Influence of Injection Technique of Premixed Insulin on Glucose Excursion in Type 2 Diabetes Mellitus

Nanjing Medical University

Status: Unknown

Conditions: Type2 Diabetes Mellitus

Treatments: Other: nurse inject premixed insulin

Study type: Interventional

Funder types: Other

Identifiers

NCT03513055

ENDO20180205-06

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

inject premixed insulin

Experimental group

Description:

patients inject premixed insulin themselves then nurse inject premixed insulin

Treatment:

Other: nurse inject premixed insulin