Study offers hope for hard-to-treat type 2 diabetes

Lisa Mercer had tried just about everything to regulate the ups and downs of her blood sugars, from a strict diet to medication to four-a-day-day insulin shots.

But her busy life with type 2 diabetes finally started to feel better when she enrolled in a clinical trial at St. Joseph’s Health Care London to test the effectiveness of a system that combined glucose monitoring with an automated insulin pump.

“It was life-changing for me. I was diagnosed with type 2 diabetes 25 years ago and my blood sugars have always been all over the map. I felt sort of helpless. I said yes to this clinical trial because I hoped it would return some normalcy to my life,” she says. Now that study, with results newly published in the prestigious New England Journal of Medicine, is being heralded as a big step forward for patients with hard-to-treat type 2 diabetes.

“This is an exciting finding because it shows we can improve patients’ blood sugars and hopefully prevent long-term negative consequences of high sugars while at the same time making it easier for patients to manage the disease,” says Dr. Tamara Spaic, Medical Director of St. Joseph’s Diabetes Education Centre and the lead Canadian researcher for the multi-site international study based at the Jaeb Center for Health Research in Tampa, Fla.

Study participants were placed either in a group testing the effectiveness of a new system called Control IQ+ or a control group continuing their existing diabetes management regimen.

The intervention group wore glucose monitors that electronically talked with high-tech pumps that delivered insulin – automatically, in the right dose and at the right time – with minimal patient input.

While the device was approved about five years ago for people with type 1 diabetes, this is the first examination of its effectiveness managing the complexities of type 2 diabetes.

“The biggest burden in diabetes control is that it’s 24/7 vigilance: did I eat or not; what did I eat and how much; did I exercise; do I need to wake up for an insulin shot in the middle of the night? This system largely removes those variables to bring blood sugars to target levels,” says Spaic, who is also a Lawson Research Institute scientist and professor of endocrinology and metabolism at Western University’s Schulich School of Medicine & Dentistry.

“What surprised us was that this worked so well across all populations regardless of duration of the disease, amount of insulin needed, whether they used other medications or not, whether they were tech-savvy or not. It worked for everyone regardless of their ethnicity, socioeconomics, and whether they were male or female, old or young,” she adds.

Researchers even asked participants in the intervention group to skip insulin with meals on occasion – generally a no-no in the highly regimented life of someone with insulin-managed diabetes – and the automated system responded appropriately and quickly to adjust blood sugars.

Mercer found improvement within a couple of weeks: “Before the pump, I felt awful. When my sugars were too low, I got the shakes, I had trouble communicating and thinking clearly and I got extremely tired. When my sugars were too high, I was exhausted. It dominated every day and was tough on my job as a police officer. Now I feel better. I feel more in control.

“Is it perfect? No. But my sugars are stable and consistent more often than not.”

Not yet approved in Canada

In February, the US Food and Drug Administration cleared the use of the Control IQ+ system in adults with type 2 diabetes – approval that also meant the expense could be covered through health insurance.

However, it has not yet been brought to Health Canada regulators for approval, Spaic says.

Even so, several of her patients, including Foster, decided to continue using the system after the 13-week trial, paying out-of-pocket or through private insurance.

Spaic and St. Joseph’s colleagues, endocrinologist Dr. Selina Liu and nurse coordinator Marsha Driscoll, were extensively involved in the design of the study, recruiting and monitoring participants and reporting results.

Diabetes type 2 usually develops in adulthood and is a condition in which body cannot make enough insulin or does not properly use the insulin it makes to regulate the amount of glucose (sugar) in the blood.

While most people with type 2 diabetes can control their blood sugars through lifestyle changes or with new treatments such as non-insulin glucose-lowering medications, the sub-set of North Americans who require insulin still numbers in the millions.

THE STUDY:

What: 13-week, large-scale clinical trial to test the effectiveness of a system combining automated insulin delivery with continuous glucose monitoring for people with type 2 diabetes.

Who: 319 study participants – including 13 at Lawson Research Institute of St. Joseph’s Health Care London – all needing multiple daily insulin doses. Age range 19 to 87, from 21 centres across the U.S. and Canada. Study led by Jaeb Centre for Health Research in Tampa, Fla., and funded by Tandem Diabetes Care, which also provided the automated insulin-delivery systems

How: Two-thirds of patients received an automated insulin pump, continuous glucose monitor and transmitter to track and automatically administer insulin to regulate their blood sugars. A control group continued their existing insulin-delivery method and also received glucose monitors.

Results: The intervention group had more stable blood sugar levels – with 3.4 more hours per day in the target glucose range – than the control group. Use of automated insulin devices was successful and safe even for patients without previous experience with an insulin pump

Why it matters: Automated insulin delivery can help insulin-dependent patients manage their type 2 diabetes better than before. Better management means improved quality of life and may result in fewer diabetes complications such as heart disease and damage to the eyes, kidneys and nerves.