Clinical trial NCT05300022: Technology Knowledge Optimization in Type 1 Diabetes (TeKnO T1D): Parents
Official title: Technology Knowledge Optimization in Type 1 Diabetes (TeKnO T1D): Parents
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Type 1 Diabetes
Keywords: pediatric
continuous glucose monitor
insulin pump
automated insulin delivery
hybrid closed loop systems
medical education
diabetes technology
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2022-03-29
Enrollment: 170
Sex: ALL
Minimum age (years): 8
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Study Recruitment
timeFrame: Arm 3: Months 30-60
measure: Intervention Satisfaction
timeFrame: Arm 3: Months 30-60
measure: Perceived Intervention Utility
timeFrame: Arm 3: Months 30-60
measure: Intervention Completion
timeFrame: Arm 3: Months 30-60
measure: Intervention Retention
timeFrame: Arm 3: Months 30-60
Secondary outcomes:
measure: Hemoglobin A1c
timeFrame: Arm 3: Months 30-60
measure: CGM Mean Sensor Glucose
timeFrame: months 0-60
measure: CGM Glucose Management Indicator
timeFrame: Arm 3: Months 30-60
measure: CGM Coefficient of Variation of the Mean
timeFrame: Arm 3: Months 30-60
measure: CGM Time in Range (70-180 mg/dL)
timeFrame: Arm 3: Months 30-60
measure: CGM Time Below Range (<70 mg/dL)
timeFrame: Arm 3: Months 30-60
measure: CGM Time Above Range (<180 mg/dL)
timeFrame: Arm 3: Months 30-60
measure: CGM Wear Time
timeFrame: Arm 3: Months 30-60
measure: Total Daily Insulin Dose
timeFrame: Arm 3: Months 30-60
measure: Total Daily Basal Insulin Dose
timeFrame: Arm 3: Months 30-60
measure: Percent Basal Insulin Dose
timeFrame: Arm 3: Months 30-60
measure: Number of boluses per day
timeFrame: Arm 3: Months 30-60
measure: Carbohydrate intake logged on insulin pump
timeFrame: Arm 3: Months 30-60
measure: Episodes of Severe Hypoglycemia
timeFrame: Arm 3: Months 30-60
measure: Emergency Department Visits
timeFrame: Arm 3: Months 30-60
measure: Hospital Admissions
timeFrame: Arm 3: Months 30-60
measure: Episodes of Diabetic Ketoacidosis
timeFrame: Arm 3: Months 30-60
measure: Parent Diabetes-Specific Quality of Life
timeFrame: Arm 3: Months 30-60
measure: Parent Emotional Distress Related to T1D
timeFrame: Arm 3: Months 30-60
measure: Parent Diabetes Self-Management
timeFrame: Arm 3: Months 30-60
measure: Parent Perceived CGM Benefits and Burdens
timeFrame: months 0-60
measure: Parent Diabetes Technology Knowledge
timeFrame: Arm 3: Months 30-60
measure: Child Diabetes-Specific Quality of Life
timeFrame: Arm 3: Months 30-60
measure: Child Emotional Distress Related to T1D
timeFrame: Arm 3: Months 30-60
measure: Child Diabetes Self-Management
timeFrame: Arm 3: Months 30-60
measure: Child Perceived CGM Benefits and Burdens
timeFrame: Arm 3: Months 30-60
Other outcomes:
measure: Qualitative analysis of semi-structured interviews
timeFrame: Arm 1: Months 0-15
measure: TeKnO T1D: Parents Curriculum difficulty
timeFrame: Arm 2: Months 10-33
measure: TeKnO T1D: Parents Curriculum discrimination
timeFrame: Arm 2: Months 10-33
measure: Child Weight Z-score
timeFrame: Arm 3: Months 30-60
measure: Child Height Z-score
timeFrame: Arm 3: Months 30-60
measure: Child BMI Z-score
timeFrame: Arm 3: Months 30-60
Locations:
city: Philadelphia
country: United States
facility: Childrens Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: Children's Hospital of Philadelphia
name: Brynn E Marks, MD, MSHPEd
role: PRINCIPAL_INVESTIGATOR
References: