Comparison of continuous subcutaneous insulin infusion and multiple daily injection regimens using insulin lispro in type 1 diabetic patients on intensified treatment: a randomized study. The Study Group for the Development of Pump Therapy in Diabetes

What Was Tested

Researchers studied Insulin Lispro in this randomized controlled trial publication.

Who Took Part

PubMed indexes the participants as adults, middle-aged adults and older adults, both men and women.

A total of 41 C-peptide-negative type 1 diabetic patients (age 43.5+/-10.3 years; 21 men and 20 women, BMI 24.0+/-2.4 kg/m2, diabetes duration 20.0+/-11.3 years) on intensified insulin therapy (MDI with regular insulin or lispro, n = 9, CSII with regular insulin, n = 32) were included in an open-label randomized crossover study comparing two 4-month periods of intensified insulin therapy with lispro: one period by MDI and the other by CSII.

How the Study Was Run

The researchers set it up as a randomized, open-label and crossover study.

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

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

In the crossover set-up each of the participants took both Insulin Lispro and the comparison in turn, acting as their own control.

Blood glucose (BG) was monitored before and after each of the 3 meals each day.

What Was Measured

The subject headings attached to it are Blood Glucose, Diabetes Mellitus, Type 1, Glycated Hemoglobin, Hypoglycemic Agents, Insulin, Insulin Infusion Systems and Insulin Lispro.

What This Means in Plain Language

The paper is a randomized, open-label and crossover study of Insulin Lispro.

The abstract goes on to report its results in about 8 sentences; this page does not restate them, so read the paper for the findings and their limits.

The publication is from 2000 (Diabetes care), a journal based in United States.

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