Clinical trial NCT03513055: Influence of Injection Technique of Premixed Insulin on Glucose Excursion in Type 2 Diabetes Mellitus
Official title: Influence of Injection Technique of Premixed Insulin on Glucose Excursion in Type 2 Diabetes Mellitus Using CGMS
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Type2 Diabetes Mellitus
Keywords: glucose excursions
insulin technique
insulin antibodies
premixed insulin
Lead sponsor: Nanjing First Hospital, Nanjing Medical University
Sponsor class: OTHER
First posted: 2018-05-01
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: The primary endpoint was the relationship between MAGE and injection score
timeFrame: 6 DAYS
measure: the relationship between HbA1C and injection score
timeFrame: 6 DAYS
measure: the relationship between SDBG and injection score
timeFrame: 6 DAYS
Secondary outcomes:
measure: the relation between insulin antibodies and glucose excursions
timeFrame: 6 DAYS
Other outcomes:
Locations:
Study officials:
affiliation: Nanjing Medical University
name: YUAN LU, master
role: STUDY_DIRECTOR
References:
citation: 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.