Continuous Glucose Monitoring for Prediabetes
(Y-HELP Trial)
Recruiting in Palo Alto (17 mi)
Overseen bySushma Reddy, MD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
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
Trial Summary
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
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.
12345Is 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.
35678How 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.
910111213Eligibility 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
+6 more
Trial 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)
Participant Groups
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.
2Treatment groups
Active Control
Group I: Group 1 : Intervention with SteloActive Control1 Intervention
Stelo CGM
Group II: Group 2 : controlActive Control1 Intervention
Group 2 will only wear a blinded CGM for 10 days at 6,12 and 24 weeks
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
YMCA of the Blue Water AreaPort Huron, MI
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Who Is Running the Clinical Trial?
Young Men's Christian Association of the Blue Water AreaLead Sponsor
DexCom, Inc.Industry Sponsor
References
Prediabetes Knowledge, Attitudes, and Practices at an Academic Family Medicine Practice. [2020]Lifestyle change programs are an effective but underutilized approach to prevent or delay type 2 diabetes in people with prediabetes. Understanding clinician prediabetes knowledge, attitudes, and practices can inform implementation efforts to increase lifestyle change program referrals.
Evaluation of a community Diabetes Prevention Program delivered by diabetes educators in the United States: one-year follow up. [2019]Strategies for management of pre-diabetes within the community setting are needed. An adaptation of the successful Diabetes Prevention Program lifestyle intervention delivered by trained diabetes educators was evaluated. Results indicate that trained diabetes educators offer an important community resource for health care providers for their patients with pre-diabetes.
Long-term effects of a community-based lifestyle intervention to prevent type 2 diabetes: the DEPLOY extension pilot study. [2021]The US Diabetes Prevention Program (DPP) and other large trials internationally have shown that an intensive lifestyle intervention can reduce the development of type 2 diabetes. We evaluated long-term effects of a lower cost, group-based adaption of the DPP lifestyle intervention offered by the YMCA.
Translating the Diabetes Prevention Program into the community. The DEPLOY Pilot Study. [2022]The Diabetes Prevention Program (DPP) found that an intensive lifestyle intervention can reduce the development of diabetes by more than half in adults with prediabetes, but there is little information about the feasibility of offering such an intervention in community settings. This study evaluated the delivery of a group-based DPP lifestyle intervention in partnership with the YMCA.
A Randomized Comparative Effectiveness Trial for Preventing Type 2 Diabetes. [2022]We evaluated the weight loss effectiveness of a YMCA model for the Diabetes Prevention Program (DPP) lifestyle intervention.
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]Efficacious lifestyle modification programs for children at risk of type 2 diabetes (T2D) have not been well established outside of clinical settings. In this study, the feasibility of a family-focused, YMCA-based prevention program for children at risk of T2D was evaluated between September 2015 and July 2016 in Tucson, Arizona. A 12-week YMCA-led lifestyle intervention was adapted for 9-12-year-old children and their families to encourage healthy eating, physical activity, and supportive home environments. Two YMCA locations were randomized to offer either a face-to-face lifestyle coach-led intervention or an alternating face-to-face and digitally-delivered intervention. Program feasibility and preliminary effects on child anthropometric and behavioral outcomes were assessed at baseline and post-intervention. Changes were assessed using linear regression combining delivery formats, with adjustment for clustering of participants within site/format. Forty-eight children (10.9 ± 1.2 years old; 45% female; 40% Hispanic; 43% White; 87% obese) and their parents enrolled, and 36 (75%) completed 12-week measures. Weekly program attendance averaged 61%. Participants and coaches highly rated program content and engagement strategies. Statistically significant changes in child BMI-z score (-0.05, p = 0.03) and family food and physical activity environment (+5.5% family nutrition and physical activity score, p = 0.01) were observed. A YMCA-led family-focused T2D intervention was feasible for the YMCA and participants and effects on child weight, behavior, and the home environment warranted further investigation.
Adapting the Diabetes Prevention Program lifestyle intervention for delivery in the community: the YMCA model. [2022]The Diabetes Prevention Program (DPP) demonstrated that a structured diet and physical activity intervention that achieves and maintains modest weight loss for overweight adults with impaired glucose tolerance can significantly reduce the development of diabetes. Although tens of millions of American adults could benefit from access to the DPP lifestyle intervention, there currently is no available model for nationwide dissemination of this highly beneficial and cost-effective approach to diabetes prevention. In this article, the authors describe the evolution of adaptations to improve DPP lifestyle intervention implementation and dissemination by a strong community partner, the YMCA. They also provide information about early field research and an ongoing clinical trial that will provide information about the feasibility and effectiveness of applying this new model on a national scale.
Accuracy and reliability of continuous glucose monitoring in individuals with type 1 diabetes during recreational diving. [2009]This study evaluated the accuracy and function of the Continuous Glucose Monitoring System (CGMS, Minneapolis, MN) during recreational scuba diving in individuals with type 1 diabetes.
Continuous glucose monitoring in non-insulin-using individuals with type 2 diabetes: acceptability, feasibility, and teaching opportunities. [2022]Continuous glucose monitoring (CGM) has the potential to provide useful data for behavioral interventions targeting non-insulin-using, sedentary individuals with type 2 diabetes mellitus (T2DM). The aims of this study were to describe CGM in terms of (1) feasibility and acceptability and (2) dietary- and exercise-teaching events.
Prediabetes and What It Means: The Epidemiological Evidence. [2021]Prediabetes is an intermediate stage between normal glycemia and diabetes and is highly prevalent, especially in older age groups and obese individuals. Five different definitions of prediabetes are used in current practice, which are based on different cut points of HbA1C, fasting glucose, and 2-h glucose. A major challenge for the field is a lack of guidance on when one definition might be preferred over another. Risks of major complications in persons with prediabetes, including diabetes, cardiovascular disease, kidney disease, and death, also vary depending on the prediabetes definition used. Randomized clinical trials have demonstrated that lifestyle and pharmacologic interventions can be cost-effective, prevent diabetes, and improve cardiovascular risk factors in adults with prediabetes. However, the practical implementation of lifestyle modification or the use of metformin for treating prediabetes is inadequate and complicated by a lack of agreement on how to define the condition. Establishing consensus definitions for prediabetes should be a priority and will help inform expansion of insurance coverage for lifestyle modification and improve current screening and diagnostic practices.
Continuous Glucose Monitoring With Low-Carbohydrate Diet Coaching in Adults With Prediabetes: Mixed Methods Pilot Study. [2022]Type 2 diabetes mellitus (T2DM) is preventable; however, few patients with prediabetes participate in prevention programs. The use of user-friendly continuous glucose monitors (CGMs) with low-carbohydrate diet coaching is a novel strategy to prevent T2DM.
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]To evaluate the sensor performance of the FreeStyle Libre intermittently viewed continuous glucose monitoring system using reference blood glucose levels during moderate-intensity exercise while on either full or reduced basal insulin dose in people with Type 1 diabetes.
The Relationship Between Dietary Patterns and Glycemic Variability in People with Impaired Glucose Tolerance. [2023]Diurnal glucose fluctuations are increased in prediabetes and might be affected by specific dietary patterns.