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NCT00340938 · ClinicalTrials.gov registry record · Phase 1
Family Management of Childhood Diabetes Study
A Phase 1 study of Diabetes and Type 1 Diabetes, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
- Completed
- Registry status
- Phase 1
- Development phase
- 1,298
- Enrollment target
- 3
- Study locations
NCT00340938: Completed Phase 1 study of Diabetes and Type 1 Diabetes, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
NCT00340938 is a Phase 1 study of Diabetes and Type 1 Diabetes that has completed, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). The registered enrollment target is 1,298 participants, below the 3,024-participant average among 338 other Diabetes trials with a reported enrollment target (57% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00340938, a Phase 1 study of Diabetes and Type 1 Diabetes, has completed, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 1,298 participants
- Enrollment target
- 3
- Study locations
Study Summary
This study will test the effectiveness of a practical, low-cost, problem-solving method called WE CAN that can be taught to families at diabetes clinics. The goal is to see if this teaching and support can help with controlling the level of blood sugar in children with type 1 diabetes as they approach adolescence. Attention would go to young people's completion of tasks necessary to manage diabetes, quality of life, and psychological adjustments, plus the role of the family in these situations. Type 1 diabetes mellitus, accounting for less than 10% of the disease cases, is marked by the inability of the pancreas to secrete insulin. People who have it must consistently manage their disease. Successful disease management for children depends on the family's adaptation to treatment demands. Yet maintaining acceptable blood sugar control becomes more difficult for adolescents, owing to changes in the body during that period of life. Also, early adolescence is a vital time in people's development of health outcomes. The title WE CAN is a way to remember the steps of the problem-solving method: * Work together to set goals * Explore barriers and solutions * Choose the best solutions * Act on your plan * Note the results Children who have reached age 9 but are not yet 14.5 years who have had type 1 diabetes for at least 1 year and who have had at least two visits to diabetes clinics at one of four clinical sites may be eligible for this study. A total of 120 children will participate in clinic visits once every 3 months. Participants and their families will attend diabetes clinic visits once every 3 months. They will be assigned to one of two groups: standard care or WE CAN. Those in the WE CAN group will have visits about 15 to 45 minutes longer than those involved in the standard care group. All participants will have two home visits: at the beginning and at 6 months. There will also be telephone interviews, about 20 minutes long, once every 3 months with the children
Conditions Studied
Interventions
- PROCEDURE Blood testing
Study Locations (3)
Illinois
- Childrens Memorial Hospital, Chicago - Chicago
Massachusetts
- Joslin Diabetes Center - Boston
Texas
- Texas Children's Hospital - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,298 participants |
| Start Date | 2004-11-08 |
| Est. Completion | 2009-08-20 |
| Phase | Phase 1 |
Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)305 total trials
What the finished NCT00340938 record still lists
NCT00340938 is an interventional study that assigns participants to a tested intervention. Its 1,298 participants enrollment target places it among the larger protocols in the corpus, below the 3,024-participant average among 338 other Diabetes trials with a reported enrollment target (57% lower).
The record links to 2 conditions, with Diabetes appearing as the primary indexed condition, and to 1 intervention - of which Blood testing is the first listed.
NCT00340938 reports a single indexed study location in Illinois, Massachusetts, Texas.
Frequently Asked Questions
What is clinical trial NCT00340938 about?
NCT00340938 is a clinical study titled "Family Management of Childhood Diabetes Study". This study will test the effectiveness of a practical, low-cost, problem-solving method called WE CAN that can be taught to families at diabetes clinics. The goal is to see if this teaching and support can help with controlling the level of blood sugar in children with type 1 diabetes as they approa...
What is the current status of trial NCT00340938?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 1,298 participants. The study started on 2004-11-08. Estimated completion is 2009-08-20.
What conditions does trial NCT00340938 study?
This clinical trial studies the following conditions: Diabetes, Type 1 Diabetes.
What interventions are being tested in trial NCT00340938?
The interventions under investigation include: Blood testing (PROCEDURE).
Who is sponsoring clinical trial NCT00340938?
This trial is sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), which has 305 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00340938 being conducted?
This trial has 3 study locations across Illinois, Massachusetts, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00340938's enrollment target sits among peer trials
1,298 34th of 338 higher than 305 of 338 other Diabetes trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diabetes 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.
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