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Principal Investigator: Susana R Patton
Organization: NEMOURS CHILDREN'S CLINIC
Fiscal Year: 2024
Award: $546,251
Funding agency: National Institute of Diabetes and Digestive and Kidney Diseases
PROJECT SUMMARY/ABSTRACT
Young children with type 1 diabetes (T1D) remain highly vulnerable to episodes of hypoglycemia despite the
introduction of new insulin analogs, insulin pumps, and continuous glucose monitors (CGM). Parents and young
children living with T1D quickly learn to fear hypoglycemia because it is uncomfortable, embarrassing, seemingly
unpredictable, and potentially dangerous. Indeed, research shows that parents of young children report high
rates of moderate to severe hypoglycemia fear (FH). Unfortunately, FH leads to two problems: impaired quality
of life and compensatory behaviors that raise children’s blood glucose levels leading to on-going poor metabolic
control (HbA1c) and an increased risk for long-term vascular complications. Responding to a critical need for
interventions to treat parental FH in families of young children, we developed an innovative video-based
telemedicine intervention, called REDCHiP (Reducing Emotional Distress for Childhood Hypoglycemia in
Parents). REDCHiP uses cognitive behavioral therapy, T1D education, and behavioral parent training in a 10-
session individual and group-based telemedicine program, to reduce parental FH and to teach parents how to
change hypoglycemic avoidance behaviors. In our pilot work, we found preliminary efficacy for REDCHiP in
reducing parental FH, parenting stress, and children’s HbA1c. The objective of this R01 is to conduct a
randomized clinical trial (RCT) comparing REDCHiP to a relevant attention control intervention (ATTN) in families
of young children, thereby continuing to establish its efficacy. The proposed R01 aims are: 1) To evaluate
whether parents who receive REDCHiP report reductions in FH and parenting stress at post-treatment compared
to parents who receive the ATTN; 2) To evaluate whether children of parents who receive REDCHiP have a
lower HbA1c and less glycemic variability at post-treatment compared to children of parents who receive ATTN;
3) To examine for maintenance of improvements in FH, parenting stress, and children’s HbA1c in a 3-month
followup. We will recruit 180 families with the goal of retaining at least 144 through the 3-month followup. After
informed consent, we will randomize parents to either REDCHiP or ATTN and have them complete baseline
measures (e.g., parent surveys, child glucose sensing, child/parent accelerometry, and child HbA1c). Then,
parents in both groups will participate in 10 video-based telemedicine sessions matched for time and format
(group v individual). At post-treatment, parents and children will repeat the baseline assessment; at the 3-month
followup, parents will complete surveys and children will undergo glucose sensing and an HbA1c. The impact of
the proposed R01 is high because parental FH is common and relates to poor T1D self-care and child glycemic
control, which can lead to expensive and dangerous present and future complications. It is Innovative because
of its use of video- and group-based telemedicine which is responsive to NIDDK initiatives as well as potentially
scalable to even smaller T1D centers. Efficacy testing REDCHiP in a larger RCT is the logical next step in our
research program and likely to yield an effective and scalable treatment that can improve children’s health.
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