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
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
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.
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
NCT ID
NCT04553380
First Posted
September 3, 2020
Last Updated
September 11, 2020
Sponsor
Shenzhen Second People's Hospital
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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