Clinical trial NCT06472297: Continuous Glucose Monitoring in Prediabetes
Official title: Diabetes Prevention Combining CGM and Artificial Intelligence Health Education
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pre-diabetes
Keywords: Prediabetes
Glucose management
Feedback
Narrative education
Artificial intelligence
Contingency-shaped learning
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2024-06-25
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: PREVENTION

Brief 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. The goal is to prevent transition to type 2 diabetes.

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.

Eligibility criteria: Inclusion Criteria:

* Prediabetes by finger prick blood A1C%
* Willingness to wear CGM sensor
* Latino 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

Primary outcomes:
measure: Glucose levels
timeFrame: maximum of 20 days of continuous wear
Secondary outcomes:
Other outcomes:
measure: Recorded narrative audio and video archives
timeFrame: Video selfie-style clips recorded each day for up to 20 days during the CGM wear period
Locations:
city: Los Angeles
country: United States
facility: Southern California Center for Latino Health SCCLH
state: California
Study officials:
affiliation: University of Southern California
name: David S Black, PhD MPH
role: PRINCIPAL_INVESTIGATOR
References: