Type 1 diabetes is a disease of the immune system that destroys pancreasÂ’ ability to make insulin (a hormone that lowers the amount of sugar in the blood), which affects approximately 400,000 people in UK. Sotagliflozin is a novel drug to treat type 1 diabetes patients together with insulin. To gather information from real world clinical practice in UK, this study will evaluate the profile of adult patients with type 1 diabetes.
This study takes a snapshot of adult type 1 diabetes patients with inadequate control of their blood sugar in UK clinical setting and describes the population and status of disease management. The finding will be used in building mathematical models related to healthcare cost in a UK-specific context.
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.
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])
Liz Zhou - Chief Investigator - Sanofi US Services Inc (USA)
Liz Zhou - Corresponding Applicant - Sanofi US Services Inc (USA)
Rikisha Gupta Shah - Collaborator - Evidera, Inc