Technology Knowledge Optimization in Type 1 Diabetes (TeKnO T1D): Parents

Last updated: October 7, 2025
Sponsor: Children's Hospital of Philadelphia
Overall Status: Trial Not Available

Phase

N/A

Condition

Diabetes And Hypertension

Diabetes Mellitus, Type 1

Diabetes Prevention

Treatment

TeKnO T1D: Parents

Clinical Study ID

NCT05300022
22-019791
K23DK129827
  • Ages > 8
  • All Genders

Study Summary

This study aims to identify the unmet psychoeducational needs of parents of children 8-12 years of age using insulin pump and CGM for pediatric T1D management and to leverage that information to develop an innovative app-based psychoeducational intervention to optimize use of these technologies and improve T1D outcomes.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. child 8-12 years of age with a diagnosis of T1D ≥ 6 months

  2. currently using insulin pump( IP) and CGM ≥ 1 month [including Hybrid Closed Loop (HCL) systems]

  3. participation of primary diabetes caregiver

  4. English fluency

  5. mean A1c >7.5% over the past 6 months (Aim 3 only)

Exclusion

Exclusion Criteria:

  1. major illnesses other than T1D in the child

  2. significant cognitive limitations or major psychiatric disorders in the child orparent

  3. the use of medications other than insulin to control blood glucose levels.

Study Design

Treatment Group(s): 1
Primary Treatment: TeKnO T1D: Parents
Phase:
Study Start date:
August 15, 2025
Estimated Completion Date:
July 31, 2027

Study Description

Despite increased use of insulin pumps and continuous glucose monitors (CGM) for pediatric type 1 diabetes (T1D) management and research studies showing benefits from the use of these devices, real-world glycemic control among youth with T1D has worsened in recent years. Although greater youth and parental diabetes knowledge is associated with better glycemic control, education alone is not sufficient to bring about the behavioral changes needed to improve outcomes in T1D. Psychoeducation recognizes the need to blend educational and behavioral approaches, including problem-solving and goal-setting, to support parents in developing optimal T1D management approaches. There are currently a lack of effective standardized tools to support patients and families in developing the knowledge and behavioral strategies needed to optimize the use of diabetes technologies. The development of innovative family-centered psychoeducational tools addressing both behavior and knowledge will help to realize the full potential of diabetes technologies to improve glycemic control and quality of life while ultimately preventing or delaying the development of both acute and long-term complications of T1D.

Interviews with parent-child dyads and diabetes clinicians will be used to identify the unmet parental psychoeducational needs regarding insulin pumps and CGM. These results will inform the use of instructional design to adapt an existing app-delivered diabetes technology curriculum to meet the specific needs of parents of children with T1D. Finally, the investigators will assess the feasibility and acceptability of this novel family-facing psychoeducational app-delivered intervention in a non-randomized pilot study.

Connect with a study center

  • Childrens Hospital of Philadelphia

    Philadelphia, Pennsylvania 19146
    United States

    Site Not Available

  • Childrens Hospital of Philadelphia

    Philadelphia 4560349, Pennsylvania 6254927 19146
    United States

    Site Not Available

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