The ACCT2 Study Individuals With Type 2 Diabetes and Non-Western Backgrounds (ACCT2)

NCT06147245 | Unknown

• 1 other identifier: H-23042245
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

The overall purpose of the present study is to examine the effect of implementing a 12-month person-centred and culturally sensitive intervention on glycaemic control in individuals with type 2 diabetes (T2D) and a non-Western background. We hypothesise that the intervention added to standard care will be superior for reducing HbA1c. Superiority will be claimed if the baseline corrected difference between the two groups is equal to, or surpass, the minimal important difference (5 mmol/mol) in favour of the intervention-group.

Conditions

Type 2 Diabetes

Keywords

Type 2 Diabetes; Glycaemic control; Cultural Sensitivity; Diabetes self-management; Non-Western immigrants; Co-creation

Outcome Measures

Primary Outcomes (1)

• Change in HbA1c (mmol/mol)

  Assessed from blood samples in non-fasted state

  Change from baseline to the end of intervention (12 months)

Secondary Outcomes (13)

• Blood lipids (mmol/l)

  Change from baseline to the end of intervention (12 months)

• Systolic blood pressure (mmHg)

  Change from baseline to the end of intervention (12 months)

• Diastolic blood pressure (mmHg)

  Change from baseline to the end of intervention (12 months)

• Resting heart rate (bpm)

  Change from baseline to the end of intervention (12 months)

• Marker of kidney function - Creatinine (μmmol/L)

  Change from baseline to the end of intervention (12 months)

Other Outcomes (13)

• Time-in-range (% 3.9-10.0 mmol/l)

  Change from baseline to the end of intervention (12 months)

• Time-below-range (% <3.9 mmol/l)

  Change from baseline to the end of intervention (12 months)

• Time-above-range (% >10.0 mmol/l)

  Change from baseline to the end of intervention (12 months)

Study Arms (2)

Person-centred culturally sensitive course of treatment

EXPERIMENTAL

The intervention consists of a 12-month person-centred and culturally sensitive course of treatment.

Behavioral: Person-centred culturally sensitive course of treatment

Control

NO INTERVENTION

The control group will follow the standard care with regular visits at the T2D outpatient clinic at SDCC 3-4 times/year.

Interventions

Person-centred culturally sensitive course of treatment BEHAVIORAL

12-month person-centred and culturally sensitive intervention: Participants will attend 6 visits at SDCC including visits with a diabetes nurse, physician and dietitian. The course of treatment is focusing on extended time in consultations, use of technology for diabetes monitoring, meeting the same healthcare professionals, awareness of language barriers and use of accurate communication and dialogue tools in participants native language.

Person-centred culturally sensitive course of treatment

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Steno Diabetes Center Copenhagen: lead

Study Sites (1)

Steno Diabetes Center Copenhagen

Herlev, 2730, Denmark

RECRUITING

Related Publications (1)

• Bjerre N, Christensen L, Hoeiberg C, Ottosson C, Jensen MK, Kildsig N, Moller TK, Termannsen AD, Ewers B, Hollender-Schou B, Grue RM, Bjerre-Christensen U, Jansen S, Akram K. Effectiveness of a Person-Centered and Culturally Sensitive Course of Treatment in Arabic-, Turkish-, and Urdu-Speaking Individuals With Type 2 Diabetes (the ACCT2 Study): Protocol for a Pragmatic Randomized Controlled Trial. JMIR Res Protoc. 2025 Jun 5;14:e67319. doi: 10.2196/67319.

  PMID: 40471662 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Ulla Bjerre-Christensen, MD

  Steno Diabetes Center Copenhagen

  PRINCIPAL INVESTIGATOR

• Natasja B Martinsen, PhD

  Steno Diabetes Center Copenhagen

  STUDY DIRECTOR

Central Study Contacts

Natasja B Martinsen, PhD

CONTACT

+45 60157718; natasja.bjerre.martinsen@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2023
• First Posted: November 27, 2023
• Study Start: November 9, 2023
• Primary Completion: December 1, 2025
• Study Completion: December 31, 2025
• Last Updated: December 2, 2024

Record last verified: 2023-11

Locations

DK (1)