Insulin Resistance, Obesity, PreDiabetes
Conditions
Keywords
pediatrics, prediabetes, obesity
Brief summary
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).
Detailed description
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.
Interventions
DEVICEAbbott Freestyle Libre 2
Subjects will be educated on use of Abbott Freestyle Libre 2 and educated on how daily activities impact glucose.
OTHERStandard physical activity and nutritional counseling for prediabetes management
Subjects will be advised on recommendations for nutrition and activity goals for preventing progression of prediabetes.
Sponsors
University of Alabama at Birmingham
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Randomized, non-blinded, parallel, intervention vs control group
Eligibility
Sex/Gender
ALL
Age
11 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 11 or older * English-speaking * stable metformin dose for 1 month prior to enrollment or no metformin use * baseline A1c of 5.7-6.4% * BMI \> = 85% for age
Exclusion criteria
* BMI \< 85% for age * chronic steroid use * diagnosis of type 1 diabetes, type 2 diabetes, other forms of diabetes * current or history of malignancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CGM Acceptability | 6 months | Caregiver and patient acceptability of CGM use |
| Change in Measured % HbA1c From Baseline to 6-months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in HOMA-IR From Baseline to 6-months. | 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. |
| Change in Triglyceride, HDL, LDL, and Total Cholesterol From Baseline to 6-month | 6 months | 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. |
| Changes in Liver Enzymes From Baseline to 6-months. | 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. |
| Glycemic Metrics | 6 months | CGM metrics collected included the percentage of time in the target range and percentage of time with glucose \>140mg/dL. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJessica A Schmitt, MD
University of Alabama at Birmingham
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 14.4 Years STANDARD_DEVIATION 2.1 |
| Hemoglobin A1c | 5.7 Percentage (%) STANDARD_DEVIATION 0.3 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 21 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants |
| Race (NIH/OMB) White | 9 Participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 21 | 0 / 12 |
| other Total, other adverse events | 0 / 21 | 0 / 12 |
| serious Total, serious adverse events | 0 / 21 | 0 / 12 |
Outcome results
None listed