T1DM - Type 1 Diabetes MellitusNCT05908448
The True Vie I3 Continuous Glucose Monitoring System in Pediatric Patients With Type 1 Diabetes Mellitus
An observational study of T1DM - Type 1 Diabetes Mellitus, run by Sinocare at 1 site in United States.
Trial summary
The purpose of the investigation is to evaluate the performance of the I3 CGM in Pediatric Patients with Type 1 Diabetes Mellitus (T1DM) according to the FDA's special controls for iCGM. Read more about this study
- Who is it for?
- Ages 2 to 17 years
- Conditions the study is for
- T1DM - Type 1 Diabetes Mellitus
- What is being tested?
- 13 CGM (continuous glucose monitor)
- Type of treatment
- Medical device
- How many people
- 134 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Feb 2024to 13 Nov 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 type 1 diabetes mellitus.
Who may be able to join
- Patients with T1DM diagnosed for at least 6 months aged 2-17 years old, inclusive.
- Must be and have been in stable treatment regimen for at least 1 month with a multiple daily insulin dosing regimen or CSII, irrespective of delivery device(s). For this criterion, "stable treatment regimen" is considered no changes in prescribed number of insulin deliveries a day, and a change in total daily insulin dose of less than 10%.
Who cannot join
- History of skin adhesive tolerance issues in the area of sensor placement.
- Insulin meal dosing based on fixed dose regimens.
- For 13-17 years old only: Absence of established correction factor for high glucose.
- Hematocrit below 10% under the lower limit of the normal range by less than 3 month old laboratory test in history, a centrifuge or POC meter test.
- For 7-17 year old: inadequate intravenous access on arms.
- Participant has had a severe hypoglycemic event requiring 3rd party assistance within the past 6 months prior to enrollment.
Show all 20Show fewer
- Conditions which may predispose subjects to hypoglycemia including, but not limited to, thyroid disease which is not well controlled, adrenal insufficiency, high dose steroid use in recent past or planned during study, significant renal or liver disease.
- Participant has had an episode of diabetic ketoacidosis (DKA) within the past 6 months prior to enrollment.
- Participant has a history of a seizure disorder.
- For girls of reproductive potential: pregnancy, planned pregnancy within the study period, or unwillingness to use reliable contraception during the study period.
- Planned MRI, CT scan or diathermia 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.
- Medical history of stroke, transitory cerebral ischemia, myocardial infarction, unstable angina or heart failure with in the past 12 months.
- History of alcohol or drug abuse within the last year.
- Participant has donated or lost >5% of estimated blood volume or more of their blood volume within 45 days prior to Day 0.
- Any condition that in the opinion of the investigator may interfere successful completion of study procedures.
- Participant is actively participating in an investigational study (e.g., drug or device) wherein he/she has received treatment from an investigational study (drug or device) in the last 2 weeks prior to Visit 1. Please note participation in observational study is acceptable.
- Participant is a member of the research staff involved with the study.
- Inability or unwillingness to conform to the required protocol procedures including both participant and guardian giving informed consent, and for 7-17 years old only also hypoglycemia and hyperglycemia induction.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Accuracy and Precision of the True Vie I3 Continuous Glucose Monitoring System in Pediatric Patients With Type 1 Diabetes Mellitus: an Open Label, Multi-Center Trial
The purpose of the investigation is to evaluate the performance of the I3 CGM in Pediatric Patients with Type 1 Diabetes Mellitus (T1DM) according to the FDA's special controls for iCGM.
Read the detailed description
All participants have T1DM and will continue normal daily activities and manage their glucose as usual between clinic visits. Participants will not have access to the I3 CGM data for the management of their BG between clinic visits and will continue their usual care including CGM, if they are CGM users.
2-6 year old participants: Participants will have 2 sensors inserted in the upper buttocks by their guardian.
Participants will complete one frequent sampling clinic visit of 4 hour duration with the goal of 10-15 BG measurements analyzed using a BG meter.
For the 2-6 year olds, there are no specific fasting or other dietary requirements during the visits, participants will be provided meal choices as needed when they are hungry and meals will be served as it fits the clinic's schedule. Study staff will determine meal and insulin doses. No attempts at manipulating glucose will be made in this age group.
7-17 year old participants will attend a screening visit, an I3 CGM insertion visit, 2 clinic visits with frequent sample testing (FST) of 6 hour duration early and late in the 15 day I3 CGM sensor life. At the 2 FST clinic visits venous blood samples will be drawn for FST over 6 hours for plasma glucose determination using a Yellow Springs Instrument 2300 Stat Plus Glucose and Lactate Analyzer (YSI).
Participants will wear 3 sensors in two anatomical locations for 15 days and complete a 6 hour frequent sampling day at the beginning and the end of the sensor life.
For the 7-12 year olds, there are no specific fasting or other dietary requirements during the visits, participants will be provided meal choices as needed when they are hungry and meals will be served as it fits the clinic's schedule. Study staff will determine meal and insulin doses. No attempts at manipulating glucose will be made in this age group.
For the 13-17 year old participants, the investigative site staff will determine the participants' insulin doses and food intake and thus manipulate blood glucose to study the device over its full operating range. There will only be one glucose manipulation session during a FST visit.
- Conditions
- T1DM - Type 1 Diabetes Mellitus
- Being tested
- 13 CGM (continuous glucose monitor)
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
13 CGM (continuous glucose monitor)Device
The I3 CGM consists of three main components: a Sensor Pack (Applicator-Sensor assembly), a Transmitter Pack (with Bluetooth Low Energy (BLE)) and a mobile 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 |
|---|---|---|
| 13-17 year old participants | 13-17 year old participants Receives: Device: 13 CGM (continuous glucose monitor) | |
| 7-12 year old participants | 7-12 year old participants Receives: Device: 13 CGM (continuous glucose monitor) | |
| 2-6 year old participants | 2-6 year old participants Receives: Device: 13 CGM (continuous glucose monitor) |
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 YSI 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 posted18 Jun 2023
- Study start7 Feb 2024
- Primary completion18 Oct 2024
- Study completion13 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for T1DM - Type 1 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
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sinocare
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Atlanta Diabetes Associates
- Responsible party
- Sponsor
- Investigators
- Bruce Bode, MD, Principal investigator, Atlanta Diabetes Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05908448
- Sponsor's protocol ID
- NPI031-CIP-003F
- Status last verified
- Feb 2024
- First submitted
- 29 May 2023
- Last updated
- 3 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2024. 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 in Pediatric Patients With Type 1 Diabetes Mellitus: an Open Label, Multi-Center Trial
- ClinicalTrials.gov ID
- NCT05908448
- Acronym / sponsor ID
- NPI031-CIP-003F
- Conditions
- T1DM - Type 1 Diabetes Mellitus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- SinocareIndustry (pharma, biotech, devices)
- Collaborators
- Atlanta Diabetes Associates
- Study start
- 7 Feb 2024 (actual)
- Primary completion
- 18 Oct 2024 (actual)
- Study completion
- 13 Nov 2024 (actual)
- First posted
- 18 Jun 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 in Pediatric Patients with Type 1 Diabetes Mellitus (T1DM) according to the FDA's special controls for iCGM.
Detailed description
All participants have T1DM and will continue normal daily activities and manage their glucose as usual between clinic visits. Participants will not have access to the I3 CGM data for the management of their BG between clinic visits and will continue their usual care including CGM, if they are CGM users.
2-6 year old participants: Participants will have 2 sensors inserted in the upper buttocks by their guardian.
Participants will complete one frequent sampling clinic visit of 4 hour duration with the goal of 10-15 BG measurements analyzed using a BG meter.
For the 2-6 year olds, there are no specific fasting or other dietary requirements during the visits, participants will be provided meal choices as needed when they are hungry and meals will be served as it fits the clinic's schedule. Study staff will determine meal and insulin doses. No attempts at manipulating glucose will be made in this age group.
7-17 year old participants will attend a screening visit, an I3 CGM insertion visit, 2 clinic visits with frequent sample testing (FST) of 6 hour duration early and late in the 15 day I3 CGM sensor life. At the 2 FST clinic visits venous blood samples will be drawn for FST over 6 hours for plasma glucose determination using a Yellow Springs Instrument 2300 Stat Plus Glucose and Lactate Analyzer (YSI).
Participants will wear 3 sensors in two anatomical locations for 15 days and complete a 6 hour frequent sampling day at the beginning and the end of the sensor life.
For the 7-12 year olds, there are no specific fasting or other dietary requirements during the visits, participants will be provided meal choices as needed when they are hungry and meals will be served as it fits the clinic's schedule. Study staff will determine meal and insulin doses. No attempts at manipulating glucose will be made in this age group.
For the 13-17 year old participants, the investigative site staff will determine the participants' insulin doses and food intake and thus manipulate blood glucose to study the device over its full operating range. There will only be one glucose manipulation session during a FST visit.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 13-17 year old participants | – | Device: 13 CGM (continuous glucose monitor)13-17 year old participants |
| 7-12 year old participants | – | Device: 13 CGM (continuous glucose monitor)7-12 year old participants |
| 2-6 year old participants | – | Device: 13 CGM (continuous glucose monitor)2-6 year old participants |
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 type 1 diabetes mellitus.
Key inclusion criteria (2 listed)
- Patients with T1DM diagnosed for at least 6 months aged 2-17 years old, inclusive.
- Must be and have been in stable treatment regimen for at least 1 month with a multiple daily insulin dosing regimen or CSII, irrespective of delivery device(s). For this criterion, "stable treatment regimen" is considered no changes in prescribed number of insulin deliveries a day, and a change in total daily insulin dose of less than 10%.
Key exclusion criteria (20 listed)
- History of skin adhesive tolerance issues in the area of sensor placement.
- Insulin meal dosing based on fixed dose regimens.
- For 13-17 years old only: Absence of established correction factor for high glucose.
- Hematocrit below 10% under the lower limit of the normal range by less than 3 month old laboratory test in history, a centrifuge or POC meter test.
- For 7-17 year old: inadequate intravenous access on arms.
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 |
|---|---|---|
| 13 CGM (continuous glucose monitor)The I3 CGM consists of three main components: a Sensor Pack (Applicator-Sensor assembly), a Transmitter Pack (with Bluetooth Low Energy (BLE)) and a mobile application (I3 CGM App). The user can view their glucose data on the I3 CGM App running on a compatible mobile device. | Device | 13-17 year old participants, 2-6 year old participants, 7-12 year old participants |
Primary outcome
Accuracy
Time frame: 0-15 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 YSI 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 3 Dec 2024.
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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.
Bruce Bode, MD principal investigator
Atlanta Diabetes Associates
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 T1DM - Type 1 Diabetes Mellitus, run by Sinocare 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 20 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 3 Dec 2024. 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?
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 3 Dec 2024.