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Behavioural Intervention

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

N/A

Waitlist Available

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

Must not have

The use of medications other than insulin to control blood glucose levels

Timeline

Screening 3 weeks

Treatment Varies

Follow Up arm 3: months 30-60

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I use medication other than insulin to manage my diabetes.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Intervention Completion

Intervention Retention

Intervention Satisfaction

+2 more

Secondary study objectives

CGM Coefficient of Variation of the Mean

CGM Glucose Management Indicator

CGM Mean Sensor Glucose

+23 more

Other study objectives

Child BMI Z-score

Child Height Z-score

Child Weight Z-score

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 1Eligibility criteria met