A Bluetooth-Enabled Smart Cap for Insulin Pens: Common Sensing’s Gocap

Recruiting participants in Boston at the Joslin Diabetes Center

Clinical Trials Identifier: NCT02914730

Trial name: Insulin Dosing Practices in Persons With Diabetes on Multiple Daily Injections

Diabetes type: Type 1 and insulin-requiring type 2 diabetes

What the trial is testing: This observational study will test the efficacy of Common Sensing’s Bluetooth-enabled smart cap for disposable insulin pens (“Gocap”) in up to 125 participants on two or more injections per day.

What the trial is measuring: The study will measure Gocap’s impact on reducing missed insulin doses at four weeks. Participants’ glucose values will also be measured with CGM.

What is new/why this is important: Right now, people on injections have to manually log how much insulin they take. Gocap uses a light sensing technology to automatically read how much insulin is in a standard disposable pen and how much was just delivered. The data is automatically collected and sent to a paired smartphone app via Bluetooth. This study aims to show that the Gocap collects insulin dose data as expected. Combining the injection data with glucose data (from either a meter or CGM) could eventually drive better and safer use of insulin, particularly if smart algorithms can detect patterns and give advice.

Common Sensing registered Gocap and the smartphone app with the FDA in July 2016. The company is searching for a partner that can help bring the product to market; the goal is for users not to have to pay anything for the device.

Trial length: 4 weeks

Trial location: Joslin Diabetes Center, Boston, MA

Do you qualify?

• Type 1 diabetes or insulin-requiring type 2 diabetes

• Take over 2 insulin injections per day

• Age 18-35 or older than 65 years

• Use of Lantus (insulin glargine) as basal insulin

• Stable insulin doses over past 3 months

[Photo Credit: Common Sensing]