CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 10 enrolled
Drug / intervention
Closed-loop Insulin Pump therapy +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01421225
NCT01421225N/ACompleted

Closed-Loop Insulin Delivery in Children Less Than 7 Years of Age

Boston Children's Hospital·interventional·Posted Aug 22, 2011·Updated Aug 9, 2018

In Brief

A clinical study evaluating Closed-loop Insulin Pump therapy and Standard Insulin Pump Therapy for Type 1 Diabetes Mellitus. Completed, enrolled 10 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedAug 22, 2011
Enrollment StartAug 1, 2011
Primary CompletionAug 15, 2013
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 14.9 years ago

Interventions

Closed-loop Insulin Pump therapydevice

Subjects insulin doses were adjusted based on a proportional-integral-derivative algorithm using the continuous glucose monitor readings from 10 PM - noon.

Standard Insulin Pump Therapydevice

Subjects insulin doses followed their usual home routine.