Culturally sensitive intervention for Type 2 Diabetes in non-Western individuals
A Person-centred and Culturally Sensitive Course of Treatment Targeting Individuals With Type 2 Diabetes and Non-Western Backgrounds (The ACCT2 Study)
This study is testing a new, culturally tailored program for people with Type 2 Diabetes from non-Western backgrounds to see if it helps them manage their blood sugar better than regular care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 96 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Steno Diabetes Center Copenhagen Academic / other |
| Locations | 1 site (Herlev) |
| Trial ID | NCT06147245 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of a 12-month person-centred and culturally sensitive intervention on glycaemic control in individuals with Type 2 Diabetes (T2D) from non-Western backgrounds. The intervention is designed to address specific challenges faced by these individuals, such as low health literacy and language barriers, which can hinder effective diabetes management. Participants will undergo a randomized controlled trial, attending multiple visits at the Steno Diabetes Center Copenhagen to monitor their progress and glycaemic levels. The study hypothesizes that this tailored approach will significantly improve HbA1c levels compared to standard care.
Who should consider this trial
Good fit: Ideal candidates are individuals with Type 2 Diabetes, poor glycaemic control, and a non-Western background who speak Urdu, Arabic, or Turkish as their native language.
Not a fit: Patients over 75 years old, those with severe mental disorders, or individuals whose general condition contraindicates participation may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could lead to improved glycaemic control and better health outcomes for individuals with Type 2 Diabetes from non-Western backgrounds.
How similar studies have performed: Previous studies have indicated that culturally appropriate diabetes education can enhance glycaemic control, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Having T2D with poor glycaemic control (HbA1c ≥53 mmol/mol) and where individual treatment goal for HbA1c has not been achieved (in two consecutive measurements) * Having a non-Western background speaking either Urdu, Arabic or Turkish as native language * Already in a course of treatment at the outpatient T2D clinic at SDCC Exclusion Criteria: * Age: \> 75 years * Residing part-time in Denmark * Marker of kidney function - estimated glomerular filtration rate (eGFR) below 30 mL/min * Having severe mental disorders * Having disabilities inhibiting physical attendance * Participant's general condition contraindicates continuing the study, as judged by the investigator or a medical expert * Participant's withdrawal of the informed consent
Where this trial is running
Herlev
- Steno Diabetes Center Copenhagen — Herlev, Denmark (Recruiting)
Study contacts
- Principal investigator: Ulla Bjerre-Christensen, MD — Steno Diabetes Center Copenhagen
- Study coordinator: Natasja B Martinsen, PhD
- Email: natasja.bjerre.martinsen@regionh.dk
- Phone: +45 60157718
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.