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Inpatient Blood Glucose Control in Taichung Veterans General Hospital

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ClinicalTrials.gov Identifier: NCT02885909
Recruitment Status : Recruiting
First Posted : September 1, 2016
Last Update Posted : March 27, 2018
Sponsor:
Information provided by (Responsible Party):
Taichung Veterans General Hospital

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.

Condition or disease Intervention/treatment Phase
HYPERGLYCEMIA Device: CONTINUE GLUCOSE MONITOR Procedure: Insulin protocal Phase 4

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  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effects of Glucose Control and Monitor on Inflammation in the Hospitalized Patients With Hyperglycemia
Study Start Date : September 2016
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : December 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Insulin protocal with CGM
Insulin protocal with continue glucose monitor
Device: CONTINUE GLUCOSE MONITOR
Continue glucose monitor

Procedure: Insulin protocal
Using insulin protocal based on glucose monitor

Active Comparator: Insulin protocal
Insulin protocal with convential glucose monitor
Procedure: Insulin protocal
Using insulin protocal based on glucose monitor

No Intervention: Convential treatment
Convential insulin treatment and glucose monitor



Primary Outcome Measures :
  1. Glucose target [ Time Frame: 6 days ]
    The ratio of glucose less than 180 mg/dl


Secondary Outcome Measures :
  1. Fasting glucose target [ Time Frame: 6 days ]
    the ratio of fasting glucose less than 140 mg/dl

  2. Hypoglycemia [ Time Frame: times ]
    symptoms or less than 70

  3. Vascular Cell Adhesion Molecule 1 (VCAM-1) [ Time Frame: 6 days ]
    Inflammation

  4. Brain-Derived Neurotrophic Factor (BDNF) [ Time Frame: 6 days ]
    Psychological assessment

  5. Orexin-A [ Time Frame: 6 days ]
    Psychological assessment



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02885909


Contacts
Contact: I-Te Lee, MD, PhD +886-4-23592525 ext 4006 itlee@vghtc.gov.tw

Locations
Taiwan
Taichung Veterans General Hospital Recruiting
Taichung, Taiwan, 40705
Sponsors and Collaborators
Taichung Veterans General Hospital
Investigators
Principal Investigator: I-Te Lee, MD,PhD Taichung Veterans General Hospital

Responsible Party: Taichung Veterans General Hospital
ClinicalTrials.gov Identifier: NCT02885909     History of Changes
Other Study ID Numbers: CF16199B
First Posted: September 1, 2016    Key Record Dates
Last Update Posted: March 27, 2018
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No plan to make individual participant data (IPD) available

Keywords provided by Taichung Veterans General Hospital:
type 2 diabetes
inpatient
glucose control
continue glucose monitor

Additional relevant MeSH terms:
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Insulin, Globin Zinc
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs