Posted by Staff
Clinical Trials
Sunday, December 29th, 2013
Springer – Diabetologia: January 2014
Aims/hypothesis
Insulin degludec (Des(B30)LysB29(γ-Glu Nε-hexadecandioyl) human insulin; IDeg) is a new basal insulin with an ultra-long flat action profile. The acute physiological responses to hypoglycaemia with IDeg and insulin glargine (A21Gly,B31Arg,B32Arg human insulin; IGlar) were compared.
Methods
Twenty-eight adult type 1 diabetic patients with normal hypoglycaemia awareness (age = 41 ± 12 years, HbA1c = 7.8 ± 0.6% [62.8 ± 7 mmol/mol]) were randomised to once-daily IDeg or IGlar for 5 days in a two-period crossover design. Participants and research staff were blinded to group assignment. Patients were assigned the lowest available randomisation number from a set of blinded randomisation codes provided by the trial sponsor. Hypoglycaemia was induced by administering three times the usual daily insulin dose at midnight on day 5. Plasma glucose (PG) was stabilised by glucose clamp (5.5 mmol/l) for 7–9 h post dosing. Next morning, PG was allowed to decrease stepwise from 5.5 to 3.5 mmol/l (maintained for 30 min) to 2.5 mmol/l (for 15 min). PG was then increased to 3.9 mmol/l (for 120 min), before being returned to baseline. Hypoglycaemic symptom score (HSS), hypoglycaemic awareness, cognitive function, counter-regulatory hormones and vital signs were assessed during each glucose plateau. The primary analysis was to compare IDeg vs IGlar with respect to HSS at nadir PG concentration (2.5 mmol/l). Read More
Posted by Staff
Clinical Trials
Sunday, December 29th, 2013
American Journal of Public Health: Sep 21, 2013
Sheba George is with the Center for Biomedical Informatics, Charles R. Drew University of Medicine and Science, and the Department of Community Health Sciences, University of California Los Angeles (UCLA) Fielding School of Public Health, Los Angeles. Nelida Duran is with the Department of Community Health Sciences, UCLA Fielding School of Public Health. Keith Norris is with the Division of General Internal Medicine and Health Services Research, David Geffen School of Medicine at UCLA, Los Angeles. Read More
Posted by Staff
Clinical Trials
Sunday, December 29th, 2013
BMJ: 12/5/13
FDA investigator Thomas Marciniak has spoken out over drug companies and missing or “bad” data, most famously over rosiglitazone. He tells Deborah Cohenhow he believes the current research and development process is broken
The clinical trial system is broken and it’s getting worse, according to longstanding Food and Drug Administration investigator, Thomas Marciniak.
For seasoned observers of the drug approval process, Marciniak will be a familiar name and his comments will come as little surprise. In his 11 years at the US federal agency, Marciniak has been embroiled in high profile controversies that have pitted him against his employer—most notably in his assessment of the diabetes drug rosiglitazone (Avandia). This particular battle is one that he may have lost. The FDA has just decided to reverse restrictions placed on the drug that it had introduced in 2010 partly as a result of his assessment of a trial assessing the cardiovascular risks of rosiglitazone (see box). Read More
Posted by Staff
Clinical Trials
Sunday, December 29th, 2013
Biostatistics: September 25, 2013
The accuracy of published medical research is critical for scientists, physicians and patients who rely on these results. However, the fundamental belief in the medical literature was called into serious question by a paper suggesting that most published medical research is false. Here we adapt estimation methods from the genomics community to the problem of estimating the rate of false discoveries in the medical literature using reported P-values as the data. We then collect P-values from the abstracts of all 77 430 papers published in The Lancet, The Journal of the American Medical Association, The New England Journal of Medicine, The British Medical Journal, and The American Journal of Epidemiology between 2000 and 2010. Among these papers, we found 5322 reported P-values. We estimate that the overall rate of false discoveries among reported results is 14% (s.d. 1%), contrary to previous claims. Read more
Posted by Staff
Clinical Trials
Sunday, December 29th, 2013
Journal of Medical Internet Research: 9/12/13
Background: Self-management is an important skill for patients with diabetes, and it involves frequent monitoring of glucose levels and behavior modification. Techniques to enhance the behavior changes of diabetic patients have been developed, such as diabetes self-management education and telehealthcare. Although the patients are engaged in self-management activities, barriers to behavior changes remain and additional work is necessary to address the impact of electronic media and telehealthcare on patient self-care behaviors.
Objective: The aims of this study were to (1) explore the behaviors of diabetic patients interacting with online applications, (2) determine the impact of a telehealthcare program among 7 self-care behaviors of the patients, and (3) determine the changes in glycosylated hemoglobin (HbA1c) levels. Read more
Posted by Diabetes South Texas Staff
Clinical Trial News
Sunday, December 15th, 2013
Diabetes Care: December 6, 2013
Objectives To develop and pilot a novel intervention addressing motivational and cognitive barriers to avoiding hypoglycemia in people with type 1 diabetes and persistent impaired awareness of hypoglycemia (IAH) despite training in flexible insulin therapy.
Research Design and Methods A 6-week intervention using motivational interviewing and cognitive behavioural techniques was designed. Diabetes educators were trained and supported in its delivery to 23 people with IAH (Gold score ≥4) Read More
Posted by Staff
News
Sunday, December 15th, 2013
Valley Morning Star: Saturday, November 23, 2013
HARLINGEN — A San Antonio filmmaker paints a grim picture of diabetes in the Rio Grande Valley.
“Diabetes hits the Valley especially hard. The impact on the country’s entire health system could become catastrophic in the next few years,” filmmaker Michael Seringer said.
“Whether South Texas will be able to curb the diabetes boom before it overloads the system remains to be seen,” he said.
Seringer was scheduled to be in Harlingen on Saturday for a showing of his documentary “Diabetesville USA: Lessons from the Frontlines of the South Texas Diabetes Epidemic.” However, he was not able to attend because of an illness in the family.
The film tells the story of how diabetes kills, cripples and blinds thousands of residents of Harlingen, Brownsville, McAllen and other Valley cities, where it is estimated that more than 29 percent of the population has diabetes. Parts of the documentary were filmed in Cameron and Hidalgo counties. Read More
