Safety and Efficacy Study of Correcting Hyperglycemia in Patients With Diabetes Having Out-patient Surgery

What Was Tested

This registered phase 4 trial tested Insulin (regular human) and Insulin Lispro.

Subjects will not be paid for their participation and will be assured of treatment for their hyperglycemia regardless of study participation.

It had two arms (groups): Group 1-Regular Insulin (active comparator) and Group 2-Humalog (active comparator).

Intravenous Regular Insulin will be administered for a preoperative Blood glucose of greater than 180.

Subcutaneous Humalog will be administered for a preoperative Blood glucose of greater than 180.

The registry classes the interventions as drug.

More on the Plan

All patients with diabetes will undergo a blood sugar measurement upon arrival to the ASC using the Accuchek blood glucose meter.

An admission blood sugar of \>180 in a patient with diabetes qualifies the patient for study screening.

Subjects will be approached after confirmation of eligibility for the study.

Randomization, then treatment, will occur immediately following written informed consent.

Who Took Part

It was open to people of any sex aged from 18 years up to 80 years.

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

Examples of who could join: Male or female patients between the ages of 18 and 80 years with type 1 and type 2 diabetes. Patients undergoing ambulatory surgery. A known history of diabetes for \> 3 months treated with diet, oral antidiabetic agents and/or insulin therapy. Patients willing and able to provide informed consent.

The full record lists 5 inclusion and 7 exclusion criteria; among the exclusions: age \< 18 or \> 80; patients on an insulin pump; current or recent (within 3 months) treatment with oral or injectable corticosteroid, parenteral nutrition and immunosuppressive treatment.

How the Study Was Run

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

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 2013-10 with completion listed for 2018-09.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: BG concentration differences at 1 and 2 hours post intervention and post operatively (time frame: one and two hours post intervention, post operative period).

It also tracked 6 secondary outcomes, for example Number and percentage of target BG readings, Episodes of hypoglycemia, Episodes of hyperglycemia, Change in glucose concentration from baseline to one, two and three hours post treatment and Number of perioperative complications.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin (regular human) and Insulin Lispro 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 Lispro compound page, all human trials.