Comparative Study of Insulin Therapy Between Inner and Outer Upper Thigh

Diabetes Mellitus Clinical Trial

— CUSTIOT  

Official title:

Comparison of Patient's Preference, Pain Perception, and Usability Between Inner and Outer Upper Thigh for Insulin Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02307968
• Other study ID #: ChiCTR-OPN-14005516
• Status: Completed
• Phase: N/A
• First received: November 25, 2014
• Last updated: February 3, 2016
• Start date: October 2014
• Est. completion date: December 2014

Study information

• Verified date: February 2016
• Source: First Affiliated Hospital of Zhejiang University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Observational

Clinical Trial Summary

To observe the patient's preference, pain perception, and usability between inner and outer upper thigh for insulin therapy. To add another injection site for insulin therapy.

Description:

The most common injection site is the abdomen (or stomach). The back of the upper arms, the upper buttocks or hips, and the outer side of the thighs are also used. These sites are the best to inject into for two reasons: They have a layer of fat just below the skin to absorb the insulin, but not many nerves - which means that injecting there will be more comfortable than injecting in other parts of your body. But while the needle for insulin therapy is becoming shorter, it is possible to inject insulin at the inner thigh site.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All adult patients more than 18 years age old with diabetes that need insulin therapy

Exclusion Criteria:

• Those diabetes with psychologic diseases and those patients won't be injected at thigh

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Other:
• insulin injection site
insulin injected site between inner thigh and out thigh

Locations

Country	Name	City	State
China	Department of Endocrinology, the First Affiliated Hospital to Zhejiang University School of Medicine	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital of Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pain	the pain degree the patient feel while insulin injected using Visual Analog scale	immediately after injection, 1-5minutes	No
Primary	bleeding	if bleeding occurs after insulin injected just by using Yes or No	immediately after injection, 1-5minutes	No
Primary	leaking	if there is leaking after insulin injected just by using Yes or No	immediately after injection, 1-5minutes	No