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

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

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.

Study Overview

• Status: Unknown
• Conditions: Type2 Diabetes Mellitus
• Intervention / Treatment: Other: nurse inject premixed insulin

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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: MA JIANHUA, PHD; Phone Number: +8618951670116; Email: majianhua196503@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: inject premixed insulin; patients inject premixed insulin themselves then nurse inject premixed insulin	Other: nurse inject premixed insulin; nurse inject premixed insulin，coaching in the injection technique

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Nanjing First Hospital, Nanjing Medical University
• Investigators: Study Director: YUAN LU, master, Nanjing Medical University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): May 7, 2018
• Primary Completion (Anticipated): September 30, 2018
• Study Completion (Anticipated): September 30, 2018

Study Registration Dates

• First Submitted: April 17, 2018
• First Submitted That Met QC Criteria: April 27, 2018
• First Posted (Actual): May 1, 2018

Study Record Updates

• Last Update Posted (Actual): May 11, 2018
• Last Update Submitted That Met QC Criteria: May 8, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: glucose excursions; insulin technique; insulin antibodies; premixed insulin
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin
• Other Study ID Numbers: ENDO20180205-06

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No