Setting the standard
In the quest to cure diabetes, better research standards needed
By Czerne M. Reid
A cure for Type 1 diabetes has been the holy grail of researchers worldwide since the first clinical trials seeking to cure the disease began some three decades ago. But despite many advances, the target still seems just out of reach. That point was made frustratingly clear for scientists worldwide this year when several clinical trials that had held great promise based on laboratory studies yielded disappointing results.
A lack of universal standards for defining diabetes and reversal of the disease in animal studies makes it difficult to translate laboratory successes into human trials, said Mark A. Atkinson, Ph.D., an eminent scholar in the College of Medicine department of pathology, immunology and laboratory medicine and co-director of the UF Diabetes Center of Excellence.
In a commentary appearing Aug. 17 in the journal Science Translational Medicine, Atkinson proposed criteria on which the scientific community can hinge discussions aimed at building a consensus and forging a foundation for more successful human trials.
Laboratory studies have paved the way for clinical trials in humans. But without better animal models and a standardized way to define the disease or its reversal in those models, it has been difficult to develop an effective clinical strategy. Individual researchers have been free to decide in their own animal studies what blood sugar levels over what time frame indicate diabetes, how long to administer therapies being tested, how many animals to treat, what represents a cure, and other variables.
Implementing standards could help advance research efforts, because laboratory studies could be compared more easily. That would enable only the most promising methods to proceed to human trial, and in so doing, ease emotional turmoil and stress for patients, families and investigators, reduce the number of animals used in laboratory studies, and cut costs.
Atkinson’s suggestions for standardizing diabetes reversal studies include establishing a minimum number of animals used, defining control groups, limiting the age of specimens used, and standardizing the time from the onset of high blood sugar to the start of treatment. He also calls for the definition of diabetes to be based on blood rather than urine measurements, establishment of a specific blood glucose concentration as the threshold for diabetes onset, and agreement on whether insulin therapy should be used after diagnosis.