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| ID | Type | Description | Link |
|---|---|---|---|
| P50MD017344 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Minority Health and Health Disparities (NIMHD) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The continuous glucose monitoring system | Device | CGM device worn on back of the arm and glucose readings are shown on the participant's smartphone as a continuous data stream. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 20 days of continuous CGM wear, comprising two sequential 10-day assessment periods (baseline Phase A and subsequent Phase B). |
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| Measure | Description | Time Frame |
|---|---|---|
| Total Duration of Participant-Generated Narrative Video Recordings | Total duration, in minutes, of narrative video recordings generated by participants, including daily selfie-style reflections recorded during the continuous glucose monitor (CGM) wear period and post-study interview recordings (as a measure of feasibility). The total number of minutes of recorded narrative video content was calculated by summing the duration of all daily reflection videos and post-study interview recordings across participants. Results are reported as total minutes. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David S Black, PhD MPH | University of Southern California | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Southern California Center for Latino Health SCCLH | Los Angeles | California | 90031 | United States |
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| Label | URL |
|---|---|
| Dexcom G CGM system specifications | View source |
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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
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.
Request from author or see study publication supplemental material on the journal website.
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Recruitment and preliminary screening activities occurred between 5/24/2024 and 8/30/2024, using baseline screening telephone calls. The Study Start Date of 6/1/2024 reflects the date on which the first participant was formally enrolled in the study. The target population included 20 community health workers who had been actively working within the past six months, were diagnosed with prediabetes, and primarily resided in Los Angeles County.
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| ID | Title | Description |
|---|---|---|
| FG000 | Unmasked CGM Feedback (Single Study Arm) | The CGM system is used by the participant according to manufacturer instructions for the condition interval in their normal living environment. The continuous glucose monitoring system: CGM device worn on back of the arm and glucose readings are shown on the participant's smartphone as a continuous data stream. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Baseline measures were collected and reported for all 23 enrolled participants. Primary outcome analyses were conducted participants with sufficient continuous glucose monitoring data (≥2 days of valid data per 10-day period), as pre-specified for the two-timepoint design.
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| ID | Title | Description |
|---|---|---|
| BG000 | Unmasked CGM Feedback (Single Study Arm) | The CGM system is used by the participant according to manufacturer instructions for the condition interval in their normal living environment. The continuous glucose monitoring system: CGM device worn on back of the arm and glucose readings are shown on the participant's smartphone as a continuous data stream. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 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. | Posted | Median | Inter-Quartile Range | mg/dL | Up to 20 days of continuous CGM wear, comprising two sequential 10-day assessment periods (baseline Phase A and subsequent Phase B). |
From participant enrollment through end of study follow-up (20 days)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Unmasked CGM Feedback (Single Study Arm) | The CGM system is used by the participant according to manufacturer instructions for the condition interval in their normal living environment. The continuous glucose monitoring system: CGM device worn on back of the arm and glucose readings are shown on the participant's smartphone as a continuous data stream. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sensor site pain | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Localized pain at the site of sensor placement. |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| My Vu | Children's Hospital Los Angeles | 323-361-8681 | myvu@chla.usc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 10, 2024 | Dec 22, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 10, 2024 | Dec 22, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D018149 | Glucose Intolerance |
| D011236 | Prediabetic State |
| ID | Term |
|---|---|
| D006943 | Hyperglycemia |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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A case series of participants wear an unmasked CGM sensor for a condition lasting 20 days while recording daily narratives of their experience.
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The CGM system feedback is unmasked. The CGM is automatically recorded and does not require an outcomes assessor.
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| Up to 20 days during the CGM wear period, plus post-study interview recordings. |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Highest level of education | Count of Participants | Participants |
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| Current employment status | Count of Participants | Participants |
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| Total household income | Count of Participants | Participants |
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| Health insurance | Count of Participants | Participants |
|
| Centers for Disease Control and Prevention (CDC) prediabetes risk score | The CDC Prediabetes Risk Score is a questionnaire-based score calculated from age, sex, family history, gestational diabetes history, hypertension, physical activity, and weight category. Higher scores indicate greater diabetes risk (worse outcomes), while lower scores indicate lower risk (better outcomes). A score of 5 or higher indicates increased risk for having prediabetes and are at high risk for type 2 diabetes. | Count of Participants | Participants |
|
| Body Mass Index | Median | Inter-Quartile Range | kg/m² |
|
| Physical Activity Level (International Physical Activity Questionnaire [IPAQ]) | IPAQ is a validated self-report instrument designed to estimate physical activity over the previous 7 days. Participants reported the frequency (days per week) and duration (minutes per day) of walking, moderate-intensity activity, and vigorous-intensity activity. Total physical activity was calculated in metabolic equivalent task minutes per week (MET-min/week). Based on total MET-min/week, participants were categorized into low, moderate, or high physical activity levels, according to established IPAQ criteria. | Count of Participants | Participants |
|
| HbA1c (%) | Finger prick HbA1c (%) | Count of Participants | Participants |
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| Self-reported history of prediabetes | Count of Participants | Participants |
|
| ID | Title | Description |
|---|
| OG000 | Unmasked CGM Feedback (Single Study Arm) | The CGM system is used by the participant according to manufacturer instructions for the condition interval in their normal living environment. The continuous glucose monitoring system: CGM device worn on back of the arm and glucose readings are shown on the participant's smartphone as a continuous data stream. |
|
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| Other Pre-specified | Total Duration of Participant-Generated Narrative Video Recordings | Total duration, in minutes, of narrative video recordings generated by participants, including daily selfie-style reflections recorded during the continuous glucose monitor (CGM) wear period and post-study interview recordings (as a measure of feasibility). The total number of minutes of recorded narrative video content was calculated by summing the duration of all daily reflection videos and post-study interview recordings across participants. Results are reported as total minutes. | All participants that provided at least 1 video. | Posted | Number | minutes | Up to 20 days during the CGM wear period, plus post-study interview recordings. |
|
|
|
| 0 |
| 23 |
| 0 |
| 23 |
| 4 |
| 23 |
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| Sensor site itching | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Itchiness at the sensor adhesive site reported by the participant; resolved without intervention and without associated redness or inflammation. |
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| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |