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

NCT05300022 | Withdrawn

• 2 other identifiers: 22-019791K23DK129827
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 1 Diabetes

Keywords

pediatric; continuous glucose monitor; insulin pump; automated insulin delivery; hybrid closed loop systems; medical education; diabetes technology

Outcome Measures

Primary Outcomes (5)

• Study Recruitment

  Percentage of eligible patients who are approached and enroll in the study in Arm 3.

  Arm 3: Months 30-60

• Intervention Satisfaction

  Score on a survey developed to assess satisfaction with the Technology Knowledge Optimization Type 1 Diabetes: Parents curriculum in Arm 3. Scores range from 0-100 with higher scores reflecting greater satisfaction.

  Arm 3: Months 30-60

• Perceived Intervention Utility

  Score on a survey developed to assess the perceived utility of the Technology Knowledge Optimization Type 1 Diabetes: Parents curriculum during Arm 3. Scores range from 0-100 with higher scores reflecting greater perceived utility.

  Arm 3: Months 30-60

• Intervention Completion

  Percentage of enrolled participants who complete the TeKnO T1D: Parents Curriculum in Arm 3.

  Arm 3: Months 30-60

• Intervention Retention

  Percentage of enrolled participants who complete the entire intervention for Arm 3.

  Arm 3: Months 30-60

Secondary Outcomes (26)

• Hemoglobin A1c

  Arm 3: Months 30-60

• CGM Mean Sensor Glucose

  months 0-60

• CGM Glucose Management Indicator

  Arm 3: Months 30-60

• CGM Coefficient of Variation of the Mean

  Arm 3: Months 30-60

• CGM Time in Range (70-180 mg/dL)

  Arm 3: Months 30-60

Other Outcomes (6)

• Qualitative analysis of semi-structured interviews

  Arm 1: Months 0-15

• TeKnO T1D: Parents Curriculum difficulty

  Arm 2: Months 10-33

• TeKnO T1D: Parents Curriculum discrimination

  Arm 2: Months 10-33

Study Arms (3)

Arm 1: Semi-structured Interviews

NO INTERVENTION

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

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.

Other: TeKnO T1D: Parents

Arm 3: TeKnO T1D: Parents Pilot Study

ACTIVE COMPARATOR

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.

Other: TeKnO T1D: Parents

Interventions

TeKnO T1D: Parents OTHER

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

Arm 2: Designing an App Delivered Curriculum; Arm 3: TeKnO T1D: Parents Pilot Study

Eligibility Criteria

• Age: 8 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• child 8-12 years of age with a diagnosis of T1D ≥ 6 months
• currently using insulin pump( IP) and CGM ≥ 1 month \[including Hybrid Closed Loop (HCL) systems\]
• participation of primary diabetes caregiver
• English fluency
• mean A1c \>7.5% over the past 6 months (Aim 3 only)

You may not qualify if:

• major illnesses other than T1D in the child
• significant cognitive limitations or major psychiatric disorders in the child or parent
• the use of medications other than insulin to control blood glucose levels.

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Childrens Hospital of Philadelphia

Philadelphia, Pennsylvania, 19146, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Brynn E Marks, MD, MSHPEd

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2021
• First Posted: March 29, 2022
• Study Start: August 15, 2025
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): July 31, 2027
• Last Updated: October 9, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)