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NCT Number: NCT07477249

Continuous Glucose Monitoring (CGM) in Prediabetes With Community Based Recruitment

The objective of this project is to develop a behavioral intervention that combines wearable continuous glucose monitoring (CGM) with smartphone feedback and educational video clips generated by artificial intelligence (AI) software to improve glycemic control among individuals with pre-diabetes. The goal is to prevent transition to type 2 diabetes (T2D).

Recruiting

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Key information

Age range

35 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Southern California Center for Latino Health (SCCLH)

Los Angeles, California, 90031, United States

Location status: Recruiting

About this study

The primary objective of this new project is to enhance glycemic control in individuals with prediabetes and deter the progression to Type 2 Diabetes (T2D) within the Los Angeles (LA) County community. Our proposal involves conducting a Phase 0 intervention development study. This study will enlist a final sample of N=50 adults who speak English and/or Spanish, have non-clinical prediabetes, and test positive for prediabetes via a finger-prick A1c% screening. Participants will wear CGM devices for 20 days, with glucose data masked for the first 10 days and unmasked for the next 10 days. During the unmasked phase, participants will receive daily health education videos on their smartphones. The study will compare the duration of glucose excursions between the masked and unmasked phases to assess the impact of CGM feedback and health education on glucose regulation.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 35 years of age or older
  • Willingness to wear CGM sensor
  • Prediabetes by finger prick blood A1C% or fasting glucose
  • Centers for Disease Control and Prevention (CDC) prediabetes risk test score of 5 or higher or recent prediabetes diagnosis from physician

Exclusion criteria

  • Diagnosed with any disorder that interferes with glucose
  • Influential medical disorder/event affecting ability to participate in study
  • Incompatible smartphone device not pairing with Dexcom G6 app
  • Currently pregnant
  • Previously participated in other Continuous Glucose Monitoring studies
  • Having a planned trip outside California in the following 2 months

Treatment and study plan

CGM

Device

The CGM sensor is worn on the back of the arm and glucose levels are recorded continuously but levels are not shown on the participant's phone app in phase A.

Primary outcomes

  1. Glucose levels

    Time frame: Maximum of 20 days of continuous wear

    Mean glucose in mg/dL

Secondary outcomes

  1. Time out of range > 140 mg/dL (TOR)

    Time frame: Maximum of 20 days of continuous wear

    Time out of range > 140 mg/dL (TOR)

Study contacts

Contact information is provided by the study sponsor or research team.

David S Black, PhD MPH

CONTACT

[email protected]

3234428223

Ruth Flores

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

David S Black, PhD

Other

Collaborators

  • National Institute on Minority Health and Health Disparities (NIMHD)

Registry information

Official study title

Continuous Glucose Monitoring (CGM) in Prediabetes With Health Education Videos

Acronym: G3

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 17, 2026
Registry last updated
Mar 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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