Medical Device Daily Executive Editor

SAN DIEGO – Several papers published as part of the collection of abstracts for the 65th scientific sessions of the American Diabetes Association (ADA; Alexandria, Virginia), held here this week, touched on topics of interest to those on the glucose testing side of the treatment equation.

In one of the papers published, but not presented either orally or as a poster, a group of Scottish and U.S. researchers reported on their meta-analysis of published studies on the choice of fingertip or palm as a less-painful site for self-monitoring of blood glucose.

A total of five clinical studies were selected for analysis, yielding data from 290 trial subjects with and without diabetes (a range of 20 mg/dl to 139 mg/dl, with 126 mg/dl being the point of determination of diabetes).

In studying pain data from each of the studies, results in four of the five studies showed “a significant decrease” in perceived pain observed when testing on the palm was compared to the traditional fingertip location.

Two U.S. researchers also looked at whether palm and fingertip glucose testing are equivalent – this time in a cohort completely comprised of pediatric patients. Noting that compliance with blood glucose testing recommendations in children “may be decreased due to the pain of fingertip testing,” they noted that the palm is an alternate site with the fewest pain receptors.

The testing involved the use of the OneTouch Ultra System from LifeScan (Milpitas, California), a unit of Johnson & Johnson (New Brunswick, New Jersey). The study cohort included 35 children, average age 13.2.

The researchers said that a high percentage of clinically acceptable glucose readings were obtained at two different palm sites (92.4% at one, 100% at the other), and that overall, palm testing, at areas known as either the thenar or hypothenar region, “was equivalent to fingertip testing whether performed by HCPs or pediatric patients.”

In a similar U.S. palm-vs.-fingertip study, this one eyeing whether the two sites produce similar results even given the presence of cardiovascular disease (CVD), researchers said atherosclerosis or medications taken for CVD may affect regional vasculature or blood flow.

Also using the OneTouch Ultra System, the study compared 95 subjects with a history of myocardial infarction, congestive heart failure, angina, hypertension, stroke or peripheral vascular disease to 86 patients without such a history.

The researchers conducted 612 palm tests in the CVD group and 483 in the non-CVD group and said their study “confirms that [blood glucose] testing at the palm is equivalent to fingertip testing, even for subjects with CVD.”

In another report published in the ADA abstracts, a group of Miami researchers looked at the reliability of continuous glucose monitoring in an intensive-care population with hyperglycemia (high blood glucose readings).

They recorded concomitant readings using the Medtronic MiniMed (Northridge, California) Guardian CGMS and SureStep Pro capillary blood glucose (CBG) system from LifeScan.

Analysis of the readings led to the statistical conclusion that CGMS “yields a measure that is as good as CBG,” the researchers said. They concluded that, “given these results . . . CGMS could complement CBG readings in critically ill patients and be used to facilitate the management of hyperglycemia in this setting.”

In a follow-up study on the feasibility of CGMS in the critically ill, that same group looked at 197 pairs of CGMS and CBG readings in 12 ICU patients and concluded that CGMS “may prove useful in the management of insulin infusions in the critically ill if developed to report measurements continuously.”

A group of German researchers studied results of continuous glucose monitoring using the Medtronic MiniMed CGMS during rapid and moderate, insulin-induced glucose variations.

Noting that “some objections have been raised about the reliability of alternate glucose measurement techniques, especially during rapid, insulin-induced glucose declines,” the researchers looked at 12 Type 1 diabetic patients, each of whom received 75 grams of liquid glucose.

After two hours, insulin was applied intraveneously or subcutaneously in randomized sequence to achieve either rapid or modest glucose decline. CGMS readings were compared to reference glucose measurements obtained by the traditional fingerstick method every 15 minutes.

The study confirmed what the researchers characterized as “a good reliability of CGMS readings” in rapid glucose decline following insulin objection.

In a pilot study, another group of German researchers looked at use of the Medtronic MiniMed CGMS in conjunction with the LifeShirt from VivoMetrics (Ventura, California), which can monitor continuous, ambulatory cardiovascular and pulmonary parameters). Change in mean heart rate and mean breath rate was investigated.

The researchers said the combined use of the LifeShirt and CGMS data “allows new insights into the correlation between physiologic reaction patterns and high [blood glucose] periods” in Type 2 diabetes patients.

A Canadian study involved premarket assessment trials of a new technology, AccuScreen from Ceapro (Edmonton, Alberta), to detect pre-diabetic and diabetic conditions. AccuScreen is a simple, point-of-care tool to detect elevated glucose levels. It consists of calibrated wafers made from a formulation of proteins, fats and complex carbohydrates consumed with a glass of water following an overnight fast. An analysis of blood glucose is carried out with a standard glucose meter.

Field trials of AccuScreen in what were described as “distinct communities and potential user sectors,” including a North American Aboriginal community in Alberta, indicated a statistically significant increase in the percentage of persons detected by the AccuScreen method as being in a pre-diabetic condition compared to the number identified using the gold-standard fasting plasma glucose and fasting capillary glucose tests.

Another group of researchers looked at the level of accuracy of paper logbooks vs. meter downloads, determining that both fictitious and missing logbook entries are common, “even when patients are followed closely and are clearly aware that analysis of the data is being used for insulin adjustment.”

They said their findings “highlight the need for HCPs [healthcare practitioners] to review electronic logbooks or computerized downloads of glucose data when adjusting therapy.”