No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
8 – 65
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
180 (estimated)
Sponsor
Nemours Children's Clinic · Other
Who this trial is looking for
This trial is looking for families with children aged 8 to 12 who have type 1 diabetes and experience diabetes distress. Participants will join a program aimed at helping reduce this distress to improve their child's blood sugar control.
Are You a Good Fit for This Trial?
You may be able to join if
I am between 8 and 12 years old.
I have been diagnosed with type 1 diabetes.
My child or I, or both of us, report high levels of diabetes distress.
My child is on an intensive insulin regimen.
You may not be able to join if
My child is on a conventional insulin regimen.
We do not report high levels of diabetes distress.
My child has an allergy or sensitivity to the adhesive used for CGM.
My child has another chronic condition.
We do not speak English.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
This R01 is in response to RFA-DK-19-021, Treating Diabetes Distress to Improve Glycemic Outcomes in Type 1 Diabetes. The objective is to test the feasibility and acceptability of a novel, practical, and potentially scalable screen to treat program for diabetes distress in families of school-age children with T1D (called Remedy to Diabetes Distress \[R2D2\]) and to test the initial efficacy of R2D…
This R01 is in response to RFA-DK-19-021, Treating Diabetes Distress to Improve Glycemic Outcomes in Type 1 Diabetes. The objective is to test the feasibility and acceptability of a novel, practical, and potentially scalable screen to treat program for diabetes distress in families of school-age children with T1D (called Remedy to Diabetes Distress \[R2D2\]) and to test the initial efficacy of R2D2 to reduce diabetes distress to improve children's glycemic control.
Trial Locations
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Status
Eligibility Criteria
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:
* chi…
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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