New app aims to tackle diabetes stress in School-Age children
NCT ID NCT05268250
First seen Jun 27, 2026 · Last updated Sep 02, 2026 · Updated 4 times
Summary
This study tests a mobile health program called R2D2 designed to reduce diabetes distress in children aged 8-12 with type 1 diabetes and their parents. The program uses cognitive behavioral therapy, mindfulness, and behavioral strategies to help families cope. Researchers will measure changes in blood sugar control and emotional well-being in 180 participants.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- R2D2 mHealth intervention (behavioral therapy using cognitive behavioral therapy, mindfulness, and behavioral activation strategies)
- What this could lead to
- If it works, this could provide a scalable, low-cost way to help families manage the emotional burden of type 1 diabetes and improve children's blood sugar levels.
- What could go wrong
- This is an early feasibility and efficacy trial with only 180 participants, so results may not apply to everyone. The intervention is behavioral, so benefits may vary and long-term effects are unknown.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 180 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2024
- Expected to finish
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Aug 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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8 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * child age between 8-12 years, physician confirmed T1D diagnosis, * either the child or the parent or both the child and parent report diabetes distress levels at or above clinical cut-points, * child is on an intensive insulin regimen (pump or MDI). Exclusion Criteria: * children on a conventional insulin regimen, children and/or parents who do not report diabetes distress levels at or above the clinical cut-points, * children who have an allergy or sensitivity to the adhesive and/or skin preparation used for CGM, children with a comorbid chronic condition (e.g., renal disease), * children and parents who do not speak English.
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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
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Genom att skicka in godkänner du våra Användarvillkor
Locations
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Children's Mercy Kansas City
RECRUITINGKansas City, Missouri, 64108, United States
Contact Email: •••••@•••••
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Nemours Children's Health
RECRUITINGJacksonville, Florida, 32207, United States
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