Insulin Infusion Diabetes Ulcer

What Was Tested

The trial (not phased) is built around Insulin (regular human) and Insulin Aspart for insulin resistance, prediabetes & type 2 diabetes.

Normoglycemia is important for the outcome of surgical and medical conditions.

Insulin given by subcutaneous injections has longer duration compared to intravenous given insulin which makes it more difficult to control.

It had two arms (groups): Insulin infusion (aspart) (experimental) and Standard care (no intervention).

Glucose control according to standard care at the ward, i.e., sliding scale insulin at the discretion of responsible physician.

The registry classes the interventions as procedure.

More on the Plan

Introduction: Normoglycemia is important for the outcome of acute surgical and medical conditions.

Insulin given by subcutaneous injections has duration between 3- 36 hours depending on the insulin brand and injection site compared to 10 minutes for intravenous given insulin.

Therefore, the researchers aim to investigate the importance of normoglycemia for the optimal treatment of ulcer infection and/ or during routine cardio- vascular surgery care among diabetics.

The infusion starts when patients who met the eligibility criteria has signed the informed consent.

Who Took Part

The registry lists 40 actual participants took part.

It was open to people of any sex aged from 18 years up to 99 years.

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

Examples of who could join: Patients are eligible for inclusion if the following criteria are fulfilled:. Patients with diabetes type 1 or type 2. Older than 18 years. Patients scheduled for cardio- vascular surgery and/ or acute ulcer infection. Informed consent obtained.

The full record lists 6 inclusion and 7 exclusion criteria; among the exclusions: patients having any of the following at randomization will not be included in the study:; unconsciousness: not possible to wake up; ketoacidosis: ph less or equal to 7.30.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

The insulin resistance, prediabetes & type 2 diabetes participants were allocated by chance, so the Insulin (regular human) group and the comparison group should start out alike.

The Insulin (regular human) group and the comparison group ran side by side rather than switching.

Being open-label, the Insulin (regular human) study did not mask who received what.

It started in 2011-11 with completion listed for 2020-12-21.

It ran at 1 site in Sweden.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Plasma glucose levels (time frame: 4 weeks).

It also tracked 3 secondary outcomes, for example Hospital stay, HbA1c and laboratories for inflammation and oxidative stress.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Insulin (regular human) and Insulin Aspart in 40 people with insulin resistance, prediabetes & type 2 diabetes.

It ended early (terminated); 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, Insulin resistance, prediabetes & type 2 diabetes research.