The progression of key clinical parameters in adult diabetes patients (selected type 1 and type 2 diabetes sub-population): a retrospective cohort analysis to support economic modelling activities in a UK-specific context

Date of Approval
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Technical Summary

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.

Health Outcomes to be Measured

Clinical parameters: HbA1c; BMI; weight; SBP; eGFR


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