Inpatient Blood Glucose Control in Taichung Veterans Gene... | NCT02885909

Studies
Inpatient Blood Glucose Control in Taichung Veterans General Hospital

NCT02885909

Sponsor

Taichung Veterans General Hospital

Status

Unknown status

Last Update Posted

Jan 7, 2020Actual

Enrollment

600Estimated

Phase

Phase 4

Conditions

HYPERGLYCEMIA

Interventions

CONTINUE GLUCOSE MONITOR
Insulin protocal

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2016

Primary Completion Date

Dec 2022Estimated

Completion Date

Dec 2025Estimated

First Submitted Date

Aug 26, 2016

First Submission Date that Met QC Criteria

Aug 26, 2016

First Posted Date

Sep 1, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 4, 2020

Last Update Posted Date

Jan 7, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

600Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Insulin protocal with CGM	Active Comparator	Insulin protocal with continue glucose monitor	Device: CONTINUE GLUCOSE MONITOR Procedure: Insulin protocal
Insulin protocal	Active Comparator	Insulin protocal with convential glucose monitor	Procedure: Insulin protocal
Convential treatment	No Intervention	Convential insulin treatment and glucose monitor

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CONTINUE GLUCOSE MONITOR	Device	Continue glucose monitor	Insulin protocal with CGM

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Glucose target	The ratio of glucose less than 180 mg/dl	6 days

Secondary Outcomes

Measure	Description	Time Frame
Fasting glucose target	the ratio of fasting glucose less than 140 mg/dl	6 days
Hypoglycemia	symptoms or less than 70	times

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
I-Te Lee, MD, PhD	Contact	+886-4-23592525	4006	itlee@vghtc.gov.tw

Overall Officials

Name	Affiliation	Role
I-Te Lee, MD,PhD	Taichung Veterans General Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Taichung Veterans General Hospital	Recruiting	Taichung		40705	Taiwan

IPD Sharing Statement Module

Plan to Share IPD

Description

No plan to make individual participant data (IPD) available

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006943	Hyperglycemia
D003924	Diabetes Mellitus, Type 2

Ancestor Terms

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D003920	Diabetes Mellitus

Browse Leaves

Not provided

Browse Branches

Not provided