Pediatric Type 1 Diabetes and Neurocognitive Complications Cohort Study
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Observational

Summary: 
      The proposed project will assess hypothesized risk factors (age of onset, Diabetic
      ketoacidosis (DKA) at presentation and glycemic control), as well as potentially modifiable
      protective factors (child sleep quality, caregiver distress, and use of diabetes devices). In
      addition, the study will optimize imaging protocols and processing tools to allow for
      harmonization of neuroimaging data across sites and scanners for the most robust analysis.
    

Detailed description: 
      The onset of type 1 diabetes (T1D) in childhood results in clinically significant deficits in
      neurocognitive functioning that manifest in adulthood. These deficits have implications for
      adaptive functioning and diabetes management. Studies of neurocognitive function and brain
      development in T1D suggest that factors such as age of onset, diabetic ketoacidosis (DKA) at
      time of onset, and exposure to chronic hyperglycemia or severe hypoglycemia may increase risk
      or severity of these deficits, but findings are mixed. The majority of previous studies were
      limited by the use of adult or older adolescent samples, cross-sectional designs or short
      duration of follow-up, lack of racial and ethnic diversity, and small sample sizes.
      Age-related changes in neurocognitive function and vascular complications associated with T1D
      in adults make isolating mechanisms more complex. The knowledge gaps are critical because
      individuals with T1D may live for decades with reduced neurocognitive function. Building on
      previous work, it is hypothesized that several risk and protective factors for neurocognitive
      deficits will be evident in youth with T1D. First, sleep is a critical and potentially
      modifiable risk or protective factor for youth. Prior work has shown that the majority of
      school-age children do not obtain sufficient sleep (67%), and that sleep disturbances are
      related to poor glycemic control and risk for DKA, both of which have been posited to
      increase risk for neurocognitive deficits. Second, caregiver distress (i.e., symptoms of
      anxiety and depression) is a significant risk factor for child wellbeing, as exposure to
      maternal depressive symptoms increases children's risk for cognitive deficits and abnormal
      white matter diffusivity. Third, improved glycemic control via use of continuous glucose
      monitors and hybrid closed-loop insulin delivery systems, are potential protective factors
      for youth with T1D, as these devices decrease glycemic variability and limit time spent in
      hypoglycemia and hyperglycemia. Thus, a prospective longitudinal cohort study of young
      children with T1D is needed to identify modifiable risk and protective factors for
      neurocognitive complications. If specific risk or protective factors for adverse or optimal
      neurocognitive outcomes are defined, treatment protocols could be developed to limit
      neurocognitive complications associated with T1D.
    

Intervention name(s): neurocognitive assessment; neuroimaging assessment
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Observational study therefore there are no interventions; Observational study therefore there are no interventions
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The Children's Diabetes Program (CDP) at Vanderbilt University Medical Center in
        collaboration with strong multidisciplinary research collaborators is well poised to answer
        these questions with considerable local expertise in behavioral research in children with
        T1D, neurocognitive testing in youth with T1D, pediatric neurology and neuroimaging, and
        data science. Further, we bring unique expertise in sleep in youth with T1D, caregiver
        distress, and use of novel measurement tools. Finally, the CDP follows over 2,800 children
        with diabetes, 85% of whom have T1D, and there are about 250 new-onset cases of T1D
        annually.