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The Blood Glucose Control in Patients With Type 2 Diabetes Treated With Glargine 100 Exercise-Based

Unknown status
Clinical Trial NCT03566472 is an observational study for Type2 Diabetes that is unknown status. It started on 12 June 2018 with plans to enroll 100 participants. Led by Nanjing First Hospital, Nanjing Medical University, it is expected to complete by 31 July 2019. The latest data from ClinicalTrials.gov was last updated on 11 June 2019.
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 variabili...Show More
Official Title

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

Conditions
Type2 Diabetes
Publications
Scientific articles and research papers published about this clinical trial:
Other Study IDs
  • KY20170904-05
NCT ID Number
NCT03566472
Start Date (Actual)
2018-06-12
Last Update Posted
2019-06-11
Completion Date (Estimated)
2019-07-31
Enrollment (Estimated)
100
Study Type
Observational
Status
Unknown status
Arms / Interventions
Participant Group/ArmIntervention/Treatment
N/A
Continuous Glucose Monitoring System
Continuous Glucose Monitoring System for 72 hours
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
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
Eligibility Criteria

Eligible Ages
Child, Adult, Older Adult
Eligible Sexes
All
  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.

  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.
Nanjing First Hospital, Nanjing Medical University logoNanjing First Hospital, Nanjing Medical University
Study Central Contact
Contact: Ma Jianhua, 8625-52887092, [email protected]
1 Study Locations in 1 Countries

Jiangsu

Nanjing First Hostital, Nanjing, Jiangsu, 210000, China
Jianhua Ma, Doctor, Contact, +8618951670116, [email protected]
Recruiting