- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02885909
Inpatient Blood Glucose Control in Taichung Veterans General Hospital
January 4, 2020 updated by: Taichung Veterans General Hospital
The Effects of Glucose Control and Monitor on Inflammation in the Hospitalized Patients With Hyperglycemia
This study will be conducted in the ward of Taichung Veterans General Hospital.
The patient with hyperglycemia in hospitalization will be enrolled by glucose management team.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
This study will be conducted in the ward of Taichung Veterans General Hospital.
The type 2 diabetic patient with hyperglycemia in hospitalization are candidates.
The glucose will be controlled using the insulin protocal based on the glucose monitor systems.
We will assess the effects of insulin protocal and glucose monitor system on the inpatient with hyperglycemia.
Study Type
Interventional
Enrollment (Anticipated)
600
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: I-Te Lee, MD, PhD
- Phone Number: 4006 +886-4-23592525
- Email: itlee@vghtc.gov.tw
Study Locations
-
-
-
Taichung, Taiwan, 40705
- Recruiting
- Taichung Veterans General Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Type 2 diabetic inpatient
- Fasting glucose >140 mg/dl or random glucose >180 mg/dl
Exclusion Criteria:
- incooperative for glucose monitor
- refusal of insulin
- pregnancy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Insulin protocal with CGM
Insulin protocal with continue glucose monitor
|
Continue glucose monitor
Using insulin protocal based on glucose monitor
|
Active Comparator: Insulin protocal
Insulin protocal with convential glucose monitor
|
Using insulin protocal based on glucose monitor
|
No Intervention: Convential treatment
Convential insulin treatment and glucose monitor
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Glucose target
Time Frame: 6 days
|
The ratio of glucose less than 180 mg/dl
|
6 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fasting glucose target
Time Frame: 6 days
|
the ratio of fasting glucose less than 140 mg/dl
|
6 days
|
Hypoglycemia
Time Frame: times
|
symptoms or less than 70
|
times
|
Vascular Cell Adhesion Molecule 1 (VCAM-1)
Time Frame: 6 days
|
Inflammation
|
6 days
|
Brain-Derived Neurotrophic Factor (BDNF)
Time Frame: 6 days
|
Psychological assessment
|
6 days
|
Orexin-A
Time Frame: 6 days
|
Psychological assessment
|
6 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: I-Te Lee, MD,PhD, Taichung Veterans General Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2016
Primary Completion (Anticipated)
December 1, 2022
Study Completion (Anticipated)
December 1, 2025
Study Registration Dates
First Submitted
August 26, 2016
First Submitted That Met QC Criteria
August 26, 2016
First Posted (Estimate)
September 1, 2016
Study Record Updates
Last Update Posted (Actual)
January 7, 2020
Last Update Submitted That Met QC Criteria
January 4, 2020
Last Verified
December 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CF16199B
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
IPD Plan Description
No plan to make individual participant data (IPD) available
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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