Clinical trial NCT04553380: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Type 2 Diabetes
Keywords: Type 2 Diabetes
basic insulin
community doctors
Lead sponsor: Shenzhen Second People's Hospital
Sponsor class: OTHER
First posted: 2020-09-17
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

1. Screening period (day 0): patients were screened according to the inclusion and exclusion criteria, and informed consent was completed.
2. 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:

1. 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.
2. 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Time to achieve target FBG
timeFrame: From the beginning of intervention to fasting blood glucose ≤ 7.0mmol/L，assessed up to 3 months.
measure: Decrease of HbA1c
timeFrame: At the end of 3 months of follow-up.
measure: Incidence of hypoglycemia
timeFrame: At the end of 3 months of follow-up.
Secondary outcomes:
measure: Daily doses of insulin at the study end point.
timeFrame: At the end of 3 months of follow-up.
Other outcomes:
Locations:
Study officials:
affiliation: Shenzhen Second People's Hospital
name: Dewen Yan
role: STUDY_CHAIR
References:
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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.
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.
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.