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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
54
Subjects will be educated on use of Abbott Freestyle Libre 2 and educated on how daily activities impact glucose.
Subjects will be advised on recommendations for nutrition and activity goals for preventing progression of prediabetes.
Children's of Alabama
Birmingham, Alabama, United States
CGM Acceptability
Caregiver and patient acceptability of CGM use
Time frame: 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.
Time frame: 6 months
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.
Time frame: 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.
Time frame: 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.
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Time frame: 6 months
Glycemic Metrics
CGM metrics collected included the percentage of time in the target range and percentage of time with glucose \>140mg/dL.
Time frame: 6 months