Co-designing Optimal Strategies for the Prevention, Detection and Management of Insulin Mediated Lipohypertrophy in People with Type 1 Diabetes.

Background Lipohypertrophy related to insulin exposure in people with Type 1 diabetes (T1DM) affects 50% of people with T1DM. Lipohypertrophy attenuates insulin absorption causing glucose variability and risk of hypoglycaemia. Lipohypertrophy is also very frustrating for patients and increases the risks of long-term diabetes complications.

Injection behaviours are the principal cause of lipohypertrophy.

Current lipohypertrophy detection methods are inadequate; and support systems for patients are not behaviourally modelled.

AIM: To co-design a novel intervention framework for the prevention, detection, and management of insulin mediated lipohypertrophy in people with T1DM. SETTING/PARTICIPANTS: We will recruit participants from two South London diabetes centres. Participants will include: people with T1DM; partners/friends/family; and diabetes health professionals.

METHODS: The study utilises a co-design methodology called Design Thinking, which involves three interrelated phases: Phase 1.

Inspiration- exploring the experiences and perceptions of the target groups, to understand their problems/needs; Phase 2. Ideation- reflecting on the problems/issues raised to generate optimal intervention content; Phase 3. Implementation- a feasibility study which we will address in a subsequent study.

The study is comprised of two work-packages (WP). WP 1. Co-designing the intervention. This WP has two phases. Phase 1. Inspiration-This will involve focus groups with patients and health professionals.

The focus-groups will explore: the experiences and challenges related to injection behaviours; and for health professionals the assessment and management of lipohypertrophy. The focus-groups will have 6-8 participants in each (4 with patients and 2 with health professionals).

The discussions will be digitally recorded and transcribed, a graphic artist will construct images related to the discussions. The transcripts will be analysed using Framework Analysis incorporating behaviour change frameworks (COM-B and BCW).

We will use the data to construct discussion tools for the next phase of the co-design process (graphic images and common scenarios). Phase 2.

Ideation- In this phase we will generate solutions and strategies that can be developed into components for the intervention. There will be two stages: 1. stimulating solutions; 2. constructing intervention strategies. Stage 1. The patients and health-professionals from phase 1 will attend further parallel focus-groups.

We will use the discussion tools to stimulate conversations eliciting solutions to the current challenges. We will also introduce different technology methods for screening and site management for discussion. We will also hold an additional focus-group with partners/friends or family (n=6-8).

The outputs from these groups will be analysed as before to construct a logic model mapping the intervention components, behavioural frameworks and outcomes. Stage 2.

We will run a joint patient, partner/friend and health professionals workshop(3hrs) to review the solutions generated in stage 1 and prioritise them in terms of acceptability and importance.

WP2 Intervention construction In this WP we will bring together the ideas from WP1 and translate the WP1 solutions into intervention components addressing: assessment; injection site management; theoretically modelled education; and supportive technologies. We will also integrate the outcome categories prioritised by participants into the logic model.

PRIMARY OUTPUT: The study will produce a testable patient-centred intervention framework to improve the detection, prevention, and management of lipohypertrophy.