A retrospective cohort study investigating the associations between adherence and persistence to basal insulin therapy and healthcare resource use for people with type 2 diabetes in England

Study type
Protocol
Date of Approval
Study reference ID
22_002337
Lay Summary

Type 2 diabetes is a common chronic disease with 1 in 10 people over 40 years old in the UK living with the condition. The disease is associated with many health complications such as kidney disease, heart disease and limber amputation, which in turn affects the quality of life of the individuals with type 2 diabetes complications. Complications of type 2 diabetes are mainly due to poor blood sugar control. Insulin therapy is usually recommended for patients who struggled to control their blood sugar levels using oral medication only.

In this study, we will use anonymous data from GP and hospital records to look at how much people with type 2 diabetes follow their recommended insulin therapy. We will then investigate whether people who take their insulin less regularly are more likely to: use healthcare services such as visits to their GP or be admitted to hospital, have higher healthcare costs, have worse blood sugar control, and complications such as kidney disease or heart disease.

Exploring the healthcare and clinical consequences of missing insulin therapy, when needed for managing type 2 diabetes, will help to improve understanding of the usability of current treatment options.

Technical Summary

Type 2 diabetes mellitus (T2DM) is a highly prevalent chronic condition in the UK. Therapy compliance is essential for secondary prevention of severe health conditions such as heart/kidney disease or amputations caused by microvascular damage. This is usually achieved by maintaining blood glucose levels under a threshold, using short-term blood glucose levels and long-term indicators such as HbA1c. When patients struggle to control HbA1c levels with oral antidiabetic medication only, the additional use of basal insulin is indicated. Previous US studies suggested the success of insulin therapy might be linked to the type of basal insulin used, differing by the number of injections needed per day.

In this study, therapy adherence and persistence to basal insulin of patients with T2DM in the UK and impact of therapy adherence on healthcare resource usage (HCRU) and costs will be investigated. A historical cohort study including all patients aged over 18 years with T2DM diagnosis plus first basal insulin prescription between January 2014 to December 2018, will be conducted.

Firstly, therapy adherence and persistence to basal insulin in T2DM patients and HCRU and costs stratified by different therapy compliance patterns will be described. Secondly, HCRU and associated cost, along with the occurrence of death by therapy adherence and persistence will be illustrated. Thirdly, investigation of the association between therapy adherence and persistence and different indicators for HCRU and associated costs as well as HbA1c levels will be performed. Generalised linear models will be used to estimate the effect of therapy adherence and persistence on different healthcare-related outcomes, specifically length of inpatient admission and overall healthcare cost adjusting for potential confounders (e.g., age, deprivation, and comorbidities).

Overall, this study will help understand the usability of currently available basal insulin options in managing patients’ T2DM and the consequences of non-adherence/non-persistence for them and healthcare system.

Health Outcomes to be Measured

Adherence and persistence to basal insulin therapy; all-cause and diabetes-related primary care consultations and cost; all-cause and diabetes-related inpatient stays and cost; all-cause and diabetes-related outpatient appointments and cost; all-cause A&E attendance and cost; mortality; HbA1c results

Collaborators

Jennifer Davidson - Chief Investigator - Health iQ Ltd ( UK ) t/a CorEvitas
Caitlin Winton - Corresponding Applicant - Health iQ Ltd ( UK ) t/a CorEvitas
Archie Farrer - Collaborator - Health iQ Ltd ( UK ) t/a CorEvitas
David Orsted - Collaborator - Novo Nordisk Ltd
Gulsah Akin Unal - Collaborator - Health iQ Ltd ( UK ) t/a CorEvitas
Hongye Ren - Collaborator - Novo Nordisk A/S
Judith Ruzangi - Collaborator - Health iQ Ltd ( UK ) t/a CorEvitas
Sara Carvalho - Collaborator - Health iQ Ltd ( UK ) t/a CorEvitas
Sasha Berry - Collaborator - Novo Nordisk Ltd
Seth Jarvis - Collaborator - Health iQ Ltd ( UK ) t/a CorEvitas
Simon Wan Yau Ming - Collaborator - Health iQ Ltd ( UK ) t/a CorEvitas

Former Collaborators

Sara Carvalho - Collaborator - Health iQ Ltd ( UK ) t/a CorEvitas

Linkages

HES Accident and Emergency;HES Admitted Patient Care;HES Outpatient;ONS Death Registration Data;Patient Level Index of Multiple Deprivation