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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03566472
Enrollment
100
Registered
2018-06-25
Start date
2018-06-12
Completion date
2019-07-31
Last updated
2019-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type2 Diabetes

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.

Interventions

DIAGNOSTIC_TESTContinuous Glucose Monitoring System

Continuous Glucose Monitoring System for 72 hours

Sponsors

Nanjing First Hospital, Nanjing Medical University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
HbA1cDay 1Blood glycated hemoglobin
MBGDay 1 to Day 424 h mean blood glucose
MAGEDay 1 to Day 424 h mean amplitude of glycemic excursions
SDBGDay 1 to Day 4the standard deviation of the MBG

Countries

China

Contacts

Primary ContactMa Jianhua
majianhua196503@126.com8625-52887092

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026