Technology Knowledge Optimization for Type 1 Diabetes in Schools
TeKnO T1D
2 other identifiers
interventional
86
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2027
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 11, 2026
CompletedFirst Posted
Study publicly available on registry
March 19, 2026
CompletedStudy Start
First participant enrolled
February 1, 2027
ExpectedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2027
Study Completion
Last participant's last visit for all outcomes
August 1, 2027
March 19, 2026
March 1, 2026
6 months
March 11, 2026
March 14, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
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 Outcomes (2)
Device knowledge
Baseline and primary endpoint (completion of 16 week curriculum)
Diabetes device confidence
Baseline and primary endpoint (completion of 16 week curriculum)
Other Outcomes (9)
Percent time in range (TIR)
Monthly from -3 months before baseline to +3 months after the primary endpoint
Percent time above range (TAR)
Monthly from -3 months before baseline to +3 months after the primary endpoint
Percent time below range (TBR)
Monthly from -3 months before baseline to +3 months after the primary endpoint
- +6 more other outcomes
Study Arms (1)
Intervention Arm
EXPERIMENTALThis group will receive 16 weeks of the TeKnO T1D e-Learning curriculum
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Pittsburghlead
- National Institute of Nursing Research (NINR)collaborator
- Children's Hospital of Philadelphiacollaborator
- University of Pennsylvaniacollaborator
Study Sites (1)
University of Pittsburgh
Pittsburgh, Pennsylvania, 15224, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Christine A March, MD, MS
University of Pittsburgh
- PRINCIPAL INVESTIGATOR
Seema Meighan, MSN, MPH, DNP
Children's Hospital of Philadelphia
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
March 11, 2026
First Posted
March 19, 2026
Study Start (Estimated)
February 1, 2027
Primary Completion (Estimated)
August 1, 2027
Study Completion (Estimated)
August 1, 2027
Last Updated
March 19, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- 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.
- 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.
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.