Diabetes MellitusNCT07122180
Post-Market Clinical Follow-Up of the CT3 Series Continuous Glucose Monitoring System: A 14-Day Observational Study Assessing Accuracy, Safety, and Glucose Control in Patients With Type 1 and Type 2 Diabetes Mellitus
An observational study of Diabetes Mellitus, run by MDCECRO LLC at 1 site in Latvia.
Trial summary
Post market Clinical follow-up of the CT3 Series Continuous Glucose Monitoring System: A 14-Day Observational Study Assessing Accuracy, Safety, and Glucose Control in patients with Type 1 and Type 2 Diabetes Mellitus 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?
- CT3 Series Continuous Glucose Monitoring System:
- Type of treatment
- Medical device
- How many people
- 72 participants
- Where
- 1 siteLatvia
- Study dates
- 4 Jun 2025to 31 Jan 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with type 1 or 2 diabetes mellitus
Who may be able to join
- 1.Patients diagnosed with type 1 or 2 diabetes mellitus. 2.People aged 18 years or older, regardless of gender. 3.Those who sign informed consent to participate in this study voluntarily. 4.The patient had good compliance and could complete this whole clinical investigation.
Who cannot join
- 1.Those who have broken, scarred, red, swollen, or infected skin on the upper arms or abdomen.
- 2.Those who are allergic to alcohol disinfectants or medical adhesive tapes. 3.Those who have hematologic diseases that affect coagulation function or have been diagnosed with a bleeding tendency.
- 4.Those who have anemia or abnormal hematocrit. 5.Pregnant and lactating women. 6.Psychiatric abnormalities, cognitive and communication disorders, or highly stressed and uncooperative.
- 7.Those with subcutaneous edema at the wearing site. 8. Those who plan to undergo magnetic resonance imaging (MRI), computed tomography (CT), or X-ray examination within 14 days of wearing.
- 9. Those who have participated in clinical trials of drugs or devices within 1 month.
- 10.Those who are considered by the investigator to be inappropriate to participate in this PMCF study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Post market Clinical follow-up of the CT3 Series Continuous Glucose Monitoring System: A 14-Day Observational Study Assessing Accuracy, Safety, and Glucose Control in patients with Type 1 and Type 2 Diabetes Mellitus
Read the detailed description
To re-assess the benefits of CT3 series CGM and the risks of skin abnormalities, hypoglycaemia, hyperglycaemia so as to improve CT3 series CGM continuously.
- Conditions
- Diabetes Mellitus
- Being tested
- CT3 Series Continuous Glucose Monitoring System:
- Keywords
- Diabetes Mellitus
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT3 Series Continuous Glucose Monitoring System:Device
The CT3 Series CGM System is a real-time, continuous glucose monitoring device indicated for the management of diabetes in adults (age≥18 years). Interpretation of the CT3 Series CGM System results should be based on the glucose trends and several sequential readings over time. The CT3 Series CGM System also aids in the detection of episodes of hyperglycaemia and hypoglycaemia. It is intended for single-patient use. It is intended to replace fingerstick blood glucose testing for diabetes treatment decisions unless otherwise indicated
What is being measured
The primary outcome is the main question the study is designed to answer.
This PMCF study (Version V2.0) uses a strong evaluation plan, with methods and timing carefully matched to the study's rules. It includes 72 patients
The Continuous Glucose Monitoring (CGM) is done for 14 days for each person. During this time, glucose readings are collected every three minutes in real-time Self-Monitoring of Blood Glucose (SMBG) involves using fingerstick tests to check glucose levels.
Important measurements-like Time in Range (TIR), Time Above Range (TAR), Time Below Range (TBR), and error grid analysis-are taken at specific times, including at the beginning and on certain follow-up days.
These timings help collect key data to check how well the device works in the short term and how it affects glucose control over the full monitoring period.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2025
- Study start4 Jun 2025
- Primary completion17 Sep 2025 (estimated)
- Study completion31 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MDCECRO LLC
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07122180
- Sponsor's protocol ID
- Yuw-CGM-20250306
- Status last verified
- Aug 2025
- First submitted
- 7 Aug 2025
- Last updated
- 22 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Market Clinical Follow-Up of the CT3 Series Continuous Glucose Monitoring System: A 14-Day Observational Study Assessing Accuracy, Safety, and Glucose Control in Patients With Type 1 and Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT07122180
- Acronym / sponsor ID
- Yuw-CGM-20250306
- Conditions
- Diabetes Mellitus
- Keywords
- Diabetes Mellitus
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- MDCECRO LLCResearch network
- Study start
- 4 Jun 2025 (actual)
- Primary completion
- 17 Sep 2025 (estimated)
- Study completion
- 31 Jan 2026 (estimated)
- First posted
- 14 Aug 2025 (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.
Post market Clinical follow-up of the CT3 Series Continuous Glucose Monitoring System: A 14-Day Observational Study Assessing Accuracy, Safety, and Glucose Control in patients with Type 1 and Type 2 Diabetes Mellitus
Detailed description
To re-assess the benefits of CT3 series CGM and the risks of skin abnormalities, hypoglycaemia, hyperglycaemia so as to improve CT3 series CGM continuously.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with type 1 or 2 diabetes mellitus
Key inclusion criteria (1 listed)
- 1.Patients diagnosed with type 1 or 2 diabetes mellitus. 2.People aged 18 years or older, regardless of gender. 3.Those who sign informed consent to participate in this study voluntarily. 4.The patient had good compliance and could complete this whole clinical investigation.
Key exclusion criteria (6 listed)
- 1.Those who have broken, scarred, red, swollen, or infected skin on the upper arms or abdomen.
- 2.Those who are allergic to alcohol disinfectants or medical adhesive tapes. 3.Those who have hematologic diseases that affect coagulation function or have been diagnosed with a bleeding tendency.
- 4.Those who have anemia or abnormal hematocrit. 5.Pregnant and lactating women. 6.Psychiatric abnormalities, cognitive and communication disorders, or highly stressed and uncooperative.
- 7.Those with subcutaneous edema at the wearing site. 8. Those who plan to undergo magnetic resonance imaging (MRI), computed tomography (CT), or X-ray examination within 14 days of wearing.
- 9. Those who have participated in clinical trials of drugs or devices within 1 month.
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 |
|---|---|---|
| CT3 Series Continuous Glucose Monitoring System:The CT3 Series CGM System is a real-time, continuous glucose monitoring device indicated for the management of diabetes in adults (age≥18 years). Interpretation of the CT3 Series CGM System results should be based on the glucose trends and several sequential readings over time. The CT3 Series CGM System also aids in the detection of episodes of hyperglycaemia and hypoglycaemia. It is intended for single-patient use. It is intended to replace fingerstick blood glucose testing for diabetes treatment decisions unless otherwise indicated | Device | – |
Primary outcome
This PMCF study (Version V2.0) uses a strong evaluation plan, with methods and timing carefully matched to the study's rules. It includes 72 patients
Time frame: 14 days
The Continuous Glucose Monitoring (CGM) is done for 14 days for each person. During this time, glucose readings are collected every three minutes in real-time Self-Monitoring of Blood Glucose (SMBG) involves using fingerstick tests to check glucose levels. Important measurements-like Time in Range (TIR), Time Above Range (TAR), Time Below Range (TBR), and error grid analysis-are taken at specific times, including at the beginning and on certain follow-up days. These timings help collect key data to check how well the device works in the short term and how it affects glucose control over the full monitoring period.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2025.
- Individual participant dataSharing planned: Undecided
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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.
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?
An observational study of Diabetes Mellitus, run by MDCECRO LLC at 1 site in Latvia.
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 6 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: enrolling by invitation, as of the sponsor's last update on 22 Aug 2025. 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 Latvia. 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?
This study is still under way. Results are not available in the source record yet.
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?
This PMCF study (Version V2.0) uses a strong evaluation plan, with methods and timing carefully matched to the study's rules. It includes 72 patients (time frame: 14 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 22 Aug 2025.