Comparative Study of Insulin Therapy Between Inner and Outer Upper Thigh
CUSTIOT
Comparison of Patient's Preference, Pain Perception, and Usability Between Inner and Outer Upper Thigh for Insulin Therapy
1 other identifier
observational
20
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Oct 2014
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2014
CompletedFirst Submitted
Initial submission to the registry
November 25, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedFirst Posted
Study publicly available on registry
December 4, 2014
CompletedFebruary 4, 2016
February 1, 2016
2 months
November 25, 2014
February 3, 2016
Conditions
Outcome Measures
Primary Outcomes (3)
pain
the pain degree the patient feel while insulin injected using Visual Analog scale
immediately after injection, 1-5minutes
bleeding
if bleeding occurs after insulin injected just by using Yes or No
immediately after injection, 1-5minutes
leaking
if there is leaking after insulin injected just by using Yes or No
immediately after injection, 1-5minutes
Study Arms (2)
inner thigh insulin injection
inject insulin at inner thigh site is the intervention arm. So we inject insulin at this site to see if this site is suitable for insulin injection.
outer thigh insulin injection
outer thigh site for insulin therapy is the usual site
Interventions
insulin injected site between inner thigh and out thigh
Eligibility Criteria
diabetes population
You may qualify if:
- All adult patients more than 18 years age old with diabetes that need insulin therapy
You may not qualify if:
- Those diabetes with psychologic diseases and those patients won't be injected at thigh
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Endocrinology, the First Affiliated Hospital to Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310003, China
Related Publications (1)
Yuan J, Chen Y, Xuan Y, Cao L, Zhu J, Wang F, Zhou X, Ye Q, Liao L, Zheng Y, Zhou Q, Chen X, Chen M, Zhou W. Can the upper inner side of the thigh become a new option for insulin injection? Curr Med Res Opin. 2016 Jul;32(7):1319-24. doi: 10.1185/03007995.2016.1174107. Epub 2016 May 17.
PMID: 27090917DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jingyun Yuan, BS
Department of Endocrinology, the First Affiliated Hospital to Zhejiang University School of Medicine
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
November 25, 2014
First Posted
December 4, 2014
Study Start
October 1, 2014
Primary Completion
December 1, 2014
Study Completion
December 1, 2014
Last Updated
February 4, 2016
Record last verified: 2016-02