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| ID | Type | Description | Link |
|---|---|---|---|
| P30DK079626 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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We are evaluating whether intermittent use of continuous glucose monitors (CGMs) in addition to standard nutritional counseling and physical activity counseling is associated with improved metabolic health for youth with pre-diabetes (PD).
The purpose of this research study is to test if CGMs are tolerable to youth with pre-diabetes (PD) and their caregivers. We are also evaluating if CGMs add benefit to standard treatment in youth with prediabetes. The CGM in question, Abbott Freestyle Libre 2 is approved by the Food and Drug Administration (FDA) to treat patients aged 4 and up with diabetes. We want to determine if this CGM may benefit people who have PD. People who enter the study will either receive standard medical care for prediabetes or receive standard medical care for prediabetes plus use a CGM for 2 weeks each month to receive real-time biofeedback on their glucose levels during the day.
There will be 3 visits over a 6-month period, baseline, 3-month, and 6-month visits. At each visit fasting labs will be obtained including: complete metabolic panel, lipid panel, pro-insulin, c-peptide, insulin. Anthropomorphics including body mass index, waist circumference, and hip circumference will be monitored.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CGM + Traditional Counseling | Experimental | Subjects in this arm will receive intermittent CGM to be used for 2-weeks each month for the 6-month study period. They will be required to wear a CGM during baseline, 3-month, and 6-month periods. Additional CGM sensors will be supplied for months 1, 2, 4, and 5 and will be optional. They will be provided with a Sworkit(R) account to monitor physical activity completed through the Sworkit(R) website/platform. |
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| Control | Active Comparator | Subjects in this arm will receive standard medical care for pre-diabetes. They will be provided with a Sworkit(R) account to monitor physical activity completed through the Sworkit(R) website/platform. |
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| Caregivers of CGM + Traditional Counseling Group | No Intervention | Caregivers of those randomized to the intervention group were enrolled to give their feedback on the continuous glucose monitor via surveys at the 3-month and 6-month visits. Outside these surveys, there were no other inputs or interventions to this group. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Abbott Freestyle Libre 2 | Device | Subjects will be educated on use of Abbott Freestyle Libre 2 and educated on how daily activities impact glucose. |
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| Measure | Description | Time Frame |
|---|---|---|
| CGM Acceptability | Caregiver and patient acceptability of CGM use | 6 months |
| Change in Measured % HbA1c From Baseline to 6-months | The difference in measured percentage of glycosylated hemoglobin (hemoglobin A1c) was obtained by subtracting the 6-month value from the baseline value for all subjects with paired data available. A negative result indicates a reduction (improvement) in hemoglobin A1c over the period. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in HOMA-IR From Baseline to 6-months. | Homeostatic model assessment of insulin resistance (HOMA-IR) at baseline and 6-month were calculated. HOMA-IR = fasting glucose (mg/dL) x fasting insulin (uIU/mL) / 405. Lower values indicate greater insulin sensitivity with values >2.5 consistent with insulin resistance. The difference in 6-month from baseline was determined for all with paired data available. A negative result indicates a reduction (improvement) in HOMA-IR over the period. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jessica A Schmitt, MD | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's of Alabama | Birmingham | Alabama | 35233 | United States |
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There were a total of 33 active subjects recruited. 21 youth in the intervention arm and 12 in the control arm. Caregivers of the 21 youth randomized to the intervention arm were enrolled to provide caregiver feedback in the form of surveys on their impression of continuous glucose monitor use. Caregiver's provided survey data only. Demographic data on caregivers was not collected.
There were a total of 33 active subjects recruited. 21 youth in the intervention arm and 12 in the control arm. Caregivers of the 21 youth randomized to the intervention arm were enrolled to provide caregiver feedback in the form of surveys on their impression of continuous glucose monitor use.
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| ID | Title | Description |
|---|---|---|
| FG000 | CGM + Traditional Counseling | Subjects in this arm will receive intermittent CGM to be used for 2-weeks each month for the 6-month study period. They will be required to wear a CGM during baseline, 3-month, and 6-month periods. Additional CGM sensors will be supplied for months 1, 2, 4, and 5 and will be optional. They will be provided with a Sworkit(R) account to monitor physical activity completed through the Sworkit(R) website/platform. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 5, 2025 |
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Randomized, non-blinded, parallel, intervention vs control group
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| Standard physical activity and nutritional counseling for prediabetes management | Other | Subjects will be advised on recommendations for nutrition and activity goals for preventing progression of prediabetes. |
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| 6 months |
| Change in Triglyceride, HDL, LDL, and Total Cholesterol From Baseline to 6-month | Changes in measured triglycerides, HDL, LDL, and total cholesterol were calculated for all subjects with paired data available. A negative result indicates a reduction (improvement) in triglycerides, LDL, and total cholesterol over the period. A negative result indicates a reduction (worsening) of HDL over the same study period. | 6 months |
| Changes in Liver Enzymes From Baseline to 6-months. | Alanine transferase (ALT) and aspartate aminotransferase (AST) were measured at baseline and 6-months. A negative result indicated a decrease (improvement) in the value. While 17 CGM+Treatment subjects returned for the final visit, only 14 had liver enzymes measured. While 8 control subjects returned for the final visit, only 6 had liver enzymes measured. | 6 months |
| Glycemic Metrics | CGM metrics collected included the percentage of time in the target range and percentage of time with glucose >140mg/dL. | 6 months |
| FG001 | Control | Subjects in this arm will receive standard medical care for pre-diabetes. They will be provided with a Sworkit(R) account to monitor physical activity completed through the Sworkit(R) website/platform. |
| FG002 | Caregivers of CGM+Traditional Counseling Group | Caregivers of those randomized to the intervention group were enrolled to give their feedback on the continuous glucose monitor via surveys at the 3-month and 6-month visits. Outside these surveys, there were no other inputs or interventions to this group. |
| COMPLETED |
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| NOT COMPLETED |
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No data on caregivers was collected beyond their surveys. They are therefore excluded from this baseline characteristics summarization.
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| ID | Title | Description |
|---|---|---|
| BG000 | CGM + Traditional Counseling | Subjects in this arm will receive intermittent CGM to be used for 2-weeks each month for the 6-month study period. They will be required to wear a CGM during baseline, 3-month, and 6-month periods. Additional CGM sensors will be supplied for months 1, 2, 4, and 5 and will be optional. They will be provided with a Sworkit(R) account to monitor physical activity completed through the Sworkit(R) website/platform. |
| BG001 | Control | Subjects in this arm will receive standard medical care for pre-diabetes. They will be provided with a Sworkit(R) account to monitor physical activity completed through the Sworkit(R) website/platform. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Hemoglobin A1c | percentage of glycosylated hemoglobin | Mean | Standard Deviation | Percentage (%) |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | CGM Acceptability | Caregiver and patient acceptability of CGM use | 0 Control subjects included in analysis as this primary outcome was CGM acceptability. Of the 17 participant/caregiver pairs in the treatment group who returned for the final visit, only 15 answered question about whether or not they wanted to continue to use the device. 16 caregivers and 17 participants answered the question about the device "being more trouble than it is worth" | Posted | Count of Participants | Participants | 6 months |
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| Primary | Change in Measured % HbA1c From Baseline to 6-months | The difference in measured percentage of glycosylated hemoglobin (hemoglobin A1c) was obtained by subtracting the 6-month value from the baseline value for all subjects with paired data available. A negative result indicates a reduction (improvement) in hemoglobin A1c over the period. | Posted | Mean | Standard Deviation | Absolute change in measured HgbA1c % | 6 months |
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| Secondary | Change in HOMA-IR From Baseline to 6-months. | Homeostatic model assessment of insulin resistance (HOMA-IR) at baseline and 6-month were calculated. HOMA-IR = fasting glucose (mg/dL) x fasting insulin (uIU/mL) / 405. Lower values indicate greater insulin sensitivity with values >2.5 consistent with insulin resistance. The difference in 6-month from baseline was determined for all with paired data available. A negative result indicates a reduction (improvement) in HOMA-IR over the period. | Posted | Mean | Standard Deviation | Index | 6 months |
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| Secondary | Change in Triglyceride, HDL, LDL, and Total Cholesterol From Baseline to 6-month | Changes in measured triglycerides, HDL, LDL, and total cholesterol were calculated for all subjects with paired data available. A negative result indicates a reduction (improvement) in triglycerides, LDL, and total cholesterol over the period. A negative result indicates a reduction (worsening) of HDL over the same study period. | While 17 CGM+Traditional counseling and 8 control subjects returned for the final visit, only 13 and 4 had cholesterol panels obtained. | Posted | Mean | Standard Deviation | mg/dL | 6 months |
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| Secondary | Changes in Liver Enzymes From Baseline to 6-months. | Alanine transferase (ALT) and aspartate aminotransferase (AST) were measured at baseline and 6-months. A negative result indicated a decrease (improvement) in the value. While 17 CGM+Treatment subjects returned for the final visit, only 14 had liver enzymes measured. While 8 control subjects returned for the final visit, only 6 had liver enzymes measured. | Posted | Mean | Standard Deviation | U/L | 6 months |
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| Secondary | Glycemic Metrics | CGM metrics collected included the percentage of time in the target range and percentage of time with glucose >140mg/dL. | While 22 were randomized to this arm, only 6 had CGM data available for Baseline and Final (6-month) visit. Data for these 6 are presented here. | Posted | Mean | Standard Deviation | Percentage of time spent in the range | 6 months |
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From enrollment until the final visit, an average of 6-months.
As the only intervention with caregivers was to obtain a survey on their perception of the use of the continuous glucose monitor, caregivers were not monitored or assessed for adverse events.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CGM + Traditional Counseling | Subjects in this arm will receive intermittent CGM to be used for 2-weeks each month for the 6-month study period. They will be required to wear a CGM during baseline, 3-month, and 6-month periods. Additional CGM sensors will be supplied for months 1, 2, 4, and 5 and will be optional. They will be provided with a Sworkit(R) account to monitor physical activity completed through the Sworkit(R) website/platform. | 0 | 21 | 0 | 21 | 0 | 21 |
| EG001 | Control | Subjects in this arm will receive standard medical care for pre-diabetes. They will be provided with a Sworkit(R) account to monitor physical activity completed through the Sworkit(R) website/platform. | 0 | 12 | 0 | 12 | 0 | 12 |
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CGM data is limited due to the number of participants with data available at baseline and 6-month follow-up. While fasting labs were requested, participants were not supervised for the 8-hours prior to their study visits, so confounding by non-fasting is possible.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jessica Schmitt | University of Alabama at Birmingham | 205-638-9107 | jessicaschmitt@uabmc.edu |
| Mar 6, 2026 |
| Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D011236 | Prediabetic State |
| D009765 | Obesity |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006946 | Hyperinsulinism |
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| ID | Term |
|---|---|
| D015596 | Nutrition Assessment |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D015991 | Epidemiologic Measurements |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Neutral |
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| Disagree or Strongly Disagree |
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| Participant: "I want to use the device when the study is over" |
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| Caregiver: The device is more trouble than it is worth |
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| Participant: The device is more trouble than it is worth |
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| Participants |
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| Units | Counts |
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| Participants |
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