PrediabetesG2NCT06883812
Continuous Glucose Monitoring in Prediabetes With Health Education Videos Among Community Health Workers
A study testing CGM in people with Prediabetes, run by David S Black, PhD at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Prediabetes
- What is being tested?
- CGM
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Mar 2025to 3 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Southern California Center for Latino Health SCCLH
Los Angeles, California, 90031
About this study
Official title: Continuous Glucose Monitoring in Prediabetes With Health Education Videos
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.
Read the 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.
- Conditions
- Prediabetes
- Being tested
- CGM
- Keywords
- Prediabetes, Glucose control, Feedback, Health education, Artificial intelligence, Behavioral analysis
- Medical subject headings
- Prediabetic State, Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CGMDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: CGM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose levels
Mean glucose in mg/dL
Measured: Maximum of 20 days of continuous wear
Secondary outcomes (1)
Time out of range > 140 mg/dL (TOR)
Time out of range > 140 mg/dL (TOR)
Measured: Maximum of 20 days of continuous wear
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2025
- Study start5 Mar 2025
- Primary completion3 Nov 2025
- Study completion3 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrediabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- An AB sequential condition design with CGM automated continuous glucose recording with glucose level masked and unmasked phases.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- David S Black, PhD
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Sponsor-investigator, David S Black, PhD, University of Southern California
- Investigators
- David S Black, PhD MPH, Principal investigator, University of Southern California Keck School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06883812
- Sponsor's protocol ID
- UP-23-01001(a)
- Other IDs
- 3P50MD017344-03S3
- Acronym
- G2
- Status last verified
- Mar 2026
- First submitted
- 12 Mar 2025
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: 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
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Glucose Monitoring in Prediabetes With Health Education Videos
- ClinicalTrials.gov ID
- NCT06883812
- Acronym / sponsor ID
- G2 / UP-23-01001(a)
- Conditions
- Prediabetes
- Keywords
- Prediabetes, Glucose control, Feedback, Health education, Artificial intelligence, Behavioral analysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- David S Black, PhDUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 5 Mar 2025 (actual)
- Primary completion
- 3 Nov 2025 (actual)
- Study completion
- 3 Nov 2025 (actual)
- First posted
- 19 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- An AB sequential condition design with CGM automated continuous glucose recording with glucose level masked and unmasked phases.
| Arm | Type | Receives |
|---|---|---|
| Single Group | Other | Device: CGMParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CGMThe 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. | Device | Single Group |
Primary outcome
Glucose levels
Time frame: Maximum of 20 days of continuous wear
Mean glucose in mg/dL
1 secondary outcome
Time out of range > 140 mg/dL (TOR)
Time frame: Maximum of 20 days of continuous wear
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
- Dexcom G CGM system specificationsLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David S Black, PhD MPH principal investigator
University of Southern California Keck School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CGM in people with Prediabetes, run by David S Black, PhD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glucose levels (time frame: Maximum of 20 days of continuous wear). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2026; AzTrials last refreshed its copy on 8 Nov 2026.