Feasibility Study to Evaluate an Intravascular Blood Continu...

About this study

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?

Condition: Diabetes Mellitus
Tested: Sensor Lead
Sponsor: Glucotrack

Who can join

Age: 21 to 75 years
Sex: All sexes
Healthy volunteers: Not accepted

Inclusion 16

Minimum age: 21 years
Maximum age: 75 years
Study condition: Diabetes Mellitus
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).

Exclusion 18

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
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.

Where

1 site, 1 recruiting

Instituto do Coração (InCor) |

São Paulo, Brazil, Brazil

Recruiting

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