14 Nov. 2018. A new clinical trial is testing a diabetes management program that includes Internet-connected glucose meters and one-on-one coaching against smartphone-enabled glucose meters alone. The study, sponsored by digital medical device company Livongo Health in Mountain View, California, is conducted by University of California in San Francisco.
Livongo Health develops digital systems to help individuals manage diabetes and other chronic health conditions. Diabetes is a chronic disorder where the pancreas does not create enough insulin to process the sugar glucose to flow into the blood stream and cells for energy in the body. In type 2 diabetes, which accounts for at least 90 percent of all diabetes cases, the pancreas produces some but not enough insulin, or the body cannot process insulin. According to the International Diabetes Federation, diabetes affects an estimated 425 million people worldwide, of which 46 million are in North America.
Livongo’s digital systems for managing diabetes, with analytics from data provided by individuals, use the company’s smartphone-based technology. The diabetes management system includes a smart blood glucose meter that connects to cellular networks, and transmits data from the meter to family members, clinicians monitoring the person’s condition, and third-party diabetes counselors certified by Livongo. The meter also collects other data related to the person’s health, such as physical activity.
Data from the smart meter are sent as well to a database in the cloud, where a rules-based inference engine analyzes the data and offers personalized guidance to the individual with diabetes and his or her physician. Livongo users with the mobile app can receive coaching, with tips on nutrition and lifestyle changes, from licensed third-party counselors. People connected to the meter in the Livongo community can provide feedback via voice telephone, e-mail, or text message.
Livongo markets its programs to health plans and employers providing health insurance. The company often studies its user base, including extent of coaching required to achieve results in managing diabetes, and effects on an individual’s health care costs. As reported by Science & Enterprise in June 2018, a Livongo study found program participants receiving intensive coaching as well as using connected glucose meters show more weight loss and lower blood glucose levels.
The new study, however, is an independent assessment, testing Livongo’s program against a digital glucose metering system made by iHealth that connects to a smartphone. The iHealth system also transmits and receives data from the cloud and provides feedback to the user.
The mid-stage clinical trial is recruiting 300 individuals at UC-San Francisco, age 18 and older, with type 2 diabetes. Participants must have an iPhone or access to WiFi, but not be users of continuous glucose monitors or insulin pumps. Those enrolled in the trial will be randomly assigned to take part in the Livongo Health program or use the iHealth smartphone-connected meter for 6 months.
The study team, led by UC-San Francisco pediatric endocrinologist Jenise Wong, will measure participants’ hemoglobin A1c, or HbA1c, levels at the beginning of the study, then after 3 and 6 months. Researchers will also measure lipid levels in the blood, a test for total cholesterol. “We are interested to see how an innovative solution like Livongo truly impacts people,” says Wong in a Livongo statement. “By conducting a randomized controlled trial, we can better understand the degree to which innovative offerings improve health outcomes.”
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