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NCT05300022 | NOT YET RECRUITING | Type 1 Diabetes


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

Children's Hospital of Philadelphia

Brief 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.

Condition or disease

Type 1 Diabetes

Intervention/treatment

TeKnO T1D: Parents

Phase

NA

Detailed 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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 170 participants
Masking : NONE
Primary Purpose : SUPPORTIVE_CARE
Official Title : Technology Knowledge Optimization in Type 1 Diabetes (TeKnO T1D): Parents
Actual Study Start Date : 2025-03-15
Estimated Primary Completion Date : 2028-06-30
Estimated Study Completion Date : 2028-06-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 8 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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 Criteria
  • 1. major illnesses other than T1D in the child
  • 2. significant cognitive limitations or major psychiatric disorders in the child or parent
  • 3. the use of medications other than insulin to control blood glucose levels.

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

Location Details

NCT05300022


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Locations


Not yet recruiting

United States, Pennsylvania

Childrens Hospital of Philadelphia

Philadelphia, Pennsylvania, United States, 19146

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