Comparison of a Twice Daily Versus a Three Times Daily Insulin Regimen in Children With Type 1 Diabetes

What Was Tested

In this not phased trial, researchers set out to test Insulin Detemir and NPH Insulin (isophane).

The purpose of this study is to determine whether there is a difference in blood sugar control (as measured by hemoglobin A1c (HA1c)), in children given twice daily insulin injections incorporating a new long acting insulin analogue (detemir) compared to children using their current three times a day insulin injections (with intermediate and rapid acting insulin).

It had two arms (groups): BID insulin with LA analogue (experimental) and Standard TID insulin (active comparator).

Treatment Group: BID Insulin Regimen with Long Acting Insulin Analogue (Detemir).

Active Control Group: Usual TID Insulin Regimen (intermediate insulin- Humulin N or Novolin NPH).

The registry classes the interventions as drug and other.

More on the Plan

Children with type 1 diabetes (DM1) can only be treated with subcutaneous insulin at the present time in Canada.

However, many patients find it difficult to adhere to TID insulin injections since it is an invasive and painful therapy, which results in frequent insulin omission.

Patients will be randomized to either the active control group (standard TID regimen) or the treatment group (BID regimen with new long acting insulin analogue).

A run-in period of 1 month will be used to facilitate the change in insulin regimen.

Who Took Part

Enrollment: 18 actual participants took part.

It was open to people of any sex aged from 6 years up to 17 years.

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

Examples of who could join: Children with DM1 6-17 years old that are currently on a TID regimen of insulin with rapid acting insulin and intermediate acting insulin. Currently being followed at the Alberta Children's Hospital Diabetes Clinic. Duration of diabetes of at least 12 months.

The full record lists 3 inclusion and 7 exclusion criteria; among the exclusions: children younger than 6 years of age will be excluded since long-acting analogue has not been approved in children younger than 6 years old; children with other chronic underlying medical conditions that could affect glycemic control i.e. uncontrolled hypothyroidism, hyperthyroidism, celiac disease, etc; diabetes duration of less than 12 months.

How the Study Was Run

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

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

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

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

It started in 2008-03 with completion listed for 2011-03.

It ran at 1 site in Canada.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Hemoglobin A1C (time frame: 6 months).

It also tracked 4 secondary outcomes, for example Number of episodes of hypoglycemia (severe and mild), Number of episodes of diabetic ketoacidosis (DKA), Body Mass Index (BMI) kg/m2 and Diabetes Quality of Life Questionaire-youth version.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Insulin Detemir and NPH Insulin (isophane) in 18 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Insulin Detemir compound page and the NPH Insulin (isophane) compound page, all human trials.