MedTrace Logo

Effects of Pulsed Intravenous (IV) Insulin on Brittle and Uncontrolled Diabetes

NCT01029444 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2016-02-03

No results posted yet for this study

Summary

The purpose of this study is to determine if restoring normal metabolic function in patients with either type I or type II diabetes can improve the impact of the consequences of diabetic complications specifically on the wide swings in blood glucoses with erratic control even under optimal conditions. Patients are treated once a week with pulsatile intravenous insulin therapy mimicking normal insulin secretion. Blood sugar diaries and laboratory tests including quarterly Hemoglobin A1c levels are monitored to measure progress and outcomes.

Conditions

Interventions

PROCEDURE

Pulsatile Intravenous Insulin Therapy (Humulin, Humulog, Novolog )

Patients receive weekly treatments of Pulsatile Intravenous insulin therapy. The patient's Endocrinologist determines the insulin dosage each week based upon the patient's response to treatment RQ levels and their insulin resistance.

Sponsors & Collaborators

  • Advanced Diabetes Treatment Centers

    collaborator OTHER

  • Florida Atlantic University

    lead OTHER

Principal Investigators

  • Betty Tuller, PhD · Florida Atlantic University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-03-31
Primary Completion
2011-03-31
Completion
2012-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01029444 on ClinicalTrials.gov