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.

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.

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

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 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.

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.

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.

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.

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.

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.

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.

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. .

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Semantic content analysis will identify widely captured themes pertaining to diabetes technology education so as to prioritize content to include in curriculum development.

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.

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.

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.

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.

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.

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.