CGM and Lifestyle Changes for Prediabetes

Overseen By Liezel Riego

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Nemours Children's Clinic

Must not be taking: Corticosteroids

Disqualifiers: Type 1 diabetes, Prepubertal, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

15 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a continuous glucose monitor (CGM) can help kids and teens who are overweight or obese maintain healthy lifestyle changes. The goal is to determine if real-time feedback on blood sugar levels encourages better habits, leading to a lower body mass index (BMI) and improved insulin sensitivity. This could reduce the risk of type 2 diabetes and other related health issues later in life. Kids aged 10 to under 17 with high blood sugar but not diabetes might be suitable candidates. Participants will use a CGM device to track their glucose levels as they make lifestyle changes. As an unphased trial, this study offers a unique opportunity for participants to contribute to important research that could shape future health strategies.

Will I have to stop taking my current medications?

If you are taking medications that affect insulin sensitivity, like chronic corticosteroids, you may need to stop them. However, if you are on a stable dose of Metformin, you can continue taking it.

What prior data suggests that continuous glucose monitoring and lifestyle changes are safe for children with prediabetes?

Research shows that continuous glucose monitoring (CGM) is generally safe and well-tolerated. Studies have found that CGM can significantly improve blood sugar control in people with diabetes, indicating the technology's reliability and safety for checking glucose levels.

These studies have not reported any major safety concerns. Most users of CGM experience only minor issues, such as skin irritation at the attachment site, which is common with many wearable devices and not considered serious.

Overall, evidence suggests that CGM is a safe method for tracking glucose levels, aiding individuals in making informed lifestyle changes. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using continuous glucose monitoring (CGM) with real-time data for prediabetes because it offers a unique, personalized approach to managing blood sugar levels. Unlike traditional methods, which often rely on periodic finger-stick tests or A1C measurements, CGM provides a constant stream of glucose data, empowering individuals to make immediate lifestyle changes based on their body's responses. This real-time feedback can lead to better understanding and management of one's diet and activity levels, potentially preventing the progression to type 2 diabetes.

What evidence suggests that CGM and lifestyle changes could be effective for prediabetes?

Research shows that continuous glucose monitoring (CGM) can significantly aid people with diabetes in managing their blood sugar levels. Studies have found that those using CGM often achieve better blood sugar control than those who do not. For individuals with Type 2 diabetes, CGM can reduce average blood sugar levels, known as HbA1c, by a small but meaningful amount. The real-time information from CGM helps users make informed choices about their diet and lifestyle, fostering healthier habits. In this trial, participants will receive CGM intervention, which could be particularly beneficial for children and teenagers by encouraging adherence to lifestyle changes, thereby reducing obesity and the risk of developing Type 2 diabetes. ^{1 3 4 6 7}

Who Is on the Research Team?

Larry A Fox, MD

Principal Investigator

Nemours Children's Health

Are You a Good Fit for This Trial?

This trial is for overweight or obese children aged 10 to less than 17 with impaired glucose tolerance but not diagnosed with diabetes. They must be in puberty and willing to wear a continuous glucose monitor (CGM). Those on medications affecting insulin sensitivity or unwilling to comply are excluded.

Inclusion Criteria

You have trouble processing sugar, as shown by a specific test.

I have started puberty.

My BMI is in the top 15% for my age and sex.

Exclusion Criteria

I am on medication that affects my body's response to insulin, like metformin.

I have been diagnosed with type 1 or type 2 diabetes.

I am unwilling or unable to wear a CGM device for the study period.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use continuous glucose monitoring (CGM) along with lifestyle changes to improve insulin sensitivity

6 months

Regular monitoring with CGM data collection

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• CGM
• Lifestyle Changes

Trial Overview

The study tests if using a CGM device helps these young patients stick better to lifestyle changes, potentially leading to weight loss and improved insulin sensitivity, reducing the risk of developing type 2 diabetes and other obesity-related complications.

How Is the Trial Designed?

Group I: CGM intervention Experimental Treatment 1 Intervention

Continuous glucose monitoring with real-time glucose data using Dexcom G6.

Who Is Running the Clinical Trial?

Nemours Children's Clinic

Lead Sponsor

Trials

128

Recruited

18,000+

Published Research Related to This Trial

In a study of 2,853 adults with prediabetes, nearly 40% reported receiving recommendations from their healthcare providers to adopt healthier lifestyle changes, such as weight loss and increased physical activity.

Those who received counseling from healthcare providers showed higher adherence to lifestyle modifications, indicating that provider recommendations play a crucial role in encouraging healthier behaviors among individuals at risk for type 2 diabetes and cardiovascular disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes of health care providers' recommendations for healthy lifestyle among U.S. adults with prediabetes. Yang, K., Lee, YS., Chasens, ER.[2019]

Continuous glucose monitoring (CGM) significantly improves glycemic control, weight management, and adherence to lifestyle changes in adults with type 2 diabetes, based on a review of 11 studies involving 5,542 participants.

CGM users showed over 90% compliance with device usage, and combining CGM with lifestyle counseling further enhanced these health benefits, although the best methods for using CGM data effectively remain unclear.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness and acceptability of continuous glucose monitoring for type 2 diabetes management: A narrative review. Taylor, PJ., Thompson, CH., Brinkworth, GD.[2023]

Healthy eating and increased physical activity are crucial for preventing or delaying diabetes, and primary care can adapt techniques to help patients adhere to these lifestyle changes.

A coaching approach that includes setting specific goals, regular follow-ups, and a team-based intervention can significantly enhance patient motivation and self-sufficiency in making long-term lifestyle changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Facilitating treatment adherence with lifestyle changes in diabetes. Koenigsberg, MR., Bartlett, D., Cramer, JS.[2006]

A systematic review of 11 randomized clinical trials involving individuals with prediabetes and type 2 diabetes found that intensive lifestyle interventions did not significantly reduce cardiovascular or all-cause mortality compared to usual care.

The analysis showed no differences in outcomes based on the type of intervention or other factors, indicating that current lifestyle interventions may not provide additional mortality benefits for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term Effect of Lifestyle Interventions on the Cardiovascular and All-Cause Mortality of Subjects With Prediabetes and Type 2 Diabetes: A Systematic Review and Meta-analysis. Zucatti, KP., Teixeira, PP., Wayerbacher, LF., et al.[2023]

An 18-item survey was created to assess how real-time continuous glucose monitoring (CGM) influences patients' behavior regarding food choices and physical activity.

The study highlights a gap in data regarding the effectiveness of CGM in promoting lifestyle changes among users, suggesting that more research is needed to understand its impact.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Continuous Glucose Monitoring As a Behavior Modification Tool. Ehrhardt, N., Al Zaghal, E.[2021]

A structured lifestyle intervention program combined with self-monitoring of blood glucose (SMBG) significantly improved glycated hemoglobin (HbA1c) levels and weight in type 2 diabetes patients over 12 weeks, with HbA1c decreasing from 7.4% to 6.9% (P<0.001).

After 1.5 years, the SMBG group maintained stable HbA1c levels while the control group saw an increase back to baseline, indicating that regular blood glucose monitoring can lead to sustained improvements in glucometabolic control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

ROSSO-in-praxi-international: long-term effects of self-monitoring of blood glucose on glucometabolic control in patients with type 2 diabetes mellitus not treated with insulin. Kempf, K., Tankova, T., Martin, S.[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]

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]

Healthy eating and increased physical activity are crucial for preventing and managing diabetes, with guidelines recommending a 5% to 7% weight loss and 150 minutes of moderate-intensity exercise weekly for those with prediabetes and diabetes.

Effective diabetes management involves personalized lifestyle changes, where physicians should assess patients' readiness for change, set specific short-term goals, and provide ongoing support to enhance adherence and confidence in their health journey.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diabetes Self-Management: Facilitating Lifestyle Change. Koenigsberg, MR., Corliss, J.[2017]

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Evidence from some studies suggested there was a significant benefit favouring rtCGM versus isCGM for these outcomes, whereas other studies found no significant ...

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Both CGM and isCGM demonstrated a reduction in HbA 1c levels in individuals with T2D, and unlike CGM, isCGM use was associated with improved user satisfaction.

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There are two main types: real-time CGM (rtCGM), which provides continuous automatic readings, and intermittently scanned CGM (isCGM), which ...

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In participants with type 2 diabetes, trials of CGM have demonstrated an average effectiveness of 0.31 % [3.4 mmol/mol] lower HbA1c compared to CBG, across 12 ...

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pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/38117991/

Efficacy and Safety of Continuous Glucose Monitoring and ...

Both CGM and isCGM demonstrated a reduction in HbA1c levels in individuals with T2D, and unlike CGM, isCGM use was associated with improved user satisfaction.

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The primary outcome was the glycated hemoglobin level at 24 weeks, analyzed according to the intention-to-treat principle. Key secondary ...