Continuous Glucose Monitoring (CGM) in Prediabetes With Community Based Recruitment
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: CGM.
- Who it may be relevant to
- Registry conditions: Prediabetes. Basic parameters: from 35 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Continuous Glucose Monitoring (CGM) in Prediabetes With Health Education Videos
Overview
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 (T2D).
Detailed description
The primary objective of this new project is to enhance glycemic control in individuals with prediabetes and deter the progression to Type 2 Diabetes (T2D) within the Los Angeles (LA) County community. Our proposal involves conducting a Phase 0 intervention development study. This study will enlist a final sample of N=50 adults who speak English and/or Spanish, have non-clinical prediabetes, and 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.
Interventions
- Device CGM
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.
Primary outcome measures
- Glucose levels [Time frame: Maximum of 20 days of continuous wear]
Secondary outcome measures (1)
- Time out of range > 140 mg/dL (TOR) [Time frame: Maximum of 20 days of continuous wear]
Eligibility criteria
Inclusion criteria
- 35 years of age or older
- Willingness to wear CGM sensor
- Prediabetes by finger prick blood A1C% or fasting glucose
- Centers for Disease Control and Prevention (CDC) prediabetes risk test score of 5 or higher or recent prediabetes diagnosis from physician
Exclusion criteria
- 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
- Currently pregnant
- Previously participated in other Continuous Glucose Monitoring studies
- Having a planned trip outside California in the following 2 months
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
United States · 1 center
- Southern California Center for Latino Health (SCCLH) — Los Angeles
Identifiers
NCT: NCT07477249 · UP-23-01001(b) · 3P50MD017344-03S3