Inspired by his son’s illness, Dr. Edward Damiano, a Boston University professor, studies diabetic pigs in hopes of helping people with diabetes automatically regulate their blood-glucose levels.
Because he helps his son cope with diabetes — a disease in which the body does not properly produce or store insulin, a hormone needed to convert sugar into energy — Damiano understands the tedious schedule and several daily finger pricks it takes to measure and manage blood-glucose levels.
Damiano, a Boston University Biomedical Engineering professor, said a grant from the Wallace H. Coulter Foundation made his group’s pre-clinical testing possible.
The Coulter Foundation awarded a five-year, $1 million-per-year grant in 2005 to the department, along with eight other U.S. schools with the intention of improving current technologies and patient care processes.
FROM PIGS TO PATIENT CARE
Damiano is using diabetic pigs to test research that aims to eventually make blood-glucose regulation automatic. People with Type 1 diabetes use a complicated open-loop system that requires frequent monitoring: They check their blood-glucose levels with a finger prick meter and then use the reading to decide how much insulin (in the case of high blood sugar or carbohydrate consumption) or carbohydrates (in the case of low blood sugar) to deliver.
Damiano’s project would develop a closed-loop system that would regulate blood sugar automatically.
“The idea would be to combine three technologies,” Damiano said.
Closed-loop blood-glucose control includes an infusion system, a sensor and a control algorithm. The infusion system is responsible for insulin injection that with closed-loop control is a pump. The sensor would give continuous data every five minutes rather than a few times a day. Finally, the control algorithm takes the data from the sensor monitor and makes a therapeutic decision as frequently as data comes in to optimally control blood-sugar levels.
“We’re in the process of building the control algorithm,” Damiano said. “The ‘smarts’ hasn’t been very well tested yet. That’s what we are hoping to do this spring in our human testing in the context of closed-loop control.”
In order to test their control algorithm, Damiano and his team are currently conducting a small pilot study on diabetic pigs. As Damiano and his team are in the process of building the control algorithm, they isolate the algorithm by using two good quality, standard infusion pumps. Each pig has a pump that injects beta insulin which lowers blood sugar and one that injects alpha glycogen which stimulates the liver to raise blood sugar.
“Using two gives us a safety net,” Damiano said. “This is exactly what people who do not have diabetes do. They produce insulin when they overshoot and glycogen when they undershoot.”
Damiano explained that people with diabetes are unable to produce insulin and they are unable to sense blood sugar levels.
While two pumps are used in Damiano’s experiment, the actual system including the infusion system, the sensor, and the algorithm will be an ambulatory system so that people can wear it while walking around and remaining active. In order to achieve this, there will be a sensor that goes through the skin and a pump the size of a cell-phone that the person wears. Damiano’s control algorithm will also be located on the pump.
The pig testing process is the same that will be conducted in clinical trials. Damiano said that pending FDA and IRB approval of their device, they hope to begin testing on healthy adults with Type 1 diabetes within three to four months.
Damiano’s project is an example of the Coulter Foundation’s goal as they have received additional post-Coulter funding from the Juvenile Diabetes Research Foundation.
“This funding from the Coulter Foundation has allowed us to procure additional funding from the Juvenile Diabetes Research Foundation for human trials and pig trials,” Damiano said. “It’s really a great resource. Not only do investigators benefit from the funding the Foundation offers, but we also benefit from the knowledge and experience that the Coulter Oversight Committee has to offer.”
“It came at a critical stage in the early phases of the project,” Damiano said. “It allowed necessary resources for the project.”
As a result of his current success and with encouragement from the Coulter Foundation, Damiano is applying for another Coulter grant Dec. 3, the first deadline for the 2008 awards. The proposed project is similar to his current project, but would be a closed loop system for Intensive Care Unit patients.
“The purpose in giving us this grant is to partner an engineer with a clinician to take something we can build in a lab and in a few years use on a patient,” said BU’s Coulter Foundation Research Administrative Director Jen Marron.
FLUX OF FUNDS FOR REFLUX
Other Coulter Foundation projects underway are those of BU Biomedical Engineering professors Dr. Irving Bigio and Dr. Satish Singh. Singh and Bigio are working together on a project developing an optical sensor, a special viewing instrument that allows surgeons to see images of the body’s internal structures through very small incisions. The optical sensor would facilitate biopsies, the removal of tissue, in Barrett’s Esophagus, a condition that affects people with chronic reflux and can lead to a higher rise of esophageal cancer. They also hope to aid the removal of malignant polyps, growths of extra tissue in the large intestine, in people with colon cancer.
The current method of care for people with Barrett’s Esophagus is random biopsies. Bigio said that their proposed optical sensor would be beneficial for doctors and patients by taking a lot of the guess work out of treatment by indicating which tissue has a higher risk of malignancy.
In patients with colon cancer, the optical sensor would allow doctors to remove only the potentially dangerous polyps rather than every one, as is the current procedure according to Bigio.
WELL-ENDOWED ENGINEERS
The members of the BU Team Coulter and their Oversight Committee act as a “funding agent” as they decide what proposed projects will be awarded a one-year grant of various amounts every year.
“We fund projects that are worthwhile and have a high clinical impact,” Marron said. “We fund ones that improve what’s currently out there, and also ones that can either make commercial impact or get to a patient in three to five years.”
Marron said the grants vary from $30,000 to $100,000 and are meant to finance primary clinical research.
“It’s a small amount of money, but it is helping fill a very specific need,” Marron said.
The Coulter grant is helping scientists obtain follow-up funding for continued research and development after the grant. It is the primary role of BU Coulter Project Director Dr. Art Rosenthal to partner projects with potential commercial outlets.
Vice President and General Counsel of the Wallace H. Coulter Foundation Wayne Barlin said the purpose of the Coulter grants is to “aid research in the late stages to move toward patient healthcare in a more rapid manner.”
As a new program, the Foundation currently has no projects in the commercial market. Out of all working projects at the nine schools including Georgia Tech, University of Virginia, Stanford University and Duke University awarded Coulter grants, Barlin said that they hold high hopes for the upcoming commercial progress of Damiano’s project.
SHOW BU THE MONEY
Current funding for these projects ends in March at which time Bigio said he hopes to have acquired a company to commercialize their instrument.
While the Coulter Foundation funds projects proposed by professors, many students have the prospect of getting involved.
“We have a lot of opportunities,” said Marron. “And this type of funding opens a lot of doors for graduate students.”
Marron said that each project is assigned a graduate student; however, some undergraduate students are given the chance to work on a project.
Bigio said an undergraduate student was able to assist him as part of her senior project.
In addition to the current five-year partnership with the Coulter Foundation, BU’s Biomedical Engineering department is being considered for a permanent $10 million endowment.
“If they like what we do with their money, we are in the running for a permanent endowment of this money,” Damiano said.
“We have a very strong Biomedical Engineering department, close contact with our medical campus and close contact with Longwood Medical area, lots of clinicians to partner with and a very committed office of tech development,” Marron said.