French digital health player Voluntis announced twin approvals on Tuesday, snagging a CE mark and FDA clearance for its management device for Type 2 diabetics who are treated with basal insulin.
Many Type 2 diabetics are treated with basal, or background insulin. These long-acting versions of the hormone are designed to work continuously, mimicking how the pancreas would secrete insulin over time. However, “more than half” of these patients fail to meet the recommended targets for blood glucose control, Voluntis said in a statement.
The prescription-only Insulia diabetes management companion works with Sanofi’s Lantus and Novo Nordisk’s Levemir. A patient may use the application via a web portal, on a smartphone or on a tablet. It will be available during the first half of 2017.
“To make a meaningful impact on patients’ daily lives as well as clinical outcomes, we need to use intelligent digital solutions that go beyond data sharing between patients and clinicians,” said Dr. Guillaume Charpentier, an endocrinologist and president of the Research Center for the Intensification of Diabetes Treatment (CERITD), in the statement. “This is what CERITD and Voluntis have been working on together for more than 10 years, designing and evaluating software that provides automated recommendations and clinical decision support to take diabetes care management to the next level.”
A physician creates a treatment plan tailored to each patient. Insulia will then provide the patient with insulin dose recommendations, usually daily, based on the parameters defined by the physician, said Romain Marmot, Voluntis chief operations officer. The patient will then decide to accept the recommended dose and inject it, or to modify the dose.
The software will take any changes into account when generating the next dosage suggestion. The patient manually enters the dose taken and at least one blood glucose reading each day, Marmot said. These data are automatically shared with the provider along with notifications that can flag very high or low blood glucose levels as well as nonadherence.
Voluntis designed the first version of Insulia so that any patient could use it, Marmot said. Whatever blood glucose meter they use, manual entry of blood glucose and insulin dose data make Insulia universal, he said. But the company does plan to automate data entry.
“We have the technology in house to connect to Bluetooth-enabled meters and have already launched this in Europe with some specific products,” Marmot said. The company plans to bring this connected version of Insulia to market next year.