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.

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.

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%.

A systems approach to diabetes care.

Diabetes can be considered from the perspective of systems analysis, in which inputs, throughputs, outputs, and feedback are seen as part of one integrated system. From this perspective, the inputs (demands and needs) are converted by the throughputs (personnel, structures, processes, and finance) into measurable outputs consisting, in part, of measures of morbidity and mortality. Feedback is reflected in the changes in the incidence and prevalence of diabetes. Variation in both systems and providers has led to considerable differences in outcomes, which result in significant costs for diabetic patients. These costs, when compared with outcomes, can be projected from individual programs (or health plans) to the nation. Based on estimates from large HMOs, the current direct and indirect cost of diabetes care approaches $100 billion.

Staged diabetes management. Toward an integrated model of diabetes care.

This paper introduces a new and innovative approach to diabetes management in the primary-care setting. Staged diabetes management (SDM) represents a four-year effort to develop and test a data-based approach to diabetes management that could be easily adapted to a variety of health-care settings in which diabetes management is principally under the direction of primary-care physicians was limited access to specialists. After testing under controlled circumstances at the International Diabetes Center (Minneapolis, MN), SDM was subjected to substantial field trials under conditions that represent the scope and variety of primary-care practices in diabetes. The following represents the work of several investigators who independently undertook a review of SDM.

Treatment of glucose intolerance in pregnancy: staged diabetes management.

Current methods for the treatment of glucose intolerance first discovered in pregnancy are reviewed and a systematic data-based approach is introduced. Gestational diabetes mellitus (GDM) is a leading cause of adverse perinatal outcome in 5% of all pregnancies in the United States. Early detection and initiation of treatment meant to restore euglycemia will prevent many of the major complications associated with hyperglycemia. Staged Diabetes Management (SDM) is introduced in this paper as an innovative approach for the detection and treatment of GDM and glucose intolerance in pregnancy. Relying on self-monitored blood glucose data, SDM guides the primary care physician through increasingly more complex regimens until euglycemia is reached. Computer-based technologies assist the clinical decision-making by producing Ambulatory Glucose Profiles (AGP), which are graphic representations of glycemic control. SDM combined with AGP technology are meant to significantly reduce the threefold greater risk of adverse outcome in pregnancy experienced by women with GDM.

Detection of glucose intolerance in pregnancy.

Current methods for the screening and diagnosis of glucose intolerance first discovered in pregnancy are reviewed and innovative approaches to the detection of metabolic disturbances in pregnancy are presented. Glucose intolerance first detected in pregnancy, termed gestational diabetes mellitus (GDM), is amongst the most significant risks of adverse fetal and maternal outcome. Normal pregnancy is characterized by both insulin resistance and pancreatic B cell compensation. In those pregnancies complicated by glucose intolerance reflected in hyperglycemia, insulin resistance appears to be heightened, both blood flow and transcapillary transport of insulin are compromised and insulin receptor and post receptor defects are exacerbated. The resulting hyperinsulinemia and hyperglycemia have, in turn, been associated with accumulated maternal fat deposition and fetal macrosomia. This cascade of events constitutes GDM or impaired glucose tolerance. The discovery of GDM is made through a process of screening and diagnosis, employing standardized oral glucose challenge tests. These tests were designed to identify those women at risk for subsequent development of non-insulin dependent diabetes mellitus. The current efficacy of glucose challenge tests has been questioned in light of increasing concern over their usefulness in detecting those women at risk for maternal and fetal complications of pregnancy. Alternative methods, including both the modification of the standardized tests, as well as the introduction of newer methodologies, such as capillary blood glucose monitoring, have been proposed. The implementation of newer approaches may result in improved detection of those women whose infants are at high risk for both metabolic and morphologic complications of persistent hyperglycemia in pregnancy.

Gestational diabetes mellitus: now is the time for detection and treatment.

The extent of universal screening for gestational diabetes and the incidence of gestational diabetes mellitus (GDM) by diagnosis were analyzed in four primary-care sites. The medical records of 798 women were reviewed to identify the presence of historical risk factors, familial determinants, and biophysical attributes associated with GDM and to determine whether screening and diagnostic tests consistent with national criteria had been completed, as well as to obtain the method of delivery and the weight and overall medical status of the infants. Of the 798 women, less than 60% underwent screening. Overall, 1.5% of the women were diagnosed with GDM, seven of whom were identified through screening. Eighty-nine infants were classified as large for gestational age, 61 of whom weighed more than 4,000 g. Of these 61 infants with macrosomia, 61% were born to women who either were not screened or had negative screening results. Most of these women had risk factors consistent with GDM. The likelihood that a substantial proportion of these women would have delivered normal-sized infants had they undergone proper screening, diagnosis, and treatment prompted us to conclude that universal screening for GDM should be adopted.

Computers and diabetes therapy: key variables and quality of data for clinical decision-making.

Approaches to clinical decision-making in diabetes have undergone a revolution over the past decade. Since the introduction of reflectance meters and subsequently the addition of a micro chip to store glucose data, clinical decision-making by both the professional and person with diabetes has significantly changed. The memory-based reflectance meter made it possible to collect, aggregate and interpret self-monitored blood glucose values at a level of reliability and accuracy heretofore impossible to obtain. With the ability to collect self-monitored blood glucose values and transmit these data to micro computers has come the development of different approaches to the interpretation of these data. Innovations, such as the Ambulatory Glucose Profile and the Modal Day permit the expression of blood glucose values as dynamic entities. Using this means of representation, blood glucose over time can be thought of as a measure of change having such properties as variability and oscillation. By viewing blood glucose from this innovative perspective it may be possible to reexamine the relationship between insulin dose and glucose level and thereby improve clinical decision-making.

Computer-based patient monitoring systems. Use in research and clinical practice.

The use of new technologies, such as computers, in the management of diabetes has changed dramatically over the past decade. The development of the memory-based reflectance meter, telephone modems for the transmission of self-monitored blood glucose, and computer programs to aggregate and analyze data have significantly altered approaches to diabetes care. The clinical application of these systems is just now being evaluated. Initial data suggest that these systems enhance treatment, improve patient performance, assist in collection and representation of accurate and reliable data, and may be associated with improved metabolic control.

Primary, secondary, and tertiary prevention. Program for diabetes in pregnancy.

Over the past 2 yr the effectiveness of a program in primary, secondary, and tertiary prevention of diabetes in pregnancy was studied. The purpose of the program was to determine the degree to which preventive medicine in terms of early screening and diagnosis, rapid initiation of treatment, and close follow-up surveillance could reduce the morbidity and mortality associated with pregestational and gestational diabetes. The study compared the program in prevention with previous programs, and its results were measured against national criteria established by the Centers for Disease Control. A significant increase in early identification of gestational diabetes and a decrease in fetal and maternal complications were detected.

Ambulatory glucose profile: representation of verified self-monitored blood glucose data.

Sixty-nine individuals with diabetes (23 with type I, 15 with pregestational, and 31 with gestational) used specially modified reflectance meters containing memory chips enabling the instruments to store 440 individual blood glucose values with corresponding time and date. These data were organized into 14-day periods and then collapsed into a graphic depiction, the Ambulatory Glucose Profile (AGP), which was represented as the pattern of the 25th, 50th, and 75th percentiles of blood glucose values. These three curves illustrate the median level of control and provide an index of variability in control at each hour of a "typical day." We observed distinctive AGPs related to the variability in metabolic control and the type of diabetes. Comparisons between diagnostic groups showed consistent differences between groups, independent of level of glycemic control. Review of serial AGPs obtained for sequential 2-wk periods for 23 non-pregnant individuals with type I diabetes and 10 women with gestational diabetes revealed changes in AGP corresponding to alterations in regimen. The AGP provides a new approach to the evaluation of glycemic control, with applications to patient and physician education, clinical investigation, and individual patient care.

Diabetes in pregnancy: evaluating self-monitoring performance and glycemic control with memory-based reflectance meters.

Reflectance meters modified by the addition of a memory microchip that stored glucose values were used to measure the difference between self-reported and actual blood glucose data in 34 pregnant diabetic women. Overall two thirds of the patients reported values that were significantly lower and less variable than those recorded in the memory meters.