Effects of Pulsed Intravenous (IV) Insulin on Brittle and Uncontrolled Diabetes
Stopped early · Phase 3
Conditions studied: Diabetes Mellitus
In brief
The purpose of this study is to determine if restoring normal metabolic function in patients with either type I or type II diabetes can improve the impact of the consequences of diabetic complications specifically on the wide swings in blood glucoses with erratic control even under optimal conditions. Patients are treated once a week with pulsatile intravenous insulin therapy mimicking normal insulin secretion. Blood sugar diaries and laboratory tests including quarterly Hemoglobin A1c levels are monitored to measure progress and outcomes.
Key facts
- Study ID
- NCT01029444
- Run by
- Florida Atlantic University
- People needed
- 300
- Starts
- 2007-03-01
- Expected to finish
- 2012-03-01
- Last updated by the study team
- 2016-02-03
Who can join
Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- The researchers will include up to 300 patients both male and female between the ages of 18 and 85 diagnosed with type 1 or type 2 diabetes mellitus.
- Self reporting or diagnosed with significant complications resulting from diabetes.
- Taking oral agents and/or insulin for diabetic control.
- Under an Endocrinologists supervision for their diabetes management.
- Endocrinologist must assess and approve patient for participation in this study.
- Ability to swallow without difficulty.
- 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.
- Positive HIV.
- Inability to breathe into machine for respiratory quotients.
Where it is running
- Florida Atlantic University — Boca Raton, Florida, United States
Full record on ClinicalTrials.gov
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