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Insulin
Effects of Pulsatile Intravenous Insulin Delivery on Hypoglycemic Unawareness
Phase 2 & 3
Waitlist Available
Led By Betty Tuller, PhD
Research Sponsored by Florida Atlantic University
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
Summary
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.
Eligible Conditions
- Hypoglycemia Anxiety Disorder
- Low Blood Sugar
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.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Pulsatile Intravenous Insulin Therapy (Humulin R, Novolog)Experimental Treatment1 Intervention
Endocrinologist reviews patient activation after treatment each week and adjust the amounts of insulin and carbohydrates to be given in the next session
Group II: TreatmentActive Control1 Intervention
Diabetic patients will complete hypoglycemia unawareness questionnaires at baseline and quarterly thereafter to monitor and assess progress with complications resulting from their diabetes. Comparisons will be performed on low blood sugar incidences reported by subjects requiring heath care intervention other than by the subject themselves.
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Who is running the clinical trial?
Florida Atlantic UniversityLead Sponsor
33 Previous Clinical Trials
11,029 Total Patients Enrolled
Advanced Diabetes Treatment CentersOTHER
10 Previous Clinical Trials
1,238 Total Patients Enrolled
Global InfusionsIndustry Sponsor
3 Previous Clinical Trials
302 Total Patients Enrolled
Betty Tuller, PhDPrincipal InvestigatorFlorida Atlanctic University
6 Previous Clinical Trials
756 Total Patients Enrolled