“It’s been just great,” said Jim Lurie, a New York City attorney and a patient at the Naomi Berrie Diabetes Center, about his participation in the WISDM (Wireless innovation for Seniors with Diabetes Mellitus) clinical trial. As part of the study, Jim, 66, is wearing a Continuous Glucose Monitor (CGM) for the first time since he was diagnosed with type 1 diabetes (T1D) two years ago. Prior to the CGM Jim was dosing his disease the old fashioned way—"two shots a day,” he said, “A Humalog shot before dinner and a long-term Lantus shot at night.”
Thanks to the Berrie Center, the WISDM trial, his CGM and the Clarity application (that allows him to see his trends on his iPhone and share them with his care team at the Berrie Center), Jim has been able to make meaningful changes to his daily diabetes management. “I’ve been able to lessen my dosage before dinner because I can see where I am and what my trend has been,” he said. “It has also helped me to see that my dosing at night has been spot on. Now I know I am better controlled rather than basing the dosage just on what the meter says.”
Jim is one of 200 people around the country enrolled in the WISDM trial, which is funded by the Leona M. and Harry B. Helmsley Charitable Trust and the Juvenile Diabetes Research Foundation (JDRF) and coordinated by the JAEB Center for Health Research in Tampa, Florida. The Berrie Center is one of a group of Centers in the United States offering WISDM to patients over 60.
The objectives of the study are multifold: To improve the quality of life for seniors; To determine if the CGM can reduce hypoglycemia, an important aspect of management of T1D in older adults; To lower A1C, the test that measures average blood glucose levels over the past two to three months; To evaluate the cost-effectiveness of the CGM relative to care as usual, and to collect badly needed data on people’s experiences with the CGM for insurance companies, Medicaid and Medicare.
WISDM is a one-year trial with two randomized groups—a CGM group and a control group. The CGM group is asked to use a Dexcom G5 on a daily basis, inserting a new sensor as needed. Participants are instructed in using the sensor according to FDA labeling and also learn how to utilize the CGM data for diabetes management as Jim did. They are monitored with monthly visits with Analia Alvarez, the Clinical Research Nurse at the Berrie Center working on WISDM, for the first six months and then bi-monthly visits with her for the rest of the year.
The control group of patients uses a blood glucose meter (issued by the study) for finger-stick glucose checks with a recommendation of 4 checks per day. Patients will also have monthly visits with Analia, and after six months, this group switches over to using the CGM.
So far, says Analia participants report a positive experience. “There was some struggle to use the technology in the beginning, but with education and reinforcement of education, the people using the CGM say they have greater peace of mind,” said Analia “One person felt relieved to have to prick her fingers fewer times per day. People on the sensor report feeling more in control of their lives. Now they have a better sense of their glucose trends for insulin doses instead of basing the dose on a point in time.”