Continuous Glucose Monitoring in Prediabetes With Health... | NCT06883812

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

NCT06883812

Sponsor

David S Black, PhD

Status

Completed

Last Update Posted

Mar 30, 2026Actual

Enrollment

30Actual

Phase

Not Applicable

Conditions

Prediabetes

Interventions

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
3P50MD017344-03S3	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 5, 2025Actual

Primary Completion Date

Nov 3, 2025Actual

Completion Date

Nov 3, 2025Actual

First Submitted Date

Mar 12, 2025

First Submission Date that Met QC Criteria

Mar 12, 2025

First Posted Date

Mar 19, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 25, 2026

Last Update Posted Date

Mar 30, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

David S Black, PhD, Tenured Associate Professor of Population and Public Health Sciences, University of Southern CaliforniaSponsor-Investigator

Lead Sponsor

David S Black, PhDOTHER

Collaborators

Name	Class
National Institute on Minority Health and Health Disparities (NIMHD)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Single Group	Other	Participants wear a CGM on the back of the arm. During Phase A, glucose values are not visible to participants. During Phase B, glucose values are visible via the phone app.	Device: CGM

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.	Single Group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Glucose levels	Mean glucose in mg/dL	Maximum of 20 days of continuous wear

Secondary Outcomes

Measure	Description	Time Frame
Time out of range > 140 mg/dL (TOR)	Time out of range > 140 mg/dL (TOR)	Maximum of 20 days of continuous wear

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
David S Black, PhD MPH	University of Southern California Keck School of Medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Southern California Center for Latino Health SCCLH		Los Angeles	California	90031	United States

Label	URL
Dexcom G CGM system specifications	View source

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

IPD sharing is set up with affiliate USC-CHLA P50 Center universities and hospitals under a registered data use agreement (DUA). Data and protocol documentation will be posted on the Open Science Framework

Types

Study Protocol
Statistical Analysis Plan (SAP)
Analytic Code

Time Frame

No longer than one year after the completion of the trial. Researchers can obtain de-identified data and statistical codes after publication of the study outcomes by email request and as supplemental material in future journal publications.

Access Criteria

Publicly available link or by request to PI or directly obtained as supplemental material from the website of the journal publication.

URL

https://www.clinicaltrials.gov

Condition Browse Module

MeSH Terms

ID	Term
D011236	Prediabetic State
D006266	Health Education

Ancestor Terms

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Masking Info

Masking

None (Open Label)

Masking Description

Participants are blinded to glucose values during Phase A. The CGM system generates automated records of glucose and does not require observation from an outcomes assessor. The investigator does not engage with participants and becomes aware of unmasking after trial is completed.

Who Masked

Not provided