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Completed

NCT Number: NCT06883812

Continuous Glucose Monitoring in Prediabetes With Health Education Videos Among Community Health Workers

The objective of this project is to deliver a behavior health education video series that combines wearable continuous glucose monitoring (CGM) with smartphone feedback and video clips generated by artificial intelligence (AI) software to improve glycemic control among individuals with prediabetes. The goal is to prevent transition to type 2 diabetes and advanced metabolic complications.

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Key information

Conditions

PreDiabetes Adherence Interventions Behavior Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Health Behavior Health Education Medication Adherence Metabolic Diseases Nutritional and Metabolic Diseases Patient Acceptance of Health Care Patient Compliance Prediabetic State Treatment Adherence and Compliance

Age range

18 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

About this study

A health education video series, ¡Mi Control!, led by community health workers known as Promotores de Salud (PdS), will be integrated with continuous glucose monitoring (CGM) to support self-monitoring of glucose levels and excursions. Study G2 is a Phase 0 feasibility study enrolling 30 Spanish- and/or English-speaking PdS who 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

  • Prediabetes by finger prick blood A1C%
  • Centers for Disease Control and Prevention (CDC) prediabetes risk test score of 5 or higher
  • Willingness to wear CGM sensor
  • Community health worker

Exclusion criteria

  • Currently pregnant
  • Less than 18 years of age, which is adult in California
  • 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

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)

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 in Prediabetes With Health Education Videos

Acronym: G2

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 19, 2025
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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