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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.
The purpose of this research is to evaluate if having blood sugar information from a continuous glucose monitor (CGM) during activities of daily living provides additional benefit to lifestyle modifications in reducing the risk of developing diabetes and achieving a healthier weight. A CGM is a small device often worn on the back of the arm that uses a very small needle to insert a small sensor just under the skin in the fatty tissue. The CGM device transmits the blood sugar level to either a smartphone or a special receiver.
The investigators expect patients will have an overall improvement in health by decreasing weight and therefore improving the way the child's insulin works in their body. This could result in decreased risk of obesity-related complications such as diabetes mellitus, cardiovascular disease, kidney disease, and loss of vision and/or limbs, among others.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CGM intervention | Experimental | Continuous glucose monitoring with real-time glucose data using Dexcom G6. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CGM | Device | Dexcom G7 sensor, transmitter and supplies will be provided to family for use. Participants will wear G7 and have real-time glucose data throughout the study. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Insulin Sensitivity Score (ISS) | Change in insulin sensitivity as measured by insulin sensitivity Score (ISS). The ISS directly correlates with insulin sensitivity. Higher scores indicate higher insulin sensitivity; lower scores indicate more insulin resistance. | Baseline to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| QUICKI insulin sensitivity | Change in insulin sensitivity as measured by QUICKI | Baseline to 3 months |
| QUICKI insulin sensitivity | Change in insulin sensitivity as measured by QUICKI |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Larry Fox, MD | Contact | 9046973674 | larry.fox@nemours.org | |
| Liezel Riego | Contact | 9046973431 | Liezel.Riego@nemours.org |
| Name | Affiliation | Role |
|---|---|---|
| Larry A Fox, MD | Nemours Children's Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nemours Children's Clinic | Recruiting | Jacksonville | Florida | 32207 | United States |
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| ID | Term |
|---|---|
| D018149 | Glucose Intolerance |
| D011236 | Prediabetic State |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D006943 | Hyperglycemia |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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|
| Baseline to 6 months |
| Insulin Sensitivity Score | Change in insulin sensitivity as measured by insulin sensitivity Score (ISS). The ISS directly correlates with insulin sensitivity. Higher scores indicate higher insulin sensitivity; lower scores indicate more insulin resistance. | Baseline to 3 months |
| Glycemic levels | Change in characteristics of glycemic levels obtained from the CGM data. This will include:
| Baseline to 3 and 6 months |
| Mean, standard deviation of sensor glucose levels | Change in characteristics of glycemic levels obtained from the CGM data, including mean and standard deviation of sensor glucose levels (mg/dL). | Baseline to 3 and 6 months |
| Time in range of sensor glucose levels | Change in glycemic levels obtained from the CGM data: Percent of time in range (glucose between 70-140 mg/dL) | Baseline to 3 and 6 months |
| Percent of sensor glucose levels in hypoglycemic range | Change in glycemic levels obtained from the CGM data: Percent of time with hypoglycemia (<70 mg/dL) | Baseline to 3 and 6 months |
| Percent of sensor glucose levels in hyperglycemic range | Change in glycemic levels obtained from the CGM data: Percent of time with hyperglycemia (>140 mg/dL) | Baseline to 3 and 6 months |
| Physical activity questionnaires | Questionnaires will be used to assess amount of time participants are active. Two questions regarding physical activity will be asked, with a scale set up as follows:
| 3 and 6 months |
| Dietary compliance questionnaires | Questionnaires will be used to assess particpants' compliance witih dietary changes. Four questions regarding their diet will be asked, with a scale set up as follows:
| 3 and 6 months |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |