PreDiabetesY-HELPNCT06841796
The YMCA Healthy Lifestyle Program for Prediabetes
A study testing Real time continuous glucose monitor (Stelo) in people with PreDiabetes, run by Young Men's Christian Association of the Blue Water Area at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PreDiabetes
- What is being tested?
- Real time continuous glucose monitor (Stelo)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Feb 2025to Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ● 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%
Who cannot join
- 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
Show all 9Show fewer
- Terminal illness
- Dementia, mental impairment
- Non English speaking
Trial locations and contacts
1 site in 1 country.
United States1 site
YMCA of the Blue Water Area
Port Huron, Michigan, 48060
About this study
Official title: The Young Men's Christian Association (YMCA) Healthy Lifestyle Program for Prediabetes
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
Read more
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
Read the detailed description
BACKGROUND:
Diabetes has a significant impact on physical, social and mental well-being and causes significant morbidity and mortality in the United States. The total direct estimated costs of diagnosed diabetes have increased from $227 billion in 2012 to $307 billion in 2022.
In 2021, 38.1 million adults aged 18 years or older (14.7% of all US adults) had diabetes with a higher prevalence of 29.2% among those aged 65 years or older. An estimated 97.6 million adults had prediabetes in 2021.
The Diabetes Prevention Program (DPP) study published in 2002 clearly showed the benefit of lifestyle intervention in reducing the risk of developing type 2 diabetes by 58% compared to placebo. The Program worked particularly well for participants ages 60 and older, lowering their chances of developing type 2 diabetes by 71 percent. However, the retention rate for the DPP program has been 32% at 10 months with only 17% achieving all three goals of weight loss, physical activity ≥ 150 min per week and low fat diet. In fact, over the 20 years since the study was published, the incidence and prevalence of diabetes have dramatically increased with prediabetes affecting more than one third of the adult population. It is clear that a new approach is needed to prevent individuals with prediabetes progressing to diabetes
RATIONALE:
CGM has been shown to be an effective behavior modification tool in individuals with diabetes resulting in improvement in A1c and weight loss. Individuals with diabetes wearing a CGM were more likely to modify their physical activity and eating habits based on the real time glucose levels from the CGM.
The Diabetes Prevention Program (DPP) has been successfully implemented in the YMCA setting using health coaches and a modified curriculum. However, overall enrollment in Diabetes Prevention Programs is low with only 16% (351/2200) of those contacted attending an information session and only 11.3% (228) enrolling in the YMCA DPP and persisting through week 9. Overall retention rate for DPP at University of Michigan was 63% of participants through 18 weeks and 32% of participants through 44 weeks.
It was felt that a healthy lifestyle program led by a YMCA health coach incorporating the real time feedback of glucose data from the CGM and elements of the DPP curriculum could effectively help individuals with prediabetes make the necessary lifestyle changes to prevent diabetes.
PRIMARY OBJECTIVE:
To determine if a healthy lifestyle program at the YMCA incorporating CGM in individuals with prediabetes can improve glucose levels, dietary habits and physical activity
SECONDARY OBJECTIVE:
To determine if a healthy lifestyle program at the YMCA incorporating CGM in individuals with prediabetes can have a beneficial effect on weight, body mass index (BMI), waist circumference, body fat percentage, self-perceived health/wellness and participant satisfaction
STUDY DESIGN:
This is a randomized controlled single center 24 week in-person trial intended to investigate the effect of CGM in improving glucose levels, physical activity and nutritional habits in individuals with prediabetes in a YMCA Healthy Lifestyle Program.
In this trial, 84 participants with prediabetes will be randomly assigned 1:1 to two groups. Baseline A1c and BMI will be taken into account during randomization to ensure that the two groups are similar.
All participants will undergo baseline assessment including wearing a blinded CGM for 10 days. The intervention arm (Group 1) will wear real time CGM continuously for 24 weeks and the control arm (Group 2) will wear only a blinded CGM at week 6, 12 and 24.
Both groups will attend sessions with a health coach weekly for the first 12 weeks followed by 3 monthly sessions. These sessions will include physical fitness activities and educational information on nutrition, motivation, coping, stress management and glucose levels.
A1c, glucose management indicator (GMI), nutritional, physical, diabetes empowerment scale modified for prediabetes (DES) and self-perceived health/wellness assessments will be obtained at baseline, 12 and 24 weeks. Weight, BMI, waist circumference and body fat percentage measurements will be obtained at baseline, 4, 8, 12, 16, 20 and 24 weeks. Semi-structured interviews will be performed on a cross section of participants about their attitudes and perceptions with CGM usage and health behaviors.
- Conditions
- PreDiabetes
- Being tested
- Real time continuous glucose monitor (Stelo)
- Keywords
- prediabetes, diabetes prevention, prevention of type 2 diabetes
- Medical subject headings
- Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Group 1 : Intervention with Stelo | Active comparator | Stelo CGM Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time in tight range (TITR)
Percent of time with glucose values in the range of 70-140 mg/dl
Measured: 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.
Measured: 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
Measured: Assessed at baseline, 12 and 24 weeks
Secondary outcomes (5)
A1c
Change in point-of-care A1c results
Measured: baseline, 12 and 24 weeks
Change in BMI
Assessed by Tanita scale through measurements of height and weight. BMI is reported as kg/m2
Measured: baseline, 4,8,12,16,20 and 24 weeks
Change in weight
Assessed by Tanita scale. Measured in pounds
Measured: baseline, 4,8,12,16,20 and 24 weeks
Change in waist circumference
Assessed by Tanita scale. Measured in inches
Measured: baseline, 4,8,12,16,20 and 24 weeks
Change in body fat percentage
Assessed by Tanita scale. Measured as body fat percentage
Measured: baseline, 4,8,12,16,20 and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2025
- Study start17 Feb 2025
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreDiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled 24 week single center in-person trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Young Men's Christian Association of the Blue Water Area
- Sponsor type
- University, hospital or other
- Collaborators
- DexCom, Inc.
- Responsible party
- Principal investigator, Sushma Reddy, MD, Young Men's Christian Association of the Blue Water Area
- Investigators
- Sushma Reddy, MD, Principal investigator, Young Men's Christian Association of the Blue Water AreaAnnette Gilmer, MD, MPH, Principal investigator, Young Men's Christian Association of the Blue Water Area
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06841796
- Sponsor's protocol ID
- IIS-2024-173
- Acronym
- Y-HELP
- Status last verified
- Aug 2026
- First submitted
- 12 Feb 2025
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: There is no plan to share individual participant data to other researchers
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Young Men's Christian Association (YMCA) Healthy Lifestyle Program for Prediabetes
- ClinicalTrials.gov ID
- NCT06841796
- Acronym / sponsor ID
- Y-HELP / IIS-2024-173
- Conditions
- PreDiabetes
- Keywords
- prediabetes, diabetes prevention, prevention of type 2 diabetes
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Young Men's Christian Association of the Blue Water AreaUniversity, hospital or other
- Collaborators
- DexCom, Inc.
- Study start
- 17 Feb 2025 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 24 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
BACKGROUND:
Diabetes has a significant impact on physical, social and mental well-being and causes significant morbidity and mortality in the United States. The total direct estimated costs of diagnosed diabetes have increased from $227 billion in 2012 to $307 billion in 2022.
In 2021, 38.1 million adults aged 18 years or older (14.7% of all US adults) had diabetes with a higher prevalence of 29.2% among those aged 65 years or older. An estimated 97.6 million adults had prediabetes in 2021.
The Diabetes Prevention Program (DPP) study published in 2002 clearly showed the benefit of lifestyle intervention in reducing the risk of developing type 2 diabetes by 58% compared to placebo. The Program worked particularly well for participants ages 60 and older, lowering their chances of developing type 2 diabetes by 71 percent. However, the retention rate for the DPP program has been 32% at 10 months with only 17% achieving all three goals of weight loss, physical activity ≥ 150 min per week and low fat diet. In fact, over the 20 years since the study was published, the incidence and prevalence of diabetes have dramatically increased with prediabetes affecting more than one third of the adult population. It is clear that a new approach is needed to prevent individuals with prediabetes progressing to diabetes
RATIONALE:
CGM has been shown to be an effective behavior modification tool in individuals with diabetes resulting in improvement in A1c and weight loss. Individuals with diabetes wearing a CGM were more likely to modify their physical activity and eating habits based on the real time glucose levels from the CGM.
The Diabetes Prevention Program (DPP) has been successfully implemented in the YMCA setting using health coaches and a modified curriculum. However, overall enrollment in Diabetes Prevention Programs is low with only 16% (351/2200) of those contacted attending an information session and only 11.3% (228) enrolling in the YMCA DPP and persisting through week 9. Overall retention rate for DPP at University of Michigan was 63% of participants through 18 weeks and 32% of participants through 44 weeks.
It was felt that a healthy lifestyle program led by a YMCA health coach incorporating the real time feedback of glucose data from the CGM and elements of the DPP curriculum could effectively help individuals with prediabetes make the necessary lifestyle changes to prevent diabetes.
PRIMARY OBJECTIVE:
To determine if a healthy lifestyle program at the YMCA incorporating CGM in individuals with prediabetes can improve glucose levels, dietary habits and physical activity
SECONDARY OBJECTIVE:
To determine if a healthy lifestyle program at the YMCA incorporating CGM in individuals with prediabetes can have a beneficial effect on weight, body mass index (BMI), waist circumference, body fat percentage, self-perceived health/wellness and participant satisfaction
STUDY DESIGN:
This is a randomized controlled single center 24 week in-person trial intended to investigate the effect of CGM in improving glucose levels, physical activity and nutritional habits in individuals with prediabetes in a YMCA Healthy Lifestyle Program.
In this trial, 84 participants with prediabetes will be randomly assigned 1:1 to two groups. Baseline A1c and BMI will be taken into account during randomization to ensure that the two groups are similar.
All participants will undergo baseline assessment including wearing a blinded CGM for 10 days. The intervention arm (Group 1) will wear real time CGM continuously for 24 weeks and the control arm (Group 2) will wear only a blinded CGM at week 6, 12 and 24.
Both groups will attend sessions with a health coach weekly for the first 12 weeks followed by 3 monthly sessions. These sessions will include physical fitness activities and educational information on nutrition, motivation, coping, stress management and glucose levels.
A1c, glucose management indicator (GMI), nutritional, physical, diabetes empowerment scale modified for prediabetes (DES) and self-perceived health/wellness assessments will be obtained at baseline, 12 and 24 weeks. Weight, BMI, waist circumference and body fat percentage measurements will be obtained at baseline, 4, 8, 12, 16, 20 and 24 weeks. Semi-structured interviews will be performed on a cross section of participants about their attitudes and perceptions with CGM usage and health behaviors.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled 24 week single center in-person trial
| Arm | Type | Receives |
|---|---|---|
| Group 1 : Intervention with Stelo | Active comparator | Device: Real time continuous glucose monitor (Stelo)Stelo CGM |
| Group 2 : control | No intervention | –Group 2 will only wear a blinded CGM for 10 days at 6,12 and 24 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ● Adults 18 years or older AND
Key exclusion criteria (9 listed)
- Pregnancy
- Previous CGM use
- Lack of smart phone/smart device
- Use of steroids
- Active cancer treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Real time continuous glucose monitor (Stelo)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 | Device | Group 1 : Intervention with Stelo |
Primary outcome
Time in tight range (TITR)
Time frame: Assessed at baseline, 6,12 and 24 weeks
Percent of time with glucose values in the range of 70-140 mg/dl
PYP
Time frame: Assessed at baseline, 12 and 24 weeks
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.
IPAQ
Time frame: Assessed at baseline, 12 and 24 weeks
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
5 secondary outcomes
A1c
Time frame: baseline, 12 and 24 weeks
Change in BMI
Time frame: baseline, 4,8,12,16,20 and 24 weeks
Change in weight
Time frame: baseline, 4,8,12,16,20 and 24 weeks
Change in waist circumference
Time frame: baseline, 4,8,12,16,20 and 24 weeks
Change in body fat percentage
Time frame: baseline, 4,8,12,16,20 and 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
- Individual participant dataSharing planned: No. There is no plan to share individual participant data to other researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sushma Reddy, MD principal investigator
Young Men's Christian Association of the Blue Water Area
Annette Gilmer, MD, MPH principal investigator
Young Men's Christian Association of the Blue Water Area
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Real time continuous glucose monitor (Stelo) in people with PreDiabetes, run by Young Men's Christian Association of the Blue Water Area at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time in tight range (TITR) (time frame: Assessed at baseline, 6,12 and 24 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2026.