Effect Pulsatile IV Insulin Therapy on the Quality of Life in Patients With Types 1 and 2 Diabetes

Stopped early · Phase 2/Phase 3

Conditions studied: Diabetes Mellitus

In brief

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 on the overall quality of life of diabetic patients. Patients are treated once a week with pulsatile intravenous insulin therapy mimicking normal insulin secretion. A 44 item questionnaire is completed prior to the start of the treatment and quarterly thereafter with detailed analysis performed to measure progress and outcomes.

Key facts

Study ID

NCT00228878

Run by

Florida Atlantic University

People needed

152

Starts

2003-03-01

Expected to finish

2009-08-01

Last updated by the study team

2016-08-10

Who can join

Age: 21 and older, up to 85. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• The researchers will include up to 200 patients both male and female between the ages of 21 and 85 diagnosed with type 1 or type 2 diabetes mellitus.
• Self reporting or diagnosed with significant complications resulting from diabetes
• Taking oral agents and/or insulin for diabetic control
• Under an Endocrinologists supervision for their diabetes management. Endocrinologist must assess and approve patient for participation in this study
• Ability to swallow without difficulty
• Ability to commit to the weekly time requirements associated with the study

You may not qualify if…

• Other causes of complications not related to diabetes
• Inability to respond to 44 item questionnaire
• Lack of intravenous access
• Pregnancy
• Alcohol abuse, drug addiction or the use of illegal drugs
• Positive HIV
• Inability to breathe into machine for respiratory quotients

Where it is running

• Florida Atlantic University — Boca Raton, Florida, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.