Patient characteristic and treatment pattern for uncontrolled adult type 1 diabetes patients: a cross-sectional analysis to support economic modelling activities in a UK-specific context

Date of Approval
Application Number
18_300
Technical Summary

Objectives: The aim of this study is to use data from the Clinical Practice Research Datalink (CPRD) to describe patient characteristics and treatment pattern of uncontrolled adult type 1 diabetes patients in a cross-sectional study design.

Methods: Retrospective cross-sectional adult type 1 diabetes cohorts will be derived. The cohorts will be patients with type 1 diabetes diagnosis and no type 2 diabetes diagnoses registered anytime and at least one insulin prescription between January 1, 2016 and December 31, 2016 (identification period). Patients must be aged 18 and older on January 1, 2016. Continuous enrolment in 2016 will be required to be eligible for inclusion. Patients with average HbA1c in 2016 less than or equal to 6.5% are excluded from the study.

Analysis: Descriptive analysis will be conducted. Patient demographic (age, gender, race), behavioural (smoking, alcohol use) and clinical characteristics (duration of diabetes, HbA1c, BMI, weight, SBP, lipids, eGFR, and comorbidities) will be described. Type 1 diabetes patientsÂ’ treatment pattern (basal, bolus, premix insulin use, average daily dose) will also be reported overall and by Multiple Daily Insulin injection (MDI) and Continuous Subcutaneous Insulin infusion (CSII) groups.

Health Outcomes to be Measured

Patient characteristics: age, gender, race, smoking status, alcohol use, duration of diabetes, HbA1c, BMI, weight, SBP, total cholesterol, LDL, HDL, triglyceride, eGFR, and comorbidities (see below)
? Myocardial Infarction (MI), Angina (stable and unstable), Peripheral Vascular Disease (PVD), Stroke, Congestive Heart Failure (CHF), Atrial Fibrillation (AF)
? End Stage Renal Disease (ESRD), Micro-albuminuria (MA), Gross Renal Proteinuria (GRP),
? Macular Edema (ME), Cataract
? Diabetic ulcer, Amputation
? Depression
? Diabetic Neuropathy, Neuropathy, Diabetic Nephropathy, Nephropathy, Diabetic Retinopathy, Background diabetic Retinopathy, Proliferative Diabetic Retinopathy
Treatment pattern:
? any, basal, bolus, premix insulin use (number and percent of patients)
? daily average consumption of total insulin, basal insulin and bolus insulin (DACON in IU/day and IU/kg/day) (mean[SD] and median [1st quartile, 3rd quartile])

Collaborators

Liz Zhou - Chief Investigator - SANOFI
Liz Zhou - Corresponding Applicant - SANOFI
Rikisha Gupta Shah - Collaborator - Evidera, Inc