Diabetes MellitusNCT06570551
Continuous Glucose Monitoring System Use in Pediatric Patients with Diabetes
An observational study of Diabetes Mellitus, run by Sinocare at 3 sites in China.
Trial summary
To verify and evaluate the efficacy and safety of i3 CGM system manufactured by Changsha Sinocare Inc. for continuous or regular monitoring of interstitial fluid glucose level in pediatric patients with diabetes. Read more about this study
- Who is it for?
- Ages 2 to 17 years
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- i3 CGM(continuous glucose monitor)
- Type of treatment
- Medical device
- How many people
- 78 participants
- Where
- 3 sitesChina
- Study dates
- 30 Mar 2024to 21 Aug 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 2 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: 2-17 year old patients with diabetes mellitus.
Who may be able to join
- Aged 2 (inclusive) - 18 years (exclusive);
- Clinically diagnosed with diabetes;
- Being willing to wear the device continuously for 15 days and conduct blood collection for blood glucose testing in accordance with the requirements of this protocol;
- Body weight not less than 10.0 kg;
- Consent to participate in this clinical investigation, and sign the Informed Consent Form (ICF).
Who cannot join
- Need to undergo magnetic resonance imaging (MRI) during the clinical investigation;
- Diffuse subcutaneous nodules;
- Acute complications of diabetes;
- Abnormal coagulation function (coagulation cannot be too quick or too slow); the criteria for judging abnormalities are: The activated partial thromboplastin time (APTT) is higher than 1.5 times the upper limit of normal value or lower than the lower limit of normal value; or The prothrombin time (PT) is higher than 1.5 times the upper limit of normal value or lower than the lower limit of normal value
- Participation in other clinical investigations within the past 1 month;
- Where the investigator does not consider the patient suitable for enrollment.
Trial locations and contacts
3 sites in 1 country.
China3 sites
Hunan Children's Hospital
Changsha, Hunan
Women and Children's Hospital of Ningbo University
Ningbo, Zhejiang
Children's Hospital of Soochow University
Suzhou, Jiangsu
About this study
To verify and evaluate the efficacy and safety of i3 CGM system manufactured by Changsha Sinocare Inc. for continuous or regular monitoring of interstitial fluid glucose level in pediatric patients with diabetes.
Read the detailed description
This clinical investigation is of a multi-center and self-controlled design.
This clinical investigation is planned to be conducted in 3 study sites, with a total of 78 subjects to be enrolled, of which no fewer than 15 cases are aged 2-5 years old, and no fewer than 60 cases are aged 6-17 years old. This clinical investigation is to verify the safety and efficacy of the investigational device. Referring to the number of pediatric patients with diabetes in the 3 study sites, it is expected that about 20 subjects will be enrolled in each site every month, and it will take about 2 months to close the site. This clinical investigation is expected to be completed in about 6 months from the first participant recruited.
The real-time glucose values measured by CGM system on the left and right abdomen are compared with the venous blood glucose value (EKF value) measured by EKF analyzer, respectively, and the consistency rate is analyzed.
- Conditions
- Diabetes Mellitus
- Being tested
- i3 CGM(continuous glucose monitor)
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
i3 CGM(continuous glucose monitor)Device
The i3 CGM consists of a Sensor Pack (including probe, iCGM-S3), a Transmitter Pack (iCGM-t3), and an application (iCGM-APP (released version: V02)).application (i3 CGM App). The user can view their glucose data on the i3 CGM App running on a compatible mobile device.
| Study group | Role | What they receive |
|---|---|---|
| 2-5 year old participants | Wear the investigational device continuously for 15 days. Receives: Device: i3 CGM(continuous glucose monitor) | |
| 6-17 year old participants | Wear the investigational device continuously for 15 days. Receives: Device: i3 CGM(continuous glucose monitor) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy
percentage of i3 CGM values in the measuring range less than 4.4 mmol/L(80 mg/dL) within ± 1.1 mmol/L(20 mg/dL) of the EKF control.
Measured: 0-15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2024
- Study start30 Mar 2024
- Primary completion21 Aug 2024
- Study completion21 Aug 2024
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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sinocare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06570551
- Sponsor's protocol ID
- NPI031-CIP-005
- Status last verified
- Aug 2024
- First submitted
- 12 Aug 2024
- Last updated
- 26 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Glucose Monitoring System Use in Pediatric Patients with Diabetes
- ClinicalTrials.gov ID
- NCT06570551
- Acronym / sponsor ID
- NPI031-CIP-005
- Conditions
- Diabetes Mellitus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- SinocareIndustry (pharma, biotech, devices)
- Study start
- 30 Mar 2024 (actual)
- Primary completion
- 21 Aug 2024 (actual)
- Study completion
- 21 Aug 2024 (actual)
- First posted
- 26 Aug 2024 (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 verify and evaluate the efficacy and safety of i3 CGM system manufactured by Changsha Sinocare Inc. for continuous or regular monitoring of interstitial fluid glucose level in pediatric patients with diabetes.
Detailed description
This clinical investigation is of a multi-center and self-controlled design.
This clinical investigation is planned to be conducted in 3 study sites, with a total of 78 subjects to be enrolled, of which no fewer than 15 cases are aged 2-5 years old, and no fewer than 60 cases are aged 6-17 years old. This clinical investigation is to verify the safety and efficacy of the investigational device. Referring to the number of pediatric patients with diabetes in the 3 study sites, it is expected that about 20 subjects will be enrolled in each site every month, and it will take about 2 months to close the site. This clinical investigation is expected to be completed in about 6 months from the first participant recruited.
The real-time glucose values measured by CGM system on the left and right abdomen are compared with the venous blood glucose value (EKF value) measured by EKF analyzer, respectively, and the consistency rate is analyzed.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2-5 year old participants | – | Device: i3 CGM(continuous glucose monitor)Wear the investigational device continuously for 15 days. |
| 6-17 year old participants | – | Device: i3 CGM(continuous glucose monitor)Wear the investigational device continuously for 15 days. |
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- 2-17 year old patients with diabetes mellitus.
Key inclusion criteria (5 listed)
- Aged 2 (inclusive) - 18 years (exclusive);
- Clinically diagnosed with diabetes;
- Being willing to wear the device continuously for 15 days and conduct blood collection for blood glucose testing in accordance with the requirements of this protocol;
- Body weight not less than 10.0 kg;
- Consent to participate in this clinical investigation, and sign the Informed Consent Form (ICF).
Key exclusion criteria (6 listed)
- Need to undergo magnetic resonance imaging (MRI) during the clinical investigation;
- Diffuse subcutaneous nodules;
- Acute complications of diabetes;
- Abnormal coagulation function (coagulation cannot be too quick or too slow); the criteria for judging abnormalities are: The activated partial thromboplastin time (APTT) is higher than 1.5 times the upper limit of normal value or lower than the lower limit of normal value; or The prothrombin time (PT) is higher than 1.5 times the upper limit of normal value or lower than the lower limit of normal value
- Participation in other clinical investigations within the past 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 |
|---|---|---|
| i3 CGM(continuous glucose monitor)The i3 CGM consists of a Sensor Pack (including probe, iCGM-S3), a Transmitter Pack (iCGM-t3), and an application (iCGM-APP (released version: V02)).application (i3 CGM App). The user can view their glucose data on the i3 CGM App running on a compatible mobile device. | Device | 2-5 year old participants, 6-17 year old participants |
Primary outcome
Accuracy
Time frame: 0-15 days
percentage of i3 CGM values in the measuring range less than 4.4 mmol/L(80 mg/dL) within ± 1.1 mmol/L(20 mg/dL) of the EKF control.
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 26 Sep 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites 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 Sinocare at 3 sites 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 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: finished, as of the sponsor's last update on 26 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
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: 0-15 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 26 Sep 2024.