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

NCT03566472 | Unknown

• 1 other identifier: KY20170904-05
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (4)

• HbA1c

  Blood glycated hemoglobin

  Day 1

• MBG

  24 h mean blood glucose

  Day 1 to Day 4

• MAGE

  24 h mean amplitude of glycemic excursions

  Day 1 to Day 4

• SDBG

  the standard deviation of the MBG

  Day 1 to Day 4

Interventions

Continuous Glucose Monitoring System DIAGNOSTIC_TEST

Continuous Glucose Monitoring System for 72 hours

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Chinese outpatients with type 2 diabetes in Nanjing First Hospital who meet the the eligibility criteria.

You may qualify if:

• Patients with T2DM, which was defined bypublished Criteria of World Health Organization in 1999;
• 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;
• Patients had relatively constant diet and exercise in 2 month before the study;
• Fasting blood glucose was between 6.1 and 16mmolL, and postprandial (or random) blood glucose \<22.2mmol/L.

You may not qualify if:

• 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;
• Patients with severe infectious diseases;
• Patients with acute complications of diabetes on admission, such as diabetic ketoacidosis, diabetic hyperosmolar nonketotic coma, and lactic acidosis;
• Patients with history of psychiatric disorders and were unsuitable to use CGMS;
• Any other situations that made patients unsuitable to participate in the study, such as alcoholism and drug abuse.

Sponsors & Collaborators

• Nanjing First Hospital, Nanjing Medical University: lead

Study Sites (1)

Nanjing First Hostital

Nanjing, Jiangsu, 210000, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 35574003 DERIVED

MeSH Terms

Interventions

Continuous Glucose Monitoring

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Investigative Techniques

Study Officials

• Ma Jianhua

  The First Affiliated Hospital with Nanjing Medical University

  STUDY CHAIR

Central Study Contacts

Ma Jianhua

CONTACT

8625-52887092; majianhua196503@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2018
• First Posted: June 25, 2018
• Study Start: June 12, 2018
• Primary Completion: December 30, 2018
• Study Completion: July 31, 2019
• Last Updated: June 11, 2019

Record last verified: 2018-06

Locations

CN (1)