Study type

Study topic

Disease /health condition

Study type

Non-interventional study
Non-interventional study

Non-interventional study design

Cohort
Study drug and medical condition

Medical condition to be studied

Diabetes mellitus
Type 2 diabetes mellitus
Population studied

Short description of the study population

All patients aged 18 years or older on 31 December 2018 being diagnosed with T2DM and without prior prescription of sodium-glucose cotransporter-2 (SGLT-2) inhibitors.

Age groups

Adult and elderly population (>18 years)
Adults (18 to < 65 years)
Adults (18 to < 46 years)
Adults (46 to < 65 years)
Elderly (≥ 65 years)
Adults (65 to < 75 years)
Adults (75 to < 85 years)
Adults (85 years and over)
Study design details

Study design

Retrospective longitudinal cohort study

Main study objective

To develop and validate a model to estimate glycated haemoglobin (HbA1c) values in patients with type 2 diabetes mellitus (T2DM) using a clinical data source, with the aim to apply this equation to administrative databases.

Setting

In-hospital and local outpatient settings in public and affiliated with SSN facilities as regards the database of Fondazione ReS. Primary care as regards the database of Health Search.

Summary results

The tested algorithms were able to explain 17%–18% variation in assessing HbA1c values. Good discrimination (70%) and calibration were obtained as well. The best algorithm (three) cut-offs, namely those providing correct classifications ranging 66%–70% was therefore calculated and applied to ReS database. By doing so, from
52 999 (27.9, 95% CI: 27.7%–28.1%) to 74 250 (40.1%, 95% CI: 38.9%–39.3%) patients were estimated with HbA1c ≥7%.
Documents
Study publications
A methodology to assess the population size and estimate the needed resources f…