Efficiency of Two Glucose Sampling Protocols for Maintenance of Euglycemia

What Was Tested

This registered early phase 1 trial tested Insulin (regular human).

The investigators hypothesize that in non-diabetic patients undergoing craniotomy, monitoring glucose and modifying insulin infusions every 30 minutes compared to every hour will help them reach target glucose levels faster and maintain them more efficiently with the same insulin protocol.

It had two arms (groups): Q1 hour protocol (active comparator) and Q30min protocol (active comparator).

Change of insulin infusion every hour.

Change of insulin infusion every 30 minutes.

The registry classes the interventions as drug.

More on the Plan

Because the strength of these data, the investigators utilize an aggressive insulin protocol in their routine clinical care of patients undergoing craniotomies.

Blood glucose levels, insulin boluses and infusion rates, and dextrose boluses will be recorded on the respective Intraoperative Insulin \& Glucose data sheet (Appendix 2 and 3 for Group 30 and Group 60, respectively).

Regardless of the protocol, glucose measurements will be conducted every 15 minutes but insulin intervention will be done at 30 minutes or one hour (per assigned treatment group).

For these rescued patients, the protocol will be continued as scheduled.

Who Took Part

Enrollment: 120 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: All English speaking, non-diabetic, non-pregnant patients over the age of 18 undergoing open craniotomy for the surgical treatment of tumors or intracranial aneurysms.

The full record lists 1 inclusion and 1 exclusion criteria; among the exclusions: patients under 18 years of age, patients who are pregnant, patients with diabetes, bmi \> 33 kg/m2.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

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.

Nothing was hidden in this open-label Insulin (regular human) study: the participants and staff both knew the treatment.

It started in 2009-10 with completion listed for 2012-08.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): performance of each of glucose sampling and insulin protocols for achieving euglycemia (time frame: duration of operation).

It also tracked 4 secondary outcomes, for example hypoglycemia, time required to reach euglycemia, relationship of BMI and performance of protocols and relationship of serum biomarkers of insulin resistance and performance of protocols.

What This Means in Plain Language

Put simply, this is a early phase 1, randomized trial of Insulin (regular human) in 120 people.

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.