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

Children's Hospital of Philadelphia (CHOP)

Status: Begins enrollment in 5 months

Conditions: Type 1 Diabetes

Treatments: Other: TeKnO T1D: Parents

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05300022

K23DK129827 (U.S. NIH Grant/Contract)

22-019791

Details and patient eligibility

About

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.

Full 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.

Enrollment: 170 estimated patients

Sex: All

Ages: 8 to 12 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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170 participants in 3 patient groups

Arm 1: Semi-structured Interviews

No Intervention group

Description:

Arm 1 will be conducted from months 0-15 and will use interviews to better understand existing challenges in diabetes technology educational practices. It is not a clinical trial, but is a crucial part of what builds to the clinical trial.

Arm 2: Designing an App Delivered Curriculum

Experimental group

Description:

Arm 2 will be conducted from months 10-33 and will use information learned in arm 1 to develop and beta test an educational curriculum. Arm 2 also is not a clinical trial, but is a crucial part of what builds to the clinical trial.

Treatment:

Other: TeKnO T1D: Parents

Arm 3: TeKnO T1D: Parents Pilot Study

Active Comparator group

Description:

Arm 3 will be conducted from months 30-60 and involves a pilot and feasibility study of the newly developed educational curriculum. This is the clinical trial.

Treatment:

Other: TeKnO T1D: Parents