NCT03804658

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 11, 2019

Completed
2 days until next milestone

Study Start

First participant enrolled

January 13, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 15, 2019

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

October 20, 2020

Status Verified

October 1, 2020

Enrollment Period

6 years

First QC Date

January 11, 2019

Last Update Submit

October 18, 2020

Conditions

Glucose VariabilityCognitive Decline

Keywords

Brain-derived neurotrophic factorVascular cell adhesion molecule 1RenalaseOrexinContinue glucose monitor

Outcome Measures

Primary Outcomes (1)

  • Glucose variability

    Data from continue glucose monitor system

    3 months

Secondary Outcomes (5)

  • brain-derived neurotrophic factor

    3 months

  • Orexin

    3 months

  • Renalase

    3 months

  • Vascular endothelial cell adhesion molecule 1

    3 months

  • Health Literacy

    3 months

Interventions

Continue glucose monitor systemDEVICE

The cardiovascular risks and data from continue glucose monitor system

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adults with diabetes both in outpatient and inpatient

You may qualify if:

  • Adults with diabetes

You may not qualify if:

  • Incooperative patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Division of Endocrinology and Metabolism in Taichung Veterans General Hospital

Taichung, 407, Taiwan

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum, Plasma and urine

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • I-Te Lee, MD,PhD

    Taichung Veterans General Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

I-Te Lee, MD,PhD

CONTACT

+886-4-23592525itlee@vghtc.gov.tw

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 11, 2019

First Posted

January 15, 2019

Study Start

January 13, 2019

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

October 20, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Not to share individual participant data

Locations

TW(1)