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

• Conditions: Type2 Diabetes

• Registration Number: NCT03566472
• Lead Sponsor: Nanjing First Hospital, Nanjing Medical University

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2018-06
• Study Start: 2018-06-12
• Study First Submitted: 2018-06-12
• Study First Submitted QC: 2018-06-12
• Study First Posted: 2018-06-25
• Primary Completion: 2018-12-30
• Last Update Submitted: 2019-06-09
• Last Update Posted: 2019-06-11
• Study Completion: 2019-07-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
MBG	Day 1 to Day 4	24 h mean blood glucose
SDBG	Day 1 to Day 4	the standard deviation of the MBG
HbA1c	Day 1	Blood glycated hemoglobin
MAGE	Day 1 to Day 4	24 h mean amplitude of glycemic excursions

Trial Locations

Locations (1)

Nanjing First Hostital; 🇨🇳 Nanjing, Jiangsu, China