Inpatient Blood Glucose Control in Taichung Veterans General Hospital
Primary Purpose
HYPERGLYCEMIA
Status
Recruiting
Phase
Phase 4
Locations
Taiwan
Study Type
Interventional
Intervention
CONTINUE GLUCOSE MONITOR
Insulin protocal
Sponsored by
About this trial
This is an interventional treatment trial for HYPERGLYCEMIA focused on measuring type 2 diabetes, inpatient, glucose control, continue glucose monitor
Eligibility Criteria
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
Sites / Locations
- Taichung Veterans General HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
No Intervention
Arm Label
Insulin protocal with CGM
Insulin protocal
Convential treatment
Arm Description
Insulin protocal with continue glucose monitor
Insulin protocal with convential glucose monitor
Convential insulin treatment and glucose monitor
Outcomes
Primary Outcome Measures
Glucose target
The ratio of glucose less than 180 mg/dl
Secondary Outcome Measures
Fasting glucose target
the ratio of fasting glucose less than 140 mg/dl
Hypoglycemia
symptoms or less than 70
Vascular Cell Adhesion Molecule 1 (VCAM-1)
Inflammation
Brain-Derived Neurotrophic Factor (BDNF)
Psychological assessment
Orexin-A
Psychological assessment
Full Information
NCT ID
NCT02885909
First Posted
August 26, 2016
Last Updated
January 4, 2020
Sponsor
Taichung Veterans General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02885909
Brief Title
Inpatient Blood Glucose Control in Taichung Veterans General Hospital
Official Title
The Effects of Glucose Control and Monitor on Inflammation in the Hospitalized Patients With Hyperglycemia
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Recruiting
Study Start Date
September 2016 (undefined)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taichung Veterans General Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HYPERGLYCEMIA
Keywords
type 2 diabetes, inpatient, glucose control, continue glucose monitor
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
600 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Insulin protocal with CGM
Arm Type
Active Comparator
Arm Description
Insulin protocal with continue glucose monitor
Arm Title
Insulin protocal
Arm Type
Active Comparator
Arm Description
Insulin protocal with convential glucose monitor
Arm Title
Convential treatment
Arm Type
No Intervention
Arm Description
Convential insulin treatment and glucose monitor
Intervention Type
Device
Intervention Name(s)
CONTINUE GLUCOSE MONITOR
Intervention Description
Continue glucose monitor
Intervention Type
Procedure
Intervention Name(s)
Insulin protocal
Intervention Description
Using insulin protocal based on glucose monitor
Primary Outcome Measure Information:
Title
Glucose target
Description
The ratio of glucose less than 180 mg/dl
Time Frame
6 days
Secondary Outcome Measure Information:
Title
Fasting glucose target
Description
the ratio of fasting glucose less than 140 mg/dl
Time Frame
6 days
Title
Hypoglycemia
Description
symptoms or less than 70
Time Frame
times
Title
Vascular Cell Adhesion Molecule 1 (VCAM-1)
Description
Inflammation
Time Frame
6 days
Title
Brain-Derived Neurotrophic Factor (BDNF)
Description
Psychological assessment
Time Frame
6 days
Title
Orexin-A
Description
Psychological assessment
Time Frame
6 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
I-Te Lee, MD, PhD
Phone
+886-4-23592525
Ext
4006
Email
itlee@vghtc.gov.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
I-Te Lee, MD,PhD
Organizational Affiliation
Taichung Veterans General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Taichung Veterans General Hospital
City
Taichung
ZIP/Postal Code
40705
Country
Taiwan
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
No plan to make individual participant data (IPD) available
Learn more about this trial
Inpatient Blood Glucose Control in Taichung Veterans General Hospital
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