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

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.

Study Overview

• Status: Recruiting
• Conditions: Type 1 Diabetes
• Intervention / Treatment: Other: TeKnO T1D: Parents

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
• Enrollment (Estimated): 170
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Grey Baker; Phone Number: (215)-590-3174; Email: bakerg3@chop.edu

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19146
      • Recruiting
      • Childrens Hospital of Philadelphia
      • Contact: Brynn Marks, MD, MSHPEd; Email: marksb@chop.edu
      • Contact: Grey Baker; Phone Number: 215-590-3174; Email: bakerg3@chop.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 12 years (Child)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: 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.
Experimental: 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.	Other: TeKnO T1D: Parents; app-delivered curriculum to provide psychoeducational education surrounding diabetes technology use
Active Comparator: 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.	Other: TeKnO T1D: Parents; app-delivered curriculum to provide psychoeducational education surrounding diabetes technology use

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hemoglobin A1c	Hemoglobin A1c will be assessed in Arm 3 prior to the curriculum start, upon completion of the TeKnO T1D: Parents curriculum, and 12 weeks after the curriculum completion.	Arm 3: Months 30-60
CGM Mean Sensor Glucose	CGM mean sensor glucose will be assessed prior to the curriculum start, upon completion of the TeKnO T1D: Parents curriculum, and 12 weeks after the curriculum completion.	months 0-60
CGM Glucose Management Indicator	The Glucose Management Indicator will be assessed in Arm 3 prior to the curriculum start, upon completion of the TeKnO T1D: Parents curriculum, and 12 weeks after the curriculum completion.	Arm 3: Months 30-60
CGM Coefficient of Variation of the Mean	The Coefficient of Variation of the Mean will be assessed in Arm 3 prior to the curriculum start, upon completion of the TeKnO T1D: Parents curriculum, and 12 weeks after the curriculum completion. .	Arm 3: Months 30-60
CGM Time in Range (70-180 mg/dL)	CGM Time in Range (70-180 mg/dL) will be assessed in Arm 3 prior to the curriculum start, upon completion of the TeKnO T1D: Parents curriculum, and 12 weeks after the curriculum completion.	Arm 3: Months 30-60
CGM Time Below Range (<70 mg/dL)	CGM Time Below Range (<70 mg/dL) will be assessed in Arm 3 prior to the curriculum start, upon completion of the TeKnO T1D: Parents curriculum, and 12 weeks after the curriculum completion.	Arm 3: Months 30-60
CGM Time Above Range (<180 mg/dL)	CGM Time Above Range (<180 mg/dL) will be assessed in Arm 3 prior to the curriculum start, upon completion of the TeKnO T1D: Parents curriculum, and 12 weeks after the curriculum completion.	Arm 3: Months 30-60
CGM Wear Time	The percentage of CGM wear time will be assessed in Arm 3 prior to the curriculum start, upon completion of the TeKnO T1D: Parents curriculum, and 12 weeks after the curriculum completion.	Arm 3: Months 30-60
Total Daily Insulin Dose	Total Daily Insulin Dose will be assessed in Arm 3 prior to the curriculum start, upon completion of the TeKnO T1D: Parents curriculum, and 12 weeks after the curriculum completion.	Arm 3: Months 30-60
Total Daily Basal Insulin Dose	Total Daily Basal Insulin Dose will be assessed in Arm 3 prior to the curriculum start, upon completion of the TeKnO T1D: Parents curriculum, and 12 weeks after the curriculum completion.	Arm 3: Months 30-60
Percent Basal Insulin Dose	The percentage of the total daily insulin derived from basal insulin (basal insulin/ total daily insulin dose) will be assessed in Arm 3 prior to the curriculum start, upon completion of the TeKnO T1D: Parents curriculum, and 12 weeks after the curriculum completion.	Arm 3: Months 30-60
Number of boluses per day	The number of boluses per day will be assessed in Arm 3 prior to the curriculum start, upon completion of the TeKnO T1D: Parents curriculum, and 12 weeks after the curriculum completion.	Arm 3: Months 30-60
Carbohydrate intake logged on insulin pump	The number of grams of carbohydrate intake logged on insulin pump will be assessed in Arm 3 prior to the curriculum start, upon completion of the TeKnO T1D: Parents curriculum, and 12 weeks after the curriculum completion.	Arm 3: Months 30-60
Episodes of Severe Hypoglycemia	The number of episodes of severe hypoglycemia will be assessed in Arm 3 prior to the curriculum start, upon completion of the TeKnO T1D: Parents curriculum, and 12 weeks after the curriculum completion.	Arm 3: Months 30-60
Emergency Department Visits	The number of diabetes-related emergency department visits will be assessed in Arm 3 prior to the curriculum start, upon completion of the TeKnO T1D: Parents curriculum, and 12 weeks after the curriculum completion.	Arm 3: Months 30-60
Hospital Admissions	The number of diabetes-related hospital admissions will be assessed in Arm 3 prior to the curriculum start, upon completion of the TeKnO T1D: Parents curriculum, and 12 weeks after the curriculum completion.	Arm 3: Months 30-60
Episodes of Diabetic Ketoacidosis	The number of episodes of diabetic ketoacidosis will be assessed in Arm 3 prior to the curriculum start, upon completion of the TeKnO T1D: Parents curriculum, and 12 weeks after the curriculum completion.	Arm 3: Months 30-60
Parent Diabetes-Specific Quality of Life	The Type 1 Diabetes and Life (T1DAL) is a validated survey assessing diabetes-specific quality of life. T1DAL will be will be completed in Arm 3 prior to the curriculum start, upon completion of the TeKnO T1D: Parents curriculum, and 12 weeks after the curriculum completion. Scores range from 0 to 100 with higher scores reflecting greater quality of life.	Arm 3: Months 30-60
Parent Emotional Distress Related to T1D	Parents of Children (P-PAID) is a validated survey assessing emotional distress related to T1D. P-PAID will be completed in Arm 3 prior to the curriculum start, upon completion of the TeKnO T1D: Parents curriculum, and 12 weeks after the curriculum completion. Scores range from 15 to 96 with higher scores reflecting greater emotional distress.	Arm 3: Months 30-60
Parent Diabetes Self-Management	The Diabetes Management Questionnaire (DMQ) is a validated survey assessing diabetes self-management. The DMQ will be completed in Arm 3 prior to the curriculum start, upon completion of the TeKnO T1D: Parents curriculum, and 12 weeks after the curriculum completion. Scores range from 0 to 100 with higher scores reflecting greater adherence to diabetes management.	Arm 3: Months 30-60
Parent Perceived CGM Benefits and Burdens	CGM Benefits and Burdens scale is a validated survey exploring perceived benefits and burdens of CGM use. CGM Benefits and Burdens will be completed prior to the curriculum start, upon completion of the TeKnO T1D: Parents curriculum, and 12 weeks after the curriculum completion. Scoring of the CGM Benefits subscale ranges from 1 to 40 with higher scores reflecting greater perceived benefits. Scoring of the CGM Burdens subscale ranges from 1 to 40 with higher scores reflecting less perceived burden.	months 0-60
Parent Diabetes Technology Knowledge	A survey assessing diabetes technology knowledge will be developed. This survey will be completed in Arm 3 prior to the curriculum start, upon completion of the TeKnO T1D: Parents curriculum, and 12 weeks after the curriculum completion. Scores range from 0 to 100 with higher scores reflecting greater knowledge.	Arm 3: Months 30-60
Child Diabetes-Specific Quality of Life	The Type 1 Diabetes and Life (T1DAL) is a validated survey assessing diabetes-specific quality of life. T1DAL will be completed in Arm 3 prior to the curriculum start, upon completion of the TeKnO T1D: Parents curriculum, and 12 weeks after the curriculum completion. Scores range from 0 to 100 with higher scores reflecting greater quality of life.	Arm 3: Months 30-60
Child Emotional Distress Related to T1D	Problem Areas in Diabetes- Child Version (PAID-C) is a validated survey assessing emotional distress related to T1D. PAID-C will be completed in Arm 3 prior to the curriculum start, upon completion of the TeKnO T1D: Parents curriculum, and 12 weeks after the curriculum completion). Scores range from 11 to 84 with higher scores reflecting greater emotional distress.	Arm 3: Months 30-60
Child Diabetes Self-Management	The Diabetes Management Questionnaire (DMQ) is a validated survey assessing diabetes self-management. The DMQ will be completed in Arm 3 prior to the curriculum start, upon completion of the TeKnO T1D: Parents curriculum, and 12 weeks after the curriculum completion. Scores range from 0 to 100 with higher scores reflecting greater adherence to diabetes management.	Arm 3: Months 30-60
Child Perceived CGM Benefits and Burdens	CGM Benefits and Burdens scale is a validated survey exploring perceived benefits and burdens of CGM use. CGM Benefits and Burdens will be completed in Arm 3 prior to the curriculum start, upon completion of the TeKnO T1D: Parents curriculum, and 12 weeks after the curriculum completion. Scoring of the CGM Benefits subscale ranges from 1 to 40 with higher scores reflecting greater perceived benefits. Scoring of the CGM Burdens subscale ranges from 1 to 40 with higher scores reflecting less perceived burden.	Arm 3: Months 30-60

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Qualitative analysis of semi-structured interviews	Semantic content analysis will identify widely captured themes pertaining to diabetes technology education so as to prioritize content to include in curriculum development.	Arm 1: Months 0-15
TeKnO T1D: Parents Curriculum difficulty	Using classical test theory as our framework, the investigators will conduct an item analysis to assess the quality of the items and the overall test, including item difficulty.	Arm 2: Months 10-33
TeKnO T1D: Parents Curriculum discrimination	Using classical test theory as our framework, the investigators will conduct an item analysis to assess the quality of the items and the overall test, including item discrimination.	Arm 2: Months 10-33
Child Weight Z-score	Weight Z-score for age will be assessed in Arm 3 prior to the curriculum start, upon completion of the TeKnO T1D: Parents curriculum, and 12 weeks after the curriculum completion.	Arm 3: Months 30-60
Child Height Z-score	Height Z-score for age will be assessed in Arm 3 prior to the curriculum start, upon completion of the TeKnO T1D: Parents curriculum, and 12 weeks after the curriculum completion.	Arm 3: Months 30-60
Child BMI Z-score	BMI Z-score for age will be assessed in Arm 3 prior to the curriculum start, upon completion of the TeKnO T1D: Parents curriculum, and 12 weeks after the curriculum completion.	Arm 3: Months 30-60

Collaborators and Investigators

• Sponsor: Children's Hospital of Philadelphia
• Investigators: Principal Investigator: Brynn E Marks, MD, MSHPEd, Children's Hospital of Philadelphia

Study record dates

Study Major Dates

• Study Start (Actual): November 10, 2022
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: December 18, 2021
• First Submitted That Met QC Criteria: March 28, 2022
• First Posted (Actual): March 29, 2022

Study Record Updates

• Last Update Posted (Estimated): March 5, 2024
• Last Update Submitted That Met QC Criteria: March 4, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: medical education; pediatric; insulin pump; continuous glucose monitor; automated insulin delivery; diabetes technology; hybrid closed loop systems
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: 22-019791

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No