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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.
The study consists of two parts: the screening period and the treatment follow-up period.
Day 2-Day 89:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| inpatient group | Active Comparator | Endocrinologists in the in-patient department use the same basic insulin dose adjustment regimen to treat patients. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| basic insulin | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Daily doses of insulin at the study end point. | The daily doses of insulin at the study end point. | At the end of 3 months of follow-up. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xue-Ting Liu | Contact | +8613682346823 | 85537054@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Dewen Yan | Shenzhen Second People's Hospital | Study Chair |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24002281 | Background | 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. | |
| 26171728 |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000069036 | Insulin Glargine |
| ID | Term |
|---|---|
| D049528 | Insulin, Long-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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| 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. |
| 31862752 | 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. |
| 30742570 | 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. |
| D004700 | Endocrine System Diseases |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |