Title: A mixed methods study to support insulin self-management for people with type 2 diabetes.
Funder: Health Education England

Abstract: Background Many people with type 2 diabetes (T2DM) will require insulin as their diabetes progresses and beta cells fail. Insulin is the most effective treatment for glycaemia and is supported by long-term safety data and non-analogue intermediate-acting insulin is relatively inexpensive. However, it is well known that patients have barriers towards insulin and it is often delayed by up to 5 years to the detriment of glycaemic control and future morbidity. Psychological factors such as depressive symptoms, diabetes distress and negative beliefs regarding insulin are more prevalent in insulin nave samples. However, the role of specific psychological factors with regard to the delay in insulin initiation is understudied as there are few prospective studies which have examined these constructs. Likewise, although psychological therapies, such as motivational interviewing (MI), are known to be effective in T2DM for improving glycaemic control and weight loss these have yet to be applied to the specific problem of insulin initiation in people with T2DM. The aim of this fellowship is to broaden our understanding as to how psychological factors delay insulin initiation and to apply psychological techniques to the process of insulin initiation in people with T2DM to counter common barriers and improve diabetes self-management. Aims The aims of this project are to: 1. determine whether psychological factors, such as insulin beliefs, diabetes distress or depressive symptoms, delay time to first insulin prescription in people with T2DM 2. describe patient perspectives of insulin initiation in T2DM 3. develop a psychological intervention integrated into insulin start groups and to establish its feasibility and acceptability as a pilot study prior to a larger RCT. Research questions What is the relative effect of psychological factors such as insulin beliefs, diabetes distress and depressive symptoms, on the uptake of insulin treatment in people with T2DM adjusting for potential confounding? Is it feasible and acceptable to run insulin-focused MI integrated into insulin start for people with T2DM in primary care? Plan of investigation This project will employ mixed research methods. Study 1: is an 8 year follow-up of an existing incident T2DM cohort (n=1790). This prospective study will identify patients who have either started insulin or are at the level of requiring insulin (on maximum doses of 2 oral antidiabetes medications with poor diabetes control, HbA1c of >/= 7.5% or 58mmols/mol on 2 occasions), to determine whether psychological factors are associated with insulin initiation. Study 2: is a qualitative interview study of ~30 patients who have recently attended or been referred to insulin education to determine barriers to insulin self-management, views on current education courses and their suggestions for additional support Study 3: is a modelling study to develop the manual for a group MI intervention as an adjunct to insulin start for people with T2DM Study 4: will recruit 60 patients to test a newly developed group MI intervention as an adjunct to insulin start for people with T2DM in a feasibility RCT. It will determine whether it is acceptable and appropriate for patients and whether the trial can be successfully delivered within primary care. Summary of potential benefits to patients and NHS Understanding the impact of psychological factors and the delay to insulin treatment for people with T2DM will help us to develop better interventions to support patients with diabetes self-management. Developing group psychological interventions to support patients with T2DM with insulin initiation will address common worries and concerns that unchecked may affect future health and help to lessen the future financial impact for the NHS.

Lay abstract: Health systems are having to cope with increasing numbers of people with type 2 diabetes (T2DM) and obesity.CHAR(13) + CHAR(10)This means that changes need to be made in terms of where and how diabetes services are provided, toCHAR(13) + CHAR(10)introduce treatments that support patients with how they manage their diabetes to prevent problems with theirCHAR(13) + CHAR(10)heart and blood vessels, eye problems, kidney problems and nerve damage and to involve patients in the designCHAR(13) + CHAR(10)of health services to ensure they are what people want and need. There are around 3 million people in the UKCHAR(13) + CHAR(10)with diabetes, 90% have T2DM and of these approximately 300,000 people use insulin to treat their diabetes andCHAR(13) + CHAR(10)keep their blood glucose levels in the non-diabetic range. However, more people than this need insulin and thereCHAR(13) + CHAR(10)can be a delay of up to 5 years putting them at further risk of diabetes problems. Often the delay is caused by aCHAR(13) + CHAR(10)combination of factors. Many people who need insulin do not want to take it because they are worried aboutCHAR(13) + CHAR(10)weight gain, low blood glucose levels (hypoglycaemia), painful injections and that it means their diabetes has gotCHAR(13) + CHAR(10)worse. Or it may be because their diabetes health professional has not emphasised the need for it. The aim ofCHAR(13) + CHAR(10)this study is to determine the number of people who need insulin but don't take it and to find out whether thereCHAR(13) + CHAR(10)are particular psychological reasons for this from the patients' perspective, such as beliefs about insulin, worryCHAR(13) + CHAR(10)about diabetes, or feeling down or depressed. It also aims to develop a new treatment to help people when theyCHAR(13) + CHAR(10)start insulin, which will address their concerns about insulin injection and support them with lifestyle changes toCHAR(13) + CHAR(10)minimise weight gain. This fellowship will use a number of different scientific methods to achieve these aims. ItCHAR(13) + CHAR(10)will involve analysis of a large sample of data from a group of people diagnosed with type 2 diabetes 8 yearsCHAR(13) + CHAR(10)ago. It will also involve interviewing approximately 30 patients who have been referred to or attended insulinCHAR(13) + CHAR(10)group education sessions to find out about what barriers they have towards starting insulin and taking it longterm,CHAR(13) + CHAR(10)their feedback on the insulin education and support they received, and their ideas about how insulin education and support can be improved. Information gathered from these studies will be used in the development of a new supportive/psychological intervention (treatment) which will then be tested. Patients will be involved in this research from start to finish. Prior to application the study was reviewed by a group of people with diabetes. Patient interviews will guide development of the intervention and 2 patients will be invited to become study advisors throughout. Patients who receive the intervention will also be asked for their feedback. Therefore this new intervention for starting people on insulin will be co-designed by patients for patients. The results of the research will be shared via academic and health networks, patient forums and social media, such as the Diabetes Online Community (DOC), so that other patients can benefit from it.

Research activity codes: 7.1 INDIVIDUAL CARE NEEDS;5.6 PSYCHOLOGICAL AND BEHAVIOURAL
Health categories: METABOLIC AND ENDOCRINE