JMIR Publications

ABSTRACT

Background:

Despite the introduction of new insulin analogs, insulin pumps, and continuous glucose monitoring (CGM), young children with type 1 diabetes mellitus (T1D) remain vulnerable to episodes of hypoglycemia because of their unpredictable eating and activity patterns and high degree of insulin sensitivity. Parents and young children living with T1D learn to fear hypoglycemia because it is uncomfortable, unpredictable, and dangerous. Up to 60% of parents of young children with T1D report moderate to severe levels of fear of hypoglycemia (FH) and parental FH relates to lower quality of life for families and suboptimal child glycemic control. Yet, until recently, there are no studies reporting on a targeted intervention to treat parental FH in families of young children.

Objective:

The aim of this project is to conduct a randomized clinical trial of an innovative, video-based telehealth intervention to treat FH in parents of young children with T1D versus a relevant, age-appropriate attention control intervention.

Methods:

We created the Reducing Emotional Distress for Childhood Hypoglycemia in Parents (REDCHiP) intervention by merging age-appropriate T1D education and behavioral parenting strategies with cognitive-behavioral therapy strategies that are effective for reducing fear and promoting adaptive coping. REDCHiP uses 10 video-based telehealth sessions, which are a combination of group and individual sessions. We will recruit up to 180 families of young children with T1D to participate in this clinical trial from two pediatric diabetes clinics located in the Midwestern and Southern United States. Once enrolled, we will randomize parents based on child age (2-3 or 4-5 years), child sex, and family CGM use, to either participate in REDCHiP or the attention control intervention (ATTN). Families will complete three assessment visits that coincide with study entry, the end of treatment, and three-month post-treatment. In each assessment visit, we will collect questionnaire data from parents, accelerometry data from parents and children, CGM data from children, and a blood sample to measure glycated hemoglobin levels from children.

Results:

Recruitment began in July 2019 and enrollment is ongoing. The first wave of intervention delivery began in December 2019. We anticipate completing enrollment in 2023. Final reporting of results will occur within 12 months of the primary completion date.

Conclusions:

We intend to submit our final study results for timely presentation at national and international diabetes research conferences and publish our study findings in peer-reviewed journals. If the REDCHiP intervention is efficacious, next steps will be to examine multiple implementation strategies to determine how best to disseminate the intervention to pediatric diabetes clinics around the world. Clinical Trial: ClinicalTrials.gov NCT03914547