Health Care for Type 1 Diabetes in Developing World

What Was Tested

This registered not phased trial tested Insulin Glargine.

This will continue until 40 patients have been enrolled at which time recruitment will be started at a provincial hospital, at which 10 further participants will be recruited.

It had two arms (groups): basal insulin approach (experimental) and standard therapy (active comparator).

Participants will be treated primarily with a daily basal insulin injection ( glargine) with later introduction of prandial coverage with a shortacting insulin.

Participants will continue current mixed insulin management and education.

The registry classes the interventions as drug.

More on the Plan

For those aged 14 - 17 years a child assent will be obtained.

For those who are unable to read the consent form a patient advocate who will read this form to them and answer any questions a potential participant may have.

Each person will have time and space to review all of the study information and they will be informed that participation is completely voluntary and that they will continue to receive their normal care if they do not wish to participate.

Each enrolled participant will be followed for a six month period post enrollment on their current treatment regimen so the impact of being enrolled in a study rather than an effect of their treatment, can be assessed.

Who Took Part

The registry lists 50 actual participants took part.

It was open to people of any sex aged from 1 Year up to 24 years.

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

The full record lists 2 inclusion and 2 exclusion criteria; among the exclusions: life expectancy less than three years.

How the Study Was Run

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

The participants were allocated by chance, so the Insulin Glargine group and the comparison group should start out alike.

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

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

It started in 2011-05 with completion listed for 2014-06.

It ran at 1 site in Rwanda.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: HbA1c (time frame: one year).

It also tracked 1 secondary outcome, for example Microalbuminuria.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Insulin Glargine in 50 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.