The Blood Glucose Control in Patients With Type 2 Diabetes Treated With Glargine

Type2 Diabetes Clinical Trial

Official title:

The Current Situation and Influence Factors of Blood Glucose Control in Patients With Type 2 Diabetes Treated With Glargine in China

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03566472
• Other study ID #: KY20170904-05
• Status: Recruiting
• Start date: June 12, 2018
• Est. completion date: July 31, 2019

Study information

• Verified date: June 2018
• Source: Nanjing First Hospital, Nanjing Medical University
• Contact: Ma Jianhua
• Phone: 8625-52887092
• Email: majianhua196503[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Glargine is commonly used in insulin supplemental therapy in patients with type 2 diabetes(T2D) at present. This study aims to investigate the current status of blood glucose control in patients with T2D treated with glargine. Glycated hemoglobin(HbA1c) will be tested in these patients to assess the blood glucose control and Continuous Glucose Monitoring System (CGMS) will be used to investigate the glucose variability. Islet function, duration of diabetes, complications, exercise, insulin dose, oral medication regimen and insulin antibodies will be recorded in detail. This study will analysis the association between these clinical characteristics and blood glucose control.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: July 31, 2019
• Est. primary completion date: December 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. Patients with T2DM, which was defined bypublished Criteria of World Health Organization in 1999;

2. Patients were using glargine with or without oral hypoglycemic drugs and having a stable dose of glargine for more than 2 month would be recruited into this study;

3. Patients had relatively constant diet and exercise in 2 month before the study;

4. Fasting blood glucose was between 6.1 and 16mmolL, and postprandial (or random) blood glucose <22.2mmol/L.

Exclusion Criteria:

1. Patients with severe cardiovascular diseases, such as stroke, transient ischemic attack, myocardial infarction, unstable angina, coronary artery bypass grafting, percutaneous coronary intervention, and heart failure;

2. Patients with severe infectious diseases;

3. Patients with acute complications of diabetes on admission, such as diabetic ketoacidosis, diabetic hyperosmolar nonketotic coma, and lactic acidosis;

4. Patients with history of psychiatric disorders and were unsuitable to use CGMS;

5. Any other situations that made patients unsuitable to participate in the study, such as alcoholism and drug abuse.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type2 Diabetes

Intervention

Diagnostic Test:
• Continuous Glucose Monitoring System
Continuous Glucose Monitoring System for 72 hours

Locations

Country	Name	City	State
China	Nanjing First Hostital	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing First Hospital, Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c	Blood glycated hemoglobin	Day 1
Primary	MBG	24 h mean blood glucose	Day 1 to Day 4
Primary	MAGE	24 h mean amplitude of glycemic excursions	Day 1 to Day 4
Primary	SDBG	the standard deviation of the MBG	Day 1 to Day 4