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.
What data supports the idea that CGM and Lifestyle Changes for Prediabetes is an effective treatment?The available research shows that lifestyle changes, such as healthy eating and increased physical activity, can prevent or delay the onset of diabetes in people with prediabetes. These changes are recommended to achieve long-term weight loss and regular physical activity. Studies highlight the importance of setting specific goals and gradually building confidence to help people stick to these changes. Follow-up and support from healthcare providers can further enhance motivation and success. While the research does not specifically mention CGM, the focus on lifestyle changes suggests that these interventions are effective in managing prediabetes.12469
What safety data exists for CGM and lifestyle changes in prediabetes?The available research primarily focuses on the effectiveness and behavioral impact of continuous glucose monitoring (CGM) and lifestyle changes, rather than direct safety data. Studies indicate that CGM can lead to improved glycemic control, weight management, and adherence to lifestyle changes in type 2 diabetes, which may be applicable to prediabetes. High compliance with CGM use is reported, suggesting it is generally well-tolerated. However, specific safety data for CGM and lifestyle changes in prediabetes is not directly addressed in the provided research.23567
Do I have to stop taking my current medications for the trial?The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are taking medications that affect insulin sensitivity, except for metformin if it's at a stable dose.
Is Lifestyle Changes a promising treatment for prediabetes?Yes, Lifestyle Changes are a promising treatment for prediabetes. They can help prevent or delay the onset of type 2 diabetes by improving blood sugar control. Programs that encourage changes in diet and physical activity are effective, and using tools like continuous glucose monitors can make these changes easier to follow and more successful.35678
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
I have started puberty.
My BMI is in the top 15% for my age and sex.
I am between 10 and 16 years old.
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.
I have not yet gone through puberty.
Treatment Details
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.
1Treatment groups
Experimental Treatment
Group I: CGM interventionExperimental Treatment1 Intervention
Continuous glucose monitoring with real-time glucose data using Dexcom G6.
Find a clinic near you
Research locations nearbySelect from list below to view details:
Nemours Children's ClinicJacksonville, FL
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Who is running the clinical trial?
Nemours Children's ClinicLead Sponsor
References
Facilitating treatment adherence with lifestyle changes in diabetes. [2006]Healthy eating and increased physical activity can prevent or delay diabetes and its complications. Techniques that facilitate adherence to these lifestyle changes can be adapted to primary care. Often, the patient's readiness to work toward change must be developed gradually. To prepare patients who are reluctant to change, it is effective to assess and address their conviction and confidence. Patients facing the long-term task of making lifestyle changes benefit from assistance in setting highly specific behavior-outcome goals and short-term behavior targets. Individualization is achieved by tailoring these goals and targets to the patient's preferences and progress, building the patient's confidence in small steps, and implementing more intensive interventions according to a stepped-care model. At each office visit, physician follow-up of the patient's self-monitored goals and targets enhances motivation and allows further customization of the plan. A coaching approach can be used to encourage positive choices, develop self-sufficiency, and assist the patient in identifying and overcoming barriers. More intensive intervention using a team approach maximizes adherence.
Outcomes of health care providers' recommendations for healthy lifestyle among U.S. adults with prediabetes. [2019]Lifestyle modification (i.e., weight loss, active lifestyle, healthy diet) is a recommended strategy for the prevention of type 2 diabetes and cardiovascular disease. The purpose of this study was to examine the relationship between receiving a health-care provider's recommendation and adherence to behavioral indicators of adaptation of a healthy lifestyle among adults with prediabetes.
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]Effects of lifestyle change on blood glucose levels can be monitored by self-monitoring of blood glucose (SMBG) in type 2 diabetes mellitus (T2DM) patients. We analyzed whether the SMBG-structured lifestyle intervention program ROSSO-in-praxi-international can improve glucometabolic control in the short and the long term.
Diabetes Self-Management: Facilitating Lifestyle Change. [2017]Healthy eating and increased physical activity can prevent or delay the onset of diabetes mellitus and facilitate diabetes management. Current guidelines recommend long-term weight loss of 5% to 7% of body weight and 150 minutes of at least moderate-intensity physical activity per week for most patients with prediabetes and diabetes. Techniques to assess and facilitate adherence to these lifestyle changes can be practical in primary care. During office visits, physicians should assess and gradually encourage patients' readiness to work toward change. Addressing patients' conviction and confidence can be effective in moving them toward action. Long-term goals are best separated into highly specific short-term outcome goals and achievable behavior targets. Lifestyle goals and targets should be tailored to patients' preferences and progress while building confidence in small steps. Screening for diabetes-related attitudes, expectations, and quality of life, and addressing psychosocial factors, both favorable and unfavorable, can facilitate the likelihood of success. Follow-up contact with patients helps maintain and expand progress by reviewing self-monitored goals, targets, and achievements; finding opportunities to encourage and empower; reviewing slips, triggers, and obstacles; and negotiating further customization of the plan.
Effectiveness and acceptability of continuous glucose monitoring for type 2 diabetes management: A narrative review. [2023]The present narrative review discusses the role of continuous glucose monitoring (CGM) in glycemic and weight control, and lifestyle behavior adherence in adults with type 2 diabetes. A literature search from January 2001 to November 2017 was carried out (MEDLINE, CINAHL, Web of Science and Scopus). Eligible studies were trials evaluating the use of CGM with the aim of achieving glucose control or lifestyle-related treatment adherence over a period of ≥8 weeks in adults with type 2 diabetes compared with usual care or another comparison intervention, or observational trials reporting CGM user experience. A total of 5,542 participants were recruited into 11 studies (eight randomized controlled trials [n = 5,346] and three observational studies [n = 196]). The sample size ranged 6-4,678 participants, the mean age was 51.7-60.0 years and diabetes duration was 2.1-19.2 years, with high heterogeneity between studies. Overall, the available evidence showed, compared with traditional self-monitoring of blood glucose levels, CGM promoted greater reductions in glycated hemoglobin, bodyweight and caloric intake; higher adherence rating to a personal eating plan; and increases in physical activity. High compliance to CGM wear-time and device calibration was reported (>90%). The addition of lifestyle and/or behavioral counseling to CGM appeared to further potentiate these improvements. Preliminary evidence suggests that CGM use promotes glycemic and weight control, and lifestyle behavior adherence in adults with type 2 diabetes. These benefits might be further enhanced with integration of diet, exercise, and glucose excursion education and counseling. However, specific attributes of effective interventions and the application of CGM information for promoting improved outcomes and healthier choices remain unclear.
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.
Continuous Glucose Monitoring As a Behavior Modification Tool. [2021]Real-time continuous glucose monitoring (CGM) use may lead to behavioral modifications in food selection and physical activity, but there are limited data on the utility of CGM in facilitating lifestyle changes. This article describes an 18-item survey developed to explore whether patients currently using CGM believe the technology has caused them to change their behavior.
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.
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]Lifestyle interventions improve the metabolic control of individuals with hyperglycemia.