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

NCT04553380 | Unknown

• 1 other identifier: YANDEWEN
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Type 2 Diabetes

Keywords

Type 2 Diabetes; basic insulin; community doctors

Outcome Measures

Primary Outcomes (3)

• Time to achieve target FBG

  Treatment days when FBG reached the standard (≤ 7.0mmol/L) after treatment with basal insulin.

  From the beginning of intervention to fasting blood glucose ≤ 7.0mmol/L，assessed up to 3 months.

• Decrease of HbA1c

  The change of HbA1c before and after treatment with basal insulin.

  At the end of 3 months of follow-up.

• Incidence of hypoglycemia

  The proportion of the occurrence of hypoglycemia to the number of total blood glucose monitoring.

  At the end of 3 months of follow-up.

Secondary Outcomes (1)

• Daily doses of insulin at the study end point.

  At the end of 3 months of follow-up.

Study Arms (2)

community patient group

EXPERIMENTAL

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

Drug: basic insulin

inpatient group

ACTIVE COMPARATOR

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

Drug: basic insulin

Interventions

basic insulin DRUG

1. Initial dose of basic insulin: 0.2U/kg/d. 2. 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. 3. Injection time: subcutaneous injection before going to bed every night.

Also known as: Glargine 300U/3ml

community patient group; inpatient group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shenzhen Second People's Hospital: lead

Related Publications (4)

• 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.

  PMID: 24002281 BACKGROUND

• 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.

  PMID: 26171728 BACKGROUND

• 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.

  PMID: 31862752 BACKGROUND

• 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.

  PMID: 30742570 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Insulin Glargine

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Dewen Yan

  Shenzhen Second People's Hospital

  STUDY CHAIR

Central Study Contacts

Xue-Ting Liu

CONTACT

+8613682346823; 85537054@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2020
• First Posted: September 17, 2020
• Study Start: December 1, 2020
• Primary Completion: December 31, 2021
• Study Completion: March 31, 2022
• Last Updated: September 17, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share