Type 2 DiabetesNCT04797416
The Evaluation of Consistency by Finger Stick Blood Glucose or Venous Blood Glucose of Flash Glucose Monitoring in Different Infiltration Time
A study testing FGM infiltration 1 hour group, FGM infiltration 6-hour group and FGM infiltration 12-hour group in people with Type 2 Diabetes and Flash Glucose Monitoring, run by Sun Yat-sen University at 1 site in China.
Trial summary
This is a prospective randomized controlled study to evaluate consistency by finger stick blood glucose or venous blood glucose in different infiltration time (including the time between activation of the sensor and storage of the first blood glucose value) of Flash glucose monitoring(FGM). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes, Flash Glucose Monitoring, Conscience
- What is being tested?
- FGM infiltration 1 hour group, FGM infiltration 6-hour group and FGM infiltration 12-hour group
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 480 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2019to 30 Dec 2021
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with type 2 diabetes fit the 1999 who diagnostic criteria for diabetes
- Aged 18 or above
- Without serious complications, such as diabetic ketoacidosis, severe infection,severe cardiac insufficiency, severe liver and kidney diseases
- Voluntary and signed informed consent to participate
- Be able to read and understand Chinese, perform all research visits and tasks, and follow research instructions
Who cannot join
- Patients with known allergy to medical grade adhesive or isopropanol used for skin disinfection, edema, skin damage, scar, redness, infection, etc. during pregnancy or preparation of pregnancy or at the sensor application site (dorsal side of upper arm).
- The examinee took drugs such as ascorbic acid (vitamin C) and salicylic acid (an ingredient in aspirin and many painkillers) that affected the accuracy of the sensor.
- MRI is required during the study.
- The examinee had poor compliance and could not continue to complete the study.
Trial locations and contacts
1 site in 1 country.
China1 site
endocrinology department of the first affiliated hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510080
About this study
This is a prospective randomized controlled study to evaluate consistency by finger stick blood glucose or venous blood glucose in different infiltration time (including the time between activation of the sensor and storage of the first blood glucose value) of Flash glucose monitoring(FGM). In this study, the relationship between the dynamic blood glucose and finger stick blood glucose or venous blood glucose in type 2 diabetes mellitus patients(T2DM), was explored. And the investigators also analyzed the deviation and accuracy of FGM in practical application,so as to provide a good reference for clinical application.
- Conditions
- Type 2 Diabetes, Flash Glucose Monitoring, Conscience
- Being tested
- FGM infiltration 1 hour group, FGM infiltration 6-hour group, FGM infiltration 12-hour group
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FGM infiltration 1 hour groupDevice
The sensor is activated immediately after wearing (including the time between the sensor activation and the first blood glucose value stored，about 1 hour).
FGM infiltration 6-hour groupDevice
Reactivate the sensor 5 hours after wearing (including the time between the sensor activation and the first blood glucose value stored，about 1 hour).
FGM infiltration 12-hour groupDevice
Reactivate the sensor 11 hours after wearing (including the time between the sensor activation and the first blood glucose value stored，about 1 hour).
| Study group | Role | What they receive |
|---|---|---|
| 1-hour group | Active comparator | The time between the activation of the sensor and the storage of the first blood glucose value is 1 hour. Receives: Device: FGM infiltration 1 hour group |
| 6-hour group | Experimental | The time between the activation of the sensor and the storage of the first blood glucose value is 6 hours. Receives: Device: FGM infiltration 6-hour group |
| 12-hour group | Experimental | The time between the activation of the sensor and the storage of the first blood glucose value is 12 hours. Receives: Device: FGM infiltration 12-hour group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference value
The difference between finger stick blood glucose or venous blood glucose and FGM value.
Measured: Up to 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2021
- Study start1 Aug 2019
- Primary completion30 Dec 2021 (estimated)
- Study completion30 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 480 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanbing Li, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04797416
- Sponsor's protocol ID
- 2020477
- Status last verified
- Mar 2021
- First submitted
- 4 Mar 2021
- Last updated
- 15 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Evaluation of Consistency by Finger Stick Blood Glucose or Venous Blood Glucose of Flash Glucose Monitoring in Different Infiltration Time
- ClinicalTrials.gov ID
- NCT04797416
- Acronym / sponsor ID
- 2020477
- Conditions
- Type 2 Diabetes, Flash Glucose Monitoring, Conscience
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 480 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 30 Dec 2021 (estimated)
- Study completion
- 30 Dec 2021 (estimated)
- First posted
- 15 Mar 2021 (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.
This is a prospective randomized controlled study to evaluate consistency by finger stick blood glucose or venous blood glucose in different infiltration time (including the time between activation of the sensor and storage of the first blood glucose value) of Flash glucose monitoring(FGM). In this study, the relationship between the dynamic blood glucose and finger stick blood glucose or venous blood glucose in type 2 diabetes mellitus patients(T2DM), was explored. And the investigators also analyzed the deviation and accuracy of FGM in practical application,so as to provide a good reference for clinical application.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1-hour group | Active comparator | Device: FGM infiltration 1 hour groupThe time between the activation of the sensor and the storage of the first blood glucose value is 1 hour. |
| 6-hour group | Experimental | Device: FGM infiltration 6-hour groupThe time between the activation of the sensor and the storage of the first blood glucose value is 6 hours. |
| 12-hour group | Experimental | Device: FGM infiltration 12-hour groupThe time between the activation of the sensor and the storage of the first blood glucose value is 12 hours. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with type 2 diabetes fit the 1999 who diagnostic criteria for diabetes
- Aged 18 or above
- Without serious complications, such as diabetic ketoacidosis, severe infection,severe cardiac insufficiency, severe liver and kidney diseases
- Voluntary and signed informed consent to participate
- Be able to read and understand Chinese, perform all research visits and tasks, and follow research instructions
Key exclusion criteria (4 listed)
- Patients with known allergy to medical grade adhesive or isopropanol used for skin disinfection, edema, skin damage, scar, redness, infection, etc. during pregnancy or preparation of pregnancy or at the sensor application site (dorsal side of upper arm).
- The examinee took drugs such as ascorbic acid (vitamin C) and salicylic acid (an ingredient in aspirin and many painkillers) that affected the accuracy of the sensor.
- MRI is required during the study.
- The examinee had poor compliance and could not continue to complete the study.
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 |
|---|---|---|
| FGM infiltration 1 hour groupThe sensor is activated immediately after wearing (including the time between the sensor activation and the first blood glucose value stored，about 1 hour). | Device | 1-hour group |
| FGM infiltration 6-hour groupReactivate the sensor 5 hours after wearing (including the time between the sensor activation and the first blood glucose value stored，about 1 hour). | Device | 6-hour group |
| FGM infiltration 12-hour groupReactivate the sensor 11 hours after wearing (including the time between the sensor activation and the first blood glucose value stored，about 1 hour). | Device | 12-hour group |
Primary outcome
Difference value
Time frame: Up to 21 days
The difference between finger stick blood glucose or venous blood glucose and FGM value.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FGM infiltration 1 hour group, FGM infiltration 6-hour group and FGM infiltration 12-hour group in people with Type 2 Diabetes and Flash Glucose Monitoring, run by Sun Yat-sen University at 1 site in China.
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 5 inclusion and 4 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 15 Mar 2021. 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 China. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference value (time frame: Up to 21 days). 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 15 Mar 2021.