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Study on the Feasibility of Community Doctors Guided by Specialists to Use Basic Insulin

Primary Purpose

Type 2 Diabetes

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
basic insulin
Sponsored by
Shenzhen Second People's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes focused on measuring Type 2 Diabetes, basic insulin, community doctors

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Diagnosis of T2DM (WHO1999 diabetes diagnostic criteria);
  2. The age is ≥ 18 and ≤ 65 years old;
  3. Continuous use of 2 or more oral hypoglycemic drugs for 1 month but HbA1c ≥ 8.0% and FPG ≥ 10mmol/L.

Exclusion Criteria:

  1. Severe abnormal liver and kidney function and cardiac insufficiency;
  2. Complicated with all kinds of acute and chronic infection or coronary heart disease, kidney disease, connective tissue disease, tumor, stroke and so on;
  3. There are acute metabolic disorders caused by stress and diseases affecting glucose metabolism, such as pheochromocytoma, acromegaly, Cushing syndrome, hyperthyroidism and so on.
  4. Acute complications of diabetes, such as diabetic ketoacidosis, hyperglycemic hyperosmotic coma or lactic acidosis, etc.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    community patient group

    inpatient group

    Arm Description

    The community doctor adjusts the basic insulin dosage daily according to the fasting blood glucose of the patient under the guidance of the specialist.

    Endocrinologists in the in-patient department use the same basic insulin dose adjustment regimen to treat patients.

    Outcomes

    Primary Outcome Measures

    Time to achieve target FBG
    Treatment days when FBG reached the standard (≤ 7.0mmol/L) after treatment with basal insulin.
    Decrease of HbA1c
    The change of HbA1c before and after treatment with basal insulin.
    Incidence of hypoglycemia
    The proportion of the occurrence of hypoglycemia to the number of total blood glucose monitoring.

    Secondary Outcome Measures

    Daily doses of insulin at the study end point.
    The daily doses of insulin at the study end point.

    Full Information

    First Posted
    September 3, 2020
    Last Updated
    September 11, 2020
    Sponsor
    Shenzhen Second People's Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04553380
    Brief Title
    Study on the Feasibility of Community Doctors Guided by Specialists to Use Basic Insulin
    Official Title
    Study on the Feasibility and Treatment Experience of Community Doctors in Shenzhen Guided by Specialists to Use Basic Insulin in the Treatment of Adult Type 2 Diabetes Mellitus
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    December 1, 2020 (Anticipated)
    Primary Completion Date
    December 31, 2021 (Anticipated)
    Study Completion Date
    March 31, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Shenzhen Second People's Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    At present, one of the reasons for the low blood sugar control rate in China is related to the late use of basic insulin and insufficient dose adjustment. If the community hospital can actively treat the diabetic patients who need to use insulin and adjust the dose in time, it will certainly improve the blood sugar control rate. However, at present, community doctors basically do not take the initiative to start insulin treatment, but only passively use insulin that has been prescribed by specialists, and there is a lack of ability to adjust the dose of insulin and treatment inertia. Therefore, it is very necessary for community doctors to receive guidance from endocrine specialists to improve their ability to use insulin. This study intends to carry out a study of endocrine specialists guiding community doctors to use basic insulin in the treatment of adult type 2 diabetes in Shenzhen Community Hospital. Through this study to understand whether the effectiveness and safety of community doctors actively using basic insulin therapy under the guidance of specialists can reach the level of specialists.
    Detailed Description
    The study consists of two parts: the screening period and the treatment follow-up period. Screening period (day 0): patients were screened according to the inclusion and exclusion criteria, and informed consent was completed. Treatment follow-up period (day 1-day 90): Day 1: (1)all patients in the group received diet and exercise education;(2)Collect patients' basic data (name, sex, age, height, weight, waist circumference, hip circumference, etc.), detect plasma FBG and HbA1c (sent to the central laboratory for testing);(3)Initial treatment: On the basis of the original oral medicine, the patient will initial basic insulin. The initial dose of basic insulin is 0.2U/kg/d. Day 2-Day 89: Community patient group:The community doctor adjusts the dosage of insulin daily according to the patient's FBG: the dose is titrated by increments of 0.07U/kg daily until the fasting blood glucose (FBG)≤7 mmol / L, and if the FBG≤ 3.9mmol/L, the 0.07U/kg is reduced. Inpatient group:Endocrinologists in the in-patient department use the same basic insulin dose adjustment regimen to treat patients. It can be discontinued when the basic insulin is reduced to 8U and the fasting blood glucose reaches the standard for 3 days. Day 90:Patients were re-examined the plasma FBG and HbA1c (sent to the central laboratory for testing), and community doctors filled in the treatment experience questionnaire. Follow-up requirements: Patients use the complimentary blood glucose meter to monitor FPG every day, 2 hours postprandial blood glucose and night blood glucose are optional, and blood sugar is measured at any time if there are symptoms of hypoglycemia. The community doctor adjusted the insulin dose according to the blood glucose level every day, and the patients were followed up by telephone every week to collect the use of hypoglycemia, diet, exercise and other hypoglycemic drugs, and record the time when the FPG reached the standard, the total amount of insulin glargine, hypoglycemia and so on.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Type 2 Diabetes
    Keywords
    Type 2 Diabetes, basic insulin, community doctors

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    150 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    community patient group
    Arm Type
    Experimental
    Arm Description
    The community doctor adjusts the basic insulin dosage daily according to the fasting blood glucose of the patient under the guidance of the specialist.
    Arm Title
    inpatient group
    Arm Type
    Active Comparator
    Arm Description
    Endocrinologists in the in-patient department use the same basic insulin dose adjustment regimen to treat patients.
    Intervention Type
    Drug
    Intervention Name(s)
    basic insulin
    Other Intervention Name(s)
    Glargine 300U/3ml
    Intervention Description
    Initial dose of basic insulin: 0.2U/kg/d. Dose titration regimens: the dose is titrated by increments of 0.07U/kg daily until the fasting blood glucose(FBG)≤7 mmol / L, and if the FBG≤ 3.9mmol/L, the 0.07U/kg is reduced. Injection time: subcutaneous injection before going to bed every night.
    Primary Outcome Measure Information:
    Title
    Time to achieve target FBG
    Description
    Treatment days when FBG reached the standard (≤ 7.0mmol/L) after treatment with basal insulin.
    Time Frame
    From the beginning of intervention to fasting blood glucose ≤ 7.0mmol/L,assessed up to 3 months.
    Title
    Decrease of HbA1c
    Description
    The change of HbA1c before and after treatment with basal insulin.
    Time Frame
    At the end of 3 months of follow-up.
    Title
    Incidence of hypoglycemia
    Description
    The proportion of the occurrence of hypoglycemia to the number of total blood glucose monitoring.
    Time Frame
    At the end of 3 months of follow-up.
    Secondary Outcome Measure Information:
    Title
    Daily doses of insulin at the study end point.
    Description
    The daily doses of insulin at the study end point.
    Time Frame
    At the end of 3 months of follow-up.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Diagnosis of T2DM (WHO1999 diabetes diagnostic criteria); The age is ≥ 18 and ≤ 65 years old; Continuous use of 2 or more oral hypoglycemic drugs for 1 month but HbA1c ≥ 8.0% and FPG ≥ 10mmol/L. Exclusion Criteria: Severe abnormal liver and kidney function and cardiac insufficiency; Complicated with all kinds of acute and chronic infection or coronary heart disease, kidney disease, connective tissue disease, tumor, stroke and so on; There are acute metabolic disorders caused by stress and diseases affecting glucose metabolism, such as pheochromocytoma, acromegaly, Cushing syndrome, hyperthyroidism and so on. Acute complications of diabetes, such as diabetic ketoacidosis, hyperglycemic hyperosmotic coma or lactic acidosis, etc.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Xue-Ting Liu
    Phone
    +8613682346823
    Email
    85537054@qq.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Dewen Yan
    Organizational Affiliation
    Shenzhen Second People's Hospital
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    24002281
    Citation
    Xu Y, Wang L, He J, Bi Y, Li M, Wang T, Wang L, Jiang Y, Dai M, Lu J, Xu M, Li Y, Hu N, Li J, Mi S, Chen CS, Li G, Mu Y, Zhao J, Kong L, Chen J, Lai S, Wang W, Zhao W, Ning G; 2010 China Noncommunicable Disease Surveillance Group. Prevalence and control of diabetes in Chinese adults. JAMA. 2013 Sep 4;310(9):948-59. doi: 10.1001/jama.2013.168118.
    Results Reference
    background
    PubMed Identifier
    26171728
    Citation
    Ji L, Zhang P, Weng J, Lu J, Guo X, Jia W, Yang W, Zou D, Zhou Z, Pan C, Gao Y, Li X, Zhu D, Li Y, Wu Y, Garg SK. Observational Registry of Basal Insulin Treatment (ORBIT) in Patients with Type 2 Diabetes Uncontrolled by Oral Hypoglycemic Agents in China--Study Design and Baseline Characteristics. Diabetes Technol Ther. 2015 Oct;17(10):735-44. doi: 10.1089/dia.2015.0054. Epub 2015 Jul 14.
    Results Reference
    background
    PubMed Identifier
    31862752
    Citation
    American Diabetes Association. 9. Pharmacologic Approaches to Glycemic Treatment: Standards of Medical Care in Diabetes-2020. Diabetes Care. 2020 Jan;43(Suppl 1):S98-S110. doi: 10.2337/dc20-S009. Erratum In: Diabetes Care. 2020 Aug;43(8):1979.
    Results Reference
    background
    PubMed Identifier
    30742570
    Citation
    Garber AJ, Abrahamson MJ, Barzilay JI, Blonde L, Bloomgarden ZT, Bush MA, Dagogo-Jack S, DeFronzo RA, Einhorn D, Fonseca VA, Garber JR, Garvey WT, Grunberger G, Handelsman Y, Hirsch IB, Jellinger PS, McGill JB, Mechanick JI, Rosenblit PD, Umpierrez GE. CONSENSUS STATEMENT BY THE AMERICAN ASSOCIATION OF CLINICAL ENDOCRINOLOGISTS AND AMERICAN COLLEGE OF ENDOCRINOLOGY ON THE COMPREHENSIVE TYPE 2 DIABETES MANAGEMENT ALGORITHM - 2019 EXECUTIVE SUMMARY. Endocr Pract. 2019 Jan;25(1):69-100. doi: 10.4158/CS-2018-0535. No abstract available. Erratum In: Endocr Pract. 2019 Feb;25(2):204.
    Results Reference
    background

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    Study on the Feasibility of Community Doctors Guided by Specialists to Use Basic Insulin

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