Feasibility Study to Evaluate an Intravascular Blood Continuous Glucose Sensor

NCT06764069 | Recruiting FDA Device

• 1 other identifier: CIP-001
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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. Additionally, the surgical procedure and device performance will be evaluated. Key Research Questions:

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

Conditions

Diabetes Mellitus

Keywords

diabetes; CBGM; CGM; type 2 diabetes; type 1 diabetes; diabetes mellitus, insulin dependent

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (1)

Glucotrack Sensor Lead

EXPERIMENTAL

One Glucotrack Sensor Lead will be inserted per Participant.

Device: Sensor Lead

Interventions

Sensor Lead DEVICE

The Glucotrack Sensor Lead will be inserted into the subclavian vein, using a Seldinger technique, where it will continuously measure blood glucose levels.

Glucotrack Sensor Lead

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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).

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Glucotrack: lead

Study Sites (1)

Instituto do Coração (InCor) |

São Paulo, Brazil, 05403-000, Brazil

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Sandra L Martha

CONTACT

6198892412; smartha@glucotrack.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: The participants will not have access to the glucose data from the investigational device.
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Each Participant will be wearing a single investigational sensor.

Study Record Dates

• First Submitted: December 13, 2024
• First Posted: January 8, 2025
• Study Start: December 13, 2024
• Primary Completion: February 4, 2025
• Study Completion: February 28, 2025
• Last Updated: January 8, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR, ANALYTIC CODE
• Time Frame: 6 months post study to support publication(s)
• 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.

Locations

BR (1)