Gluten-free rice & bean biscuit: characterization of a new food product.

As the market does not offer a portable and long-lasting product combining rice and beans in a single preparation, this study intends to characterize a new and alternative gluten-free biscuit, based on the most classic Brazilian staple food: rice and beans. For that, six formulations were designed to test using those ingredients as raw flours and cooked grains. One of them, formulated with wheat flour served as control.

The Fallacy of Average: How Using HbA Alone to Assess Glycemic Control Can Be Misleading.

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Regular Expressions: The Build Study Vignette.

The author creates a fictional vignette to illustrate how a medical director can use data analysis to help review cases comparing attending physician statement (APS) values for build vs those reported by the paramedical examiners for the same lives. In this first of two articles, a method for extracting suitable data is explored.

T-Tests: The BMI Study Continues.

Medical directors may be asked to analyze their company's experienced laboratory results. This practical research note explores the use of the statistical programming language R for analysis. Use of the two different t-tests available in R (unpaired and paired) is explained.

Actual to expected studies--Part 2.

In Part I of this two-part series, we used a synthetic dataset which we called the "Health Risk Appraisal" dataset. Using this dataset, we performed an actual/expected mortality study using one and only one health assessment per individual. This synthetic dataset is actually more realistic in that many persons were evaluated more than once.

Converting Lab Report Files into Usable Data.

Medical directors may be asked to analyze their company's experienced laboratory results. This practical research note uses the example of trying to help predict the distribution of proposed insured's under a new preferred risk program as a way to illustrate how to marshal a company's lab results into a suitable dataset for analysis.

Mortality and Disease Prevalence among the Oldest Old.

Despite mortality improvements, mortality rates among the oldest old (ie, ages 90+) are still extremely high - high enough to invalidate commonly used rules of thumb that apply at younger ages. Due to the "bathtub" relationship between incidence, recovery, death, and prevalence, the prevalence of such chronic conditions may actually drop at the oldest ages, even without medical improvements in prevention or treatment.

Actual to expected studies--Part 1.

In this Part 1 of a two-part series, pivot tables are used to analyze mortality and then a step-by-step process is demonstrated of converting seriatim data that is suitable for pivot table analysis.

Recommendations for standardizing glucose reporting and analysis to optimize clinical decision making in diabetes: the ambulatory glucose profile.

Underutilization of glucose data and lack of easy and standardized glucose data collection, analysis, visualization, and guided clinical decision making are key contributors to poor glycemic control among individuals with type 1 diabetes mellitus. An expert panel of diabetes specialists, facilitated by the International Diabetes Center and sponsored by the Helmsley Charitable Trust, met in 2012 to discuss recommendations for standardizing the analysis and presentation of glucose monitoring data, with the initial focus on data derived from continuous glucose monitoring systems. The panel members were introduced to a universal software report, the Ambulatory Glucose Profile, and asked to provide feedback on its content and functionality, both as a research tool and in clinical settings.

Modeling total cholesterol as predictor of mortality: the low-cholesterol paradox.

Elevated total cholesterol is well-established as a risk factor for coronary artery disease and cardiovascular mortality. However, less attention is paid to the association between low cholesterol levels and mortality--the low cholesterol paradox. In this paper, restricted cubic splines (RCS) and complex survey methodology are used to show the low-cholesterol paradox is present in the laboratory, examination, and mortality follow-up data from the Third National Health and Nutrition Examination Survey (NHANES III).

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.

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.

Evaluating the accuracy, reliability, and clinical applicability of continuous glucose monitoring (CGM): Is CGM ready for real time?

Background: This study was designed to assess the accuracy, reliability, and contribution to clinical decision-making of two commercially available continuous glucose monitoring (CGM) devices using a novel analytical approach.

Study Design: Eleven individuals with type 1 diabetes and five with type 2 diabetes wore a Guardian RT (GRT) (Medtronic Minimed, Northridge, CA) or DexCom STS Continuous Monitoring System (DEX) (San Diego, CA) device for 200 h followed by an 8-h laboratory study. A subset of these subjects wore both devices simultaneously.

Secondary cancer and relapse rates following radical prostatectomy for prostate-confined cancer.

In the SEER database, it is relatively easy to identify secondary cancers that follow an initial diagnosis of cancer. However, the SEER public-use data does not explicitly capture relapse of the initial cancer. One can assume that organ-confined prostate cancer treated by radical prostatectomy will show no evidence of disease after treatment.

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.

Pivot tables for mortality analysis, or who needs life tables anyway?

Actuarial life-table analysis has long been used by life insurance medical directors for mortality abstraction from clinical studies. Ironically, today's life actuary instead uses pivot tables to analyze mortality. Pivot tables (a feature/function in MS Excel) collapse various dimensions of data that were previously arranged in an "experience study" format.

Secondary cancer rates following breast cancer diagnosis.

Life table analysis and other mortality methods apply well to end points other than mortality. This paper demonstrates the application of mortality experience methodology to the recurrence of breast cancer and/or new primaries in women previously diagnosed with primary breast cancer. Specific recurrence rates are broken out by duration as well as attributes available at the time of primary breast cancer diagnosis: stage, histology, age band, and year of diagnosis.