Feasibility Study to Evaluate an Intravascular Blood Continuous Glucose Sensor

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:

1. Were there any adverse events associated with the insertion of the Sensor Lead?
2. 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?
3. How effectively did the device capture data during the 96-hour wear period?

Study Overview

• Status: Recruiting
• Conditions: Diabetes Mellitus
• Intervention / Treatment: Device: Sensor Lead

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 Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sandra L Martha; Phone Number: 6198892412; Email: smartha@glucotrack.com

Study Locations

• Brazil
  • São Paulo, Brazil, 05403-000
    • Recruiting
    • Instituto do Coração (InCor) |
    • Contact: Alex Abizaid, MD; Phone Number: +55 (11) 99613-1055; Email: alexandre.abizaid@hc.fm.usp.br
    • Contact: Alex Abizaid, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age 21 to 75 years old inclusive
2. Generally, in good health, as determined by the investigator
3. 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
4. Intensive Insulin Therapy - 3 plus injections/day (MDI) or Continuous Subcutaneous Insulin Infusion (CSII)
5. HbA1c <9.0 % in the last 3 months.
6. Study subject has adequate venous access as assessed by investigator or appropriate staff.
7. Willing to comply with study procedures and be admitted to hospital for up to 5 days.
8. Willing to perform up to 7 blood glucose (fingerstick) measurements a day using provided blood glucose meters and strips
9. Willing to wear subcutaneous continuous wear glucose sensor for the duration of the study
10. Willing to always carry study provided Android Phone during study
11. Access to internet for required periodic uploads of study device data
12. BMI in the range 18-35 kg/m2
13. 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).

Exclusion Criteria:

1. Currently taking Acetaminophen and unable to switch to another anti-inflammatory or pain reliever
2. Currently being treated with an anticoagulation agent
3. 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.
4. Currently using one of the following non-insulin glucose-lowering agent, SGLT2 and Insulin Secretagogues
5. Female study subject of childbearing potential and has a positive pregnancy screening test
6. Female study subject of childbearing potential who is planning to become pregnant or not using adequate method of contraception deemed reliable by Investigator
7. 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.
8. Study subject has a hematocrit (Hct) lower than the normal reference range
9. Known cardiovascular disease considered to be clinically relevant by the investigator

10. 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

11. Significant history of any of the following, that in the opinion of the investigator would compromise safety or successful study participation:

    • Alcoholism
    • Drug abuse
12. Significant acute or chronic illness, that in the opinion of the investigator might interfere with safety or integrity of study results
13. Current participation in another clinical drug or device study
14. Study subject may not be on the research staff of those performing this study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Glucotrack Sensor Lead; One Glucotrack Sensor Lead will be inserted per Participant.	Device: Sensor Lead; The Glucotrack Sensor Lead will be inserted into the subclavian vein, using a Seldinger technique, where it will continuously measure blood glucose levels.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From enrollment through 7-days (+/-3 days) post Sensor Lead removal.

Collaborators and Investigators

• Sponsor: Glucotrack

Study record dates

Study Major Dates

• Study Start (Actual): December 13, 2024
• Primary Completion (Estimated): February 4, 2025
• Study Completion (Estimated): February 28, 2025

Study Registration Dates

• First Submitted: December 13, 2024
• First Submitted That Met QC Criteria: January 7, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 7, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: diabetes; type 2 diabetes; CGM; type 1 diabetes; CBGM; diabetes mellitus, insulin dependent
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus
• Other Study ID Numbers: CIP-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: 6 months post study to support publication(s)
• IPD Sharing Access Criteria: Statisticians, medical writers. They may be able to access through a direct share site and/or the report may be provided to them.
• IPD Sharing Supporting Information Type: ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes