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Insulin
Effects of Intensive Bolus Intravenous Insulin Delivery on Metabolic Integrity in Type 1 and Type 2 Diabetes
Phase 3
Waitlist Available
Led By Michael Cockrell, MD
Research Sponsored by Global Infusion and Aspiration Systems, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Pivotal Trial
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.
Eligible Conditions
- Diabetes
- Metabolic Syndrome
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
1Treatment groups
Experimental Treatment
Group I: IV bolus insulin, metabolic integrityExperimental Treatment1 Intervention
Diabetic patients will complete diagnostic testing and complete quality of life questionnaires at baseline and every six months thereafter while enrolled in the study to monitor and assess progress with metabolic integrity and complications resulting from their diabetes. Comparisons will be performed on lab values performed at baseline and every six months thereafter. Supervising physician may request testing be performed more frequently as deemed medically necessary, testing may include retinal photography, nerve conduction and labs. Meds and medical intervention information is collected weekly at the Intravenous Bolus Insulin treatment sessions. An annual evaluation is performed to review clinical data collected and evaluate progress for analysis and comparison.
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Who is running the clinical trial?
Global Infusion and Aspiration Systems, LLCLead Sponsor
Michael Cockrell, MDPrincipal InvestigatorGlobal Infusion and Aspiration Systems, LLC