For years, doctors and patients have been waiting for the arrival of an “artificial pancreas” to take the guesswork out of life with diabetes by measuring blood sugar levels and automatically delivering the amount of insulin needed to keep the disease in check.
But now that this experimental device is close to becoming reality, a new study suggests that tests to date have largely ignored a big segment of the patient population that might use it – people of color.
This oversight is leading to “a minority digital diabetes divide,” said senior study author Dr. David Kerr of the William Sansun Diabetes Center in Santa Barbara, California.
“Minorities already have worse control and more complications of diabetes in general,” Kerr said by email. “Failure to understand the potential social and cultural determinants of health and disease could lead to their exclusion from accessing and affording this potential life-changing technology.”
To see how many non-white patients have been included in tests of the artificial pancreas, Kerr and colleagues reviewed 99 previously published studies on the device.
Only six of these studies mentioned race or ethnicity at all, and just four reported the number of participants belonging to different racial or ethnic groups, researchers report in The Lancet Diabetes and Endocrinology.
In one of those four studies, 43 of the 46 participants were white. Similarly, in a second study 24 of 25 people were white, as were 11 of 15 and 11 of 12 in the two other tests that included racial and ethnic data.
These patients had what’s known as type 1 diabetes, a chronic condition typically diagnosed in children and young adults. With this type of diabetes, the pancreas produces little or no insulin, a hormone needed to allow blood sugar, or glucose, to enter cells and produce energy.
People with type 1 diabetes typically have to test their own blood sugar levels throughout the day and inject insulin to manage it. Nights are often a problem because dangerous blood sugar changes can happen while the person is sleeping, and automatic blood sugar monitoring and delivery of insulin is one solution.
Poorly controlled, diabetes can lead to cardiovascular disease, kidney complications and death.
While the artificial pancreas remains an experimental device, research to date suggests it may be a safe and effective way for patients to manage diabetes and minimize the risk of complications.
Because white patients appear to make up the majority of trial participants, they’re getting access to the device much sooner than patients of color who might benefit from the chance to join the trials, the study authors argue.
This would put white patients at the front of the line to get the device, also known as a closed loop insulin-delivery system, when it becomes commercially available as early as next year, the authors note.
At the same time, it’s possible patients of color might have different outcomes with the device that won’t be discovered because the trials included mostly white people.
It isn’t unusual for smaller initial tests of new devices to exclude data on the race or ethnicity of participants, said Dr. Roman Hovorka, of the University of Cambridge Metabolic Research Laboratories in the UK.
But when these tests include mostly white people, it can limit how much the results will apply to the general population, Hovorka, who wasn’t involved in the current study, added by email.
“The research should be inclusive to allow generalizability of the results,” Hovorka said.