Exploratory CSII Trial on Erectile Dysfunction in T2DM Patients

What Was Tested

The trial (phase 4) is built around Insulin (regular human).

It had two arms (groups): CSII (experimental) and MDI (active comparator).

Continuous subcutaneous insulin infusion.

Multiple daily insulin injections.

The registry classes the interventions as drug.

More on the Plan

Neuropathy is a major contributor to diabetic ED.

Continuous Sub-cutaneous Insulin Infusion The Continuous Subcutaneous Insulin Infusion (CSII) Pump (insulin pump for short) is a pager-sized device which can be connected to the body through an infusion set so as to deliver insulin continuously.

It consists of a disposable reservoir for insulin, a disposable infusion set, including a cannula for subcutaneous insertion and a tubing system which connects the insulin reservoir to the cannula.

Insulin pumps were popularly used in T1DM but nowadays insulin pumps are commonly used in T2DM patients as well.

Who Took Part

The registry lists 20 actual participants took part.

It was open to men only aged from 25 years up to 65 years.

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

Examples of who could join: Mild ED to Moderate ED as defined by International Index of Erectile Function (IIEF) questionnaire. Able and willing to use insulin pumps for at least the duration of the study.

The full record lists 3 inclusion and 5 exclusion criteria; among the exclusions: severe dysfunction in iief score or duration of ed more than 3 years; medications: substance abuse, anticancer and steroid therapy; sexual dysfunction in partner, lack of stable relationship.

How the Study Was Run

The set-up was randomized, parallel-group and single-blind.

Because people in this Insulin (regular human) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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: outcomes assessor.

It started in 2012-01 with completion listed for 2014-09.

It ran at 1 site in India.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change in total International Index of Erectile Function (IIEF) score from baseline to six months (time frame: baseline and six months).

It also tracked 1 secondary outcome, for example Global assessment question on erectile function.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin (regular human) in 20 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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