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NCT03324438 · ClinicalTrials.gov registry record · NA
Home Telemedicine to Optimize Health Outcomes in High-Risk Youth With Type 1 Diabetes
A NA study, sponsored by University of Colorado, Denver.
- Completed
- Registry status
- NA
- Development phase
- 108
- Enrollment target
NCT03324438: Completed NA study, sponsored by University of Colorado, Denver.
NCT03324438 is a NA study that has completed, run by University of Colorado, Denver. The registered enrollment target is 108 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03324438, a NA study, has completed, sponsored by University of Colorado, Denver.
- COMPLETED
- Registry status
- NA
- Development phase
- 108 participants
- Enrollment target
Study Summary
This study addresses the critical need for improving Type 1 Diabetes (T1D) health outcomes in high-risk youth (A1C=9-12%; ages 10-17 yrs) (AIC: glycated hemoglobin) where suboptimal glycemic control has severe acute and long-term complications with potentially life threatening consequences. Lack of regular contact with T1D care providers, continued T1D nonadherence, and suboptimal behavioral and mental health functioning compromises the physical health of youth with T1D and the ability of T1D teams to provide effective treatment. If the aims of this study are achieved, this study will change T1D care practices by providing high-risk youth with T1D, and their parents, medical and behavioral health support via home telehealth intervention. This has the potential to significantly change access to T1D care, decrease time spent in hyperglycemia, reduce the frequency of hospital admissions, and improve glycemic control. In addition, this study's use of Multiphase Optimization Strategy (MOST), a highly efficient experimental strategy to determine effective intervention components, should be generalizable to all individuals with T1D, leading to cost-effective, home telehealth intervention programs. Innovative aspects include: 1) assessment of physical and behavioral health characteristics associated with high-risk status; 2) delivery of home telehealth that incorporates: 2a) medical and behavioral health care delivered with the endocrinologist and behavioral health specialist working together with high-risk youth; 2b) personalized intervention to improve T1D adherence and T1D clinical health outcomes; 2c) personalized intervention to improve mental health comorbidities and T1D clinical health outcomes; and 3) an underused methodological approach for optimizing intervention components to be delivered at point of care.
Primary Outcome
A1C will be measured in the central lab located within the Barbara Davis Center at Study Visits 1 (week 1), 5 (week 24) and 9 (week 48), and Follow-Up Visit 2 (week 72) or 4 (week 72) which correspond to in-person T1D visits. In addition, participants will be asked to complete A1C measurements at an outside, independent Certified Laboratory Improvement Amendments (CLIA) lab prior to home telehealth T1D Study Visits 3 (week 12) and 7 (week 36). The rationale for measurement at these study visits
Interventions
- BEHAVIORAL Home Telehealth T1D C2oYoT1-HR
- BEHAVIORAL Personalized Behavioral Health
- BEHAVIORAL Personalized Adherence Feedback
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 108 participants |
| Start Date | 2017-11-01 |
| Est. Completion | 2021-09-30 |
| Phase | NA |
What the finished NCT03324438 record still lists
NCT03324438 is an interventional study that assigns participants to a tested intervention. The registered 108 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 3 interventions - of which Home Telehealth T1D C2oYoT1-HR is the first listed.
NCT03324438 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03324438 about?
NCT03324438 is a clinical study titled "Home Telemedicine to Optimize Health Outcomes in High-Risk Youth With Type 1 Diabetes". This study addresses the critical need for improving Type 1 Diabetes (T1D) health outcomes in high-risk youth (A1C=9-12%; ages 10-17 yrs) (AIC: glycated hemoglobin) where suboptimal glycemic control has severe acute and long-term complications with potentially life threatening consequences. Lack of ...
What is the current status of trial NCT03324438?
This trial is currently completed. It is a NA study. The enrollment target is 108 participants. The study started on 2017-11-01. Estimated completion is 2021-09-30.
What interventions are being tested in trial NCT03324438?
The interventions under investigation include: Home Telehealth T1D C2oYoT1-HR (BEHAVIORAL), Personalized Behavioral Health (BEHAVIORAL), Personalized Adherence Feedback (BEHAVIORAL).
Who is sponsoring clinical trial NCT03324438?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03324438's enrollment target sits among peer trials
108 825th of 2000 higher than 1,171 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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