Patterns of Pharmacological Treatments for Type 2 Diabetes among Children and Youths in the United Kingdom

Study type
Protocol
Date of Approval
Study reference ID
24_003984
Lay Summary

Type 2 diabetes mellitus (T2DM) is a condition characterized by elevated blood sugar levels. While it most commonly occurs in adults, its occurrence among children and adolescents has increased rapidly over the past two decades, primarily due to the obesity epidemic. Youth-onset T2DM is associated with a high risk of complications of diabetes (e.g., stroke, heart attacks, blindness), leading to increased morbidity and mortality at a younger age than those diagnosed later in life. Paediatric patients with T2DM present distinctive characteristics that differ from those observed in adults. There is a lack of treatment options for paediatric patients with T2DM, and the transition from paediatric to adult care is particularly challenging. Furthermore, fragmentation in health care delivery can lead negatively impact cost, quality, and outcomes of care. As new oral antidiabetic agents become available for adults, it is important to explore changes in treatment patterns during the transitional period from paediatric to adult care. To address this knowledge gap, we will use the Clinical Practice Research Datalink (CPRD) to describe prescription trends and treatment patterns among children and youths with T2DM, including during transition period (ages 16-20 years). Similar analyses will be conducted using data from Korea. The findings from this study will provide comprehensive information of the usage of antidiabetic medications in this young population.

Technical Summary

Over the past two decades, the prevalence of type 2 diabetes mellitus (T2DM) has increased rapidly among children and adolescents in the UK, with over 120,000 children and adolescents now diagnosed with T2DM. Understanding treatment patterns for this population is crucial for maintaining their quality of life and preventing complications. While the 2022 American Diabetes Association and 2023 National Institute for Health and Care Excellence (UK) guidelines recommend certain treatment options, off-label use of other drugs may occur. There is also a lack of evidence about treatment patterns in a real-world setting and during the transition from paediatric to adult care (ages 16-20 years), which is important given the availability of various oral antidiabetic agents approved for adults.

To address these gaps, we propose to describe prescription rates, prescription trends, and treatment trajectories of antidiabetic drugs for T2DM among children and youths between 2002 and 2022. We will use Poisson regression to estimate annual prescription rates and corresponding 95% confidence interval (CIs) overall and in subgroup analyses defined by age groups, sex, and glycated hemoglobin level. The prescription rate ratio between the last and first year of the study period for each drug class will also be estimated overall and in these subgroups. Secondary endpoints will include changes in treatment subgroups across antidiabetic drug classes. The treatment subgroups will be identified by using group-based multi-trajectory models with a systematic procedure to characterize the model. In addition, we will repeat analyses for patients aged 16-20 years (transition period) to observe changes in the annual percentage of patients and treatment trajectories across antidiabetic drug use as they age. Analyses will be repeated using population-based data from Korea; all analyses will be stratified by country.

Health Outcomes to be Measured

1. Annual prescription rate of anti-diabetic drugs, classified by class between 2002 and 2022
2. Total number of yearly prescriptions between 2002 and 2022
3. Percentage of patients using anti-diabetic drugs among aged 16-20 years patients between 2002 and 2022
4. Treatment trajectories and patterns of T2DM care

Collaborators

Samy Suissa - Chief Investigator - Sir Mortimer B Davis Jewish General Hospital
Kristian Filion - Corresponding Applicant - McGill University
Cristina Longo - Collaborator - University Of Montreal
In-Sun Oh - Collaborator - McGill University
pauline reynier - Collaborator - Sir Mortimer B Davis Jewish General Hospital
SUNG HO BEA - Collaborator - Brigham & Women's Hospital