A Trial Investigating the Influence of Injection Speed and Volume on the Perception of Subcutaneous Injection Pain

Phase 1

Completed

• Conditions: Diabetes Mellitus
• Interventions: Other: 0.9% NaCl (sodium chloride)

• Registration Number: NCT01937702
• Lead Sponsor: Profil Institut für Stoffwechselforschung GmbH

Brief Summary

A trial, investigating the influence of injection speed and volume on the perception of subcutaneous injection pain.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-08-27
• Study First Submitted QC: 2013-09-04
• Study First Posted: 2013-09-09
• Study Start: 2014-04
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-29
• Last Update Posted: 2014-12-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Subject has signed the informed consent form prior to screening
• Age 18-74 years at screening (both included)

Exclusion Criteria

• Known or suspected hypersensitivity to needle, ink ball pen or other that are in contact with the injection area during the clinical visit
• Previous participation in this trial. Participation is defined as having received at least one injection

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Anti-diabetes medication	0.9% NaCl (sodium chloride)	Insulin

Primary Outcome Measures

Name	Time	Method
injection pain	within 24 hours after injection

Secondary Outcome Measures

Name	Time	Method
variability of injection pain	within the first 24 hours after injection

Trial Locations

Locations (1)

Profil Mainz GmbH & Co. KG; 🇩🇪 Mainz, Rheinland-Pfalz, Germany