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, this study will evaluate the change of important clinical variables over time for adult patients with type 1 diabetes and selected type 2 diabetes population.
Adult patients with type 1 diabetes and inadequate control of their blood sugar in CPRD are followed for 5 years where clinical variables related to blood sugar control, weight, blood pressure and kidney function are measured every year. Selected type 1 diabetes treatment subgroups and a subgroup of type 2 diabetes patients are also studied. The finding will provide valuable insight into the progress of disease for type 1 diabetes patients and 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 evaluate the progression of key clinical parameters for uncontrolled adult T1DM patients over five years of follow-up.
Methods: Retrospective adult T1DM cohorts will be derived. The cohorts will be patients aged 18 and older with T1DM diagnosis and no T2DM diagnosis registered anytime and at least one insulin prescription between January 1, 2011 and December 31, 2011 (identification period) after T1DM diagnosis. Index date will be defined as the first insulin prescription during identification period. Baseline period will be defined by 12-month pre-index date and follow-up period by 60 months after index date. Continuous enrolment over baseline and follow-up will be required to be eligible for inclusion. Patients with most recent HbA1c measure in baseline less than or equal to 6.5% are excluded from the study. Four subpopulations of T1DM cohort are evaluated to assess how treatment impacts the progression of clinical parameters: those treated with continuous subcutaneous Insulin Infusion (CSII), multiple daily insulin injection (MDI), insulin plus metformin, and insulin plus SGLT2. A subpopulation of T2DM patients treated with basal bolus plus SGLT2 (those mimicking T1DM patient treatment regimen) are also studied. Included patients are age 18 and older, with T2DM diagnosis and no T1DM diagnosis, at least one antihyperglycemic prescription during identification period, continuous enrolment baseline and follow-up, no gestational diabetes, under basal bolus treatment, having SGLT2 use and valid HbA1c in baseline.
Analysis: Descriptive analysis will be conducted. Clinical parameters (HbA1c, BMI, weight, SBP, and eGFR) will be described at baseline and yearly in the 5 year follow-up. All these parameters will be described in overall T1DM population and in the five T1DM/T2DM sub-populations. For the T2DM sub-population, their non-insulin treatment use in baseline will also be described.
Clinical parameters: HbA1c; BMI; weight; SBP; eGFR
Liz Zhou - Chief Investigator - Sanofi US Services Inc (USA)
Liz Zhou - Corresponding Applicant - Sanofi US Services Inc (USA)
Rikisha Gupta Shah - Collaborator - Evidera, Inc