Diabetes Mellitus
Conditions
Keywords
diabetes, CBGM, CGM, type 2 diabetes, type 1 diabetes, diabetes mellitus, insulin dependent
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. 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?
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.
Interventions
DEVICESensor Lead
The Glucotrack Sensor Lead will be inserted into the subclavian vein, using a Seldinger technique, where it will continuously measure blood glucose levels.
Sponsors
Glucotrack
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Masking description
The participants will not have access to the glucose data from the investigational device.
Intervention model description
Each Participant will be wearing a single investigational sensor.
Eligibility
Sex/Gender
ALL
Age
21 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary outcome: study device safety as evidence by absence of serious procedure or device related adverse event(s). | 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. |
Countries
Brazil
Contacts
Primary ContactSandra L Martha
Outcome results
None listed