PreDiabetesNCT05505565
Tolerability, Acceptance, and Utility of Intermittent CGM Use in Youth With Prediabetes
A study testing Abbott Freestyle Libre 2 and Standard physical activity and nutritional counseling for prediabetes management in people with PreDiabetes and Obesity, run by University of Alabama at Birmingham at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 11 years and older
- Conditions the study is for
- PreDiabetes, Obesity, Insulin Resistance
- What is being tested?
- Abbott Freestyle Libre 2 and Standard physical activity and nutritional counseling for prediabetes management
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jun 2023to 15 May 2025
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- BMI < 85% for age
- chronic steroid use
- diagnosis of type 1 diabetes, type 2 diabetes, other forms of diabetes
- current or history of malignancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Continuous Glucose Monitors in the Management of Youth With Prediabetes
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).
Read the 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.
- Conditions
- PreDiabetes, Obesity, Insulin Resistance
- Being tested
- Abbott Freestyle Libre 2, Standard physical activity and nutritional counseling for prediabetes management
- Keywords
- pediatrics, prediabetes, obesity
- Medical subject headings
- Prediabetic State, Obesity, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abbott Freestyle Libre 2Device
Subjects will be educated on use of Abbott Freestyle Libre 2 and educated on how daily activities impact glucose.
Standard physical activity and nutritional counseling for prediabetes managementOther
Subjects will be advised on recommendations for nutrition and activity goals for preventing progression of prediabetes.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Abbott Freestyle Libre 2; Other: Standard physical activity and nutritional counseling for prediabetes management |
| 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. Receives: Other: Standard physical activity and nutritional counseling for prediabetes management |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
CGM Acceptability
Caregiver and patient acceptability of CGM use
Measured: 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.
Measured: 6 months
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2022
- Study start5 Jun 2023
- Primary completion15 May 2025
- Study completion15 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PreDiabetesStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, non-blinded, parallel, intervention vs control group
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jessica Schmitt, University of Alabama at Birmingham
- Investigators
- Jessica A Schmitt, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05505565
- Sponsor's protocol ID
- IRB-300009480
- Other IDs
- P30DK079626
- Status last verified
- Aug 2025
- First submitted
- 15 Aug 2022
- Last updated
- 17 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No