NCT03495908

Regular Insulin vs Rapid Insulin Delivered by V-Go

Efficacy and Safety Comparison Between U-100 Regular Human Insulin and Rapid Acting Insulin When Delivered by VGo Wearable Insulin Delivery in Type 2 Diabetes

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 136 (actual)
• Sponsor: East Coast Institute for Research · Network
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to collect data about how well U-100 Regular Human Insulin can be used in the V-Go Insulin Delivery Device compared to U-100 Rapid Acting Insulin in the V-Go Insulin Delivery Device. The data collected will be used to see how much subjects' blood sugar levels change over time after they switch from using U-100 Rapid Acting Insulin to U-100 Regular Human Insulin within their V-Go Insulin Delivery Device.

Conditions

• Type 2 Diabetes
• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
DEVICE	VGo	Eligible subjects will be randomized to either stay on RAI delivered by V-Go or randomized to switch to U-100 RHI delivered by V-Go.

Timeline

• Start date: 2018-04-09
• Primary completion: 2019-08-12
• Completion: 2019-08-12
• First posted: 2018-04-12
• Last updated: 2021-03-02
• Results posted: 2021-01-25

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study