Health Outcomes of Patients With Type 2 Diabetes Treated With Dapagliflozin in Conjunction With Insulin
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Observational

Summary: 
      Real-world data can supplement the knowledge gained from traditional randomized controlled
      trials. To date, only a couple of studies (Andrew et al. 2014 and Wilding et al. 2015) have
      been conducted assessing the use of dapagliflozin in the real-world clinical settings in the
      United Kingdom and no research has been done on the use of dapagliflozin in Canadian clinical
      practice settings.

      To the investigators' knowledge, no real-world study exits assessing the impact of using
      dapagliflozin in conjunction with insulin in people with type 2 diabetes mellitus on dosage
      and frequency of insulin, oral antiglycemic agents and hypertension drugs. This study will
      use an electronic medical record-based data that contains demographic, drug coverage, vitals,
      lab results, medical problems and diabetes-related complications, and medication prescription
      information of patients with diabetes received care from all outpatient diabetes clinics in
      London Ontario, Canada to assess the impact of using dapagliflozin in conjunction with
      insulin in patients with type 2 diabetes mellitus on health outcomes, and medications dosing
      and frequency.
    

Detailed description: 
      Adult individuals (age≥18) with type 2 diabetes mellitus receiving care at the diabetes
      outpatient clinics at St. Joseph's Health Centre London (Canada) who have been treated with
      dapagliflozin in conjunction with insulin therapy will be selected from the Web DR
      researchable database for this study. Web DR is a diabetes-specific, web-based, researchable,
      electronic medical record and database. With no existing electronic medical record tailored
      for diabetes patients, the system was designed and implemented by the Centre for Diabetes,
      Endocrinology and Metabolism of St. Joseph's Health Care London. The St. Joseph's Centre for
      Diabetes, Endocrinology and Metabolism is the primary regional center for diabetes and
      endocrine disease management in Southwestern Ontario. Web DR is an electronic medical record
      with clinician-friendly pick-lists to enable structured electronic medical record data
      collection at the point of care, and is currently being used by 14 Endocrinologists and three
      Family Physician Diabetologists in the outpatient diabetes clinics at St. Joseph's Health
      Care London, Canada.

      The baseline period will be 6 months to allow for more complete observation of comorbidities
      and medication use patterns. HbA1c, lipid, blood pressure, weight and other clinical
      indicators measured during the baseline period (closest to the date of dapagliflozin
      prescription) and follow-up period (3 and 6 months after prescription of dapagliflozin) will
      be extracted from the database. The last clinical value within the follow-up period and ≥30
      days after the start of the medication data will be selected as follow-up information.

      The type of insulin used and dosages prescribed during the study follow-up period will be
      extracted from the database to examine the insulin dosage prescription pattern and understand
      the use of insulin with dapagliflozin and its impact on clinical outcomes.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        This retrospective study will use data from an EMR-based (Web DR) researchable database,
        which has been used to study patient's socioeconomic characteristics, treatment patterns
        and health outcomes of patients with diabetes. The Web DR de-identified researchable
        database contains integrated demographic, clinical and laboratory test result data of
        patients who received care from outpatient diabetes clinics in London, Ontario. The
        database includes more than 16,000 patients and their clinic visit information since 2000.
        Adult individuals (age>=18) with type 2 diabetes registered in Web DR who have been treated
        with dapagliflozin in conjunction with insulin therapy will be selected for this study.
      
Keywords: dapagliflozin; type 2 diabetes; real-world data