NCT07482488

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

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
86

participants targeted

Target at P50-P75 for not_applicable

Timeline
6mo left

Started Feb 2027

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 19, 2026

Completed
11 months until next milestone

Study Start

First participant enrolled

February 1, 2027

Expected
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2027

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2027

Last Updated

March 19, 2026

Status Verified

March 1, 2026

Enrollment Period

6 months

First QC Date

March 11, 2026

Last Update Submit

March 14, 2026

Conditions

Keywords

technologydevicesschool nurseeducation

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

EXPERIMENTAL

This group will receive 16 weeks of the TeKnO T1D e-Learning curriculum

Other: TeKnO T1D 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.

Intervention Arm

Eligibility Criteria

Age5 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

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

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15224, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Christine A March, MD, MS

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR
  • Seema Meighan, MSN, MPH, DNP

    Children's Hospital of Philadelphia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Research Coordinator

CONTACT

Principal Investigator

CONTACT

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

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.

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.

Locations