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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Type 1 Diabetes

Intervention / Treatment
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* Other: TeKnO T1D: Parents


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Arm 1: Semi-structured Interviews<br>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<br>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<br>* app-delivered curriculum to provide psychoeducational education surrounding diabetes technology use<br>|
| Active Comparator: Arm 3: TeKnO T1D: Parents Pilot Study<br>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<br>* app-delivered curriculum to provide psychoeducational education surrounding diabetes technology use<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetes technology, pediatric, continuous glucose monitor, insulin pump, automated insulin delivery, hybrid closed loop systems, medical education