Continuous Glucose Monitoring for Prediabetes

(Y-HELP Trial)

Overseen By Josh Chapman

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Young Men's Christian Association of the Blue Water Area

Must not be taking: Steroids, Antibiotics

Disqualifiers: Pregnancy, Cancer, Dementia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 15

Duration: 24 weeks

84 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are using steroids or undergoing active cancer treatment, you would not be eligible to participate.

What data supports the effectiveness of the YMCA Healthy Lifestyle Program treatment for prediabetes?

Research shows that lifestyle change programs, like the YMCA Healthy Lifestyle Program, can effectively prevent or delay type 2 diabetes in people with prediabetes. Studies have found that similar programs, such as the Diabetes Prevention Program, can reduce the risk of developing diabetes by more than half. ^{1 2 3 4 5}

Is continuous glucose monitoring safe for humans?

The research does not provide specific safety data for continuous glucose monitoring in humans, but it has been used in studies with individuals with type 1 diabetes, suggesting it is generally considered safe for use in humans. ^{3 5 6 7 8}

How does the YMCA Healthy Lifestyle Program treatment for prediabetes differ from other treatments?

The YMCA Healthy Lifestyle Program is unique because it combines continuous glucose monitoring (CGM) with lifestyle coaching, focusing on diet and exercise, to prevent the progression to type 2 diabetes. This approach is novel as it uses real-time glucose data to guide personalized lifestyle changes, unlike traditional treatments that may rely solely on medication or general lifestyle advice. ^{9 10 11 12 13}

What is the purpose of this trial?

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

Research Team

Annette Gilmer, MD, MPH

Principal Investigator

Young Men's Christian Association of the Blue Water Area

Sushma Reddy, MD

Principal Investigator

Young Men's Christian Association of the Blue Water Area

Eligibility Criteria

This trial is for adults with prediabetes who want to join a YMCA healthy lifestyle program. Participants should be interested in monitoring their glucose levels, improving diet and exercise habits. People already using continuous glucose monitors or those unable to attend regular sessions and tests may not qualify.

Inclusion Criteria

I am an adult with prediabetes, as shown by my blood sugar or A1c levels.

Exclusion Criteria

Terminal illness

Pregnancy

Previous continuous glucose monitoring (CGM) use

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants undergo baseline assessment including wearing a blinded CGM for 10 days

2 weeks

1 visit (in-person)

Treatment

Participants attend weekly health coach sessions for 12 weeks followed by 3 monthly sessions, and engage in physical fitness activities and educational sessions

24 weeks

12 weekly visits (in-person), 3 monthly visits (in-person)

Follow-up

Participants are monitored for changes in glucose levels, dietary habits, and physical activity

4 weeks

2 visits (in-person)

Treatment Details

Interventions

• YMCA Healthy Lifestyle Program

Trial Overview The study is testing if a real time continuous glucose monitor (CGM) can help people with prediabetes manage their blood sugar better when combined with health coaching and YMCA classes. It will compare the effects of CGM use on maintaining ideal glucose levels, enhancing dietary habits, and increasing physical activity.

Participant Groups

Group I: Group 1 : Intervention with Stelo Active Control 1 Intervention

Stelo CGM

Group II: Group 2 : control Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Young Men's Christian Association of the Blue Water Area

Lead Sponsor

Trials

1

Recruited

80+

DexCom, Inc.

Industry Sponsor

Trials

151

Recruited

35,700+

Kevin Sayer

DexCom, Inc.

Chief Executive Officer since 2015

Bachelor’s and Master’s degrees in Accounting and Information Systems from Brigham Young University

Dr. Shelly Lane

DexCom, Inc.

Chief Medical Officer since 2023

MD from University of California, San Diego

Findings from Research

Clinicians recognize the importance of prediabetes screening and diagnosis, with 93.7% acknowledging it as a significant health issue, yet only 45.2% are familiar with the National Diabetes Prevention Program (DPP).

Despite high screening rates (75.9%) for diabetes among eligible patients, only 50.7% of those diagnosed with prediabetes had their condition documented, and no patients were referred to a DPP, indicating a gap in the implementation of lifestyle change programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prediabetes Knowledge, Attitudes, and Practices at an Academic Family Medicine Practice. Keck, JW., Thomas, AR., Hieronymus, L., et al.[2020]

The study highlights the effectiveness of trained diabetes educators in delivering a community-based adaptation of the Diabetes Prevention Program to manage pre-diabetes.

This intervention provides a valuable resource for healthcare providers, suggesting that community support can play a crucial role in preventing the progression of pre-diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a community Diabetes Prevention Program delivered by diabetes educators in the United States: one-year follow up. Kramer, MK., Miller, RG., Siminerio, LM.[2019]

A group-based lifestyle intervention adapted from the US Diabetes Prevention Program (DPP) at the YMCA led to significant weight loss in participants, with a 6.0% reduction in the intensive lifestyle group and a 3.6% reduction in the brief advice group after 28 months.

Participants who initially received the intensive lifestyle intervention also showed notable improvements in blood pressure and total cholesterol levels, suggesting that the YMCA program is an effective and low-cost option for diabetes prevention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term effects of a community-based lifestyle intervention to prevent type 2 diabetes: the DEPLOY extension pilot study. Ackermann, RT., Finch, EA., Caffrey, HM., et al.[2021]

A pilot study involving 92 participants showed that a group-based lifestyle intervention delivered by the YMCA led to a significant 6.0% reduction in body weight after 6 months, compared to only a 2.0% reduction in the control group.

The intervention also resulted in a notable decrease in total cholesterol levels, with a reduction of 22 mg/dL in the intervention group versus an increase of 6 mg/dL in controls, indicating the program's effectiveness in improving health markers associated with diabetes risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Translating the Diabetes Prevention Program into the community. The DEPLOY Pilot Study. Ackermann, RT., Finch, EA., Brizendine, E., et al.[2022]

The YMCA adaptation of the Diabetes Prevention Program (YDPP) led to a mean weight loss of 2.3 kg over 12 months compared to standard care for low-income, overweight or obese adults, indicating its effectiveness.

Participants who attended 9 or more YDPP lessons experienced an even greater weight loss of 5.3 kg, highlighting the importance of engagement in the program for achieving better outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Randomized Comparative Effectiveness Trial for Preventing Type 2 Diabetes. Ackermann, RT., Liss, DT., Finch, EA., et al.[2022]

A 12-week family-focused lifestyle intervention at YMCA showed feasibility for children at risk of type 2 diabetes, with 75% of the 48 enrolled children completing the program.

The intervention led to significant improvements in child BMI-z scores and enhanced family nutrition and physical activity environments, indicating potential effectiveness in promoting healthier lifestyles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of a family-focused YMCA-based diabetes prevention program in youth: The E.P.I.C. Kids (Encourage, Practice, and Inspire Change) Study. Hingle, MD., Turner, T., Going, S., et al.[2020]

The Diabetes Prevention Program (DPP) showed that a structured diet and exercise plan can significantly lower the risk of developing diabetes in overweight adults with impaired glucose tolerance.

The YMCA is adapting the DPP lifestyle intervention for broader implementation, and ongoing research will assess the feasibility and effectiveness of this model for nationwide diabetes prevention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adapting the Diabetes Prevention Program lifestyle intervention for delivery in the community: the YMCA model. Ackermann, RT., Marrero, DG.[2022]

The Continuous Glucose Monitoring System (CGMS) proved to be accurate and reliable for monitoring glucose levels in individuals with type 1 diabetes during recreational scuba diving, with a mean absolute difference of 14.4% in readings.

The CGMS effectively detected hypoglycemia before and after dives, showing high specificity (94%) and negative predictive value (98%), indicating it is a useful tool for managing diabetes in challenging environments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Accuracy and reliability of continuous glucose monitoring in individuals with type 1 diabetes during recreational diving. Adolfsson, P., Ornhagen, H., Jendle, J.[2009]

Continuous glucose monitoring (CGM) was found to be feasible and acceptable for 27 non-insulin-using adults with type 2 diabetes, with 82% accurately logging their dietary and exercise events despite some difficulties in entering data.

CGM provided valuable insights, identifying 141 dietary and 71 exercise-teaching events, indicating its potential to enhance behavioral interventions for managing diabetes, even though some participants experienced minor discomfort.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Continuous glucose monitoring in non-insulin-using individuals with type 2 diabetes: acceptability, feasibility, and teaching opportunities. Allen, NA., Fain, JA., Braun, B., et al.[2022]

Prediabetes is a common condition that serves as a warning sign for diabetes and other serious health issues, but there are five different definitions for it, leading to confusion about when to use each one.

Randomized clinical trials show that lifestyle changes and medications like metformin can effectively prevent diabetes and improve heart health in people with prediabetes, but inconsistent definitions hinder effective treatment and insurance coverage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prediabetes and What It Means: The Epidemiological Evidence. Echouffo-Tcheugui, JB., Selvin, E.[2021]

A pilot study involving 15 adults with prediabetes showed a high satisfaction rate of 93% for using continuous glucose monitors (CGMs) combined with low-carbohydrate diet coaching, indicating that this approach is well-accepted by patients.

Participants experienced a significant reduction in HbA1c levels by 0.71% and a modest weight loss of 1.4 lbs, suggesting that this intervention may effectively promote dietary changes and help prevent the progression to type 2 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Continuous Glucose Monitoring With Low-Carbohydrate Diet Coaching in Adults With Prediabetes: Mixed Methods Pilot Study. Yost, O., DeJonckheere, M., Stonebraker, S., et al.[2022]

The FreeStyle Libre continuous glucose monitoring system showed reduced accuracy during moderate-intensity exercise in people with Type 1 diabetes, with a median absolute relative difference of 22% compared to reference blood glucose levels.

Using a reduced basal insulin dose (75%) improved sensor performance during exercise, indicating that insulin dosing may significantly impact the accuracy of glucose monitoring in this context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of physical exercise on sensor performance of the FreeStyle Libre intermittently viewed continuous glucose monitoring system in people with Type 1 diabetes: a randomized crossover trial. Moser, O., Eckstein, ML., Mueller, A., et al.[2022]

In a study of 94 participants (41 with normal glucose tolerance and 53 with impaired glucose tolerance), glycemic variability (GV) was found to be higher in individuals with impaired glucose tolerance, indicating a potential risk factor for diabetes.

The study revealed that higher overall carbohydrate and refined grain consumption worsened GV, while increased intake of whole grains and protein was associated with improved GV, suggesting dietary modifications could help manage glycemic fluctuations in those with impaired glucose tolerance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Relationship Between Dietary Patterns and Glycemic Variability in People with Impaired Glucose Tolerance. Dimova, R., Chakarova, N., Del Prato, S., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

Prediabetes Knowledge, Attitudes, and Practices at an Academic Family Medicine Practice. [2020]

2. Ireland pubmed.ncbi.nlm.nih.gov

Evaluation of a community Diabetes Prevention Program delivered by diabetes educators in the United States: one-year follow up. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Long-term effects of a community-based lifestyle intervention to prevent type 2 diabetes: the DEPLOY extension pilot study. [2021]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Translating the Diabetes Prevention Program into the community. The DEPLOY Pilot Study. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

A Randomized Comparative Effectiveness Trial for Preventing Type 2 Diabetes. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Feasibility of a family-focused YMCA-based diabetes prevention program in youth: The E.P.I.C. Kids (Encourage, Practice, and Inspire Change) Study. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

Adapting the Diabetes Prevention Program lifestyle intervention for delivery in the community: the YMCA model. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Accuracy and reliability of continuous glucose monitoring in individuals with type 1 diabetes during recreational diving. [2009]

9. United States pubmed.ncbi.nlm.nih.gov

Continuous glucose monitoring in non-insulin-using individuals with type 2 diabetes: acceptability, feasibility, and teaching opportunities. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Prediabetes and What It Means: The Epidemiological Evidence. [2021]

11. Canada pubmed.ncbi.nlm.nih.gov

Continuous Glucose Monitoring With Low-Carbohydrate Diet Coaching in Adults With Prediabetes: Mixed Methods Pilot Study. [2022]

12. England pubmed.ncbi.nlm.nih.gov

Impact of physical exercise on sensor performance of the FreeStyle Libre intermittently viewed continuous glucose monitoring system in people with Type 1 diabetes: a randomized crossover trial. [2022]

13. United States pubmed.ncbi.nlm.nih.gov

The Relationship Between Dietary Patterns and Glycemic Variability in People with Impaired Glucose Tolerance. [2023]