Glucose VariabilityNCT03804658
The Factors Affecting the Achievement of Glucose Monitor in the Patients on Diabetes
An observational study of Glucose Variability and Cognitive Decline, run by Taichung Veterans General Hospital at 1 site in Taiwan.
Trial summary
To assess the effect of glucose monitors on glucose control and cardiovascular risks. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Glucose Variability, Cognitive Decline
- What is being tested?
- Continue glucose monitor system
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 1 siteTaiwan
- Study dates
- 13 Jan 2019to 31 Dec 2024
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults with diabetes both in outpatient and inpatient
Who may be able to join
- Adults with diabetes
Who cannot join
- Incooperative patients
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Division of Endocrinology and Metabolism in Taichung Veterans General Hospital
Taichung, 407
I-Te Lee, MD, 886-4-23741340, itlee@vghtc.gov.tw
I-Te Lee, MD
About this study
Official title: The Effects of Glucose Monitor on Patients With Diabetes
To assess the effect of glucose monitors on glucose control and cardiovascular risks.
Read the 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.
- Conditions
- Glucose Variability, Cognitive Decline
- Being tested
- Continue glucose monitor system
- Keywords
- Brain-derived neurotrophic factor, Vascular cell adhesion molecule 1, Renalase, Orexin, Continue glucose monitor
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continue glucose monitor systemDevice
The cardiovascular risks and data from continue glucose monitor system
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose variability
Data from continue glucose monitor system
Measured: 3 months
Secondary outcomes (5)
brain-derived neurotrophic factor
Biomarker of cognition
Measured: 3 months
Orexin
Biomarker of cognition
Measured: 3 months
Renalase
Biomarker of cognition
Measured: 3 months
Vascular endothelial cell adhesion molecule 1
Biomarker for inflammation
Measured: 3 months
Health Literacy
Questionnaire of health
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2019
- Study start13 Jan 2019
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glucose VariabilityStudies of the same condition, open and under way.
- More trials run by Taichung Veterans General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Taichung Veterans General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- I-Te Lee, MD,PhD, Principal investigator, Taichung Veterans General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03804658
- Sponsor's protocol ID
- CG18308A
- Status last verified
- Oct 2020
- First submitted
- 11 Jan 2019
- Last updated
- 20 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not to share individual participant data
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Glucose Monitor on Patients With Diabetes
- ClinicalTrials.gov ID
- NCT03804658
- Acronym / sponsor ID
- CG18308A
- Conditions
- Glucose Variability, Cognitive Decline
- Keywords
- Brain-derived neurotrophic factor, Vascular cell adhesion molecule 1, Renalase, Orexin, Continue glucose monitor
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Taichung Veterans General HospitalUniversity, hospital or other
- Study start
- 13 Jan 2019 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 15 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with diabetes both in outpatient and inpatient
Key inclusion criteria (1 listed)
- Adults with diabetes
Key exclusion criteria (1 listed)
- Incooperative patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continue glucose monitor systemThe cardiovascular risks and data from continue glucose monitor system | Device | – |
Primary outcome
Glucose variability
Time frame: 3 months
Data from continue glucose monitor system
5 secondary outcomes
brain-derived neurotrophic factor
Time frame: 3 months
Orexin
Time frame: 3 months
Renalase
Time frame: 3 months
Vascular endothelial cell adhesion molecule 1
Time frame: 3 months
Health Literacy
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2020.
- Individual participant dataSharing planned: No. Not to share individual participant data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
I-Te Lee, MD,PhD principal investigator
Taichung Veterans General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glucose Variability and Cognitive Decline, run by Taichung Veterans General Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact I-Te Lee, MD,PhD (+886-4-23592525 ext. 4006, itlee@vghtc.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glucose variability (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2020.