Evaluation of the Prandial Treatment Adjustment Effect Via Continuous Glucose Monitoring on Type 2 Diabetes Mellitus (DM) Patients Uncontrolled With a Basal Insulin or Premix Once a Day

What Was Tested

In this phase 4 trial, researchers set out to test Insulin Glargine.

Primary Objective: To evaluate the effect of prandial treatment adjustment, based on continuous blood glucose monitoring, on glucose control in type 2 diabetes patients who are not controlled by treatment with once daily basal insulin or mixed insulin, requiring treatment with basal plus regimen.

It had two arms (groups): Arm A: Without Continous Glucose Monitoring (CGM) sensor (active comparator) and Arm B: Continous Glucose Monitoring (CGM) sensor (experimental).

The registry classes the interventions as drug.

More on the Plan

The study duration for each patient is 24 weeks +/- 1 week broken down as follows: * Run-in phase: 8 weeks * Follow - up Period: 16 weeks The maximal possible time window during the study is +/- one week throughout the study.

Who Took Part

219 actual participants took part.

It was open to people of any sex aged from 21 years with no upper age limit.

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

Examples of who could join: Type 2 diabetes. Age above 21 years. Patients continuously treated with basal insulin or mixed insulin once daily for the last 6 months. Signed informed consent form. Patients who according to their physician are eligible to the study.

The full record lists 8 inclusion and 6 exclusion criteria; among the exclusions: type 1 diabetes; patients continuously treated with short-acting insulin or mixed insulin more than once daily for 3 weeks during the last 6 months; pregnant or breastfeeding women.

How the Study Was Run

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

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.

Groups ran in parallel: each of the participants stayed in one arm throughout.

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 2012-12 with completion listed for 2015-04.

It ran at 11 sites in Israel (11).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Changes in Hemoglobin A1c (HbA1c) level (time frame: Baseline, week 24).

It also tracked 3 secondary outcomes, for example Rate of hypoglycemia.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Glargine in 219 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.