Closed-loop Control of Overnight Glucose Levels (Artificial Pancreas) in

Status Completed

Clinical Trial 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 sensor's 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

Clinical Trial 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 sensor's 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02189694
Study type	Interventional
Source	Institut de Recherches Cliniques de Montreal
Contact
Status	Completed
Phase	Phase 2
Start date	June 2014
Completion date	August 2014

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05653518` - Artificial Pancreas Technology to Reduce Glycemic Variability and Improve Cardiovascular Health in Type 1 Diabetes	N/A
Enrolling by invitation	`NCT05515939` - Evaluating the InPen in Pediatric Type 1 Diabetes
Completed	`NCT05109520` - Evaluation of Glycemic Control and Quality of Life in Adults With Type 1 Diabetes During Continuous Glucose Monitoring When Switching to Insulin Glargine 300 U/mL
Recruiting	`NCT04016987` - Automated Structured Education Based on an App and AI in Chinese Patients With Type 1 Diabetes	N/A
Active, not recruiting	`NCT04190368` - Team Clinic: Virtual Expansion of an Innovative Multi-Disciplinary Care Model for Adolescents and Young Adults With Type 1 Diabetes	N/A
Recruiting	`NCT05413005` - Efficacy of Extracorporeal Photopheresis (ECP) in the Treatment of Type 1 Diabetes Mellitus	Early Phase 1
Active, not recruiting	`NCT04668612` - Dual-wave Boluses in Children With Type 1 Diabetes Insulin Boluses in Children With Type 1 Diabetes	N/A
Completed	`NCT02837094` - Enhanced Epidermal Antigen Specific Immunotherapy Trial -1	Phase 1
Recruiting	`NCT05414409` - The Gut Microbiome in Type 1 Diabetes and Mechanism of Metformin Action	Phase 2
Recruiting	`NCT05670366` - The Integration of Physical Activity Into the Clinical Decision Process of People With Type 1 Diabetes	N/A
Active, not recruiting	`NCT05418699` - Real-life Data From Diabetic Patients on Closed-loop Pumps
Completed	`NCT04084171` - Safety of Artificial Pancreas Therapy in Preschoolers, Age 2-6	N/A
Recruiting	`NCT06144554` - Post Market Registry for the Omnipod 5 System in Children and Adults With Type 1 Diabetes
Recruiting	`NCT05153070` - Ciclosporin Followed by Low-dose IL-2 in Patients With Recently Diagnosed Type 1 Diabetes	Phase 2
Recruiting	`NCT05379686` - Low-Dose Glucagon and Advanced Hybrid Closed-Loop System for Prevention of Exercise-Induced Hypoglycaemia in People With Type 1 Diabetes	N/A
Completed	`NCT05281614` - Immune Effects of Vedolizumab With or Without Anti-TNF Pre-treatment in T1D	Early Phase 1
Withdrawn	`NCT04259775` - Guided User-initiated Insulin Dose Enhancements (GUIDE) to Improve Outcomes for Youth With Type 1 Diabetes	N/A
Active, not recruiting	`NCT01600924` - Study on the Assessment of Determinants of Muscle and Bone Strength Abnormalities in Diabetes
Completed	`NCT02914886` - Beneficial Effect of Insulin Glulisine by Lipoatrophy and Type 1 Diabetes (LAS)	Phase 4
Completed	`NCT02855307` - Closed-loop Control of Glucose Levels (Artificial Pancreas) During Postprandial Exercise in Adults With Type 1 Diabetes	Phase 2

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Closed-loop Control of Overnight Glucose Levels (Artificial Pancreas) in Children With Type 1 Diabetes in a Diabetes Camp

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms