Powered by SteadiFlow technology platform, the infusion set has been developed to enhance the wear time of insulin infusion sets
CapBio has received FDA approval to begin SteadiFlow seven-day-wear infusion set trial. (Credit: Silas Camargo Silão from Pixabay)
The US Food and Drug Administration (FDA) has granted an investigational device exemption (IDE) approval for Capillary Biomedical (CapBio) to begin a pivotal trial of its SteadiFlow seven-day-wear infusion set technology.
For people on insulin pump therapy, the infusion sets are developed to help deliver insulin under the skin to maintain healthy blood glucose levels.
Capillary has designed new infusion sets to significantly expand patient wear time to seven days and maintain insulin stability.
Powered by SteadiFlow technology platform, the infusion set enhances the wear time of insulin infusion sets by addressing the common causes of infusion site failure.
The new non-randomised and prospective single arm study trial will enroll up to 240 subjects with type 1 diabetes on insulin pump therapy. The patients will be aged between 18 and 80.
According to the company, each participant will undergo 12 one-week wear periods and the trial will assess Novolog and Humalog insulin.
Jaeb Centre for Health Research, which is based in Tampa of Florida, will serve as the CRO.
CapBio CEO Paul Strasma said: “With this pivotal trial we are pleased to be taking a significant next step in the evolution of our SteadiFlow infusion set.
“Based on the strength of previous clinical data, we’re optimistic about the results of this forthcoming trial and we’re excited to play a leadership role in what might be possible with insulin pump technology.”
CapBio’s SteadiSet includes an integrated inserter that will facilitate easy, painless, hidden needle and one-handed insertion.
The company has designed its cannula to filter particulates and aggregates prior to their delivery to the tissue. It will help to remove aggregates that form in the tubing before reaching the tissue.
The SteadiFlow cannula technology consists of a soft and flexible cannula that moves with the body tissue during physical activity. It will also help increase comfort and decrease tissue damage and inflammation.