Insulin in Total Parenteral Nutrition

What Was Tested

This registered phase 4 trial tested Insulin Glargine.

Analyze the level of metabolic control achieved with a routine of regular insulin in the parenteral nutrition (PN) reservoir in addition to subcutaneous glargine insulin, versus only regular insulin in the PN reservoir.

It had two arms (groups): Glargine insulin (experimental) and Regular insulin (active comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 163 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

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

Examples of who could join: Adults (\>18 years). Previously diagnosed with diabetes mellitus. Hospitalized but without intensive cares. Signature of informed consent.

The full record lists 5 inclusion and 6 exclusion criteria; among the exclusions: diabetes mellitus type 1, diabetes secondary to total pancreatectomy; patients with intensive cares; patients who have been prescribed tpn in intensive cares unity more than 48 hours before admission to hospitalization.

How the Study Was Run

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

Random assignment meant chance, not the researchers, decided who got Insulin Glargine and who got the comparison, which limits bias.

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

Everyone knew when Insulin Glargine was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2016-07-01 with completion listed for 2018-03-31.

It ran at 32 sites in Spain (32).

Its stated primary purpose is screening.

What Was Measured

The main thing measured (primary outcome): Basal blood glucose value before starting TPN (time frame: Before starting total parenteral nutrition). Periodical blood glucose (time frame: Every 6h during 15 days of treatment). Number of hypoglycaemia (time frame: During TPN treatment up to 15 days).

It also tracked 2 secondary outcomes, for example Standard deviation of blood glucose and Blood glucose coefficient of variation (CV).

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Glargine in 163 people.

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

More context: the Insulin Glargine compound page, all human trials.