2 statistic with Yates' correction. Initial analysis of continuous variables was done by analysis of variance. The changes in variables between time periods were analyzed by paired t test, and comparisons between groups were analyzed using a t test for independent groups. RESULTS: At 6 months, PGC resulted in significant improvements in blood glucose control as indicated by FPG and HbA1c levels and BC resulted in significant improvements in HbA1c level. Participants assigned to the PGC group had a mean FPG level at 6 months that was 10.5% lower than the level at entry, and those in the BC group had a 5.3% lower value. Among subjects who had diabetes for longer than 6 months, those who received PGC had a significantly better HbA1c level at 3 months compared with those receiving BC. The comparison group showed no improvement in glycemic control over a comparable 6 months. PGC subjects had significant improvements in cholesterol values at 6 months, and subjects in both the PGC and the BC groups had significant weight loss. CONCLUSIONS: MNT provided by dietitians resulted in significant improvements in medical and clinical outcomes in both the BC and PGC groups and is beneficial to persons with NIDDM. Persons with a duration of diabetes longer than 6 months tended to do better with PGC than with BC. Because of the upward trend in glucose levels after 3 months, ongoing MNT by dietitians is important for long-term metabolic control.

Cost-effectiveness of medical nutrition therapy provided by dietitians for persons with non-insulin-dependent diabetes mellitus.

OBJECTIVE: To conduct a cost analysis and cost-effectiveness study based on a randomized clinical trial of basic nutrition care (BC) and practice guidelines nutrition care (PGC) provided by dietitians in outpatient clinics. DESIGN: Subjects with non-insulin-dependent diabetes mellitus (NIDDM) from three states (Minnesota, Florida, Colorado) were randomly assigned to a group receiving BC or a group receiving PGC for a 6-month clinical trial. Along with data about medical and clinical outcomes, data about cost resources were collected. The cost-effectiveness of PGC compared with BC was calculated using per-patient costs and glycemic outcomes for the 6 months of the study. A net cost-effectiveness ratio comparing BC and PGC, including the cost savings resulting from changes in medical therapy, was also calculated. SUBJECTS: The study reports on a sample of 179 subjects with NIDDM between the ages of 38 and 76 years who completed the clinical trial. RESULTS: Patients in the PGC group experienced a mean 1.1 +/- 2.8 mmol/L decrease in fasting plasma glucose level 6 months after entry to the study, for a total per-patient cost of $112. PGC costs included one glycated hemoglobin assay used by the dietitian to evaluate nutrition outcomes. Patients in the BC group experienced a mean 0.4 +/- 2.7 mmol/L decrease, for a total per-patient cost of $42. In the PGC group, 17 persons had changes in therapy, which yielded an average 12-month cost savings prorated for all patients of $31.49. In contrast, in the BC group, 9 persons had changes in therapy, for an average 12-month prorated cost savings of $3.13. Each unit of change in fasting plasma glucose level from entry to the 6-month follow-up can be achieved with an investment of $5.75 by implementing BC or of $5.84 by implementing PGC. If net costs are considered (per-patient costs--cost savings due to therapy changes), the cost-effectiveness ratios become $5.32 for BC and $4.20 for PGC, assuming the medical changes in therapy were maintained for 12 months. APPLICATIONS: These findings suggest that individualized nutrition interventions can be delivered by experienced dietitians with a reasonable investment of resources. Cost-effectiveness is enhanced when dietitians are engaged in active decision making about intervention alternatives based on the patient's needs.

Intensified diabetes management: lessons from the diabetes control and complications trial.

The results of the multicenter diabetes control and complications trial are examined and methods for the implementation of the findings for individuals with type I and type II diabetes are discussed. More than a decade ago the question was raised of whether tight glycemic control would prevent or slow the progression of microvascular complications. In 1993, having studied 1441 individuals with type I diabetes randomized to either intensive glycemic control (HbA1c < 7%) or conventional glycemic control (HbA1c > 9%), it was concluded that a reduction in risk of retinopathy, neuropathy and nephropathy could be realized if near normal glycemic control were achieved. Some questions remained, however. For example, could intensive treatment be achieved in routine practice under the auspices of primary care physicians? Are the findings in this study applicable to individuals with type II diabetes? These questions are addressed through the introduction of staged diabetes management (SDM), an innovative approach to the treatment of diabetes and the prevention of its complications. SDM is designed as a data-based systematic approach to diabetes treatment that targets blood glucose control. Studied in 40 clinical sites throughout the United States and evaluated in 30 sites worldwide, SDM promises to provide appropriate clinical guidance to both primary care and specialist physicians seeking to alter current practice patterns by adopting a systematic approach to diabetes management.

Comparison of home glucose monitoring with the oral glucose tolerance test to detect gestational glucose intolerance.

BACKGROUND: Recent evidence suggests that infant morbidity is increased among women who have abnormal prenatal glucose screening tests but who do not have gestational diabetes mellitus (GDM). These women fall into a diagnostic gray zone and historically have not been treated. METHODS: Forty-eight pregnant women with abnormal oral glucose challenge test results performed self-monitored blood glucose (SMBG) testing seven times per day for 1 week before undergoing a diagnostic 100-g oral glucose tolerance test (OGTT). At delivery, perinatal complications and birthweights were recorded. Results of SMBG tests for women with normal OGTTs were correlated with infant birthweights. RESULTS: Thirteen infants (37%) were found to be large for gestational age (LGA). Significant correlation was found between increasing birthweight and increasing average fasting SMBG values (P < .001), increasing percentage of SMBG values above 120 mg/dL (6.7 mmol/L) (P < .01), and increasing average SMBG values (P < .016). CONCLUSIONS: Maternal home glucose values at 28 weeks correlate with the risk of LGA infant births among women in the diagnostic gray zone. Women with average fasting SMBG values > 95 mg/dL (5.3 mmol/L) are at increased risk for giving birth to LGA infants and may be more likely to exhibit complications usually associated with GDM.

Patient and physician analytic goals for self-monitoring blood glucose instruments.

The study's objective was to determine the maximum analytical error that is allowable in portable whole blood glucose meters. Interviews were conducted to derive personal reference values and significant deviations from these values for the limit of hypoglycemia, the limit of hyperglycemia, and the upper and lower limits of acceptable blood glucose for physicians and patients with diabetes at the Park Nicollet Medical Center, Minneapolis, Minnesota. Fifty patients with diabetes (30 type I and 20 type II), and 43 physicians (14 endocrinologists, 14 family practitioners, and 15 general internists) were enrolled in the study. The results showed no significant differences between type I and type II diabetic patient responses. Nor were there significant differences among family practitioner, internist, and endocrinologist responses for any of the parameters (the limit of hypoglycemia, the limit of hyperglycemia, the upper and lower limits of acceptable blood glucose for the patient, and the corresponding allowable coefficients of variation at each of these glucose levels). There were significant differences when patients were compared to physicians. Physicians require the highest degree of precision at the limit of hyperglycemia (8.4 +/- 0.28 mmol/L [150.8 +/- 5.1 mg/dL]) with a maximum allowable coefficient of variation (CV) of 7%, a CV significantly lower than that of the patients (CV = 10%). Patients require the highest precision for glucose concentration around the lower acceptable limit (4.7 +/- .013 mmol/L [84.1 +/- 2.5 mg/dL]), with an allowable CV of 8%, a CV significantly lower than that of the physicians (CV = 14%). The authors conclude that the accuracy required by patients and physicians at normal and higher glucose concentrations is achievable by currently available meters. Manufacturers should ascertain that glucose measurements are optimally accurate at glucose levels of 4.7 mmol/L (84.1 mg/dL) and have CVs no higher than 7%.