Effects of Pulsatile Intravenous Insulin Delivery on Hypoglycemic Unawareness
Withdrawn before enrolling · Phase 2/Phase 3
Conditions studied: Hypoglycemia
In brief
Hypoglycemic unawareness is a major problem in the treatment of Diabetes Mellitus. Hypoglycemic unawareness is the inability to recognize or sense early symptoms of low blood sugar. This study was instituted to evaluate the effect of Pulsatile intravenous (IV) Insulin on improving or reinstating the diabetics ability to sense or feel the symptoms associated with low blood sugar.
Key facts
- Study ID
- NCT01029639
- Run by
- Florida Atlantic University
- People needed
- 0
- Starts
- 2007-01-01
- Expected to finish
- 2009-08-01
- Last updated by the study team
- 2016-08-10
Who can join
Age: 20 and older, up to 90. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Up to 400 patients both male and female between the ages of 20 and 90 diagnosed with type 1 or type 2 diabetes mellitus.
- All patients were diagnosed by their endocrinologists as having hypoglycemic unawareness, inability to sense low blood sugars.
- All patients had failed conventional treatment for hypoglycemic unawareness.
- All patients are taking oral agents and/or insulin for diabetic control.
- All patients are under an endocrinologist's supervision for their diabetes management.
- Endocrinologist must assess and approve patient for participation in this study.
- All patients must demonstrate the ability to swallow without difficulty and the ability to commit to the weekly time requirements associated with the study.
You may not qualify if…
- Other causes of complications not related to diabetes.
- Lack of intravenous access.
- Pregnancy.
- Alcohol abuse, drug addiction or the use of illegal drugs.
- HIV positive.
- Inability to breathe into machine for respiratory quotients.
Where it is running
- Florida Atlantic University Center for Complex Systems and Brain Sciences — Boca Raton, Florida, United States
Full record on ClinicalTrials.gov
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