Pulsatile Intravenous Insulin Therapy (Humulin R, Novolog) for Hypoglycemia

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
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

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

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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