The SENCE Trial for Kids Under 8

“Before, it was all about a guessing game, but not anymore,” said Monique Coleman, mom to 7-year-old Bria Curtis, a Naomi Berrie Diabetes Center clinical trial patient who has been wearing a Dexcom G5 Continuous Glucose Monitor (CGM) for the last six months, as part of the trial funded by the Leona M. and Harry B. Helmsley Charitable Trust and sponsored by the Jaeb Center for Health Research. Now, when her blood sugar goes low or high, her Dexcom beeps, and Bria and her mom follow the simple plan they have set in place: Said Monique, “if it’s low, she comes to me, I double check and she knows to get a juice box to make it go up. If it’s high, I tell her to give herself more insulin thru her pump. It’s been a huge improvement in everybody’s life, even the school nurse’s.”

The biggest change has been for Bria, who has had type 1 diabetes (T1D) since she was 3. A sweet 1stgrader in New York who models in her spare time, Bria is one of a small group of children under 8 around the country participating in a clinical trial called SENCE (Strategies to Enhance New CGM use in Early Childhood). “The aims of the trial came out of the need to optimize the use of this newer technology that may have a great impact on blood glucose monitoring and control,” said pediatric endocrinologist Kristen Williams, MD, an investigator on the study. Added Sarah Pollak, RN, MS and the program coordinator for the type 1 diabetes (T1D) research team, “This is a study to compare the efficacy and safety of CGM alone and CGM combined with a family behavioral intervention with a control group using home blood glucose monitoring (BGM) alone.”

There are three groups of participants in the SENCE trial. The first receives only the CGM and the second group gets a CGM while their families receive “a behavioral intervention” at multiple time-points during the trial. The control group checks their blood sugar with a regular home blood glucose monitor (BGM) for the first six months of the trial and then switches over to the CGM. “CGM devices have an important role in the management of diabetes,” said Sarah. “This trial gives families an opportunity to try one without the hassle of insurance coverage.” 

There are few data on the effectiveness of CGM use in very young children, yet another reason for the SENCE trial. "In our experience”, said Dr. Williams, "there may be a multitude of reasons why a family may discontinue the use of a CGM, not limited to issues in the wearability and accuracy of prior generation devices.”  There may also be behavioral barriers to consistent and effective CGM use in this younger age group, which the trial addresses. “Intervention strategies to support young patients and their parents with newer diabetes technology are greatly needed,” said Dr. Williams. 

A similar trial is underway for patients over 60 with T1D and another trial recently started at the Naomi Berrie Diabetes Center for 14 to 24-year-olds with T1D. Recruitment is open for the SENCE trial through June. If you would like to participate, please contact Sarah Pollak at 212-851-5425 or sjp2174@columbia.edu