InvesTigation and Analysis of uRine - Glucose Control in patiEnts With Type 2 Diabetes - TARGET Study

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other
Study Type: Observational
SUMMARY

Non-adherence is defined as: the extent to which a person's behaviour - taking medication, following a diet, and/or executing lifestyle changes, corresponds with agreed recommendations from a health care provider. Non-adherence in chronic cardiometabolic diseases including diabetes is very common and is often the primary reason for treatment failure. This leads to significant excess costs to the health economy through avoidable investigations, treatment escalations, hospital admissions, and disease complications. Methods to diagnose non-adherence have until recently been poor. We have recently developed an objective and robust chemical adherence test to detect the presence of 160 cardiovascular medications in urine using high performance liquid chromatography-tandem mass spectrometry (LC-MS/MS). Chemical adherence testing has not been utilised in people with diabetes, further its relationship with other measures of adherence is unknown. The main aim of this observational study is to compare chemical non-adherence with other commonly used measures of non-adherence in people with diabetes. Chemical testing for non-adherence will be performed using urine provided by 600 patients with poorly controlled diabetes attending primary care recruited over a 15-month period. Participants will also be required to complete a self- reported questionnaire and pharmacy records will be reviewed to ascertain prescription refill rates. The prevalence and metabolic control of non-adherence as diagnosed chemically will be compared with those obtained by pharmacy refill rates and patient self-reported questionnaires. Further, the determinants of non-adherence as ascertained by urine LC-MS/MS analysis will be studied. It is hoped that this innovative study will lead to further larger intervention studies that will change the management of non-adherence in diabetes.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
United Kingdom
The Banks Surgery
RECRUITING
Loughborough
The Cottage Surgery
RECRUITING
Loughborough
Contact Information
Primary
Hanad Osman
hao7@leicester.ac.uk
07814121184
Time Frame
Start Date: 2022-08-30
Estimated Completion Date: 2026-05-31
Participants
Target number of participants: 600
Related Therapeutic Areas
Sponsors
Leads: University of Leicester

This content was sourced from clinicaltrials.gov