Ignite Creation Date:
2024-05-06 @ 3:02 AM
Last Modification Date:
2024-10-26 @ 11:27 AM
Study NCT ID:
NCT02189694
Status:
COMPLETED
Last Update Posted:
2014-09-03
First Post:
2014-07-03
Brief Title:
Closed-loop Control of Overnight Glucose Levels Artificial Pancreas in Children With Type 1 Diabetes in a Diabetes Camp
Sponsor:
Institut de Recherches Cliniques de Montreal
Organization:
Institut de Recherches Cliniques de Montreal
Study Overview
Official Title:
An Open-label Randomized Three-way Cross-over Study to Assess the Efficacy of Single-hormone Closed-loop Strategy Dual-hormone Closed-loop Strategy and Conventional Pump Therapy in Regulating Overnight Glucose Levels in Children With Type 1 Diabetes in a Diabetes Camp
Status:
COMPLETED
Status Verified Date:
2014-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Closed-loop strategy is composed of three components glucose sensor to read glucose levels insulin pump to infuse insulin and a dosing mathematical algorithm to decide on the required insulin dosages based on the sensors readings A dual-hormone closed-loop system would regulate glucose levels through the infusion of two hormone insulin and glucagon
The main objective of this project is to compare the efficacy of single-hormone closed-loop strategy dual-hormone closed-loop strategy and pump therapy to regulate overnight glucose levels in children with type 1 diabetes in a diabetes camp
The investigators hypothesized that dual-hormone closed-loop strategy reduces the time spent in hypoglycemia in children with type 1 diabetes T1D compared to single-hormone closed-loop strategy which in turn is more effective than the conventional pump therapy to reduce time spent in hypoglycemia
The main objective of this project is to compare the efficacy of single-hormone closed-loop strategy dual-hormone closed-loop strategy and pump therapy to regulate overnight glucose levels in children with type 1 diabetes in a diabetes camp
The investigators hypothesized that dual-hormone closed-loop strategy reduces the time spent in hypoglycemia in children with type 1 diabetes T1D compared to single-hormone closed-loop strategy which in turn is more effective than the conventional pump therapy to reduce time spent in hypoglycemia
Detailed Description:
Closed-loop strategy is composed of three components glucose sensor to read glucose levels insulin pump to infuse insulin and a dosing mathematical algorithm to decide on the required insulin dosages based on the sensors readings A dual-hormone closed-loop system would regulate glucose levels through the infusion of two hormone insulin and glucagon
The investigators aim to conduct a randomized three-way cross-over trial comparing single hormone closed-loop strategy dual-hormone closed-loop strategy and the conventional pump therapy The investigators aim to compare the three interventions for 3 consecutive nights in children with type 1 diabetes in a diabetes camp
The investigators aim to conduct a randomized three-way cross-over trial comparing single hormone closed-loop strategy dual-hormone closed-loop strategy and the conventional pump therapy The investigators aim to compare the three interventions for 3 consecutive nights in children with type 1 diabetes in a diabetes camp
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None