Effects of Intensive Bolus Intravenous Insulin Delivery on Metabolic Integrity in Type 1 and Type 2 Diabetes
NCT01023165 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2000
Last updated 2011-06-22
Summary
The purpose of this study is to determine if restoring normal metabolic function in patients with type 1 or type 2 diabetes can improve the impact of the consequences of diabetic complications on the overall health and quality of life for diabetic patients.Patients are treated once per week with intensive bolus intravenous insulin delivery mimicking normal insulin secretions in a non diabetic individual. Baseline and periodic diagnostic tests are performed and questionnaires completed to evaluate and monitor progress and outcomes.
Conditions
- Diabetes Mellitus
- Metabolic Integrity
Interventions
- PROCEDURE
-
Humulin, Humalog, Novolog
Supervising Physician reviews patient activation after intravenous bolus insulin treatment each week and adjusts the amounts of insulin and carbohydrates to be given in the next treatment session based on patient treatment outcomes.
Sponsors & Collaborators
-
Global Infusion and Aspiration Systems, LLC
lead OTHER
Principal Investigators
-
Michael Cockrell, MD · Global Infusion and Aspiration Systems, LLC
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 95 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2009-11-30
- Primary Completion
- 2014-11-30
- Completion
- 2015-11-30
Countries
- United States
Study Locations
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