Pre-diabetesG1NCT06472297

Continuous Glucose Monitoring in Prediabetes

A study testing The continuous glucose monitoring system in people with Pre-diabetes, run by University of Southern California at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

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. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Pre-diabetes
What is being tested?: The continuous glucose monitoring system
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 23 participants
Where: 1 siteUnited States
Study dates: 1 Jun 2024to 30 Sep 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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
Latino 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

Other trials in United States

About this study

Official title: Diabetes Prevention Combining CGM and Artificial Intelligence Health Education

Read the detailed description

Video narratives will be provided by Latino community health workers, known as Promotores de Salud (PdS), who will wear and experience the continuous glucose monitoring (CGM) system and its glycemic variability feedback. Study 1 (G1) is a Phase 0 intervention development study, enrolling a sample of 20 Spanish- and/or English-speaking PdS who test positive for pre-diabetes via a finger prick screening. Participants will wear CGM devices for 20 days, during which they will record daily narratives about their experiences with the CGM feedback and their glucose variability. Structured interviews between staff and participants will explore the benefits and barriers of CGM use. These recorded video clips will serve as the foundation for educational cinematic smartphone videos for future interventions. Artificial intelligence (AI) tools will be used to translate the text, audio, and video clips into various languages for broad dissemination. Blood glucose levels in mg/dL will be recorded continuously over the wear period.

Conditions: Pre-diabetes
Being tested: The continuous glucose monitoring system
Keywords: Prediabetes, Glucose management, Feedback, Narrative education, Artificial intelligence, Contingency-shaped learning
Medical subject headings: Glucose Intolerance, Prediabetic State

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

The continuous glucose monitoring systemDevice
Also called CGM feedback
CGM device worn on back of the arm and glucose readings are shown on the participant's smartphone as a continuous data stream.

Study groups in NCT06472297
Study group	Role	What they receive
Unmasked CGM feedback	Experimental	The CGM system is used by the participant according to manufacturer instructions for the condition interval in their normal living environment. Receives: Device: The continuous glucose monitoring system

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Mean Glucose (mg/dL) From Baseline
Mean glucose was derived from continuous glucose monitoring (CGM) data obtained from the Dexcom Clarity system. Raw glucose values were processed and analyzed using the R statistical software package iglu to generate the full CGM variability metrics panel. For each participant, mean glucose was calculated separately for each 10-day assessment period. The outcome measure represents the change in mean glucose, defined as the difference between the baseline (Phase A) 10-day assessment period and the subsequent (Phase B) 10-day assessment period.
Measured: Up to 20 days of continuous CGM wear, comprising two sequential 10-day assessment periods (baseline Phase A and subsequent Phase B).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jun 202430 Sep 2024

First posted25 Jun 2024
Study start1 Jun 2024
Primary completion30 Sep 2024
Study completion30 Sep 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Pre-diabetesStudies of the same condition, open and under way.
More trials run by University of Southern CaliforniaThe sponsor's other registered studies.
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: Single group
Model description: A case series of participants wear an unmasked CGM sensor for a condition lasting 20 days while recording daily narratives of their experience.
Masking: None (open label)
Enrolment: 23 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06472297
Sponsor's protocol ID: UP-23-01001
Other IDs: P50MD017344
Acronym: G1
Status last verified: Jan 2026
First submitted: 18 Jun 2024
Last updated: 30 Jan 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: Yes: IPD sharing is set up with affiliate P50 Center universities and hospitals under a registered data use agreement (DUA). Data will be posted on the Open Science Framework url

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
RecruitingObservational study
Food-i-Sense Analytics: Integrating AI Into Continuous Glucose Monitoring Data Analysis for Precision Nutrition.
Prediabetes (Insulin Resistance, Impaired Glucose Tolerance), Artificial Intelligence Mobile Application
RecruitingPhase 3
A Study of Orforglipron in Participants With Overweight at Risk of Development of Obesity-Related Complications or Progression to Class 1 Obesity
Overweight, Prediabetic State
RecruitingObservational study
Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
Enrolling by invitationEarly Phase 1
Truway Diagnostic Tools in Primary Care
Chronic Disease, Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight

All Pre-diabetes trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Diabetes Prevention Combining CGM and Artificial Intelligence Health Education
ClinicalTrials.gov ID: NCT06472297
Acronym / sponsor ID: G1 / UP-23-01001
Conditions: Pre-diabetes
Keywords: Prediabetes, Glucose management, Feedback, Narrative education, Artificial intelligence, Contingency-shaped learning
Study type: Interventional
Recruitment status: Completed
Enrolment: 23 participants (actual)
Lead sponsor: University of Southern CaliforniaUniversity, hospital or other
Collaborators: National Institute on Minority Health and Health Disparities (NIMHD)
Study start: 1 Jun 2024 (actual)
Primary completion: 30 Sep 2024 (actual)
Study completion: 30 Sep 2024 (actual)
First posted: 25 Jun 2024 (actual)
Results: Posted 30 Jan 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: A case series of participants wear an unmasked CGM sensor for a condition lasting 20 days while recording daily narratives of their experience.

Arm	Type	Receives
Unmasked CGM feedback	Experimental	Device: The continuous glucose monitoring systemThe CGM system is used by the participant according to manufacturer instructions for the condition interval in their normal living environment.

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
Latino 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
The continuous glucose monitoring systemAlso: CGM feedbackCGM device worn on back of the arm and glucose readings are shown on the participant's smartphone as a continuous data stream.	Device	Unmasked CGM feedback

Primary outcome

Change in Mean Glucose (mg/dL) From Baseline
Time frame: Up to 20 days of continuous CGM wear, comprising two sequential 10-day assessment periods (baseline Phase A and subsequent Phase B).
Mean glucose was derived from continuous glucose monitoring (CGM) data obtained from the Dexcom Clarity system. Raw glucose values were processed and analyzed using the R statistical software package iglu to generate the full CGM variability metrics panel. For each participant, mean glucose was calculated separately for each 10-day assessment period. The outcome measure represents the change in mean glucose, defined as the difference between the baseline (Phase A) 10-day assessment period and the subsequent (Phase B) 10-day assessment period.

Results and safety

Results posted to the registry on 30 Jan 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Unmasked CGM Feedback (Single Study Arm)	23	21

Primary outcome: Change in Mean Glucose (mg/dL) From Baseline

Time frame: Up to 20 days of continuous CGM wear, comprising two sequential 10-day assessment periods (baseline Phase A and subsequent Phase B).. Median (Inter-Quartile Range). Unit: mg/dL

Measure	Unmasked CGM Feedback (Single Study Arm) n = 20
Value	2.1 (-7.4 to 9.3)

Unmasked CGM Feedback (Single Study Arm): Median Difference (Net): 2.1, p = 0.8, Wilcoxon Signed Rank test

Population analysed: Participants included in the analysis had sufficient continuous glucose monitoring (CGM) data. Inclusion required at least 2 days of valid CGM data within each 10-day assessment period. Three participants were excluded: two withdrew before completion of data collection, and one was later deemed ineligible based on protocol criteria identified after enrollment. Primary outcome analyses were therefore conducted on 20 participants.

Adverse events

Time frame: From participant enrollment through end of study follow-up (20 days). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Unmasked CGM Feedback (Single Study Arm)	0 of 23 (0%)	4 of 23 (17.4%)	0 of 23

Limitations and caveats (from the sponsor): The Phase 0 intervention goal raises few concerns regarding scientific rigor; however, focusing on a single major racial/ethnic group limits the generalizability of the content to other racial/ethnic groups, which will be addressed in future work.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Dexcom G CGM system specificationsLink provided by the sponsor.
Individual participant dataSharing planned: Yes. IPD sharing is set up with affiliate P50 Center universities and hospitals under a registered data use agreement (DUA). Data will be posted on the Open Science Framework url

Related trials for Pre-diabetes

Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
RecruitingObservational study
Food-i-Sense Analytics: Integrating AI Into Continuous Glucose Monitoring Data Analysis for Precision Nutrition.
Prediabetes (Insulin Resistance, Impaired Glucose Tolerance), Artificial Intelligence Mobile Application
RecruitingPhase 3
A Study of Orforglipron in Participants With Overweight at Risk of Development of Obesity-Related Complications or Progression to Class 1 Obesity
Overweight, Prediabetic State
RecruitingObservational study
Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
Enrolling by invitationEarly Phase 1
Truway Diagnostic Tools in Primary Care
Chronic Disease, Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight

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

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing The continuous glucose monitoring system in people with Pre-diabetes, run by University of Southern California 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 Jan 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?

Yes. Results are posted in the registry (first posted 30 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Change in Mean Glucose (mg/dL) From Baseline (time frame: Up to 20 days of continuous CGM wear, comprising two sequential 10-day assessment periods (baseline Phase A and subsequent Phase B).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06472297.

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 Jan 2026.