Disease burden of diabetes patients with high dose insulin treatment in CPRD

Study type
Protocol
Date of Approval
Study reference ID
15_195
Lay Summary

Background: Scientific literature review shows that many patients with diabetes, obesity, and severe insulin resistance require high dose insulin treatment to achieve optimal glucose target (HbA1c level <7.5%) in clinical practice in UK. However, little research has been done to understand the disease burden and patients characteristics among patients with diabetes who are treated with high dose insulin.
Purpose of the study: Describe patient characteristics and disease burden among patients using insulin, especially those who are prescribed high dose insulin (>200 units/day) as well its effectiveness in achieving optimal HbA1c target. The trends of incidence and prevalence per year of patients using insulin from 2009 to 2013 will also be evaluated.
Potential importance of the findings: This research will help us to understand the real world healthcare practice for diabetic patients treated by insulin in UK. The treatment patterns and patient composition would help us to highlight the unmet needs in diabetes management in UK.

Technical Summary

Objectives: The purpose is to assess the treatment patterns, disease burden, and characteristics of patients in UK with diabetes who are using insulin, with a particular focus on patients who are prescribed high daily doses (>200 units/day) of insulin, to achieve optimal glucose target and the change of treatment pattern in recent years.
Methods: A retrospective analysis will be conducted using the data from clinical practical research datalink (CPRD). A cohort of patients with diabetes who are currently using insulin will be identified and grouped into four categories based on the amount of insulin total daily dose (TDD): group 1: TDD≤200 units/day; group 2: 200units/day<TDD≤300units/day; group 3: 300units/day<TDD≤600units/day; group 4: TDD>600 units/day. The patients’ demographic and clinical characteristics, including concomitant medications, comorbidities and resource utilization will be analysed.
Data analysis: Descriptive statistics will be used for describing the characteristics of high dose insulin users, as well as the general insulin users. The trend of using high dose insulin will be assessed by the Cochran-Armitage trend test and Generalized Estimating Equations (GEE) for the incidence and prevalence of patients, respectively. Chi-square test and two sample T test will be used appropriately to compare the characteristics of different insulin user groups.

Collaborators

Xiaomei Peng - Chief Investigator - Eli Lilly & Co Ltd - US Headquarters
Dingfeng (Daniel) Jiang - Collaborator - Eli Lilly & Co Ltd - US Headquarters
Elemer Balogh - Collaborator - Eli Lilly & Co Ltd - US Headquarters
Iskandar Idris - Collaborator - University of Nottingham
Kate Van Brunt - Collaborator - Eli Lilly & Co Ltd - US Headquarters

Linkages

HES Admitted Patient Care;HES Outpatient