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

NCT ID: NCT05300022

Last Updated: 2025-10-09

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-15
• Study Completion Date: 2027-07-31

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.

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.

Conditions

Type 1 Diabetes

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Arm 1: Semi-structured Interviews

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Arm 2: Designing an App Delivered Curriculum

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.

Group Type: EXPERIMENTAL

TeKnO T1D: Parents

Intervention Type: OTHER

app-delivered curriculum to provide psychoeducational education surrounding diabetes technology use

Arm 3: TeKnO T1D: Parents Pilot Study

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.

Group Type: ACTIVE_COMPARATOR

TeKnO T1D: Parents

Intervention Type: OTHER

app-delivered curriculum to provide psychoeducational education surrounding diabetes technology use

Interventions

TeKnO T1D: Parents

app-delivered curriculum to provide psychoeducational education surrounding diabetes technology use

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 8 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

Children's Hospital of Philadelphia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Brynn E Marks, MD, MSHPEd

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital of Philadelphia

Locations

Childrens Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

K23DK129827

Identifier Type: NIH

Identifier Source: secondary_id

View Link

22-019791

Identifier Type: -

Identifier Source: org_study_id