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Diabetes and Endocrinology clinical trial

StartRight: Getting the right classification and treatment from diagnosis in young adults with diabetes

Summary:
The treatment of Type 1 and Type 2 diabetes is very different. People with Type 1 diabetes rapidly stop making their
own insulin, so need insulin injections from diagnosis. People with Type 2 diabetes can keep making their own
insulin but it may not work as well as it should, so they can be treated with diet or tablets. While they may eventually
need insulin treatment it is usually not until many years after diagnosis.
It is often difficult for doctors to tell which kind of diabetes a person has, particularly in younger adults where both Type
1 and Type 2 diabetes are common. Because of this, sometimes (in about 15-20% of young adults) people are given
the wrong diagnosis. This can have a huge impact as it means they could receive the wrong treatment. A person
incorrectly diagnosed with Type 1 diabetes will be prescribed unnecessary insulin injections and miss out on other
helpful therapies. A person incorrectly diagnosed with Type 2 diabetes may develop severely high glucose and
become unwell with a condition called Diabetic Ketoacidosis if they do not receive insulin treatment.
This study aims to improve this situation by helping doctors more accurately tell the type of diabetes a person has
when they are first diagnosed. We will recruit 1000 participants who have recently been diagnosed with diabetes
between the ages of 18 and 50. We will record clinical features and measure blood tests that may help us determine
diabetes type at diagnosis and follow participants for 3 years to see whether they stop producing their own insulin and
need insulin treatment, which confirms Type 1 diabetes. We will assess whether clinical features and blood tests can
help us tell if a patient needs rapid insulin treatment and should be initially treated as Type 1 or Type 2 diabetes.
We will combine results from this study and existing previous studies to produce a calculator, called a clinical
probability model that will allow doctors and patients to combine information from clinical features and (where
necessary) blood tests to accurately diagnose what type of diabetes a person has and therefore give the correct
treatment. This will be freely available to doctors and patients as a website calculator and smartphone app.

Inclusion criteria:
• Adults diagnosed with diabetes within the previous 12 months.
• Aged ≥18 and ≤50 at the time of diabetes diagnosis*
• Able and willing to provide informed consent.
* Clinical diagnosis of diabetes mellitus. Biochemical diagnosis confirmed from healthcare records post recruitment.

Exclusion criteria:
• Gestational diabetes
• Known secondary diabetes (diabetes considered likely due to medication, cystic fibrosis, pancreatitis, pancreatic
cancer, pancreatic surgery, hemochromatosis or Cushing’s syndrome).

Principal Investigator for this trial: Dr Peter Mansell

Research Ethics Committee Reference: 16/SW/0130

Contact us about participating in this study by emailing R&IActiveStudyEnquiries@nuh.nhs.uk or telephoning 0115 924 9924 Ext. 70076

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