The YMCA Healthy Lifestyle Program for Prediabetes

NCT06841796 | Recruiting DMC FDA Device

• 1 other identifier: IIS-2024-173
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this 26 week randomized controlled clinical trial is to learn if using a real time continuous glucose monitor (CGM) in a healthy lifestyle program for adults with prediabetes at the YMCA can improve glucose levels, dietary habits and physical activity The main questions it aims to answer is

• Does use of a CGM improve the percent of time spent with glucose values between 70-140 mg/dl
• Does use of a CGM improve nutritional habits as measured by Picture Your Plate (PYP) score
• Does use of a CGM improve physical activity as measured by International Physical Activity Questionnaire (IPAQ) score Researchers will compare individuals using real time CGM to those not using CGM Participants will be asked to:
• attend weekly health coach sessions for 12 weeks followed by 3 monthly sessions.
• attend a YMCA class of their choice
• fill out questionnaires at baseline, 12 and 24 weeks
• have an A1c blood test at baseline, 12 and 24 weeks.
• wear a CGM. All participants will wear a blinded CGM at baseline. The intervention group will wear a real time CGM for 24 weeks. The control group will wear a blinded CGM for 10 days at 6, 12 and 24 weeks

Conditions

PreDiabetes

Keywords

prediabetes; diabetes prevention; prevention of type 2 diabetes

Outcome Measures

Primary Outcomes (3)

• Time in tight range (TITR)

  Percent of time with glucose values in the range of 70-140 mg/dl

  Assessed at baseline, 6,12 and 24 weeks

• PYP

  Change in picture your plate (PYP) score. The score ranges from 0 to 96 with a higher score indicating a healthier diet. A score \< 40 indicates greater likelihood of an unhealthy dietary pattern with much room for improvement. A PYP score greater than 60 indicates a healthful dietary pattern, although there may be some specific eating behaviors that could be improved.

  Assessed at baseline, 12 and 24 weeks

• IPAQ

  Change in International Physical Activity Questionnaire (IPAQ) score. This score is reported as Metabolic Equivalent (MET) minutes/week. Values can range from 0 to 4000 with a higher value indicating more physical activity

  Assessed at baseline, 12 and 24 weeks

Secondary Outcomes (5)

• A1c

  baseline, 12 and 24 weeks

• Change in BMI

  baseline, 4,8,12,16,20 and 24 weeks

• Change in weight

  baseline, 4,8,12,16,20 and 24 weeks

• Change in waist circumference

  baseline, 4,8,12,16,20 and 24 weeks

• Change in body fat percentage

  baseline, 4,8,12,16,20 and 24 weeks

Study Arms (2)

Group 1 : Intervention with Stelo

ACTIVE COMPARATOR

Stelo CGM

Device: Real time continuous glucose monitor (Stelo)

Group 2 : control

NO INTERVENTION

Group 2 will only wear a blinded CGM for 10 days at 6,12 and 24 weeks

Interventions

Real time continuous glucose monitor (Stelo) DEVICE

Real time CGM will be worn continuously for 24 weeks. Participants will be able to see the glucose data from the CGM facilitating changes in nutritional habits and physical activity

Group 1 : Intervention with Stelo

Eligibility Criteria

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

You may qualify if:

• ● Adults 18 years or older AND
• A diagnosis of prediabetes as defined by:
• Fasting glucose 100-125 mg/dl OR
• A1c 5.7-6.4%

You may not qualify if:

• Pregnancy
• Previous CGM use
• Lack of smart phone/smart device
• Use of steroids
• Active cancer treatment
• Active chronic infection requiring long term use of antibiotics
• Terminal illness
• Dementia, mental impairment
• Non English speaking

Sponsors & Collaborators

• Young Men's Christian Association of the Blue Water Area: lead
• DexCom, Inc.: collaborator

Study Sites (1)

YMCA of the Blue Water Area

Port Huron, Michigan, 48060, United States

RECRUITING

MeSH Terms

Conditions

Prediabetic State

Condition Hierarchy (Ancestors)

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

Study Officials

• Sushma Reddy, MD

  Young Men's Christian Association of the Blue Water Area

  PRINCIPAL INVESTIGATOR

• Annette Gilmer, MD, MPH

  Young Men's Christian Association of the Blue Water Area

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sheila Volker

CONTACT

810-987-6400; svolker@bluewaterymca.com

Josh Chapman

CONTACT

810-987-6400; jchapman@bluewaterymca.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: All study personnel will be blinded to the "blinded' CGM data until the participant completes all study visits.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized controlled 24 week single center in-person trial

Study Record Dates

• First Submitted: February 12, 2025
• First Posted: February 24, 2025
• Study Start: February 17, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: February 24, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)