A Study of the Rules for Insulin Dosing in Patients Using Multiple Daily Injections

What Was Tested

This registered not phased trial tested Insulin Glargine and Insulin Lispro.

Subjects will be evaluated using continuous glucose monitoring.

The registry classes the interventions as drug.

More on the Plan

Subjects will be placed on continuous glucose sensor (CGMS) and an isocaloric diet.

Subject will do four SMBGs daily to calibrate CGMS and on last day a 7-point SMBG. subjects will be on lispro and glargine insulin.

Basal insulin will be once a day.

Who Took Part

50 planned participants were the target.

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: Age: \>17 years. On treatment with multiple daily injections either one or more basal insulin injections each day for 6 weeks.

The full record lists 8 inclusion and 11 exclusion criteria; among the exclusions: major stress event during or for 6 weeks before the evaluation; taking a medication that can alter insulin sensitivity; within one week of menses.

How the Study Was Run

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

Nothing was hidden in this open-label Insulin Glargine study: the participants and staff both knew the treatment.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2010-01 with completion listed for 2010-08.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What This Means in Plain Language

Put simply, this is a not phased, non-randomized trial of Insulin Glargine and Insulin Lispro in 50 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

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