Medical Device Daily

Short of a cure for diabetes, the “Holy Grail” to treat this disease is rather obvious — a “closed-loop” system that connects a continuous blood glucose sensor that provides real-time data to an insulin pump, with the pump then responding with the exactly right amount of insulin, the sensor then establishing that the correct balance has been achieved ... and around ... and around.

But a panel discussion at this year’s Piper Jaffray Healthcare Conference to discuss the latest developments in diabetes treatment made it clear that this loop has to contain more than these two technologies, even in advanced form.

Panelist Aaron Kowalski, MD, PhD, director of strategic research projects for the Juvenile Diabetes Research Foundation (JDRF; New York), said that the “nuts and bolts are here” for such a closed-loop system that is foreseen and essentially intended to work as an artificial pancreas. And he and the other panelists agreed that while the ultimate may be a system that is totally implanted within the body, this was not necessary in a first-generation device.

Rather, he said that a sensor/pump combination essentially working in outside-the-body modalities would “make it convenient for people who right now can’t use implanted continuous sensors.”

But he noted a rather large piece needed to create these technology combinations: dollars.

“We need a thriving market for continuous glucose sensors,” Kowalski said. “The companies won’t keep going [to create them] if they can’t make money on continuous sensors.”

Heartily agreeing was William Tamberlane, MD, professor and chief of diabetes medicine of the School of Medicine at Yale University (New Haven, Connecticut).

Tamberlane said that the required technologies to provide the sensing and pumping in a combined, outside-the-body system “are here, now — no technical or clinical obstacles.” And he cited research at Yale demonstrating the ability of automatic systems to produce “target-range” glucose levels “with no patient interaction” — meaning no need for the patient to push buttons or take manual measurements.”

And he too said that to put such systems into commercialization the need was for a “viable market” for the sensors and pumps.”

Tamberlane noted the “Catch 22” of early pump development that persists today. While he said that the early roll-outs were greeted with enthusiasm, the business was nearly “dead in the mid-to late-80s” for lack of sufficient data on their efficacy. And because they weren’t being used, the data was difficult to develop.

But Tamberlane noted a gradual upsurge, pointing to his group’s work with children at the end of the last century and the ability to use the pumps even with children having “difficult” diabetes.

The pumps “got better and continue to get better,” he said. “We’re looking for the retirement dinner for the syringes and the pens.”

The development of clinical evidence concerning pump efficacy was just one more part of the development loop — and seen especially important for what Kowalski described as leading to a final piece to complete it: governmental reimbursement.

JDRF in September rolled out its program to fund a broad array of clinical studies, and Kowalski said this was first based on some significant background work. He said the foundation put together a team to survey “a number of payers, private HMOS, leading people in the payment world.” And he said that what resulted from those contacts was “interesting” — they were not as interested in some of the clinical endpoints and hospitalizations as they were in “well-done, quality-of-life studies. We found out that quality of life was important.”

Using some of this information, the JDRF in September rolled out a broad array of studies that will investigate the benefits of strong glucose control in about 500 patients using close monitoring techniques to control glucose ranges and also look at the “health economics” of short-term and long-term benefits.

The amount of time spent “out of work, out of school is quantifiable,” Kowalski said, and that these studies are about to be launched in several cities following independent review board approvals.

Which technologies will be used in the studies, he said, has been a frequent question. But he said that it is “impossible trying to pick a winner — all of these devices function very, very well if you do it with the right mindset.”

Thus, the research will not be tied to particular devices but rather will emphasize a strategy of “intensive management vs. regular management, continuous sensing vs. regulator management,” and that allowing physicians to use devices from any of the three companies making them “allows the flexibility ot have the physician prescribe the device best suited for the patient.

Tamberlane — who will be one of the researchers involved in the study — praised the efforts of the JDRF to push forward this type of independent study to develop a broad database of usable evidence.

“JDRF has set the standard for raising funds for Type 1 diabetes,” he said. “But even more remarkable is their lobbying ability.” He said the organization represents “the voice of the consumer. They are incredible people when they think something is valuable.”

JDRF’s trials are of two kinds:

A Continuous Glucose Sensor Clinical Trial will compare health outcomes — such as HbA1c levels and avoidance of hypoglycaemia — of people who use continuous glucose sensors to those who do not, to quantify the benefits of these devices.

And an Artificial Pancreas Consortium will work collaboratively to research potential algorithms for a closed-loop system that links continuous glucose sensors and insulin pumps to automatically dispense insulin to patients with Type 1 diabetes. The trial will specifically investigate whether continuous glucose sensors have a direct impact on better glycemic control, reduced HbA1c levels, and hypoglycemia. It also will explore the impact of sensors on other aspects of diabetes care, such as quality-of-life issues, for the children using the devices, as well as their parents.

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