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

Study Overview
=================
Brief 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.

Detailed Description
-----------------
We will perform a randomized cross-over study of semi-closed-loop insulin therapy in children less than 7 years old with type 1 diabetes. Subjects will be admitted to the inpatient clinical research center for 48 hours. They will receive their standard home insulin therapy for one day and semi-closed-loop insulin therapy for the other day.

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

Conditions
-----------------
Type 1 Diabetes Mellitus

Intervention / Treatment
-----------------
* Device: Closed-loop Insulin Pump therapy
* Device: Standard Insulin Pump Therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age < 7 years old Type 1 Diabetes (as diagnosed by outpatient endocrinologist) with duration greater than 6 months Treated with insulin pump therapy for greater than 6 weeks Exclusion Criteria: Any other chronic medical condition Weight below 10 kg as this is the minimal required weight for the amount of blood being drawn

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 7 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard Insulin Pump Therapy first, then Closed Loop<br>Standard therapy day 1, Closed-Loop therapy day 2. | Device: Closed-loop Insulin Pump therapy<br>* Subjects insulin doses were adjusted based on a proportional-integral-derivative algorithm using the continuous glucose monitor readings from 10 PM - noon.<br>* Other names: Continuous glucose monitor and computer-linked insulin pump;Device: Standard Insulin Pump Therapy<br>* Subjects insulin doses followed their usual home routine.<br>* Other names: Open-Loop Therapy;|
| Active Comparator: Closed Loop first, then Standard Insulin Pump Therapy<br>Closed-loop therapy day 1, standard therapy day 2. | Device: Closed-loop Insulin Pump therapy<br>* Subjects insulin doses were adjusted based on a proportional-integral-derivative algorithm using the continuous glucose monitor readings from 10 PM - noon.<br>* Other names: Continuous glucose monitor and computer-linked insulin pump;Device: Standard Insulin Pump Therapy<br>* Subjects insulin doses followed their usual home routine.<br>* Other names: Open-Loop Therapy;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nocturnal Glycemic Control | 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. | Participants will be followed for the duration of the 48 hour protocol. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-prandial Glycemic Control | Peak post-prandial blood sugar between 8 AM and noon | Participants will be followed for the duration of the 48 hour protocol | 
| Number of Interventions for Hypoglycemia | The number of interventions for hypoglycemia between 10 PM - 8 AM. | Participants will be followed for the duration of the 48 hour protocol | 
| Pre-lunch Blood Glucose Level | Blood glucose levels were documented at 12 pm just prior to being served lunch. | Participants will be followed for the duration of the 48 hour protocol | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Type 1 Diabetes, Closed Loop Insulin Delivery, Diabetes, Artificial pancreas