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

Type2 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03513055
• Other study ID #: ENDO20180205-06
• Status: Not yet recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type2 Diabetes Mellitus

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