Status:
COMPLETED
Counter-Regulatory Impairment and the Effect of Microvascular Insulin Transfer in Type 1 Diabetes Mellitus
Lead Sponsor:
University of Virginia
Conditions:
Diabetes Mellitus, Type 1
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The researchers plan to test the following hypothesis: A good level of glucose control in Type 1 Diabetes Mellitus (T1DM) is dependent on two levels of feedback from the body: 1. the transport of in...
Eligibility Criteria
Inclusion
- Participated in and satisfied all of the inclusion criteria of NCT00315939
- 18 years of age or older
- Have Type 1 Diabetes Mellitus defined by American Diabetes Association criteria or judgment of physician
- Since our major goal is the investigation of hypoglycemia, we will preferentially recruit patients with a history of severe hypoglycemia/moderate hypoglycemia anticipating that approximately (\~) half of the recruited subjects will have had two or more severe or moderate hypoglycemia episodes in the past 12 months
Exclusion
- Age \< 18
- Pregnancy
- Use of oral steroids
- Hematocrit \< 36% (females); \< 38% (males)
- Symptomatic heart disease (e.g., history of myocardial infarction, history of coronary bypass or stenting procedure, angina, episode of chest pain of cardiac etiology with documented EKG changes, positive stress test or catheterization with coronary blockages \> 50%)
- History of an ischemic cerebrovascular event
- Active substance abuse
- Psychosis
- Mental retardation
- Severe depression
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2009
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT00943787
Start Date
January 1 2006
End Date
May 1 2009
Last Update
September 8 2014
Active Locations (1)
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1
University of Virginia Health System - Behavioral Medicine Center
Charlottesville, Virginia, United States, 22908