Diabetes MellitusNCT05806554
Accuracy and Precision of the True Vie I3 Continuous Glucose Monitoring System: an Open Label, Multi-Center Trial
An observational study of Diabetes Mellitus, run by Sinocare at 6 sites in 2 countries.
Trial summary
The purpose of the investigation is to evaluate the performance of the I3 CGM according to the FDA's special controls for iCGM. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Continuous glucose monitoring device
- Type of treatment
- Medical device
- How many people
- 159 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 19 Jul 2023to 22 Oct 2024
- 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 80 years
- All sexes
- Adult, Older adult
Study population: Patients with type 1 diabetes mellitus (T1DM) or type 2 diabetes mellitus (T2DM) using an insulin treatment regimen based on carbohydrate (CHO) counting for meal insulin dose determination and 18-80 years of age will be recruited to participate in the study. Both participants using and not using CGM will be recruited, and participants with a wide range of BMIs and ages will be represented.
Who may be able to join
- 1. Patients with T1DM or T2DM diagnosed for at least 6 months. 2. Individual is 18-80 years old, inclusive, at the time of screening. 3. Must be and have been in stable treatment regimen for at least 1 month with a multiple daily insulin dosing regimen (at least two insulin doses with meals daily) or CSII using at least two bolus doses a day with meals, irrespective of delivery device(s).
Who cannot join
- 1. History of skin adhesive tolerance issues in the area of sensor placement. 2. HbA1c > 9%. 3. Insulin meal dosing based on fixed dose regimens. 4. Absence of established correction factor for high glucose. 5. Hematocrit below 10% under the lower limit of the normal range. 6. Body mass index < 18.5 kg/m2. 7. Inadequate intravenous access on arms. 8. Participant has had a hypoglycemic seizure within the past 6 months prior to enrollment.
- 9. Participant has had an episode of diabetic ketoacidosis (DKA) within the past 6 months prior to enrollment.
- 10. Participant has a history of a seizure disorder. 11. Pregnancy, planned pregnancy within the study period, or unwillingness to use reliable contraception during the study period.
- 12. Planned MRI, CT scan or diathermia procedure for the duration of the study.
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
United States4 sites
Atlanta Diabetes Associates
Atlanta, Georgia, 30318
Rainier Clinical Research Center
Renton, Washington, 98057
Woodland Research Northwest
Rogers, Arkansas, 72758
Diablo Clinical Research
Walnut Creek, California, 94598
Germany2 sites
PSHI Praxis GmbH
Mainz, 55128
Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm
Ulm, D-89081
About this study
The purpose of the investigation is to evaluate the performance of the I3 CGM according to the FDA's special controls for iCGM.
Read the detailed description
Participants will attend a screening visit, 4 clinic visits with Frequent Sampling Testing (FST) at the beginning, 2 in the middle, and end of the I3 CGM sensor wear, and a visit for removal of the I3 CGM. Participants will wear 3 I3 CGM devices for up to 15 days and be instructed to continue their normal daily activities and manage their glucose as usual between in clinic FST per routine care. Participants will not have access to the I3 CGM data for the management of their blood glucose between clinic visits and will continue their usual care including CGM, if they are CGM users.
At the clinic FST visits venous blood samples will be drawn from an intravenous cannula for FST for up to 10 hours for plasma glucose determination. During the clinic visits the investigative site staff will determine the participants' insulin doses and meals and may induce both hypoglycemia and hyperglycemia of up to an hour duration.
- Conditions
- Diabetes Mellitus
- Being tested
- Continuous glucose monitoring device
- Medical subject headings
- Diabetes Mellitus
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
| Study group | Role | What they receive |
|---|---|---|
| T1DM | Participants with type 1 diabetes mellitus Receives: Device: Continuous glucose monitoring device | |
| T2DM | Participants with type 2 diabetes mellitus Receives: Device: Continuous glucose monitoring device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy
percentage of iCGM values in the measuring range less than 70 mg/dL (3.9 mmol/l) within +/- 15 mg/dL (0.83 mmol/l) of the
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 posted10 Apr 2023
- Study start19 Jul 2023
- Primary completion13 Jun 2024
- Study completion22 Oct 2024
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 Diabetes MellitusStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 159 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sinocare
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Integrated Medical Development
- Responsible party
- Sponsor
- Investigators
- Ron Brazg, MD, Principal investigator, RCRC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05806554
- Sponsor's protocol ID
- NPI031-CIP-002F
- Status last verified
- Nov 2025
- First submitted
- 28 Mar 2023
- Last updated
- 25 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Jendrike N, Link M, Oter S, Fei J, Zheng J, Gao F, Gao A, Zhu S, Shi L, Strange P, Flacke F, Eichenlaub M, Freckmann G. Performance of a New Continuous Glucose Monitoring System in German Adults Living with Diabetes. Diabetes Ther. 2026 Feb;17(2):287-299. doi: 10.1007/s13300-025-01832-6. Epub 2025 Dec 29.
PubMed 41461989
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy and Precision of the True Vie I3 Continuous Glucose Monitoring System: an Open Label, Multi-Center Trial
- ClinicalTrials.gov ID
- NCT05806554
- Acronym / sponsor ID
- NPI031-CIP-002F
- Conditions
- Diabetes Mellitus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 159 participants (actual)
- Lead sponsor
- SinocareIndustry (pharma, biotech, devices)
- Collaborators
- Integrated Medical Development
- Study start
- 19 Jul 2023 (actual)
- Primary completion
- 13 Jun 2024 (actual)
- Study completion
- 22 Oct 2024 (actual)
- First posted
- 10 Apr 2023 (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 evaluate the performance of the I3 CGM according to the FDA's special controls for iCGM.
Detailed description
Participants will attend a screening visit, 4 clinic visits with Frequent Sampling Testing (FST) at the beginning, 2 in the middle, and end of the I3 CGM sensor wear, and a visit for removal of the I3 CGM. Participants will wear 3 I3 CGM devices for up to 15 days and be instructed to continue their normal daily activities and manage their glucose as usual between in clinic FST per routine care. Participants will not have access to the I3 CGM data for the management of their blood glucose between clinic visits and will continue their usual care including CGM, if they are CGM users.
At the clinic FST visits venous blood samples will be drawn from an intravenous cannula for FST for up to 10 hours for plasma glucose determination. During the clinic visits the investigative site staff will determine the participants' insulin doses and meals and may induce both hypoglycemia and hyperglycemia of up to an hour duration.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| T1DM | – | Device: Continuous glucose monitoring deviceParticipants with type 1 diabetes mellitus |
| T2DM | – | Device: Continuous glucose monitoring deviceParticipants with type 2 diabetes mellitus |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with type 1 diabetes mellitus (T1DM) or type 2 diabetes mellitus (T2DM) using an insulin treatment regimen based on carbohydrate (CHO) counting for meal insulin dose determination and 18-80 years of age will be recruited to participate in the study. Both participants using and not using CGM will be recruited, and participants with a wide range of BMIs and ages will be represented.
Key inclusion criteria (1 listed)
- 1. Patients with T1DM or T2DM diagnosed for at least 6 months. 2. Individual is 18-80 years old, inclusive, at the time of screening. 3. Must be and have been in stable treatment regimen for at least 1 month with a multiple daily insulin dosing regimen (at least two insulin doses with meals daily) or CSII using at least two bolus doses a day with meals, irrespective of delivery device(s).
Key exclusion criteria (4 listed)
- 1. History of skin adhesive tolerance issues in the area of sensor placement. 2. HbA1c > 9%. 3. Insulin meal dosing based on fixed dose regimens. 4. Absence of established correction factor for high glucose. 5. Hematocrit below 10% under the lower limit of the normal range. 6. Body mass index < 18.5 kg/m2. 7. Inadequate intravenous access on arms. 8. Participant has had a hypoglycemic seizure within the past 6 months prior to enrollment.
- 9. Participant has had an episode of diabetic ketoacidosis (DKA) within the past 6 months prior to enrollment.
- 10. Participant has a history of a seizure disorder. 11. Pregnancy, planned pregnancy within the study period, or unwillingness to use reliable contraception during the study period.
- 12. Planned MRI, CT scan or diathermia procedure for the duration of 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 |
|---|---|---|
| Continuous glucose monitoring deviceContinuous glucose monitoring device | Device | T1DM, T2DM |
Primary outcome
Accuracy
Time frame: 15 days
percentage of iCGM values in the measuring range less than 70 mg/dL (3.9 mmol/l) within +/- 15 mg/dL (0.83 mmol/l) of the
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 25 Nov 2025.
- Derived from this study: PubMed 41461989Jendrike N, Link M, Oter S, Fei J, Zheng J, Gao F, Gao A, Zhu S, Shi L, Strange P, Flacke F, Eichenlaub M, Freckmann G. Performance of a New Continuous Glucose Monitoring System in German Adults Living with Diabetes. Diabetes Ther. 2026 Feb;17(2):287-299. doi: 10.1007/s13300-025-01832-6. Epub 2025 Dec 29.
- Individual participant dataSharing planned: No
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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.
Ron Brazg, MD principal investigator
RCRC
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, run by Sinocare at 6 sites in 2 countries.
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 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: finished, as of the sponsor's last update on 25 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States, Germany. 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?
Accuracy (time frame: 15 days). 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 NCT05806554, 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 25 Nov 2025.