An Exciting Opportunity to Help Move the Dial on CGM

By Jeemin Kwon

One study seeks 920 adults with type 1 or type 2 diabetes not currently using a CGM; another is recruiting 400 children and teens with diabetes

Clinical Trials Identifier: NCT03448380 (adults) and NCT03448367 (pediatric)

Trial name: FreeStyle Libre Flash Glucose Monitoring System Post Approval Study and FreeStyle Libre Flash Glucose Monitoring System Post Approval Study for Pediatric Patients

Diabetes type: Types 1 and 2

What the trial is testing: Both trials are collecting further information on the safety of FreeStyle Libre in real-world conditions. This no-calibration CGM received approved from the FDA last year for adults and is now available in pharmacies. Participants in both trials will use finger sticks and a blood glucose meter for six months and then use the FreeStyle Libre system for free for the following six months. Importantly, the pediatric trial will also collect safety data on FreeStyle Libre in people under the age of 18. 

Why is this new/important? Manufacturers are often asked to conduct studies on a device after it’s approved and available so that they can identify any safety concerns that may have not emerged in previous clinical trials. Since FreeStyle Libre is approved for dosing insulin and does not require finger sticks for calibration, it will be particularly important to show that the system is safe for real-world use.

In addition, FreeStyle Libre is not yet FDA-approved for use in people younger than 18. Several studies have shown that CGM is helpful in children and adolescents, and children as young as two years old are approved to use the Dexcom G5, another CGM device. If the pediatric safety study results are positive, the data might be used to support approval of FreeStyle Libre for children.

Trial length: One year

Trial locations: The full list of study locations has not been posted yet. Check here for an up-to-date list for the adult study and here for an up-to-date list of locations for the pediatric study. Idaho Falls, Idaho is the only site currently recruiting. However, given the study size, more will join.

Do you qualify? Select inclusion criteria include:

• Adult study: At least 18 years old

• Pediatric study: 4-17 years old

• Diagnosis of type 1 or type 2 diabetes

• Currently using a blood glucose meter and strips (fingersticks)

• Cannot be currently using or have previously used a CGM

• Must have access to internet to upload data

• Cannot be on dialysis

• Pediatric study participants must have an adult caregiver present during the night

Where to get more information: For more information about this trial or trial locations, please contact Dr. Mohamed Nada at [email protected].