Technology Knowledge Optimization for Type 1 Diabetes in Schools (TeKnO T1D)

Technology Knowledge Optimization for Type 1 Diabetes in Schools (TeKnO T1D: Schools): A Novel E-learning Platform for School Nurses to Advance Health Outcomes

The goal of this study is to evaluate the feasibility and acceptability of a school nurse focused e-Learning application to improve their diabetes device knowledge and confidence. School nurses will be asked to complete pre-/post-surveys around a 16-week curriculum.

Study Overview

• Status: Not yet recruiting
• Conditions: Type 1 Diabetes (T1D)
• Intervention / Treatment: Other: TeKnO T1D curriculum

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 86
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Clinical Research Coordinator; Phone Number: 412-692-5797; Email: smo47@pitt.edu
• Study Contact Backup: Name: Principal Investigator; Phone Number: 412-692-9156; Email: chm150@pitt.edu

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15224
      • University of Pittsburgh
      • Contact: Clinical Research Coordinator; Phone Number: 412-692-5797; Email: smo47@pitt.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Intervention Arm; This group will receive 16 weeks of the TeKnO T1D e-Learning curriculum

Other: TeKnO T1D curriculum; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Study Enrollment	The percentage of eligible participants (school nurses) who consent to participate among those approached.	Baseline
Curriculum completion	The percentage of enrolled participants who complete the TeKnO T1D: School curriculum	Primary endpoint (completion of 16 week curriculum)
Retention	The percent of enrolled participants who complete all study procedures.	Primary endpoint (completion of 16 week curriculum)
Feasibility of Intervention Measure	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.	Primary endpoint (completion of 16 week curriculum)
Acceptability	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.	Primary endpoint (completion of 16 week curriculum)
Appropriateness	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.	Primary endpoint (completion 16 week curriculum)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Device knowledge	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%.	Baseline and primary endpoint (completion of 16 week curriculum)
Diabetes device confidence	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.	Baseline and primary endpoint (completion of 16 week curriculum)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent time in range (TIR)	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.	Monthly from -3 months before baseline to +3 months after the primary endpoint
Percent time above range (TAR)	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.	Monthly from -3 months before baseline to +3 months after the primary endpoint
Percent time below range (TBR)	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.	Monthly from -3 months before baseline to +3 months after the primary endpoint
Mean Glucose	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.	Monthly from -3 months before baseline to +3 months after the primary endpoint
Coefficient of Variation (CV)	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.	Monthly from -3 months before baseline to +3 months after the primary endpoint
Parent-reported Hemoglobin A1c	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.	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).
Frequency of in-school diabetes interventions	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.	Baseline to primary endpoint (completion of 16 week curriculum)
Parent satisfaction with school-based diabetes care	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.	Baseline and primary endpoint (completion of 16 week curriculum)
Rate of school absences	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.	Baseline to primary endpoint (completion of 16 week curriculum)

Collaborators and Investigators

• Sponsor: University of Pittsburgh
• Collaborators: Children's Hospital of Philadelphia; University of Pennsylvania; National Institute of Nursing Research (NINR)
• Investigators: Principal Investigator: Christine A March, MD, MS, University of Pittsburgh; Principal Investigator: Seema Meighan, MSN, MPH, DNP, Children's Hospital of Philadelphia

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2027
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027

Study Registration Dates

• First Submitted: March 11, 2026
• First Submitted That Met QC Criteria: March 14, 2026
• First Posted (Actual): March 19, 2026

Study Record Updates

• Last Update Posted (Actual): March 19, 2026
• Last Update Submitted That Met QC Criteria: March 14, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: education; technology; devices; school nurse
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Autoimmune Diseases; Immune System Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 1
• Other Study ID Numbers: STUDY25070015 (Aim 3); 1R21NR022207 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data generated will include curriculum performance data from the e-learning app and survey data from school nurses (n=36) that will assess feasibility, device knowledge, and device confidence. Survey data will include some metrics from their students with type 1 diabetes, including school attendance, missed classroom time during the school day, and parent-reported hemoglobin A1c and parental satisfaction with school-based diabetes care. Continuous glucose monitoring (CGM) data, which provides glucose levels every 5 minutes throughout the study period, will be accessed through secure cloud-based accounts. Data will be de-identified and aggregated. All survey and CGM data will be captured and preserved in REDCap.
• IPD Sharing Time Frame: Final data submission and release of data used in publications will occur approximately 8 and 12 months following the end of fieldwork, respectively. Datasets underlying publications will be shared at the initial publication date.

IPD Sharing Access Criteria

The scales and data making up any proprietary scales used in this research cannot be shared due to licensing restrictions. However, the computed measures resulting from these scales will be shared.

To protect research participants' privacy and confidentiality and ensure appropriate data sharing, reuse of this dataset should use the following Data Use Limitations (DULs) under Controlled Access that is made available by a data repository only after approval of the request. The requesting institution's IRB or equivalent body must approve the requested use.

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

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