NCT07140848

Brief Summary

Prediabetes affects over one-third of adults in the United States, placing them at a higher risk for developing type 2 diabetes and heart disease, which can lead to serious health complications and increased medical costs. Although a program called the Diabetes Prevention Program (DPP) has been shown to lower the risk of diabetes through healthy lifestyle changes, many people find it difficult to stick with these changes over the long term. This study seeks to find out if combining DPP coaching with continuous glucose monitoring (CGM) technology can help people stay on track with their health goals.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
214

participants targeted

Target at P75+ for not_applicable

Timeline
22mo left

Started Apr 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress6%
Apr 2026Mar 2028

First Submitted

Initial submission to the registry

August 22, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 26, 2025

Completed
8 months until next milestone

Study Start

First participant enrolled

April 13, 2026

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2028

Last Updated

April 24, 2026

Status Verified

August 1, 2025

Enrollment Period

1.9 years

First QC Date

August 22, 2025

Last Update Submit

April 21, 2026

Conditions

PreDiabetes

Outcome Measures

Primary Outcomes (1)

  • Glycemic Control (HbA1c)

    Blood specimens (10 cc of blood) will be obtain by trained phlebotomists or nurse for HbA1c.

    Change from baseline HbA1c at 12 months post intervention follow-ups

Secondary Outcomes (1)

  • Quality of Life as measured by SF-12

    Change from baseline quality of life measure at 12 months post intervention follow-ups

Other Outcomes (1)

  • Self-Care

    Change from baseline self-care at 12 months post intervention follow-ups

Study Arms (2)

Control

ACTIVE COMPARATOR

Diabetes Prevention Program

Behavioral: Control

Intervention

EXPERIMENTAL

Diabetes Prevention Program + Continuous Glucose Monitors/Coaching

Behavioral: CGM-DPP

Interventions

CGM-DPPBEHAVIORAL

Participants in the DPP who receive personalized CGM coaching.

Intervention
ControlBEHAVIORAL

Participants in control group will be referred to DPP.

Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • adults aged 18 years or older,
  • diagnosis of prediabetes, as defined by current clinical guidelines (HbA1c 5.7% to 6.4%, fasting plasma glucose 100-125 mg/dL, or 2-hour plasma glucose 140-199 mg/dL following a 75g oral glucose tolerance test),
  • body mass index (BMI) of at least 24 kg/m² (or 22 kg/m² for Asian Americans),
  • willingness to comply with all aspects of the study protocol, including attending coaching sessions and using CGM devices.

You may not qualify if:

  • Individuals will be excluded from the study if they
  • have a diagnosis of type 1 or type 2 diabetes,
  • are currently using CGMs or have medical contraindications to CGM use, such as severe skin allergies or implantable defibrillators, or
  • are currently enrolled in another clinical trial for prediabetes. Additionally, using validated assessments, we will exclude participants with significant dementia, alcohol or drug abuse/dependency, active psychosis, or life expectancy less than 12 months as these conditions are likely to interfere with adherence to the intervention.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Division of Population Health, Department of Medicine

Buffalo, New York, 14203, United States

RECRUITING

MeSH Terms

Conditions

Prediabetic State

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Central Study Contacts

Raphael A Fraser, PhD, MS

CONTACT

7168295733rfraser@buffalo.edu

Jocelyn Stooks, MPH

CONTACT

7168292364jstooks@buffalo.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Medicine

Study Record Dates

First Submitted

August 22, 2025

First Posted

August 26, 2025

Study Start

April 13, 2026

Primary Completion (Estimated)

March 1, 2028

Study Completion (Estimated)

March 1, 2028

Last Updated

April 24, 2026

Record last verified: 2025-08

Locations

US(1)