Continuous Glucose Monitoring in Prediabetes

NCT07455435 | Not Yet Recruiting

• 1 other identifier: 25-01-397
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

This research explores how wearable glucose monitors might help prevent type 2 diabetes in people at risk of developing the disease. Type 2 diabetes affects more than 1 in 10 Americans and costs the nation $327 billion annually. Even though it's clear that physical activity helps prevent diabetes, and that even small increases in daily movement (like walking or climbing stairs) can significantly lower risk, getting people to be more active remains challenging. A device called a continuous glucose monitor (CGM) might offer a solution. This small wearable sensor tracks blood sugar levels throughout the day and sends the information to a phone or watch. While these devices are already helping people who have diabetes manage their condition better, the investigators want to study if wearing a CGM may encourage at-risk people to become more physically active. The investigators are particularly interested in seeing whether real-time blood sugar data plus education can be an effective tool to promote lifestyle changes, such as walk more steps every day. The study also aims to examine whether using a CGM helps stabilize blood sugar levels in prediabetes. The researchers believe that even short-term use of these monitors could lead to increased physical activity and more stable blood sugar levels, potentially helping prevent diabetes development.

Conditions

Prediabetes

Outcome Measures

Primary Outcomes (1)

• Physical activity level

  step count

  from day 1 to day 20

Secondary Outcomes (3)

• endothelial function

  At day 1 and day 20

• arterial stiffness

  at day 1 and day 20

• blood glucose

  from day 1 to day 20

Study Arms (2)

CGM Blind group

NO INTERVENTION

The control group will wear the CGM for 20 days but without access to the real-time glucose data (blind mode). They will receive the data upon completion of the study.

CGM Unblind group

EXPERIMENTAL

The CGM unblind group will wear the CGM for 20 days. They will have the real time glucose data during the study.

Behavioral: CGM Access

Interventions

CGM Access BEHAVIORAL

The intervention is the access to the real-time glucose via a CGM system.

CGM Unblind group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 18 years or older Prediabetes confirmed by the recent lab tests (within three month). If not available, it will be confirmed at lab Body mass index (BMI) \>= 25 kg/m2 Ability to provide informed consent Ownership of a smartphone compatible with Dexcom G6 application Willing and able to comply with study procedures for 20 days

You may not qualify if:

• Diabetes and Glycemic Management:
• Diagnosed type 1 or type 2 diabetes mellitus
• Current use of glucose-lowering medications (metformin, sulfonylureas, GLP-1 agonists, SGLT2 inhibitors, insulin, etc.)
• HbA1c \>= 6.5% or fasting plasma glucose \>= 126 mg/dL
• Cardiovascular Conditions:
• History of cardiovascular disease (myocardial infarction, stroke, heart failure, coronary artery disease)
• Peripheral artery disease
• Uncontrolled hypertension (systolic BP \> 160 mmHg or diastolic BP \> 100 mmHg)
• Raynaud phenomenon or other conditions affecting peripheral vascular assessment
• Atrial fibrillation or other arrhythmias affecting pulse wave velocity measurement
• Medications Affecting Vascular Function:
• Current use of vasoactive medications (nitrates, phosphodiesterase inhibitors)
• Recent changes (\< 4 weeks) in antihypertensive medications
• Chronic use of non-steroidal anti-inflammatory drugs (NSAIDs)
• Systemic corticosteroid use

Sponsors & Collaborators

• University of Hartford: lead

MeSH Terms

Conditions

Prediabetic State

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Jinghui Yang, PT, MPT, PhD

CONTACT

347-429-0843; jiyang@hartford.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: The eligible participants will be randomly allocated to a control group and an experimental group. Both groups will wear CGM for 20 days, with only the experimental group will receive real-time glucose data during the study period. The CGM in the control group will be in the blind mode.

Study Record Dates

• First Submitted: February 15, 2026
• First Posted: March 6, 2026
• Study Start: March 21, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: March 6, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Expected from May 2027 to Dec 2027