NCT01745549

Efficacy, Safety and Satisfaction of the New Pen Needle 33 Gauge x 4 mm.

Efficacy, Safety and Satisfaction of the New Pen Needle 33G x 4 mm 33G x 4 mm: Cross-over Randomized Controlled Clinical Trial. Studio AGO 01

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 87 (actual)
• Sponsor: Consorzio Mario Negri Sud · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

During the last years, even more little needles are used for the injection of sub cutaneous insulin, for the diabetes therapy. The aim of this study is to evaluate the non inferiority of a new needle, smaller than another needle, in terms of hematic levels od fructosamine, an indicator of glycemic control.

Conditions

• Type 1 Diabetes
• Type 2 Diabetes

Interventions

Type	Name	Description
DEVICE	Needle for insulin pen, 4 mm long and with a diameter of 33 gauge
DEVICE	Needle for insulin pen, 4 mm long and with a diameter of 32 gauge

Timeline

• Start date: 2012-12-01
• Primary completion: 2013-09-01
• Completion: 2013-11-01
• First posted: 2012-12-10
• Last updated: 2014-03-18

Locations

4 sites across 1 country: Italy