Influence of Injection Technique of Premixed Insulin on Glucose Excursion in Type 2 Diabetes Mellitus
Primary Purpose
Type2 Diabetes Mellitus
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
nurse inject premixed insulin
Sponsored by
About this trial
This is an interventional treatment trial for Type2 Diabetes Mellitus focused on measuring glucose excursions, insulin technique, insulin antibodies, premixed insulin
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
inject premixed insulin
Arm Description
patients inject premixed insulin themselves then nurse inject premixed insulin
Outcomes
Primary Outcome Measures
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
the relationship between HbA1C and injection score
the relationship between HbA1C and injection score
the relationship between SDBG and injection score
the relationship between SDBG and injection score
Secondary Outcome Measures
the relation between insulin antibodies and glucose excursions
the 24-h mean amplitude of glycemic excursions (MAGE)
Full Information
NCT ID
NCT03513055
First Posted
April 17, 2018
Last Updated
May 8, 2018
Sponsor
Nanjing First Hospital, Nanjing Medical University
1. Study Identification
Unique Protocol Identification Number
NCT03513055
Brief Title
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
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Unknown status
Study Start Date
May 7, 2018 (Anticipated)
Primary Completion Date
September 30, 2018 (Anticipated)
Study Completion Date
September 30, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nanjing First Hospital, Nanjing Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type2 Diabetes Mellitus
Keywords
glucose excursions, insulin technique, insulin antibodies, premixed insulin
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
inject premixed insulin
Arm Type
Experimental
Arm Description
patients inject premixed insulin themselves then nurse inject premixed insulin
Intervention Type
Other
Intervention Name(s)
nurse inject premixed insulin
Intervention Description
nurse inject premixed insulin,coaching in the injection technique
Primary Outcome Measure Information:
Title
The primary endpoint was the relationship between MAGE and injection score
Description
the relationship between the 24-h mean amplitude of glycemic excursions (MAGE) and injection score
Time Frame
6 DAYS
Title
the relationship between HbA1C and injection score
Description
the relationship between HbA1C and injection score
Time Frame
6 DAYS
Title
the relationship between SDBG and injection score
Description
the relationship between SDBG and injection score
Time Frame
6 DAYS
Secondary Outcome Measure Information:
Title
the relation between insulin antibodies and glucose excursions
Description
the 24-h mean amplitude of glycemic excursions (MAGE)
Time Frame
6 DAYS
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
MA JIANHUA, PHD
Phone
+8618951670116
Email
majianhua196503@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
YUAN LU, master
Organizational Affiliation
Nanjing Medical University
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
30341664
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.
Results Reference
derived
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Influence of Injection Technique of Premixed Insulin on Glucose Excursion in Type 2 Diabetes Mellitus
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