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

NCT ID: NCT03566472

Last Updated: 2019-06-11

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-06-12
• Study Completion Date: 2019-07-31

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.

Conditions

Type2 Diabetes

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Interventions

Continuous Glucose Monitoring System

Continuous Glucose Monitoring System for 72 hours

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nanjing First Hospital, Nanjing Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ma Jianhua

Role: STUDY_CHAIR

The First Affiliated Hospital with Nanjing Medical University

Locations

Nanjing First Hostital

Nanjing, Jiangsu, China

Site Status: RECRUITING

Countries

China

Central Contacts

Ma Jianhua

Role: CONTACT

majianhua196503@126.com

8625-52887092

Facility Contacts

Jianhua Ma, Doctor

Role: primary

majianhua196503@126.com

+8618951670116

References

Wang H, Zhou Y, Wang Y, Cai T, Hu Y, Jing T, Ding B, Su X, Li H, Ma J. Basal Insulin Reduces Glucose Variability and Hypoglycaemia Compared to Premixed Insulin in Type 2 Diabetes Patients: A Study Based on Continuous Glucose Monitoring Systems. Front Endocrinol (Lausanne). 2022 Apr 27;13:791439. doi: 10.3389/fendo.2022.791439. eCollection 2022.

Reference Type: DERIVED

PMID: 35574003 (View on PubMed)

Other Identifiers

KY20170904-05

Identifier Type: -

Identifier Source: org_study_id