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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a continuous glucose monitor (CGM) can help people with prediabetes improve blood sugar control, eating habits, and physical activity levels. Participants will use either a real-time CGM or a blinded CGM (which provides no real-time feedback) and join the YMCA Healthy Lifestyle Program. The trial seeks adults diagnosed with prediabetes, characterized by slightly high blood sugar levels but not yet diabetes. Participants will engage in health coaching, attend YMCA classes, complete questionnaires, and undergo blood tests during the study. As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance prediabetes management.

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 prior data suggests that continuous glucose monitoring is safe for prediabetes?

Research shows that the Stelo Glucose Biosensor, the device used in this trial, has received FDA approval for purchase without a prescription. It is intended for people with type 2 diabetes who are not using insulin. This approval suggests safety for similar groups. However, it is not recommended for those on dialysis, as it hasn't been tested in that group.

The Stelo device lacks alerts for low blood sugar, so it might not suit those needing immediate warnings for low glucose levels. Studies have not reported any major safety concerns, but information on specific side effects is limited. Overall, users seem to tolerate the device well. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the use of continuous glucose monitoring (CGM) for people with prediabetes, a group that typically doesn't use CGMs. Unlike standard options that focus just on lifestyle changes or medications, this trial uses the Stelo CGM to continuously track glucose levels, potentially offering real-time insights and personalized feedback. This innovative approach might help individuals understand how their lifestyle choices affect their blood sugar, leading to more effective management and prevention of diabetes progression. By integrating cutting-edge technology with established lifestyle programs, this trial could redefine early interventions for prediabetes.

What evidence suggests that using a CGM is effective for improving glucose levels in prediabetes?

Research has shown that using a continuous glucose monitor (CGM) like the Stelo, which participants in this trial may receive, can improve blood sugar management. Studies have found that people using CGMs experienced a significant drop in their A1C levels, a measure of average blood sugar over time. Specifically, one study showed a 2.4% reduction in A1C after six months. This indicates that CGMs can help maintain blood sugar within the target range of 70-140 mg/dL, benefiting those with prediabetes. The Stelo CGM is designed to help people track and manage their glucose levels more easily. ^{3 6 7 8 9}

Who Is on the 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

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Published Research Related to This Trial

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]

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]

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]

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]

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 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]

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]

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]

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]

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]

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]

Citations

1. adces.org adces.org/education/danatech/glucose-monitoring/continuous-glucose-monitors-(cgm)/cgm-selection-training/dexcom-g7-and-stelo-differences

Dexcom G7 and Stelo: Key Differences and Insights Target Glucose Range: Stelo targets a glucose range of 70–140 mg/dL for people without diabetes or prediabetes, aiming for 96% time in range (TIR). For people ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1530891X25008936

Continuous Glucose Monitoring for Prediabetes CGM use has been demonstrated to lower hemoglobin A1c (HbA1c) in individuals with T1D or T2D,6 and the hope is that CGM can be used as illustrated in the Figure ...

3. diatribe.org diatribe.org/diabetes-technology/diatribe-reviews-stelo-dexcom

diaTribe Reviews: Stelo by Dexcom CGMs provide great data that can help you notice whether you're regularly experiencing abnormal glycemic levels and could be at risk for ...

4. provider.dexcom.com provider.dexcom.com/dexcom-community-glucose-monitoring-project-six-month-results-using-continuous-glucose-monitoring

Six-Month Results Using Continuous Glucose Monitoring ... Participants using a glucose sensor (n=237) showed clinically meaningful and statistically significant (p<0.001) decrease in A1C of 2.4%+1.9% at 6 months.

5. stelo.com stelo.com/en-us?srsltid=AfmBOool-H6-S1F0A9XCMGNodbKsU3rYAxBs1HvLe56YvzlAqTa_ZloK

Stelo Wearable Glucose Biosensor | OTC CGM | Stelo by ... Stelo is the first over the counter glucose biosensor (OTC CGM) available without a prescription, suitable for people with type 2 diabetes not on insulin.

6. stelo.com stelo.com/en-us/safety-information?srsltid=AfmBOoo58ylGcEKZrZbR6wKQ84p1KxuZeuwJ1iK2_rY81hLm26wLtWvK

Stelo Glucose Biosensor Safety Information Don't use if you are on dialysis: The Stelo Glucose Biosensor System performance hasn't been evaluated in this population and sensor reading may be inaccurate.

7. stelo.com stelo.com/en-us?srsltid=AfmBOopOt6659qlognpFye41Tvi6Q9DIMrNQc88eSVGqd68dYQ81eN0k

Stelo Wearable Glucose Biosensor | OTC CGM | Stelo by ... Stelo is the first over the counter glucose biosensor (OTC CGM) available without a prescription, suitable for people with type 2 diabetes not on insulin.

8. fda.gov fda.gov/news-events/press-announcements/fda-clears-first-over-counter-continuous-glucose-monitor

FDA Clears First Over-the-Counter Continuous Glucose ... Data from a clinical study provided to the FDA showed that the device performed similarly to other iCGMs. Adverse events reported in the study ...

9. dexcom.com dexcom.com/en-us/glucose-sensing

Glucose Sensing Technology: Dexcom G7 CGM and Stelo ... The Stelo Glucose Biosensor System helps to detect normal (euglycemic) and low or high (dysglycemic) glucose levels. The Stelo Glucose Biosensor System may also ...