Glucose Risk Assessment in Employer Populations

Completed

Conditions studied: Diabetes, Pre-diabetes, Glucose Intolerance

In brief

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 continuous glucose monitor (CGM) derived metrics. Physical activity will also be measured using a Fitbit activity tracker. The study will inform future programs that use CGM and activity tracking to identify people at risk for diabetes in the population.

Key facts

Study ID

NCT04529824

Run by

DexCom, Inc.

People needed

207

Starts

2019-04-01

Expected to finish

2021-08-01

Last updated by the study team

2023-02-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Lakeland Clinic — Lakeland, Florida, United States

Full record on ClinicalTrials.gov

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