Impact of Hypoglycemia Unawareness on Brain Metabolism Cognition in T1DM

Status Completed

Clinical Trial Summary

The research study is designed to examine the impact of low blood sugar on brain function in individuals with Type 1 Diabetes who have frequent and severe hypoglycemia (low blood sugar) compared to those who do not.

Clinical Trial Description

During the course of treating diabetes (for example, after an insulin injection), blood sugar levels will sometimes drop too low. This condition is known as hypoglycemia. Normally, a healthy body responds to hypoglycemia by producing a number of "anti-insulin" hormones which raise blood sugar levels. In addition, these hormones provide the individual with warning signals of hypoglycemia, including hunger, sweating, shaking and heart palpitations. These warning signals allow diabetics to correct low blood sugar levels by eating sugar tablets or by having a snack.

Unfortunately, and for unclear reasons, many people with longstanding diabetes lose their ability to recognize low blood sugar levels-a condition called "hypoglycemia unawareness." The brain, in particular, is extremely sensitive to hypoglycemia. Unable to sense and respond to low blood sugar levels, these individuals may experience a sudden onset of blurred vision, confusion, seizures, coma, or even death.

In recent years, a new technique called "islet cell transplantation" has been developed as an alternate means of treating insulin-dependent diabetes. Pancreatic islet cells (the cells that produce insulin), from human donors, are injected into the diabetic patient's liver where the cells are capable of making insulin and can regulate blood sugar levels without the need for insulin injections. Currently, this technique is used primarily in patients with severe hypoglycemia unawareness.

While it is known that islet cell transplantation can reduce the risk of severe hypoglycemia, the effects of transplantation on hypoglycemia unawareness are unknown. This study is designed to investigate why hypoglycemia unawareness happens and the impact it has on brain function in individuals with type 1 diabetes. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00575783
Study type	Observational
Source	Yale University
Contact
Status	Completed
Phase
Start date	August 2005
Completion date	August 2008

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	`NCT05379686` - Low-Dose Glucagon and Advanced Hybrid Closed-Loop System for Prevention of Exercise-Induced Hypoglycaemia in People With Type 1 Diabetes	N/A
Recruiting	`NCT05153070` - Ciclosporin Followed by Low-dose IL-2 in Patients With Recently Diagnosed Type 1 Diabetes	Phase 2
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	`NCT02750527` - Pediatric Population Screening for Type 1 Diabetes and Familial Hypercholesterolemia in Lower Saxony, Germany
Completed	`NCT02897557` - Insulet Artificial Pancreas Early Feasibility Study	N/A