The DCCT demonstrated that intensive diabetes therapy prevents the onset or slows the progression of the long-term complications of type 1 diabetes. Yet, intensive diabetes therapy as implemented in the DCCT was associated with a 3-fold increase in the risk of severe hypoglycemia, which is presumed to be a trigger of cardiac arrhythmias and subsequent sudden death. Additional risk factors for the development of arrhythmias include cardiovascular autonomic neuropathy, genetic predisposition, and coronary artery disease; all of which have been assessed in the DCCT/EDIC cohort over time. To more fully understand the relationship of hypoglycemia and disturbances in cardiac rhythm, we propose to monitor the electrocardiogram and glucose levels for one week in at least 1,200 of the surviving DCCT/EDIC participants with the following objectives: 1) to determine the effects of hypoglycemia on the risk of ventricular and other arrhythmias in patients with type 1 diabetes; 2) to characterize the phenotype of those patients with type 1 diabetes with the highest risk for arrhythmia in the presence of hypoglycemia. The information uncovered through this proposal will guide clinicians in their individualized management of patients with type 1 diabetes to prevent catastrophic sudden death.

Public Health Relevance

Hypoglycemia remains a frequent and major concern for patients living with type 1 diabetes and practicing intensive diabetes management. With over 30 years of prospectively gathered data, the DCCT/EDIC cohort provides the unique opportunity to study the relationship of hypoglycemia and cardiac rhythm and to identify the risk factors for cardiac arrhythmias in long-established type 1 diabetes. We plan to complete this work with simultaneous, continuous monitoring of the electrocardiogram and glucose levels over one week in the DCCT/EDIC cohort. Thus, this study will be the largest cardiac safety assessment of hypoglycemia and help guide clinicians' efforts to prevent cardiac arrhythmias and sudden death in patients with type 1 diabetes.

Agency
National Institute of Health (NIH)
Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Type
Type 1 Diabetes Targeted Research Award (DP3)
Project #
1DP3DK106890-01
Application #
8973702
Study Section
Special Emphasis Panel (ZDK1-GRB-N (M2))
Program Officer
Teff, Karen L
Project Start
2015-09-24
Project End
2018-08-31
Budget Start
2015-09-24
Budget End
2018-08-31
Support Year
1
Fiscal Year
2015
Total Cost
$1,144,367
Indirect Cost
$312,501
Name
Case Western Reserve University
Department
Pediatrics
Type
Schools of Medicine
DUNS #
077758407
City
Cleveland
State
OH
Country
United States
Zip Code
44106