Effects of Pulsatile Intravenous Insulin Delivery on Hypoglycemic Unawareness

What Was Tested

In this phase 2, phase 3 trial, researchers set out to test Insulin (regular human) and Insulin Aspart.

Hypoglycemic unawareness is the inability to recognize or sense early symptoms of low blood sugar.

It had two arms (groups): one (no intervention) and Pulsatile Intravenous Insulin Therapy (Humulin R, Novolog) (experimental).

The registry classes the interventions as procedure.

More on the Plan

Hypoglycemic Unawareness is the inability for the diabetic patient to sense early symptoms of low blood sugar.

Pulsatile IV insulin therapy encourages the glucose metabolism in diabetics to normalize in multiple organs, especially muscle, retina, liver, kidney and nerve endings.

The process is monitored by frequent measuring of glucose levels and respiratory quotients (RQ).

RQ is measured by a metabolic cart which determines the ratio VCO2/VO2.

Who Took Part

It was open to people of any sex aged from 20 years up to 90 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: All patients were diagnosed by their endocrinologists as having hypoglycemic unawareness, inability to sense low blood sugars. All patients are taking oral agents and/or insulin for diabetic control. Endocrinologist must assess and approve patient for participation in this study.

The full record lists 7 inclusion and 6 exclusion criteria; among the exclusions: lack of intravenous access; alcohol abuse, drug addiction or the use of illegal drugs; HIV positive.

How the Study Was Run

Design: non-randomized, parallel-group and single-blind.

Groups ran in parallel: each of the participants stayed in one arm throughout.

In this single-blind Insulin (regular human) study one party knew the assignments and the other did not.

Those kept unaware of assignments: investigator.

It started in 2007-01 with completion listed for 2009-08.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Questionnaires completed by subjects at baseline quarterly to assess ability to sense low blood sugar. Tracking incidences requiring outside assistance including paramedics, ER visits and hospitalizations due to low blood sugar incidences (time frame: Every 3 months).

What This Means in Plain Language

Put simply, this is a phase 2, phase 3, non-randomized trial of Insulin (regular human) and Insulin Aspart in people.

It was withdrawn before enrolling anyone; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Insulin (regular human) compound page and the Insulin Aspart compound page, all human trials.