Diabetes MellitusNCT06764069
Feasibility Study to Evaluate an Intravascular Blood Continuous Glucose Sensor
A study testing Sensor Lead in people with Diabetes Mellitus, run by Glucotrack at 1 site in Brazil.
Trial summary
The goal of this early first in man clinical trial is to evaluate the safety of an implantable continuous blood glucose monitoring system in participants with Diabetes Mellitus. Safety will be assessed by looking at the absence of procedure or device related adverse events. Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Sensor Lead
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteBrazil
- Study dates
- 13 Dec 2024to 28 Feb 2025
- Phase
- Interventional
- 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 21 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 21 to 75 years old inclusive
- Generally, in good health, as determined by the investigator
- Clinical diagnosis or type 1 or type 2 diabetes as determined via medical records or source documentation by an individual qualified to make a medical diagnosis
- Intensive Insulin Therapy - 3 plus injections/day (MDI) or Continuous Subcutaneous Insulin Infusion (CSII)
- HbA1c \<9.0 % in the last 3 months.
- Study subject has adequate venous access as assessed by investigator or appropriate staff.
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- Willing to comply with study procedures and be admitted to hospital for up to 5 days.
- Willing to perform up to 7 blood glucose (fingerstick) measurements a day using provided blood glucose meters and strips
- Willing to wear subcutaneous continuous wear glucose sensor for the duration of the study
- Willing to always carry study provided Android Phone during study
- Access to internet for required periodic uploads of study device data
- BMI in the range 18-35 kg/m2
- Has the ability to understand and comply with protocol procedures and to provide informed consent (i.e., proficient in both verbal and written communication in English or from a translator (Portuguese to English).
Who cannot join
- Currently taking Acetaminophen and unable to switch to another anti-inflammatory or pain reliever
- Currently being treated with an anticoagulation agent
- History of Deep Vein Thrombosis (DVT), Pulmonary Embolism (PE), or blood clotting disorder that in the opinion of the Investigator would compromise safety of the study subject.
- Currently using one of the following non-insulin glucose-lowering agent, SGLT2 and Insulin Secretagogues
- Female study subject of childbearing potential and has a positive pregnancy screening test
- Female study subject of childbearing potential who is planning to become pregnant or not using adequate method of contraception deemed reliable by Investigator
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- 1 of more episodes of hypoglycemia or diabetic ketoacidosis (DKA) in the last 6 months requiring care in a medical facility or assistance from another individual to treat.
- Study subject has a hematocrit (Hct) lower than the normal reference range
- Known cardiovascular disease considered to be clinically relevant by the investigator
- Currently undergoing treatment with:
- Systemic oral or intravenous corticosteroids (current or within the last 8 weeks from screening),
- Thyroid hormones, unless use has been stable during the past 3 months
- Significant history of any of the following, that in the opinion of the investigator would compromise safety or successful study participation:
- Alcoholism
- Drug abuse
- Significant acute or chronic illness, that in the opinion of the investigator might interfere with safety or integrity of study results
- Current participation in another clinical drug or device study
- Study subject may not be on the research staff of those performing this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
Instituto do Coração (InCor) |
São Paulo, Brazil, 05403-000
Alex Abizaid, MD, +55 (11) 99613-1055, alexandre.abizaid@hc.fm.usp.br
Alex Abizaid, MD
About this study
Official title: Early Feasibility Study to Evaluate an Intravascular Blood Continuous Glucose Sensor in Adults with Diabetes Mellitus
The goal of this early first in man clinical trial is to evaluate the safety of an implantable continuous blood glucose monitoring system in participants with Diabetes Mellitus. Safety will be assessed by looking at the absence of procedure or device related adverse events. Additionally, the surgical procedure and device performance will be evaluated.
Key Research Questions:
- Were there any adverse events associated with the insertion of the Sensor Lead?
- Did Participants experience any device-related adverse events from the Sensor Lead insertion through the 96-hour observation period and subsequent removal of the Sensor Lead?
- How effectively did the device capture data during the 96-hour wear period?
Read the detailed description
Eligible Participants will be inserted with the Sensor Lead of the investigational continuous blood glucose monitoring device and stay in the hospital for a 96-hour observation period.
Glucose measurements, medications and food will be tracked throughout the 96-hour Observation period.
Two 3-hour frequent sample tests (sampling every 15-min for glucose measurement) will occur during the 96-hour Observation period.
After approximately 96-hours is complete the participant will have the Sensor Lead removed and will be discharged after an hour observation post removal. A final follow-up visit will occur approximately 1-week post sensor removal to check on the removal site and formally exit that participant from the study.
All safety events will be recorded.
- Conditions
- Diabetes Mellitus
- Being tested
- Sensor Lead
- Keywords
- diabetes, CBGM, CGM, type 2 diabetes, type 1 diabetes, diabetes mellitus, insulin dependent
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sensor LeadDevice
The Glucotrack Sensor Lead will be inserted into the subclavian vein, using a Seldinger technique, where it will continuously measure blood glucose levels.
| Study group | Role | What they receive |
|---|---|---|
| Glucotrack Sensor Lead | Experimental | One Glucotrack Sensor Lead will be inserted per Participant. Receives: Device: Sensor Lead |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary outcome: study device safety as evidence by absence of serious procedure or device related adverse event(s).
No procedure or device related serious adverse events from implant through the 7 days post-explant appointment.
Measured: From enrollment through 7-days (+/-3 days) post Sensor Lead removal.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2025
- Study start13 Dec 2024
- Primary completion4 Feb 2025 (estimated)
- Study completion28 Feb 2025 (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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Each Participant will be wearing a single investigational sensor.
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Glucotrack
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06764069
- Sponsor's protocol ID
- CIP-001
- Status last verified
- Dec 2024
- First submitted
- 13 Dec 2024
- Last updated
- 8 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Participants will be identified by a participant ID only. Data that may be provided includes demographic data, as well as glucose results from the investigational and supporting commercial devices.
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Feasibility Study to Evaluate an Intravascular Blood Continuous Glucose Sensor in Adults with Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT06764069
- Acronym / sponsor ID
- CIP-001
- Conditions
- Diabetes Mellitus
- Keywords
- diabetes, CBGM, CGM, type 2 diabetes, type 1 diabetes, diabetes mellitus, insulin dependent
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- GlucotrackIndustry (pharma, biotech, devices)
- Study start
- 13 Dec 2024 (actual)
- Primary completion
- 4 Feb 2025 (estimated)
- Study completion
- 28 Feb 2025 (estimated)
- First posted
- 8 Jan 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.
The goal of this early first in man clinical trial is to evaluate the safety of an implantable continuous blood glucose monitoring system in participants with Diabetes Mellitus. Safety will be assessed by looking at the absence of procedure or device related adverse events. Additionally, the surgical procedure and device performance will be evaluated.
Key Research Questions:
- Were there any adverse events associated with the insertion of the Sensor Lead?
- Did Participants experience any device-related adverse events from the Sensor Lead insertion through the 96-hour observation period and subsequent removal of the Sensor Lead?
- How effectively did the device capture data during the 96-hour wear period?
Detailed description
Eligible Participants will be inserted with the Sensor Lead of the investigational continuous blood glucose monitoring device and stay in the hospital for a 96-hour observation period.
Glucose measurements, medications and food will be tracked throughout the 96-hour Observation period.
Two 3-hour frequent sample tests (sampling every 15-min for glucose measurement) will occur during the 96-hour Observation period.
After approximately 96-hours is complete the participant will have the Sensor Lead removed and will be discharged after an hour observation post removal. A final follow-up visit will occur approximately 1-week post sensor removal to check on the removal site and formally exit that participant from the study.
All safety events will be recorded.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Each Participant will be wearing a single investigational sensor.
| Arm | Type | Receives |
|---|---|---|
| Glucotrack Sensor Lead | Experimental | Device: Sensor LeadOne Glucotrack Sensor Lead will be inserted per Participant. |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Age 21 to 75 years old inclusive
- Generally, in good health, as determined by the investigator
- Clinical diagnosis or type 1 or type 2 diabetes as determined via medical records or source documentation by an individual qualified to make a medical diagnosis
- Intensive Insulin Therapy - 3 plus injections/day (MDI) or Continuous Subcutaneous Insulin Infusion (CSII)
- HbA1c \<9.0 % in the last 3 months.
Key exclusion criteria (18 listed)
- Currently taking Acetaminophen and unable to switch to another anti-inflammatory or pain reliever
- Currently being treated with an anticoagulation agent
- History of Deep Vein Thrombosis (DVT), Pulmonary Embolism (PE), or blood clotting disorder that in the opinion of the Investigator would compromise safety of the study subject.
- Currently using one of the following non-insulin glucose-lowering agent, SGLT2 and Insulin Secretagogues
- Female study subject of childbearing potential and has a positive pregnancy screening test
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 |
|---|---|---|
| Sensor LeadThe Glucotrack Sensor Lead will be inserted into the subclavian vein, using a Seldinger technique, where it will continuously measure blood glucose levels. | Device | Glucotrack Sensor Lead |
Primary outcome
Primary outcome: study device safety as evidence by absence of serious procedure or device related adverse event(s).
Time frame: From enrollment through 7-days (+/-3 days) post Sensor Lead removal.
No procedure or device related serious adverse events from implant through the 7 days post-explant appointment.
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 8 Jan 2025.
- Individual participant dataSharing planned: Yes. Participants will be identified by a participant ID only. Data that may be provided includes demographic data, as well as glucose results from the investigational and supporting commercial devices.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sensor Lead in people with Diabetes Mellitus, run by Glucotrack at 1 site in Brazil.
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 13 inclusion and 18 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: looking for participants now, as of the sponsor's last update on 8 Jan 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 Brazil. 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?
Contact Sandra L Martha (6198892412, smartha@glucotrack.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary outcome: study device safety as evidence by absence of serious procedure or device related adverse event(s). (time frame: From enrollment through 7-days (+/-3 days) post Sensor Lead removal.). 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 8 Jan 2025.