Status:
COMPLETED
Glucose Risk Assessment in Employer Populations
Lead Sponsor:
DexCom, Inc.
Conditions:
Diabetes
Pre-diabetes
Eligibility:
All Genders
18+ years
Brief Summary
This is an observational study to understand the glucose characteristics of the general population (normal glucose, pre-diabetes, and diabetes). Glucose risk will be measured with laboratory HbA1c and...
Detailed Description
This is a prospective, single-center, observational study that will enroll a maximum of 550 subjects. All potential study subjects will be current or former employees or dependents eligible to enroll ...
Eligibility Criteria
Inclusion
- Current or former employee or dependent eligible to enroll in Employer's group health plan
- Aged 18 years or older
- Reads, speaks and understands English
- Women of reproductive potential using one of the following highly effective modes of contraception: implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomized partner.
- Willing to comply with all study procedures (including CGM wear) and be available for the duration of the 10 day study
- If a subject consents to optional wear of an activity tracker, the subject must:
- own a smartphone compatible with the Fitbit mobile application
- be willing to download the application on their smartphone
- be willing to use their assigned research account to sync data
- be willing to charge and sync data as directed during the 10 day wear
Exclusion
- Currently using continuous glucose monitoring
- An intellectual or learning disability, or unstable mental state, that could limit ability to obtain written or electronic informed consent and/or adhere to the study protocol
- Medical condition that precludes participation, including the following contraindications to CGM wear:
- Pregnant or planning to become pregnant
- Critically ill
- Planned medical interventions that are listed as contraindications to CGM wear, including
- CT or MRI scan within 4 days of CGM insertion
- Dialysis
- Surgery
- Diathermy
- Known skin issues and/or allergic reactions to components of the study product(s) (ex. medical-grade adhesives)
- Anything that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study.
- Participation in another drug or device clinical trial concluding within 30 days of the screening visit.
Key Trial Info
Start Date :
April 1 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 1 2021
Estimated Enrollment :
207 Patients enrolled
Trial Details
Trial ID
NCT04529824
Start Date
April 1 2019
End Date
August 1 2021
Last Update
February 15 2023
Active Locations (1)
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1
Lakeland Clinic
Lakeland, Florida, United States, 33803