FreeStyle Libre System for Type 2 Diabetes

Recruiting in Palo Alto (17 mi)

+3 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Abbott Diabetes Care

No Placebo Group

Trial Summary

What is the purpose of this trial?A multi-center, randomized, prospective, non-significant risk study to compare the impact of the FreeStyle Libre Flash Glucose Monitoring System with and without a food logging smartphone application on reducing time above 180 mg/dL in subjects with type 2 diabetes who are not adequately controlled on their existing oral anti-diabetes medication regimen.

Eligibility Criteria

This trial is for adults with type 2 diabetes who have high blood sugar levels despite taking certain oral medications. Participants need to own a smartphone, be willing to track their diet and lifestyle changes, and not change their diabetes medication during the study. Pregnant individuals, those on insulin or sulfonylurea drugs, or with allergies to medical adhesives/isopropyl alcohol cannot join.

Inclusion Criteria

Your HbA1c level is between 7.5% and 12%.

I am willing to change my diet and lifestyle based on health advice and glucose data.

I agree not to change my diabetes medications for 3 months.

+4 more

Exclusion Criteria

I have skin conditions that could affect glucose monitoring device placement.

Subject has known allergy to medical grade adhesive or isopropyl alcohol used to disinfect skin

Subject is known to be pregnant at the time of study enrollment (applicable to female subjects only)

+1 more

Participant Groups

The study compares two approaches: using the FreeStyle Libre Flash Glucose Monitoring System alone versus pairing it with a food logging app. The goal is to see which method better reduces periods of high blood sugar in people whose condition isn't well-controlled by oral meds.

2Treatment groups

Active Control

Group I: FreeStyle LibreActive Control1 Intervention

Subjects will be randomized to use the FreeStyle Libre Flash Glucose Monitoring System to manage their diabetes.

Group II: FreeStyle Libre plus food loggingActive Control1 Intervention

Subjects will be randomized to use the FreeStyle Libre Flash Glucose Monitoring System and a food logging smartphone application to manage their diabetes.