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

Not Applicable

• Conditions: Type2 Diabetes Mellitus
• Interventions: Other: nurse inject premixed insulin

• Registration Number: NCT03513055
• Lead Sponsor: Nanjing First Hospital, Nanjing Medical University

Brief 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.

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 Timeline

• Status Verified: 2018-04
• Study First Submitted: 2018-04-17
• Study First Submitted QC: 2018-04-27
• Study First Posted: 2018-05-01
• Study Start: 2018-05-07
• Last Update Submitted: 2018-05-08
• Last Update Posted: 2018-05-11
• Primary Completion: 2018-09-30
• Study Completion: 2018-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
inject premixed insulin	nurse inject premixed insulin	patients inject premixed insulin themselves then nurse inject premixed insulin

Primary Outcome Measures

Name	Time	Method
the relationship between HbA1C and injection score	6 DAYS	the relationship between HbA1C and injection score
The primary endpoint was the relationship between MAGE and injection score	6 DAYS	the relationship between the 24-h mean amplitude of glycemic excursions (MAGE) and injection score
the relationship between SDBG and injection score	6 DAYS	the relationship between SDBG and injection score

Secondary Outcome Measures

Name	Time	Method
the relation between insulin antibodies and glucose excursions	6 DAYS	the 24-h mean amplitude of glycemic excursions (MAGE)