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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
Nanjing First Hospital, Nanjing Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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

    First Posted
    April 17, 2018
    Last Updated
    May 8, 2018
    Sponsor
    Nanjing First Hospital, Nanjing Medical University
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    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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