New Study Will Test Use of Continuous Glucose Monitors to Evaluate Risk for Developing Type 2 Diabetes in Children and Adolescents

The prevalence of type 2 diabetes (T2D) in children and adolescents has seen a steady increase over the last decade or more, mirroring the increases seen in adults, with obesity playing a central role in developing the disease.

Assessing children and adolescents who may be at risk for developing the condition and its life-long effects on overall health and quality of life can be challenging. While effective, current standards of assessment, such as hemoglobin A1c (HbA1c) and the 2-hour oral glucose tolerance test (OGTT), are suboptimal.

"The testing and screening we use routinely, like the HbA1c and 2-hour OGTT, really only give us averaged data or data points from a single point in time," says Mary Ellen Vajravelu, MD, MSHP, assistant professor of Pediatrics in the Division of Pediatric Endocrinology at UPMC Children’s Hospital of Pittsburgh. “These tests are helpful but not ideal. We need more uniform and longitudinal screening data of what's happening with these children, and our current testing and screening methods make it difficult, if not impossible, to do that effectively and in real-time.”

So, to try and break down the barriers to more effective screening options for children at risk for developing type 2 diabetes, Dr. Vajravelu, along with second-year pediatric endocrinology fellow Adriana Rodriguez Gonzalez, MD, developed and are now recruiting participants for a new clinical trial that will test the use of continuous glucose monitoring coupled with activity monitoring and text message-based nutrition surveys to determine whether this strategy could be a potential alternative to the current gold standards in assessing type 2 diabetes risk.

Dr. Rodriguez Gonzalez is leading the study under the mentorship of Dr. Vajravelu, and the investigation is partly funded by a grant from the Endocrinology Fellows Foundation, awarded to Dr. Rodriguez Gonzalez for this project.

"The Endocrine Fellows Foundation, a peer-reviewed platform, allows trainees to obtain their own independent research funding, an essential step in building autonomy and self-confidence. I strongly believe this award will be a springboard for Dr. Rodriguez Gonzalez to achieve future success in her career," says Kanthi Bangalore Krishna, MD, associate professor of Pediatrics and Director of the Pediatric Endocrinology Fellowship Program at UPMC Children’s.

Trial Details

For this trial, Drs. Rodriguez Gonzalez and Vajravelu are recruiting participants between the ages of 8 and 18 with clinical markers indicative of obesity or being overweight without a known diagnosis of diabetes.

Participants in the study will be evaluated in the lab and administered a baseline 2-hour OGTT. Subsequently, they will wear a continuous glucose monitor for 10 days and will be asked to keep a diary of nutrition, activity, and sleep, along with using an activity monitor on the wrist.

"One of my interests as a clinician and researcher who is focused on diabetes is how we can leverage all of the new technologies that exist to improve patient care," says Dr. Rodriguez Gonzalez. "This includes medical devices like CGMs, but also communications platforms and devices such as text messaging, email, and smartphones to help us better understand in real-time what our patients are experiencing – their glucose levels, diet, activity and sleep, and how we can use those metrics to better understand or predict risk for developing T2D.”

In addition to the real-time, continuous monitoring of blood glucose and activity, participants will be contacted periodically via text messaging to their smartphone to report on their activities, including what foods they eat and other measures.

“Our participants will also do two ‘challenges’ at home, one using the same drink we gave them in the lab for their 2-hour OGTT, and a second challenge using a mixed combination of foods of their choice, which they will carefully document, to gain insight on what’s happening with them when they eat a normal, everyday meal,” says Dr. Rodriguez Gonzalez.

The team will then analyze the study data to determine if the methodology provides a similar understanding of the risk for developing T2D, as well as interview participants to hear their thoughts on the approach.

“With this kind of technology, I think you can see its potential power for helping to monitor patients and those at risk, providing flexibility for assessments to individuals with geographic or other challenges that make it difficult to make repeated visits to the hospital, and many other factors,” says Dr. Rodriguez Gonzalez. “It’s a noninvasive, flexible, and adaptable approach that we’re hopeful will provide the efficacy data necessary to expand into a larger trial and perhaps make a significant change in clinical practice in the future.”

More Information and Patient Study Referrals

Children or adolescents may be eligible to participate in the investigation if they are 8-18 years old, have a BMI at or above the 85th percentile, and meet other study eligibility criteria.

To learn more or to make a patient referral, please contact either Brianna Hewitt, Clinical Research Coordinator for the study, at hewittbl2@upmc.edu, or Dr. Vajravelu at vajravelume@upmc.edu

Additional information about the clinical trial is available using the reference below.

Reference

Continuous Glucose Monitors (CGM) for Type 2 Diabetes (TD2) Risk Evaluation. ClinicalTrials.gov Identifier: NCT0504711. Currently recruiting participants.