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Insulin

Pulsatile Intravenous Insulin Therapy (Humulin R, Novolog) for Low Blood Sugar

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

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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

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.

Find a Location

Who is running the clinical trial?

Florida Atlantic UniversityLead Sponsor
30 Previous Clinical Trials
9,849 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
~0 spots leftby Sep 2025
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