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Behavioural Intervention

TeKnO T1D App for Type 1 Diabetes (TeKnO T1D Trial)

Q: Does this clinical experiment grant access to elderly individuals?

<p>Participation in this trial is restricted to children between the ages of 8 and 12. Conversely, there are 219 medical studies for minors under 18 and 926 trials specifically designated for individuals over 65 years old.</p>

Q: Are there any available slots in this clinical experiment for participants?

<p>According to the clinicaltrial.gov website, recruitment for this trial is still ongoing. This research was initially posted on November 10th 2022 and has since been amended on that same date.</p>

N/A

Recruiting

Led By Brynn E Marks, MD, MSHPEd

Research Sponsored by Children's National Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up arm 3: months 30-60

Awards & highlights

TeKnO T1D Trial Summary

This trialaims to create an app to help parents of children (8-12) with type 1 diabetes manage insulin pumps and CGM to improve outcomes. #T1D

Who is the study for?

This trial is for parents of children aged 8-12 with Type 1 Diabetes who use an insulin pump and CGM. The child must have been diagnosed at least 6 months ago, and the parent should be the primary caregiver. Parents or children with significant cognitive issues, major psychiatric disorders, other serious illnesses, or using non-insulin medications for diabetes are excluded.Check my eligibility

What is being tested?

The study is developing an app to help parents better manage their child's Type 1 Diabetes by using insulin pumps and CGMs more effectively. It aims to address educational gaps through this technology-based intervention to improve diabetes outcomes.See study design

What are the potential side effects?

Since this trial focuses on a psychoeducational app rather than a medical treatment, traditional physical side effects are not applicable. However, participants may experience stress or frustration if they encounter difficulties in using the app.

TeKnO T1D Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ arm 3: months 30-60

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~arm 3: months 30-60

This trial's timeline: 3 weeks for screening, Varies for treatment, and arm 3: months 30-60 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Intervention Completion

Intervention Retention

Intervention Satisfaction

+2 more

Secondary outcome measures

CGM Coefficient of Variation of the Mean

CGM Glucose Management Indicator

CGM Mean Sensor Glucose

+23 more

Other outcome measures

Child BMI Z-score

Child Height Z-score

Child Weight Z-score

+3 more

TeKnO T1D Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Arm 2: Designing an App Delivered CurriculumExperimental Treatment1 Intervention

Arm 2 will be conducted from months 10-33 and will use information learned in arm 1 to develop and beta test an educational curriculum. Arm 2 also is not a clinical trial, but is a crucial part of what builds to the clinical trial.

Group II: Arm 3: TeKnO T1D: Parents Pilot StudyActive Control1 Intervention

Arm 3 will be conducted from months 30-60 and involves a pilot and feasibility study of the newly developed educational curriculum. This is the clinical trial.

Group III: Arm 1: Semi-structured InterviewsActive Control1 Intervention

Arm 1 will be conducted from months 0-15 and will use interviews to better understand existing challenges in diabetes technology educational practices. It is not a clinical trial, but is a crucial part of what builds to the clinical trial.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Children's National Research InstituteLead Sponsor

211 Previous Clinical Trials

207,987 Total Patients Enrolled

Children's Hospital of PhiladelphiaLead Sponsor

708 Previous Clinical Trials

8,580,889 Total Patients Enrolled

Brynn E Marks, MD, MSHPEdPrincipal InvestigatorChildren's Hospital of Philadelphia

Media Library

TeKnO T1D: Parents (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05300022 — N/A

Type 1 Diabetes Research Study Groups: Arm 3: TeKnO T1D: Parents Pilot Study, Arm 2: Designing an App Delivered Curriculum, Arm 1: Semi-structured Interviews

Type 1 Diabetes Clinical Trial 2023: TeKnO T1D: Parents Highlights & Side Effects. Trial Name: NCT05300022 — N/A

TeKnO T1D: Parents (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05300022 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people can be involved in this experiment at any given time?

"Indeed, the clinicaltrials.gov website verifies that this research is still in need of volunteers. The trial was first made available on November 10th 2022 and has since been updated with no changes to its 170 participant goal across one medical centre."

Answered by AI

Is it possible to become a volunteer for this experiment?

"This trial requires 170 children, aged 8-12 and diagnosed with type 1 diabetes mellitus. All participants must meet the further criteria of having used an insulin pump or CGM device for at least one month as well as being fluent in English with a mean A1c above 7.5% over the past 6 months (for Aim 3 only). Additionally, each child participating is expected to have their primary caregiver involved throughout the study duration."

Answered by AI

What are the projected results of this investigation?

"The primary measure of success for this trial, which will be monitored from Months 30-60, is Participant Retention in the Intervention. Secondary metrics are Parent Diabetes Technology Knowledge (using a survey ranging from 0 to 100 with higher scores representing more knowledge), CGM Glucose Management Indicator, and CGM Time Above Range (<180 mg/dL). All these values will be tracked prior to curriculum start, after completion of TeKnO T1D: Parents curriculum and 12 weeks post-curriculum conclusion."

Answered by AI

Does this clinical experiment grant access to elderly individuals?

"Participation in this trial is restricted to children between the ages of 8 and 12. Conversely, there are 219 medical studies for minors under 18 and 926 trials specifically designated for individuals over 65 years old."

Answered by AI

Are there any available slots in this clinical experiment for participants?

"According to the clinicaltrial.gov website, recruitment for this trial is still ongoing. This research was initially posted on November 10th 2022 and has since been amended on that same date."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Technology Knowledge Optimization in Type 1 Diabetes (TeKnO T1D): Parents

Brynn Marks 2022. "Technology Knowledge Optimization in Type 1 Diabetes (TeKnO T1D): Parents". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05300022.