Type 1 Diabetes (T1D)TeKnO T1DNCT07482488
Technology Knowledge Optimization for Type 1 Diabetes in Schools
A study testing TeKnO T1D curriculum in people with Type 1 Diabetes (T1D), run by University of Pittsburgh at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 years and older
- Conditions the study is for
- Type 1 Diabetes (T1D)
- What is being tested?
- TeKnO T1D curriculum
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2027to Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Pittsburgh
Pittsburgh, Pennsylvania, 15224
Clinical Research Coordinator, 412-692-5797, smo47@pitt.edu
About this study
Official title: 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.
Read the 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.
- Conditions
- Type 1 Diabetes (T1D)
- Being tested
- TeKnO T1D curriculum
- Keywords
- technology, devices, school nurse, education
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TeKnO T1D curriculumOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Experimental | This group will receive 16 weeks of the TeKnO T1D e-Learning curriculum Receives: Other: TeKnO T1D curriculum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Study Enrollment
The percentage of eligible participants (school nurses) who consent to participate among those approached.
Measured: Baseline
Curriculum completion
The percentage of enrolled participants who complete the TeKnO T1D: School curriculum
Measured: Primary endpoint (completion of 16 week curriculum)
Retention
The percent of enrolled participants who complete all study procedures.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Primary endpoint (completion 16 week curriculum)
Secondary outcomes (2)
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%.
Measured: 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.
Measured: Baseline and primary endpoint (completion of 16 week curriculum)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2026
- Study startFeb 2027 (estimated)
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 Diabetes (T1D)Studies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR), Children's Hospital of Philadelphia, University of Pennsylvania
- Responsible party
- Principal investigator, Christine March, University of Pittsburgh
- Investigators
- Christine A March, MD, MS, Principal investigator, University of PittsburghSeema Meighan, MSN, MPH, DNP, Principal investigator, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07482488
- Sponsor's protocol ID
- STUDY25070015 (Aim 3)
- Other IDs
- 1R21NR022207
- Acronym
- TeKnO T1D
- Status last verified
- Mar 2026
- First submitted
- 11 Mar 2026
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Technology Knowledge Optimization for Type 1 Diabetes in Schools (TeKnO T1D: Schools): A Novel E-learning Platform for School Nurses to Advance Health Outcomes
- ClinicalTrials.gov ID
- NCT07482488
- Acronym / sponsor ID
- TeKnO T1D / STUDY25070015 (Aim 3)
- Conditions
- Type 1 Diabetes (T1D)
- Keywords
- technology, devices, school nurse, education
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR), Children's Hospital of Philadelphia, University of Pennsylvania
- Study start
- Feb 2027 (estimated)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 19 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Other: TeKnO T1D curriculumThis group will receive 16 weeks of the TeKnO T1D e-Learning curriculum |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TeKnO T1D curriculumThe 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. | Other | Intervention Arm |
Primary outcome
Study Enrollment
Time frame: Baseline
The percentage of eligible participants (school nurses) who consent to participate among those approached.
Curriculum completion
Time frame: Primary endpoint (completion of 16 week curriculum)
The percentage of enrolled participants who complete the TeKnO T1D: School curriculum
Retention
Time frame: Primary endpoint (completion of 16 week curriculum)
The percent of enrolled participants who complete all study procedures.
Feasibility of Intervention Measure
Time frame: 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
Time frame: 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
Time frame: 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.
2 secondary outcomes
Device knowledge
Time frame: Baseline and primary endpoint (completion of 16 week curriculum)
Diabetes device confidence
Time frame: Baseline and primary endpoint (completion of 16 week curriculum)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Christine A March, MD, MS principal investigator
University of Pittsburgh
Seema Meighan, MSN, MPH, DNP principal investigator
Children's Hospital of Philadelphia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TeKnO T1D curriculum in people with Type 1 Diabetes (T1D), run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Research Coordinator (412-692-5797, smo47@pitt.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Study Enrollment (time frame: Baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2026.