Diabetes MellitusCUSTIOTNCT02307968
Comparative Study of Insulin Therapy Between Inner and Outer Upper Thigh
An observational study of Diabetes Mellitus, run by First Affiliated Hospital of Zhejiang University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- insulin injection site
- Type of treatment
- Injection or infusion
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- Oct 2014to Dec 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: diabetes population
Who may be able to join
- All adult patients more than 18 years age old with diabetes that need insulin therapy
Who cannot join
- Those diabetes with psychologic diseases and those patients won't be injected at thigh
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Endocrinology, the First Affiliated Hospital to Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310003
About this study
Official title: Comparison of Patient's Preference, Pain Perception, and Usability Between Inner and Outer Upper Thigh for Insulin Therapy
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.
Read the detailed 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.
- Conditions
- Diabetes Mellitus
- Being tested
- insulin injection site
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
insulin injection siteOther
insulin injected site between inner thigh and out thigh
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: insulin injection site | |
| outer thigh insulin injection | outer thigh site for insulin therapy is the usual site |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain
the pain degree the patient feel while insulin injected using Visual Analog scale
Measured: immediately after injection, 1-5minutes
bleeding
if bleeding occurs after insulin injected just by using Yes or No
Measured: immediately after injection, 1-5minutes
leaking
if there is leaking after insulin injected just by using Yes or No
Measured: immediately after injection, 1-5minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2014 (estimated)
- Study startOct 2014
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhou Weibin, First Affiliated Hospital of Zhejiang University
- Investigators
- Jingyun Yuan, BS, Principal investigator, Department of Endocrinology, the First Affiliated Hospital to Zhejiang University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02307968
- Sponsor's protocol ID
- ChiCTR-OPN-14005516
- Acronym
- CUSTIOT
- Status last verified
- Feb 2016
- First submitted
- 25 Nov 2014
- Last updated
- 4 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 27090917
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Patient's Preference, Pain Perception, and Usability Between Inner and Outer Upper Thigh for Insulin Therapy
- ClinicalTrials.gov ID
- NCT02307968
- Acronym / sponsor ID
- CUSTIOT / ChiCTR-OPN-14005516
- Conditions
- Diabetes Mellitus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- First Affiliated Hospital of Zhejiang UniversityUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 4 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| inner thigh insulin injection | – | Other: insulin injection siteinject 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- diabetes population
Key inclusion criteria (1 listed)
- All adult patients more than 18 years age old with diabetes that need insulin therapy
Key exclusion criteria (1 listed)
- Those diabetes with psychologic diseases and those patients won't be injected at thigh
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| insulin injection siteinsulin injected site between inner thigh and out thigh | Other | inner thigh insulin injection |
Primary outcome
pain
Time frame: immediately after injection, 1-5minutes
the pain degree the patient feel while insulin injected using Visual Analog scale
bleeding
Time frame: immediately after injection, 1-5minutes
if bleeding occurs after insulin injected just by using Yes or No
leaking
Time frame: immediately after injection, 1-5minutes
if there is leaking after insulin injected just by using Yes or No
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2016.
- Derived from this study: PubMed 27090917Yuan 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.
Related trials for Diabetes Mellitus
Recruiting
Prevalence of Diabetes-related Distress Among Patients Living With Type 2 Diabetes in a University Hospital Center and Identification of Its Associated Factors.
Diabetes Mellitus, Psychological Distress
Not yet recruiting
The Effect of Individualized Nursing Interventions on Glycemic Variability and Self-Management in Type 2 Diabetes
Type 2 Diabetes Mellitus (T2DM)
Not yet recruitingObservational study
Evaluation of the Clinical Spectrum of Diabetes and Obesity in Youth and Adults
Obesity, Diabetes
Active, not recruitingObservational study
Non-Invasive MASLD Diagnosis & T2D Remission Biomarkers
MASLD, T2DM (Type 2 Diabetes Mellitus)
Recruiting
Effects of Medisinstart for Type 2 Diabetes
Type 2 Diabetes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jingyun Yuan, BS principal investigator
Department of Endocrinology, the First Affiliated Hospital to Zhejiang University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, run by First Affiliated Hospital of Zhejiang University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain (time frame: immediately after injection, 1-5minutes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02307968, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2016.