adAPT is a clinical trial which is testing a new approach to the prevention of type 1 diabetes. If successful, it could offer a safe, cheap and readily available means of avoiding insulin injections .
WHAT is diabetes?
- Sugar (glucose) levels in the blood are regulated by the hormone insulin.
- Diabetes is a state of high blood sugar which results from loss of the beta cells that make insulin.
- The rate of beta cell loss varies from person to person.
- Beta cells are lost faster (accelerated) when they are made to work too hard.
- The faster the loss of beta cells, the earlier in life the diabetes occurs. The fastest loss results in childhood (type 1) diabetes.
WHY are we conducting the trial?
- Diabetes is the fastest growing chronic disorder of childhood. Figures from Scotland record a five-fold increase in just 40 years.
- We still don’t have a means of preventing type 1 diabetes.
- adAPT is testing a new approach, which will try to protect the beta cells from being worked too hard.
- If successful, adAPT could offer a simple, cheap and widely available means of preventing type 1 diabetes.
HOW are we going about it?
- adAPT is a clinical trial, and clinical trials are used to show whether, and how, a medication works.
- Clinical trials are randomised and ‘blinded’, which means that half the participants receive the medicine and the other half the placebo (dummy). Nobody knows who is taking which until the end of the study, so that nothing except the medicine on test can influence the result.
- adAPT will be using metformin, a medication which is known to ease the workload and protect the beta cell.
- We aim to find out whether the medication can reduce the numbers who develop type 1 diabetes .
- The Juvenile Diabetes Research Foundation (JDRF), a premier funding body for research into type 1 diabetes, is supporting adAPT. JDRF’s mission is to find a cure for childhood diabetes.
WHO is the trial meant for?
- Children in Scotland and the North of England aged between 5 and 16 years old who have a brother, sister or parent who developed type 1 diabetes before they were 25 years old.
- A simple blood test will tell us which of these children is at high risk of type 1 diabetes.
- The children at high risk will be invited to join the trial.
WHEN is it going to happen?
- adAPT will start screening in early 2016, and will be rolled out in three stages over five years once the screening is complete.
- Stage 1 (four months, pilot study) will show us whether the study design works, and how many children we will need.
- Stage 2 (36 months, proof of principle) will measure markers in the blood to measure the effect of the study medication.
- Stage 3 (60 months, clinical outcome) will show whether or not diabetes developed less frequently over the five years in those receiving the medicine.
- The final result will be available in 2022.