Continuous Glucose MonitoringNCT05348928
A Pilot Study of the Feasibility and Accuracy of the TrueVie CGM System - A Non-Significant Risk Study
An observational study of Continuous Glucose Monitoring, run by Sinocare Meditech Inc. at 1 site in United States.
Trial summary
The purpose of the investigation is to obtain sufficient preliminary information about the performance of the TrueVie Continuous Glucose Monitoring (CGM) device to identify any need for any design modifications. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Continuous Glucose Monitoring
- What is being tested?
- Continuous glucose monitoring device and Laboratory plasma glucose concentration determination
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 4 May 2022to 16 Jun 2022
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with type 1 diabetes
Who may be able to join
- 1 Type 1 diabetes mellitus 2. Must be and have been in stable treatment regimen for at least 3 months with a multiple daily insulin dosing regimens or Continuous Subcutaneous Insulin Infusion (CSII), irrespective of delivery device(s).
- 3. Must have normal exercise tolerance.
Who cannot join
- Skin adhesive tolerance issues in the area of sensor placement
- HbA1c > 9%.
- Insulin meal dosing based on fixed dose regimens.
- Absence of established corrective factor for high glucose.
- Hematocrit below 10% under the lower limit of the normal range.
- Body mass index < 20 kg/m2.
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- Inadequate intravenous access on arms.
- Absence of moderate exercise tolerance per history
- Pregnancy, planned pregnancy within the study period, or unwillingness to use reliable contraception during the study period.
- Planned MRI, CT scan or diathermic procedure for the duration of the study.
- Any medical history of malignant melanoma or breast cancer.
- Medical history of any other cancers within the last five years except adequately treated basal cell or squamous carcinoma of the skin, or cervical carcinoma in-situ.
- History of alcohol or drug abuse within the last year.
- Any condition that in the opinion of the investigator may interfere successful completion of study procedures.
- Participation in other clinical trials involving receipt of investigational drug that cannot be disclosed within the last 30 days.
- Inability or unwillingness to conform to the required protocol procedures including giving informed consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
Rainier Clinical Research Center
Renton, Washington, 98057
About this study
Official title: A Pilot Study of the Feasibility and Accuracy of the TrueVie Continuous Glucose Monitoring System - A Non-Significant Risk Study
The purpose of the investigation is to obtain sufficient preliminary information about the performance of the TrueVie Continuous Glucose Monitoring (CGM) device to identify any need for any design modifications.
Read the detailed description
After being informed about the study and potential risks, all participants giving written informed consent will be screened for participation. Qualifying participants will insert CGM sensors and come to 3 clinic visits at the beginning, middle and end of the 15 days intended sensor life. At the clinic visits participants are served two meals and perform a brief period of exercise of moderate intensity while blood samples are drawn according to a planned schedule timed to coincide with the TrueVie measurements.
- Conditions
- Continuous Glucose Monitoring
- Being tested
- Continuous glucose monitoring device, Laboratory plasma glucose concentration determination
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous glucose monitoring deviceDevice
Continuous glucose monitoring device
Laboratory plasma glucose concentration determinationOther
Laboratory plasma glucose concentration determination
| Study group | Role | What they receive |
|---|---|---|
| With oral ascorbic acid | 1 g ascorbic acid orally Receives: Device: Continuous glucose monitoring device; Other: Laboratory plasma glucose concentration determination | |
| Without oral ascorbic acid | No oral ascorbic acid is taken Receives: Device: Continuous glucose monitoring device; Other: Laboratory plasma glucose concentration determination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events
safety is assessed by adverse events
Measured: 15 days
Incidence of Treatment-Emergent Adverse Device Events
safety is assessed by adverse device effects
Measured: 15 days
Insertion Site Intensity of any Erythema on a Likert scale
tolerability by intensity of erythema at the insertion site
Measured: 15 days
Insertion Site Erythema Size estimated from Lengths of Major and Minor Axis
tolerability by size of erythema at the insertion site
Measured: 15 days
Edema by Maximal Height from Surrounding Skin Surface
tolerability by edema at insertion site
Measured: 15 days
Secondary outcomes (1)
Sensor Accuracy by Mean Absolute Glucose Concentration Difference from Reference
Sensor accuracy will be determined against plasma glucose concentrations determined by laboratory quality instrumentation
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2022
- Study start4 May 2022
- Primary completion16 Jun 2022
- Study completion16 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Continuous Glucose MonitoringStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sinocare Meditech Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Integrated Medical Development
- Responsible party
- Sponsor
- Investigators
- Poul Strange, MD, PhD, Study director, Integrated Medical Development
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05348928
- Sponsor's protocol ID
- NPI031-CEP-001F
- Status last verified
- May 2022
- First submitted
- 14 Apr 2022
- Last updated
- 30 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Brazg R, Mitchell T, Fei J, Zheng J, Gao F, Gao A, Zhu S, Flacke F, Shi L, Strange P. Impact of Ascorbic Acid and Exercise on Accuracy of a Glucose Monitoring System with GDH-FAD Technology in Adult Patients with Type 1 Diabetes Mellitus: A Double-Blinded, Randomized Trial. Diabetes Ther. 2026 Oct 9. doi: 10.1007/s13300-026-01918-9. Online ahead of print.
PubMed 42853347
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of the Feasibility and Accuracy of the TrueVie Continuous Glucose Monitoring System - A Non-Significant Risk Study
- ClinicalTrials.gov ID
- NCT05348928
- Acronym / sponsor ID
- NPI031-CEP-001F
- Conditions
- Continuous Glucose Monitoring
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Sinocare Meditech Inc.Industry (pharma, biotech, devices)
- Collaborators
- Integrated Medical Development
- Study start
- 4 May 2022 (actual)
- Primary completion
- 16 Jun 2022 (actual)
- Study completion
- 16 Jun 2022 (actual)
- First posted
- 27 Apr 2022 (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.
The purpose of the investigation is to obtain sufficient preliminary information about the performance of the TrueVie Continuous Glucose Monitoring (CGM) device to identify any need for any design modifications.
Detailed description
After being informed about the study and potential risks, all participants giving written informed consent will be screened for participation. Qualifying participants will insert CGM sensors and come to 3 clinic visits at the beginning, middle and end of the 15 days intended sensor life. At the clinic visits participants are served two meals and perform a brief period of exercise of moderate intensity while blood samples are drawn according to a planned schedule timed to coincide with the TrueVie measurements.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| With oral ascorbic acid | – | Device: Continuous glucose monitoring device, Other: Laboratory plasma glucose concentration determination1 g ascorbic acid orally |
| Without oral ascorbic acid | – | Device: Continuous glucose monitoring device, Other: Laboratory plasma glucose concentration determinationNo oral ascorbic acid is taken |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with type 1 diabetes
Key inclusion criteria (2 listed)
- 1 Type 1 diabetes mellitus 2. Must be and have been in stable treatment regimen for at least 3 months with a multiple daily insulin dosing regimens or Continuous Subcutaneous Insulin Infusion (CSII), irrespective of delivery device(s).
- 3. Must have normal exercise tolerance.
Key exclusion criteria (16 listed)
- Skin adhesive tolerance issues in the area of sensor placement
- HbA1c > 9%.
- Insulin meal dosing based on fixed dose regimens.
- Absence of established corrective factor for high glucose.
- Hematocrit below 10% under the lower limit of the normal range.
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 |
|---|---|---|
| Continuous glucose monitoring deviceContinuous glucose monitoring device | Device | With oral ascorbic acid, Without oral ascorbic acid |
| Laboratory plasma glucose concentration determinationLaboratory plasma glucose concentration determination | Other | With oral ascorbic acid, Without oral ascorbic acid |
Primary outcome
Incidence of Treatment-Emergent Adverse Events
Time frame: 15 days
safety is assessed by adverse events
Incidence of Treatment-Emergent Adverse Device Events
Time frame: 15 days
safety is assessed by adverse device effects
Insertion Site Intensity of any Erythema on a Likert scale
Time frame: 15 days
tolerability by intensity of erythema at the insertion site
Insertion Site Erythema Size estimated from Lengths of Major and Minor Axis
Time frame: 15 days
tolerability by size of erythema at the insertion site
Edema by Maximal Height from Surrounding Skin Surface
Time frame: 15 days
tolerability by edema at insertion site
1 secondary outcome
Sensor Accuracy by Mean Absolute Glucose Concentration Difference from Reference
Time frame: 15 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2022.
- Derived from this study: PubMed 42853347Brazg R, Mitchell T, Fei J, Zheng J, Gao F, Gao A, Zhu S, Flacke F, Shi L, Strange P. Impact of Ascorbic Acid and Exercise on Accuracy of a Glucose Monitoring System with GDH-FAD Technology in Adult Patients with Type 1 Diabetes Mellitus: A Double-Blinded, Randomized Trial. Diabetes Ther. 2026 Oct 9. doi: 10.1007/s13300-026-01918-9. Online ahead of print.
- Individual participant dataSharing planned: No
Related trials for Continuous Glucose Monitoring
Active, not recruiting
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Food-i-Sense Analytics: Integrating AI Into Continuous Glucose Monitoring Data Analysis for Precision Nutrition.
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Inter-Arm Differences in Continuous Glucose Monitor Readings in Adults With Diabetes
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A Study of Orforglipron (LY3502970) Compared With Dulaglutide in Pediatric Participants With Type 2 Diabetes
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Recruiting
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Type 2 Diabetes
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.
Poul Strange, MD, PhD study director
Integrated Medical Development
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 Continuous Glucose Monitoring, run by Sinocare Meditech Inc. at 1 site in United States.
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 2 inclusion and 16 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: finished, as of the sponsor's last update on 30 Jun 2022. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence of Treatment-Emergent Adverse Events (time frame: 15 days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05348928, which also lists 1 linked publication.
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 30 Jun 2022.