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NCT01421225 · ClinicalTrials.gov registry record · NA
Closed-Loop Insulin Delivery in Children Less Than 7 Years of Age
A NA study, sponsored by Boston Children's Hospital.
- Completed
- Registry status
- NA
- Development phase
- 10
- Enrollment target
NCT01421225: Completed NA study, sponsored by Boston Children's Hospital.
NCT01421225 is a NA study that has completed, run by Boston Children's Hospital. The registered enrollment target is 10 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01421225, a NA study, has completed, sponsored by Boston Children's Hospital.
- COMPLETED
- Registry status
- NA
- Development phase
- 10 participants
- Enrollment target
Study Summary
The investigators are conducting this study to find out whether a new device can control blood sugar levels in children who have Type 1 diabetes. In Type 1 diabetes, children have high blood sugar levels because they do not make enough insulin. The standard treatment is to give insulin either by shots or using an insulin pump. A new device, called closed-loop insulin therapy, uses a continuous glucose monitor (CGMs) linked to an insulin pump by a computer. The CGM will send the sugar levels to a computer which automatically figures out how much insulin to give and then gives that amount of insulin through the insulin pump. It will give the child insulin to bring sugar levels down if they are high, and will give less insulin if the child's blood sugar is getting lower. Earlier research using closed-loop insulin therapy has shown the ability for it to improve diabetes care in adults and older children, but there has been no research of closed-loop insulin therapy in young children. This study will compare children's current insulin therapy with the closed-loop system. The knowledge that the investigators gain from this research will help us to figure out whether closed-loop therapy can work in young children, hopefully leading to better Type 1 diabetes care.
Primary Outcome
Time spent within target glucose range based on the glucose meter measurements between 10 PM and 8 AM. The target range is 110-200 mg/dl as this is the American Diabetes Association defined target overnight range for this age group.
Interventions
- DEVICE Closed-loop Insulin Pump therapy
- DEVICE Standard Insulin Pump Therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2011-08 |
| Est. Completion | 2013-08-15 |
| Phase | NA |
What the finished NCT01421225 record still lists
NCT01421225 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 2 interventions - of which Closed-loop Insulin Pump therapy is the first listed.
NCT01421225 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01421225 about?
NCT01421225 is a clinical study titled "Closed-Loop Insulin Delivery in Children Less Than 7 Years of Age". The investigators are conducting this study to find out whether a new device can control blood sugar levels in children who have Type 1 diabetes. In Type 1 diabetes, children have high blood sugar levels because they do not make enough insulin. The standard treatment is to give insulin either by sho...
What is the current status of trial NCT01421225?
This trial is currently completed. It is a NA study. The enrollment target is 10 participants. The study started on 2011-08. Estimated completion is 2013-08-15.
What interventions are being tested in trial NCT01421225?
The interventions under investigation include: Closed-loop Insulin Pump therapy (DEVICE), Standard Insulin Pump Therapy (DEVICE).
Who is sponsoring clinical trial NCT01421225?
This trial is sponsored by Boston Children's Hospital, which has 462 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01421225's enrollment target sits among peer trials
10 1927th of 2000 higher than 26 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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