NCT02912728

Strategies to Enhance New CGM Use in Early Childhood (SENCE)

Strategies to Enhance New CGM Use in Early Childhood: A Randomized Clinical Trial to Assess the Efficacy and Safety of Continuous Glucose Monitoring in Youth < 8 With Type 1 Diabetes

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 143 (actual)
• Sponsor: Jaeb Center for Health Research · Academic / Other
• Sex: All
• Age: 2 Years – 7 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is 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.

Detailed description

Although prior studies have not demonstrated that continuous glucose monitoring (CGM) use results in improved glycemic control in children \<8 years of age, many of the barriers to CGM efficacy in this age group may have been due to problems in the wearability and accuracy of prior generation devices, as well as to the setting of glycemic targets aimed primarily at preventing hypoglycemia at all costs. There may also be behavioral barriers to consistent and effective CGM use in this age range. The goal of this study is to assess the impact of CGM alone and CGM combined with a family behavioral intervention focused on supporting CGM use on glycemic control in very young children with T1D compared with usual care without CGM.

Conditions

• Type 1 Diabetes Mellitus

Interventions

Type	Name	Description
BEHAVIORAL	CGM + Family Behavioral Intervention	use of CGM combined with a CGM focused family behavioral intervention and to assess CGM adherence
DEVICE	Standard CGM	use of CGM alone to assess CGM adherence

Timeline

• Start date: 2017-01-30
• Primary completion: 2019-06-30
• Completion: 2019-06-30
• First posted: 2016-09-23
• Last updated: 2020-10-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study