Impact of a Diabetes Camp on Glycemic Control Among Children and Adolescents Living With Type 1 Diabetes in Cameroon

What Was Tested

This registered not phased trial tested Insulin (regular human).

Camps represent an ideal environment for education.

It had 1 arm (groups): Insulin therapy and diabetes education (other).

Children and adolescents living with type 1 diabetes already on insulin therapy received collective diabetes education during a five days camp.

The registry classes the interventions as drug.

More on the Plan

All children enrolled in the project have a systematic visit every three months.

During this visit, clinical and biological assessment are done, also adjustment of treatment, therapeutic education and record of data in the medical record.

Many children also consult outside systematic visits to collect the material for treatment or in case of an emergency related or not with diabetes.

The forms of insulin available in the project are regular insulin (Actrapid®), intermediate-acting insulin (Insulatard®) and pre-mixed insulin (Mixtard 30®).

Who Took Part

Enrollment: 46 actual participants took part.

It was open to people of any sex aged from 6 years up to 23 years.

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

Examples of who could join: Children living with type 1 diabetes and enrolled in the "Changing Diabetes in Children project". Aged between 6 and 23 years old. Informed consent signed by parents or guardians prior to enrollment in the CDiC project allowing investigators of the project to used data for research. Informed consent forms signed by parents or guardians before participation to the 2013 camp in Yaoundé.

The full record lists 5 inclusion and 1 exclusion criteria; among the exclusions: nonattendance of the routinely follow-up visits at the cdic clinic yaoundé both at 3 and 12 months after camp.

How the Study Was Run

It was run as a single-group and open-label study.

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

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2013-07 with completion listed for 2013-08.

What Was Measured

The main thing measured (primary outcome): Changes in HbA1c (time frame: Baseline to 3 months and 12 months after camp).

It also tracked 3 secondary outcomes, for example Hypoglycemic episode per camper per day and Changes in weight.

What This Means in Plain Language

Put simply, this is a not phased trial of Insulin (regular human) in 46 people.

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

More context: the Insulin (regular human) compound page, all human trials.