Glucose Risk Assessment in Employer Populations

NCT04529824 | Completed FDA Device

• 1 other identifier: PTL-903595
• Study Type: observational
• Target: 207
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Diabetes; Pre-diabetes; Glucose Intolerance

Keywords

continuous glucose monitoring; CGM

Outcome Measures

Primary Outcomes (1)

• Diabetes Status

  diabetes status will be determined by A1C record or clinically measured point-of-care A1C (no diabetes \<5.7%, pre-diabetes 5.7% to 6.4%, and diabetes \> or = to 6.5%).

  Clinic Visit 2 (about 10 days from study enrollment)

Secondary Outcomes (8)

• CGM-derived Time in Range (TIR)

  10-days

• CGM-derived Time Above Range (TAR)

  10-days

• CGM-derived Time Below Range (TBR)

  10-days

• CGM-derived Glucose Variability

  10-days

• Fitbit-derived daily steps

  10-days

Other Outcomes (1)

• Healthcare medical costs

  prior 3-years to study and 3-years after study participation

Interventions

Dexcom G6 Continuous Glucose Monitor (CGM) System DEVICE

Participants wear a blinded Dexcom G6 CGM and a Fitbit Charge 3 activity tracker for 10 days.

Also known as: Fitbit Charge 3 Activity Tracker

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Potential volunteers will be adults (≥18 years) either currently or formerly employed by Employer and eligible to enroll for their health plan or added as dependents to the health plan.

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.

Sponsors & Collaborators

• DexCom, Inc.: lead

Study Sites (1)

Lakeland Clinic

Lakeland, Florida, 33803, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus; Glucose Intolerance

Interventions

Continuous Glucose Monitoring; Drug Delivery Systems

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperglycemia

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Investigative Techniques; Drug Therapy; Therapeutics

Study Officials

• David Price, MD

  DexCom, Inc.

  STUDY CHAIR

• Jennifer Ksailbati, CCRP

  MOORE Clinical Research, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2020
• First Posted: August 28, 2020
• Study Start: April 1, 2019
• Primary Completion: July 22, 2019
• Study Completion: August 1, 2021
• Last Updated: February 15, 2023

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)