Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 is a NA study that has completed, run by Boston Children's Hospital. The registered enrollment target is 10 participants.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01421225
The ClinicalTrials.gov registry entry for NCT01421225 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boston Children's Hospital, which has 462 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Closed-loop Insulin Pump therapy is the first listed.
NCT01421225 reports 0 study locations.
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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.