Improving blood pressure control in individuals with diabetes: a quality improvement collaborative.

BACKGROUND: Studies show that it is difficult to achieve blood pressure (BP) targets among people with diabetes. Methods to improve BP control are needed. A quality improvement (QI) collaborative was established to improve systolic BP (SBP) control in persons with diabetes. METHODS: A longitudinal study with a three-phase QI collaborative as the intervention was conducted with 51 primary care practices within 12 health care organizations in the United States. Baseline, 6-, and 12-month posteducation performance data were collected. Phase 1 began in October 2006, and all sites completed all three phases by June 2008. Sites participated on four collaborative conference calls to discuss shared data and individual site activities, as well as on monthly calls with their project consultant. Some 624 staff participated in interactive education programs, and data were collected on 11,510 patients with diabetes. FINDINGS: All site champions stated that the collaborative supported process changes and engaged stakeholders and patients, focused staff on accurate BP measurement and treatment options, and served to identify and address gaps in outcomes. Mean SBP significantly improved from baseline (130.4 mmHg) to 6 months (127.4 mmHg; p < .001) and to 12 months (128.6 mmHg; p < .001). The proportion of patients with SBP < 130 mmHg increased from baseline (47.3%) to 6 months (56.4%; p < .001) and to 12 months (53.1%; p < .001). The proportion of patients with BP < 130/80 mmHg increased from baseline (36.8%) to 6 months (45.1%; p < .001) and to 12 months (42.2%; p < .001) CONCLUSIONS: A QI collaborative that provides focus, structure, and strategies to help health care organizations customize and standardize processes related to BP management can improve BP control in patients with diabetes.

Continuous glucose monitoring reveals different glycemic responses of moderate- vs high-carbohydrate lunch meals in people with type 2 diabetes.

This single-center, meal-intervention, crossover study was conducted to determine the glycemic response to fixed meals with varying carbohydrate content. Continuous glucose monitoring was used to document the glycemic response. Participants were 14 people with type 2 diabetes on metformin only. On 4 consecutive days in March or July 2008, study participants consumed a fixed breakfast and one of two test meals (lunch) provided in random order. The two lunch types varied only in carbohydrate content; the protein, fat, fiber, and glycemic index were similar. They consumed no caloric food or beverages for 4 hours after each meal. Consuming double the carbohydrate content did not double the glycemic response variables, yet most were substantially different in glucose value (mg/dL) or minutes. General linear model analyses revealed substantial differences for peak glucose, change from baseline glucose to peak, time to return to preprandial glucose, 4-hour glucose area under the curve, and 4-hour mean glucose. Continuous glucose monitoring data provided a robust description of the glycemic response to the two meals. Such data can help improve postprandial glucose levels through more informed nutrition recommendations and synchronization of food intake, diabetes medication, and/or physical activity.

Diurnal glucose patterns of exenatide once weekly: a 1-year study using continuous glucose monitoring with ambulatory glucose profile analysis.

OBJECTIVE: To use continuous glucose monitoring (CGM) to characterize diurnal glucose patterns produced by a novel formulation of exenatide consisting of biodegradable polymeric microspheres that entrap exenatide and provide extended release enabling once-weekly administration. METHODS: We performed a subgroup analysis of patients with type 2 diabetes who participated in a multicenter trial (DURATION-1: Effects of Exenatide Long-Acting Release on Glucose Control and Safety in Subjects With Type 2 Diabetes Mellitus) comparing once-weekly with twice-daily formulations of exenatide. We are the only center to use CGM with ambulatory glucose profile (AGP) analysis to characterize glucose exposure, variability, and stability in participants assigned to exenatide once weekly. RESULTS: Seven of the 303 patients in the larger study population were included in the subgroup analysis. Mean age (57.6 +/- 7 years), weight (102 +/- 17 kg), body mass index (34 +/- 3 kg/m2), and duration of diabetes (5 +/- 2 years) were comparable to characteristics of the larger study population. At 30 weeks and 52 weeks, participants treated with exenatide once weekly had a mean reduction in hemoglobin A1c level of 1.3 +/- 0.3% and 1.0 +/- 0.3%, respectively (P<.05). CGM analysis revealed a significant (P<.01) decrease in diurnal glucose exposure for 4 participants during nocturnal and daytime periods. Excess glucose exposure (compared with reference values) decreased in 6 of 7 participants, as did glucose variability. Glucose stability improved in 5 participants. The percentage of glucose values less than 70 mg/dL initially increased during the first half of the study then decreased to baseline levels by study end. CONCLUSIONS: Individual glucose profiles revealed that changes in hemoglobin A1c did not consistently parallel alterations in glucose exposure, variability, and stability. AGPs provided a visual representation of improved glucose responses to exenatide once weekly.

Characterizing glucose exposure for individuals with normal glucose tolerance using continuous glucose monitoring and ambulatory glucose profile analysis.

BACKGROUND: Efforts to mimic euglycemia depend upon targets from epidemiologic studies that rely on episodic measurements reduced to statistical summaries, leaving open the question, "What is normal glycemia?" We postulated that portrayal of euglycemia was possible through application of continuous glucose monitoring (CGM) and a novel analytical tool, the ambulatory glucose profile (AGP). METHODS: Individuals with normal glucose tolerance (NGT) and with diabetes used CGM for 30 days. AGP analysis, which graphs CGM data by time without regard to date, was used to characterize glucose exposure, variability, and stability. RESULTS: Sixty-two subjects completed the study, employing CGM for 28 +/- 4 days averaging 99 +/- 18 (range, 33-125) readings per day. NGT subjects (n = 32) had a mean CGM of 102 +/- 7 mg/dL, ranging between 94 and 117 mg/dL and averaging 105 +/- 8 mg/dL daytime and 97 +/- 6 mg/dL overnight. Glucose variability, as expressed by the interquartile range, was 21 +/- 4 mg/dL (range, 14-29 mg/dL). Stability in glycemic control (hourly change in the median) for NGT subjects averaged 3 +/- 1 mg/dL/h. Subjects with diabetes (n = 30) were significantly higher on all glycemic characteristics with the exception of the percentage of hypoglycemic (CGM <70 mg/dL) episodes for type 2 diabetes (2.9%), compared to 2.7% for subjects with NGT. CONCLUSIONS: CGM technologies enabled collection of verified data under normal living conditions, providing an exceptional vantage point from which to obtain important clinical information. This will facilitate an understanding of the range of euglycemic patterns, provide a sensitive means of detecting impaired glucose tolerance, and help set realistic treatment goals for individuals with diabetes.

Evaluation of admission blood glucose levels in the intensive care unit.

OBJECTIVE: To assess the availability and clinical value of blood glucose (BG) testing at the time of admission to the intensive care unit (ICU) after such testing was implemented as routine care in the ICU. METHODS: We studied ICU admission BG testing rates and the prevalence of hyperglycemia. In this effort, we assessed the frequency of baseline BG testing in 330 consecutive patients during a period of 3 months and then implemented routine BG monitoring in 1,147 consecutive ICU patients during a 7-month period. RESULTS: Of the total study population, 25% had previously diagnosed diabetes (PDD). At baseline, 70% had BG measured within 4 hours before or after ICU admission (99% of patients with and 60% of patients without PDD). After implementation of routine BG monitoring, there was a significant increase in testing (70% before versus 87% after, P<0.001; 70% during the baseline 3-month period versus 93% in the final 3 months of the study, P<0.001). In patients without PDD, 41% had BG levels < or =140 mg/dL, and 8% had BG concentrations < or =200 mg/dL. Overall in the ICU setting, 57% of BG values < or =140 mg/dL and 33% of BG levels < or =200 mg/dL were in patients without PDD. Frequencies of BG testing by admission diagnosis included the following (at baseline and during the final 3 months after implementation of routine BG tests): postsurgical status (46%, 85%), peripheral vascular disease (51%, 90%), neurologic disease (52%, 83%), gastrointestinal disease (58%, 91%), infection (69%, 100%), and diabetes (100%, 100%). CONCLUSION: Rates of routine BG testing are low in ICU patients without PDD. Elevations in BG levels were detected in 41% of our study patients without PDD, suggesting that routine implementation of BG monitoring in an ICU will identify patients at increased risk for hyperglycemia-associated higher morbidity and mortality.

5% imiquimod cream and reflectance-mode confocal microscopy as adjunct modalities to Mohs micrographic surgery for treatment of basal cell carcinoma.

BACKGROUND: Imiquimod is an immune response modifier that up-regulates cytokines and has been shown in clinical studies to reduce or clear basal cell carcinoma tumors when applied topically. OBJECTIVE: The objectives were to evaluate the efficacy of 5% imiquimod cream in treating basal cell carcinoma preceding excision by Mohs micrographic surgery and to determine if reflectance-mode confocal microscopy is useful to establish the need for surgical intervention after imiquimod treatment. METHODS: Subjects applied study cream to one biopsy-confirmed basal cell carcinoma tumor 5 x/week for 2, 4, or 6 weeks in this vehicle-controlled, double-blind study. Confocal microscopy was used for the 6-week treatment group to examine the target tumor area at each interval visit and immediately before Mohs micrographic surgery. After the Mohs micrographic surgery excision, the tissue was evaluated histologically, and the excision area was measured. Confocal microscopy readings were correlated to the histologic diagnosis. RESULTS: Tumors cleared or the target tumor area was reduced in subjects in the 4- and 6-week dosing regimens. Confocal microscopy assessments correlated well with the histologic diagnosis. CONCLUSION: Imiquimod improved excision results relative to vehicle when used for treating basal cell carcinoma before Mohs micrographic surgery. Confocal microscopy assessments correlated well with tumor response to therapy, suggesting that confocal microscopy may help determine the need for surgery.