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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Influence of Injection Technique of Premixed Insulin on Glucose Excursion in Type 2 Diabetes Mellitus Using CGMS

Conditions
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Type2 Diabetes Mellitus

Intervention / Treatment
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* Other: nurse inject premixed insulin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: inject premixed insulin<br>patients inject premixed insulin themselves then nurse inject premixed insulin | Other: nurse inject premixed insulin<br>* nurse inject premixed insulin，coaching in the injection technique<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| the relationship between HbA1C and injection score | the relationship between HbA1C and injection score | 6 DAYS | 
| the relationship between SDBG and injection score | 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 | the 24-h mean amplitude of glycemic excursions (MAGE) | 6 DAYS | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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glucose excursions, insulin technique, insulin antibodies, premixed insulin