The purpose of this study is to understand the possible benefits of restoring insulin secretion in people living with diabetes, and to understand how we can best measure insulin secretion.
Most people living with type 1 diabetes stop making their own insulin and need insulin injections to survive. It also means their blood glucose is variable and often difficult to control. This is in contrast to type 2 diabetes, where most people keep making their own insulin, and loss of insulin production is uncommon.
Previous research has shown that some people with type 1 diabetes keep making some of their own insulin which can be very helpful for their blood glucose control, but there is limited information on the long-term benefits. It is important we know the full benefits of making insulin as new treatments have been developed to preserve and/or restore insulin secretion in type 1 diabetes. These treatments are expensive, can have side effects, and have been studied only in small numbers for a short amount of time. It is important to fully understand the likely long-term benefits of preserving or restoring insulin secretion to know whether healthcare providers like the NHS should fund these treatments.
At present, research studies that are testing these new treatments need to frequently test insulin secretion, using a test called a mixed meal tolerance test. That test is undertaken in a clinical setting and takes at least 2.5 hours, making the studies difficult to take part in, and expensive to run. We can now measure insulin production at home, on a finger-prick test, but more information is needed on the best way to do the home test for these kinds of studies.
This research has two parts:
In Study 1, we will extend a large existing prospective study of new adult onset diabetes, StartRight, which has followed 1800 participants for around 4 years from diabetes diagnosis. Startright participants with insulin treated diabetes will be invited to take part in a further research visit remotely or face to face, to measure insulin secretion. We will assess their quality of life and other measures related to their diabetes. We will use this information, and the information already collected in the study, to understand the effects of retaining or loosing insulin production over up to 9 years from diabetes diagnosis, and compare whether this differs in type 1 and 2 diabetes.
In Study 2, we will recruit 200 participants with type 1 diabetes who have had their insulin secretion measured in research or in clinical care. Participants will attend a research facility for assessment of their insulin production over 2 hours after a liquid meal. They will then undertake this test at home, using finger-prick samples after the same liquid meal, and after 3 of their own normal meals. They will also monitor their glucose using a continuous glucose monitor. We will use this information to understand if home measures are as accurate as the test in the research facility, and work as well in predicting a person’s risk of low glucose (hypoglycaemia) and their glucose variability.
The end result of this research will be important information to inform the design of studies of new treatments to preserve or restore insulin secretion for people living with diabetes and understand the likely long-term benefits of these treatments.
