The Factors Affecting the Achievement of Glucose Monitor... | NCT03804658

Studies
The Factors Affecting the Achievement of Glucose Monitor in the Patients on Diabetes

NCT03804658

Sponsor

Taichung Veterans General Hospital

Status

Unknown status

Last Update Posted

Oct 20, 2020Actual

Enrollment

200Estimated

Phase

Not provided

Conditions

Glucose Variability
Cognitive Decline

Interventions

Continue glucose monitor system

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

Oct 2020

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

Jan 13, 2019Actual

Primary Completion Date

Dec 31, 2024Estimated

Completion Date

Dec 31, 2024Estimated

First Submitted Date

Jan 11, 2019

First Submission Date that Met QC Criteria

Jan 11, 2019

First Posted Date

Jan 15, 2019Actual

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

Oct 18, 2020

Last Update Posted Date

Oct 20, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

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

To assess the effect of glucose monitors on glucose control and cardiovascular risks.

Detailed Description

The investigators will enroll patients with diabetes. The answered questionnaire and blood samples will be collected at baseline. After change the methods or frequency of glucose monitor, the blood samples will be collected again. The investigators will analyze the factors which may affect the glucose control after changes in methods of glucose monitor.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

3 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Continue glucose monitor system	Device	The cardiovascular risks and data from continue glucose monitor system

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Glucose variability	Data from continue glucose monitor system	3 months

Secondary Outcomes

Measure	Description	Time Frame
brain-derived neurotrophic factor	Biomarker of cognition	3 months
Orexin	Biomarker of cognition	3 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adults with diabetes

Exclusion Criteria:

Incooperative patients

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

Adults with diabetes both in outpatient and inpatient

Sampling Method

Non-Probability Sample

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
Division of Endocrinology and Metabolism in Taichung Veterans General Hospital	Recruiting	Taichung		407	Taiwan

IPD Sharing Statement Module

Plan to Share IPD

Description

Not to share individual participant data

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D060825	Cognitive Dysfunction

Ancestor Terms

ID	Term
D003072	Cognition Disorders
D019965	Neurocognitive Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided