Technology Knowledge Optimization for Type 1 Diabetes in Schools

The standard of care for pediatric type 1 diabetes (T1D) is the use of continuous glucose monitoring (CGM) and automated insulin delivery (AID) systems to optimize glycemia. These diabetes technologies hold the potential to decrease the risk of acute and long-term complications. Yet, the rapid developments over the last decade have posed challenges for youth, caregivers, and healthcare professionals who must learn to use these devices. Use of these devices requires significant user interaction and remains labor-intensive, leading to variability in glycemic outcomes. Schools offer a unique opportunity to support these vulnerable populations. Youth with T1D spend nearly one third of their weekdays in school under the care of school nurses. School nurses have expressed a critical gap in their knowledge of T1D devices, which can negatively affect parent and student school experiences. To date, little to no research has explored interventions to support school nurses with T1D devices. Structured education may directly impact school nurse CGM and AID knowledge and confidence and student outcomes. e-Learning, defined as the delivery of education through digital resources, allows for flexible, asynchronous learning at a self-determined pace. App-based CGM and AID education stimulates active, problem-centered learning that improves the knowledge and confidence of endocrinology trainees. This study will adapt an existing diabetes technology e-Learning tool to meet the needs of school nurses. In earlier phases focus groups and user-centered design methods are used to adapt the TeKnO T1D curriculum. The TeKnO T1D: School app content will be pilot tested with school nurses in Pennsylvania to assess feasibility. The curriculum will be delivered to 36 school nurses over 16 weeks according to principles of spaced learning, which has been shown to optimize knowledge retention. Simultaneously, methods to collect health and school outcomes from the students of participating school nurses will be explored.

• TeKnO T1D curriculum (Other): The TeKnO T1D: School Intervention will be an e-Learning CGM and AID curriculum developed for nurses and delivered entirely through 20-25 multiple-choice questions developed from case-based scenarios reflecting real-world, school-based T1D management. After answering each question, participants receive immediate access to the correct answer, a comparison of their answer choice with that of their peers, and a detailed explanation of the correct answer choice. Participants receive 2 questions every 3 days. Based on educational principles and forgetting curves, which assess declines in memory retention over time, questions answered incorrectly are repeated in 7 days and those answered correctly in 13 days.

Primary outcomes

• Study Enrollment [Baseline]: The percentage of eligible participants (school nurses) who consent to participate among those approached.
• Curriculum completion [Primary endpoint (completion of 16 week curriculum)]: The percentage of enrolled participants who complete the TeKnO T1D: School curriculum
• Retention [Primary endpoint (completion of 16 week curriculum)]: The percent of enrolled participants who complete all study procedures.
• Feasibility of Intervention Measure [Primary endpoint (completion of 16 week curriculum)]: Feasibility will be measured using the Feasibility of Intervention Measure. This scale includes 4 items on a 1-5 Likert-type response scale with higher scores indicating greater feasibility. The scale score is an average of the 4 items (range 1-5). There are no subscales.
• Acceptability [Primary endpoint (completion of 16 week curriculum)]: Acceptability will be measured using the Acceptability of Intervention Measure. This scale includes 4 items on a 1-5 Likert-type response scale with higher scores indicating greater acceptability. The scale score is an average of the 4 items (range 1-5). There are no subscales.
• Appropriateness [Primary endpoint (completion 16 week curriculum)]: Appropriateness will be measured using the Intervention Appropriateness Measure. This scale includes 4 items on a 1-5 Likert-type response scale with higher scores indicating greater appropriateness. The scale score is an average of the 4 items (range 1-5). There are no subscales.

Secondary outcomes

• Device knowledge [Baseline and primary endpoint (completion of 16 week curriculum)]: Diabetes device knowledge will be assessed with a modified version of the Knowledge Assessment of T1D (KAT-1), a validated 112 item instrument. The instrument includes multiple choice questions. The KAT-1 score will be tabulated as the percent correct, ranging from 0-100%.
• Diabetes device confidence [Baseline and primary endpoint (completion of 16 week curriculum)]: This will be measured with the Diabetes Device Confidence Scale (DDCS), a 25-item validated scale. Items are scored on a 1-5 Likert-type response scale from 1=not at all confident to 5=extremely confident. The DDCS is scored as a sum of all items with scores ranging from 25-125, with higher scores indicating greater confidence. There are no sub-scales.

Other outcomes

• Percent time in range (TIR) [Monthly from -3 months before baseline to +3 months after the primary endpoint]: This measure will be obtained from parents who consent to data sharing if their child's school nurse is participating. Percent TIR is defined as the percent of time the sensor glucoses are within 70-180 mg/dL on a continuous glucose monitor and/or automated insulin delivery system. Percent TIR will be obtained from monthly reports of their child's diabetes device.
• Percent time above range (TAR) [Monthly from -3 months before baseline to +3 months after the primary endpoint]: This measure will be obtained from parents who consent to data sharing if their child's school nurse is participating. Percent TAR is defined as the percent of time the sensor glucoses are >180 mg/dL on a continuous glucose monitor and/or automated insulin delivery system. Percent TAR will be obtained from monthly reports of their child's diabetes device.
• Percent time below range (TBR) [Monthly from -3 months before baseline to +3 months after the primary endpoint]: This measure will be obtained from parents who consent to data sharing if their child's school nurse is participating. Percent TBR is defined as the percent of time the sensor glucoses are <70 mg/dL on a continuous glucose monitor and/or automated insulin delivery system. Percent TBR will be obtained from monthly reports of their child's diabetes device.
• Mean Glucose [Monthly from -3 months before baseline to +3 months after the primary endpoint]: This measure will be obtained from parents who consent to data sharing if their child's school nurse is participating. Mean glucose is defined as the average sensor reading within a window of time (30 days) on a continuous glucose monitor and/or automated insulin delivery system. Mean glucose will be obtained from monthly reports of their child's diabetes device.
• Coefficient of Variation (CV) [Monthly from -3 months before baseline to +3 months after the primary endpoint]: This measure will be obtained from parents who consent to data sharing if their child's school nurse is participating. CV is defined as the ratio of the standard deviation to the mean sensor reading within a given time window (30 days) on a continuous glucose monitor and/or automated insulin delivery system. CV will be obtained from monthly reports of their child's diabetes device.
• Parent-reported Hemoglobin A1c [Baseline (before enrolling in the intervention; up to 180 days pre-enrollment) and primary endpoint (from 30 days before study completion to 180 days post-completion).]: This measure will be obtained from parents who consent to data sharing if their child's school nurse is participating. This will be obtained on a pre/post survey. Parents will report the point-of-care or lab-measured hemoglobin A1c from their child's diabetes clinic visit, if available.
• Frequency of in-school diabetes interventions [Baseline to primary endpoint (completion of 16 week curriculum)]: This measure will be obtained from parents who consent to data sharing if their child's school nurse is participating. School nurses will report the frequency of diabetes care delivered to the student outside of routine dosing times and/or for medical emergencies. The proprietary form was developed and tested by the PI.
• Parent satisfaction with school-based diabetes care [Baseline and primary endpoint (completion of 16 week curriculum)]: Parent satisfaction will include two items addressing safety and satisfaction with overall diabetes care in school. This will be obtained on a pre/post survey. These items will be scored on a 1-5 Likert (1=very unsatisfied, 5=very satisfied) type response scale and will be reported descriptively.
• Rate of school absences [Baseline to primary endpoint (completion of 16 week curriculum)]: This measure will be obtained from parents who consent to data sharing if their child's school nurse is participating. School nurses will report school days where the student is either absent or receives an early dismissal due to diabetes concerns.

Sex: All, ages: 5 Years to any

Inclusion Criteria (School Nurses):

* Certified school nurse or obtaining certification
* Actively managing at least 1 student with type 1 diabetes ≤14 years of age who uses a diabetes device (CGM, insulin pump, or automated insulin delivery system)
* Employed in a school district in PA
* Equipped with a smartphone or device compatible with the app used to deliver curriculum

Inclusion Criteria (Parent-Child Dyads)

* Parent of a child diagnosed with T1D for ≥6 months
* Child ≤14 years of age and attends in-person school in Pennsylvania
* Child uses a CGM and/or AID system

Exclusion Criteria:

* Not able to participate in English (all)
* For School Nurses: No current work with in-person students (e.g., retired, cyber school only), not clinical school staff, prior participation in the study

• Christine A March, MD, MS, Principal investigator, University of Pittsburgh
• Seema Meighan, MSN, MPH, DNP, Principal investigator, Children's Hospital of Philadelphia

NIH grants: R21NR022207