Assessing medication adherence in people with Type 2 diabetes
InvesTigation and Analysis of uRine - Glucose Control in patiEnts With Type 2 Diabetes - TARGET Study
This study is trying a new urine test to see how well people with Type 2 diabetes are sticking to their medication compared to what they say about it.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 600 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Leicester Academic / other |
| Locations | 2 sites (Loughborough and 1 other locations) |
| Trial ID | NCT05256875 on ClinicalTrials.gov |
What this trial studies
This observational study aims to analyze non-adherence to medication in individuals with Type 2 diabetes using a newly developed chemical adherence test. The test detects the presence of 160 cardiovascular medications in urine samples through high-performance liquid chromatography-tandem mass spectrometry (LC-MS/MS). By comparing this objective measure with traditional self-reported adherence methods, the study seeks to better understand the prevalence and implications of non-adherence in this population. The findings could inform strategies to improve medication adherence and health outcomes for patients with diabetes.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and over with a confirmed diagnosis of Type 2 diabetes and an HbA1c level of 7.5% or higher.
Not a fit: Patients with Type 1 diabetes, those unable to provide informed consent, or individuals with major medical or psychiatric illnesses may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved methods for identifying and addressing medication non-adherence, ultimately enhancing patient outcomes in Type 2 diabetes management.
How similar studies have performed: While the approach of using chemical adherence testing is novel in the context of diabetes, similar methods have shown promise in other chronic conditions, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Aged 18 years and over * Confirmed diagnosis of type 2 diabetes * People with at least one HbA1c ≥ 7.5% (59mmol/mol) measured in the last 6 months * Patients on at least one OHA and one other oral cardiovascular medication for blood pressure, diabetes or lipid lowering therapy * Patients able to understand written and verbal English Exclusion Criteria: * Type 1 diabetes * Age less than 18 years * Patients unable to give informed consent * Pregnant or planning pregnancy * Terminally ill * Patients on simvastatin and or aspirin if they are the only other medication for cardiovascular disease besides the OHAs that the patient is prescribed. * Patients on insulin or GLP-1 analogues if they are the only other medication for cardiovascular disease that the patient is prescribed. * Major medical or psychiatric illness * Patients unable to understand written and verbal English
Where this trial is running
Loughborough and 1 other locations
- The Banks Surgery — Loughborough, United Kingdom (Recruiting)
- The Cottage Surgery — Loughborough, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Hanad Osman
- Email: hao7@leicester.ac.uk
- Phone: 07814121184
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.