CGM and Lifestyle Changes for Prediabetes

Overseen By Liezel Riego

Age: < 18

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

Trial Summary

What is the purpose of this trial?

The incidence of type 2 diabetes (T2D) in children is increasing, paralleling the rising incidence of obesity. Preventing children and adolescents from developing T2D is critical. The health benefits of lifestyle modifications are well documented in this population, but success rates are low. Obesity in children and adolescents increases the risk of not only T2D but other complications as well, such as hypertension, dyslipidemias and more. The investigators hypothesize that having real-time glucose data with the use of a continuous glucose monitor (CGM) in obese patients with impaired glucose tolerance will improve adherence to lifestyle modifications. As a result, a decrease in body mass index (BMI) is expected with subsequent improvement in insulin sensitivity, thus reducing risk of obesity-related complications later in childhood/adolescence and adulthood.

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 data supports the effectiveness of the treatment CGM and Lifestyle Changes for Prediabetes?

Research shows that lifestyle changes like healthy eating and increased physical activity can prevent or delay diabetes. These changes, when combined with continuous glucose monitoring (CGM), can help people with prediabetes manage their blood sugar levels more effectively. ^{1 2 3 4 5}

Is continuous glucose monitoring (CGM) safe for humans?

Research shows that continuous glucose monitoring (CGM) is generally safe for humans, with high compliance to device use reported. It helps in managing blood sugar levels and promoting healthy lifestyle changes, especially when combined with diet and exercise counseling. ^{1 4 6 7 8}

How is the treatment of lifestyle changes with CGM unique for prediabetes?

The use of continuous glucose monitoring (CGM) combined with lifestyle changes, such as dietary and physical activity adjustments, is a novel approach for prediabetes. This method allows individuals to see real-time effects of their lifestyle choices on blood sugar levels, potentially leading to more effective behavior modifications compared to traditional methods. ^{4 6 7 8 9}

Research Team

Larry A Fox, MD

Principal Investigator

Nemours Children's Health

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

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]

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]

References

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

Outcomes of health care providers' recommendations for healthy lifestyle among U.S. adults with prediabetes. [2019]

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

Facilitating treatment adherence with lifestyle changes in diabetes. [2006]

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

Diabetes Self-Management: Facilitating Lifestyle Change. [2017]

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

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

5. United States 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. [2023]

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

Continuous Glucose Monitoring As a Behavior Modification Tool. [2021]

7. United States 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. [2022]

8. Japan pubmed.ncbi.nlm.nih.gov

Effectiveness and acceptability of continuous glucose monitoring for type 2 diabetes management: A narrative review. [2023]

9. Canada pubmed.ncbi.nlm.nih.gov

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