Long Acting Insulin Glargine Titration Web Tool (LTHome) vs Enhanced Usual Therapy of Glargine Titration

What Was Tested

The trial (not phased) is built around Insulin Glargine.

It had two arms (groups): LTHome web tool (experimental) and Enhanced Usual Therapy (EUT) (active comparator).

The registry classes the interventions as other.

Who Took Part

The registry lists 139 actual participants took part.

It was open to people of any sex aged from 18 years up to 75 years.

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

Examples of who could join: Signed written informed consent. Patients with poor blood glucose control defined by:. Patients proficient in computer literacy.

The full record lists 9 inclusion and 17 exclusion criteria; among the exclusions: any technical/administrative reason that makes it impossible to include the patient in the study, including closing enrollment due to full enrollment; patient who has previously participated in any clinical trial investigating the lthome algorithm; patient who withdraws consent during screening (starting from signed informed consent form).

How the Study Was Run

Design: randomized, parallel-group and open-label.

Because people in this Insulin Glargine study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Insulin Glargine group and the comparison group ran side by side rather than switching.

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 2013-12 with completion listed for 2015-03.

It ran at 1 site in Canada.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Percentage of subjects reaching fasting plasma glucose (FPG) target (time frame: 12 weeks).

It also tracked 20 secondary outcomes, for example Number of days to first reach fasting plasma glucose target, Number of days in target range after reaching fasting plasma glucose target, Fasting plasma glucose, Hemoglobin A1c (HbA1c), Rate of documented hypoglycemia in subjects that reach target and Rate of documented hypoglycemia in subjects that do not reach target.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Insulin Glargine in 139 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.