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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03513055
Other study ID # ENDO20180205-06
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date May 7, 2018
Est. completion date September 30, 2018

Study information

Verified date April 2018
Source Nanjing First Hospital, Nanjing Medical University
Contact MA JIANHUA, PHD
Phone +8618951670116
Email majianhua196503@126.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 60
Est. completion date September 30, 2018
Est. primary completion date September 30, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

1. type 2 diabetes patients

2. aged 20-80 years

3. had been on premixed insulin and used an insulin pen for at least 3 months

4. fasting glucose between 6.1-16 mmolL, postprandial(or random) glucose below 22.2mmol/L.

5. No acute complications such as diabetic ketoacidosis, diabetic hypertosmolar syndrome.

6. Subjects were able and willing to ues CGMS and eat regularly.

7. Patients who were able to inject insulin themselves or actual injections can be accompanied.

Exclusion Criteria:

1. Insulin allergy.

2. There has been a history of drug abuse and alcohol dependence in the past five years, or systemic hormone therapy within 3 months.

3. Patients with poor compliance and irregular eating and exercise.

4. Infection or stress within four weeks.

5. Patients unable to tolerate CGMS.

6. patients with pregnancy, breast-feeding, planning to have a baby

7. 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 Design


Intervention

Other:
nurse inject premixed insulin
nurse inject premixed insulin,coaching in the injection technique

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Nanjing First Hospital, Nanjing Medical University

Outcome

Type Measure Description Time frame Safety issue
Primary The primary endpoint was the relationship between MAGE and injection score the relationship between the 24-h mean amplitude of glycemic excursions (MAGE) and injection score 6 DAYS
Primary the relationship between HbA1C and injection score the relationship between HbA1C and injection score 6 DAYS
Primary the relationship between SDBG and injection score the relationship between SDBG and injection score 6 DAYS
Secondary the relation between insulin antibodies and glucose excursions the 24-h mean amplitude of glycemic excursions (MAGE) 6 DAYS
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