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

NCT03513055 | Unknown

• 1 other identifier: ENDO20180205-06
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Type2 Diabetes Mellitus

Keywords

glucose excursions; insulin technique; insulin antibodies; premixed insulin

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• the relation between insulin antibodies and glucose excursions

  6 DAYS

Study Arms (1)

inject premixed insulin

EXPERIMENTAL

patients inject premixed insulin themselves then nurse inject premixed insulin

Other: nurse inject premixed insulin

Interventions

nurse inject premixed insulin OTHER

nurse inject premixed insulin，coaching in the injection technique

inject premixed insulin

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Nanjing First Hospital, Nanjing Medical University: lead

Related Publications (1)

• 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.

  PMID: 30341664 DERIVED

Study Officials

• YUAN LU, master

  Nanjing Medical University

  STUDY DIRECTOR

Central Study Contacts

MA JIANHUA, PHD

CONTACT

+8618951670116; majianhua196503@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2018
• First Posted: May 1, 2018
• Study Start: May 7, 2018
• Primary Completion: September 30, 2018
• Study Completion: September 30, 2018
• Last Updated: May 11, 2018

Record last verified: 2018-04