- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03513055
Influence of Injection Technique of Premixed Insulin on Glucose Excursion in Type 2 Diabetes Mellitus
May 8, 2018 updated by: Nanjing First Hospital, Nanjing Medical University
Influence of Injection Technique of Premixed Insulin on Glucose Excursion in Type 2 Diabetes Mellitus Using CGMS
To compare patients and nurses using insulin pen injector to inject premixed insulin respectively, using continuous glucose monitoring system to evaluate the glucose excursion in the two sets, study the relationship between glucose excursion and inject technique in type 2 diabetes mellitus.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
A total of 60 patients with type 2 diabetes who used premixed insulin will enrolled in this study.Measure their blood pressure,height and weight, BMI, liver and kidney function, blood lipids, glycosylated hemoglobin, fasting glucose, 2 hour postprandial glucose,fasting C peptide, 2 hour postprandial C peptide, fasting glucagon, 2 hour postprandial glucagon,fasting serum insulin,2 hour postprandial serum insulin,urinary albumin and insulin antibodies.The first and second days,the patients inject premixed insulin themselves,the specialist nurse graded the patient's injection technique score.The third and the fourth days the nurse change a new insulin with the same types maintain the same injection dosage.The patient need perform continuous glucose monitoring system(CGMS) for 96-hours.
Study Type
Interventional
Enrollment (Anticipated)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: MA JIANHUA, PHD
- Phone Number: +8618951670116
- Email: majianhua196503@126.com
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 78 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- type 2 diabetes patients
- aged 20-80 years
- had been on premixed insulin and used an insulin pen for at least 3 months
- fasting glucose between 6.1-16 mmolL, postprandial(or random) glucose below 22.2mmol/L.
- No acute complications such as diabetic ketoacidosis, diabetic hypertosmolar syndrome.
- Subjects were able and willing to ues CGMS and eat regularly.
- Patients who were able to inject insulin themselves or actual injections can be accompanied.
Exclusion Criteria:
- Insulin allergy.
- There has been a history of drug abuse and alcohol dependence in the past five years, or systemic hormone therapy within 3 months.
- Patients with poor compliance and irregular eating and exercise.
- Infection or stress within four weeks.
- Patients unable to tolerate CGMS.
- patients with pregnancy, breast-feeding, planning to have a baby
- patients with coagulopathy, serious complication,such as cardiovascular disease, end stage renal disease; and patients with severe retinopathy or other eye problems that impair their visual function, or cognitive dysfunction
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: inject premixed insulin
patients inject premixed insulin themselves then nurse inject premixed insulin
|
nurse inject premixed insulin,coaching in the injection technique
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The primary endpoint was the relationship between MAGE and injection score
Time Frame: 6 DAYS
|
the relationship between the 24-h mean amplitude of glycemic excursions (MAGE) and injection score
|
6 DAYS
|
the relationship between HbA1C and injection score
Time Frame: 6 DAYS
|
the relationship between HbA1C and injection score
|
6 DAYS
|
the relationship between SDBG and injection score
Time Frame: 6 DAYS
|
the relationship between SDBG and injection score
|
6 DAYS
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
the relation between insulin antibodies and glucose excursions
Time Frame: 6 DAYS
|
the 24-h mean amplitude of glycemic excursions (MAGE)
|
6 DAYS
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: YUAN LU, master, Nanjing Medical University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
May 7, 2018
Primary Completion (Anticipated)
September 30, 2018
Study Completion (Anticipated)
September 30, 2018
Study Registration Dates
First Submitted
April 17, 2018
First Submitted That Met QC Criteria
April 27, 2018
First Posted (Actual)
May 1, 2018
Study Record Updates
Last Update Posted (Actual)
May 11, 2018
Last Update Submitted That Met QC Criteria
May 8, 2018
Last Verified
April 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ENDO20180205-06
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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