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

NCT ID: NCT03513055

Last Updated: 2018-05-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-07
• Study Completion Date: 2018-09-30

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.

Conditions

Type2 Diabetes Mellitus

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

inject premixed insulin

patients inject premixed insulin themselves then nurse inject premixed insulin

Group Type: EXPERIMENTAL

nurse inject premixed insulin

Intervention Type: OTHER

nurse inject premixed insulin，coaching in the injection technique

Interventions

nurse inject premixed insulin

nurse inject premixed insulin，coaching in the injection technique

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nanjing First Hospital, Nanjing Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

YUAN LU, master

Role: STUDY_DIRECTOR

Nanjing Medical University

Central Contacts

MA JIANHUA, PHD

Role: CONTACT

majianhua196503@126.com

+8618951670116

References

Yuan L, Li F, Jing T, Ding B, Luo Y, Sun R, Wang X, Diao H, Su X, Ye L, Ma J. Insulin Injection Technique is Associated with Glycemic Variability in Patients with Type 2 Diabetes. Diabetes Ther. 2018 Dec;9(6):2347-2356. doi: 10.1007/s13300-018-0522-1. Epub 2018 Oct 19.

Reference Type: DERIVED

PMID: 30341664 (View on PubMed)

Other Identifiers

ENDO20180205-06

Identifier Type: -

Identifier Source: org_study_id