Type 2 DiabetesACCT2NCT06147245
The ACCT2 Study Individuals With Type 2 Diabetes and Non-Western Backgrounds (ACCT2)
A study testing Person-centred culturally sensitive course of treatment in people with Type 2 Diabetes, run by Steno Diabetes Center Copenhagen at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Person-centred culturally sensitive course of treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteDenmark
- Study dates
- 9 Nov 2023to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Steno Diabetes Center Copenhagen
Herlev, 2730
Natasja B Martinsen, Postdoc, +4560157718, natasja.bjerre.martinsen@regionh.dk
About this study
Official title: A Person-centred and Culturally Sensitive Course of Treatment Targeting Individuals With Type 2 Diabetes and Non-Western Backgrounds (The ACCT2 Study)
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.
Read the detailed description
Individuals with a non-Western background have a higher prevalence of T2D and exhibit poorer glycaemic control (HbA1c levels) than those with Danish ethnic background. Research indicates that individuals with non-Western backgrounds face a number of challenges for effective diabetes management. These challenges include low health literacy, language barriers in accessing and comprehending information, adherence to medication, lifestyle factors, and limited social support. Although studies show that culturally appropriate diabetes education can enhance glycaemic control and improve health behaviours, little is known about effective strategies and methods targeting individuals with non-Western backgrounds and T2D. This suggests a strengthened and systematic effort towards the treatment of individuals with T2D and non-Western backgrounds.
Overall, the ACCT2 study consists of three phases; 1) Need assessment, 2) Intervention development and testing, and 3) Randomized controlled trial (RCT). The aim of the present study (RCT) is to examine the effectiveness of a 12-month person-centred and culturally sensitive intervention on glycaemic control in individuals with T2D and a non-Western background (speaking either Urdu, Arabic or Turkish as native language). Participants will attend 6 visits at Steno Diabetes Center Copenhagen (SDCC): Visit 1 (baseline), visit 2 (two weeks after baseline), visit 3 (4 weeks after baseline), visit 4 (4 months after baseline), visit 5 (7-8 months after baseline), visit 6 (12 months after baseline).
The specific objectives are:
- To investigate the effect of a 1-year person-centred and culturally sensitive intervention on change in glycaemic control (HbA1c)
- To describe changes in cardiometabolic risk factors (including blood lipids, markers of glucose metabolism, blood pressure)
- To describe changes in patient-reported outcomes including overall health, well-being, quality of life, social support, diabetes management, diabetes distress, health behaviour, health literacy, medicine adherence, time-below-range (TBR), time-above-range (TAB), time-in-range (TIR), body weight and use of antidiabetic medicine
- To describe the extent to which the intervention was conducted as planned (visits, person-centred approach, tools)
- To explore participants' experiences with following the intervention and acceptance of it, including how a person-centred and culturally sensitive approach worked for them as well as the use of using technology for diabetes monitoring (sub-population).
- Conditions
- Type 2 Diabetes
- Being tested
- Person-centred culturally sensitive course of treatment
- Keywords
- Type 2 Diabetes, Glycaemic control, Cultural Sensitivity, Diabetes self-management, Non-Western immigrants, Co-creation
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Person-centred culturally sensitive course of treatmentBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Person-centred culturally sensitive course of treatment | Experimental | The intervention consists of a 12-month person-centred and culturally sensitive course of treatment. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HbA1c (mmol/mol)
Assessed from blood samples in non-fasted state
Measured: Change from baseline to the end of intervention (12 months)
Secondary outcomes (13)
Blood lipids (mmol/l)
Concentrations of: Total cholesterol, LDL cholesterol, HDL cholesterol and triglycerides
Measured: Change from baseline to the end of intervention (12 months)
Systolic blood pressure (mmHg)
Measured in resting state. Blood pressure measurements are repeated three times and mean value is calculated
Measured: Change from baseline to the end of intervention (12 months)
Diastolic blood pressure (mmHg)
Measured in resting state. Blood pressure measurements are repeated three times and mean value is calculated
Measured: Change from baseline to the end of intervention (12 months)
Resting heart rate (bpm)
Measured in resting state
Measured: Change from baseline to the end of intervention (12 months)
Marker of kidney function - Creatinine (μmmol/L)
Concentration of creatinine
Measured: Change from baseline to the end of intervention (12 months)
Marker of kidney function - eGFR (mL/min)
Estimated glomerular filtration rate (eGFR)
Measured: Change from baseline to the end of intervention (12 months)
Serum sodium (mmol/L)
Serum sodium concentration
Measured: Change from baseline to the end of intervention (12 months)
Serum potassium (mmol/L)
Serum potassium concentration
Measured: Change from baseline to the end of intervention (12 months)
Thyroid-stimulating hormone (TSH) (mIU/L)
Level of TSH assessed from blood samples
Measured: Change from baseline to the end of intervention (12 months)
Marker of liver function - Alanine aminotransferase (U/L)
Concentration of alanine aminotransferase
Measured: Change from baseline to the end of intervention (12 months)
C-peptide
Plasma concentration of c-peptide
Measured: Change from baseline to the end of intervention (12 months)
Coefficient of variation (CV) of glucose concentrations
Measured using continous glucose monitoring
Measured: Change from baseline to the end of intervention (12 months)
Screening for diabetic nephropathy - Urine albumin (mg)/creatinine (g) ratio
Measured in a urine sample
Measured: Change from baseline to the end of intervention (12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2023
- Study start9 Nov 2023
- Primary completionDec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Steno Diabetes Center Copenhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ulla Bjerre-Christensen, MD, Principal investigator, Steno Diabetes Center CopenhagenNatasja B Martinsen, PhD, Study director, Steno Diabetes Center Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06147245
- Sponsor's protocol ID
- H-23042245
- Acronym
- ACCT2
- Status last verified
- Nov 2023
- First submitted
- 19 Nov 2023
- Last updated
- 2 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40471662
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Person-centred and Culturally Sensitive Course of Treatment Targeting Individuals With Type 2 Diabetes and Non-Western Backgrounds (The ACCT2 Study)
- ClinicalTrials.gov ID
- NCT06147245
- Acronym / sponsor ID
- ACCT2 / H-23042245
- Conditions
- Type 2 Diabetes
- Keywords
- Type 2 Diabetes, Glycaemic control, Cultural Sensitivity, Diabetes self-management, Non-Western immigrants, Co-creation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Steno Diabetes Center CopenhagenUniversity, hospital or other
- Study start
- 9 Nov 2023 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 27 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Individuals with a non-Western background have a higher prevalence of T2D and exhibit poorer glycaemic control (HbA1c levels) than those with Danish ethnic background. Research indicates that individuals with non-Western backgrounds face a number of challenges for effective diabetes management. These challenges include low health literacy, language barriers in accessing and comprehending information, adherence to medication, lifestyle factors, and limited social support. Although studies show that culturally appropriate diabetes education can enhance glycaemic control and improve health behaviours, little is known about effective strategies and methods targeting individuals with non-Western backgrounds and T2D. This suggests a strengthened and systematic effort towards the treatment of individuals with T2D and non-Western backgrounds.
Overall, the ACCT2 study consists of three phases; 1) Need assessment, 2) Intervention development and testing, and 3) Randomized controlled trial (RCT). The aim of the present study (RCT) is to examine the effectiveness of a 12-month person-centred and culturally sensitive intervention on glycaemic control in individuals with T2D and a non-Western background (speaking either Urdu, Arabic or Turkish as native language). Participants will attend 6 visits at Steno Diabetes Center Copenhagen (SDCC): Visit 1 (baseline), visit 2 (two weeks after baseline), visit 3 (4 weeks after baseline), visit 4 (4 months after baseline), visit 5 (7-8 months after baseline), visit 6 (12 months after baseline).
The specific objectives are:
- To investigate the effect of a 1-year person-centred and culturally sensitive intervention on change in glycaemic control (HbA1c)
- To describe changes in cardiometabolic risk factors (including blood lipids, markers of glucose metabolism, blood pressure)
- To describe changes in patient-reported outcomes including overall health, well-being, quality of life, social support, diabetes management, diabetes distress, health behaviour, health literacy, medicine adherence, time-below-range (TBR), time-above-range (TAB), time-in-range (TIR), body weight and use of antidiabetic medicine
- To describe the extent to which the intervention was conducted as planned (visits, person-centred approach, tools)
- To explore participants' experiences with following the intervention and acceptance of it, including how a person-centred and culturally sensitive approach worked for them as well as the use of using technology for diabetes monitoring (sub-population).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Person-centred culturally sensitive course of treatment | Experimental | Behavioral: Person-centred culturally sensitive course of treatmentThe intervention consists of a 12-month person-centred and 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Person-centred culturally sensitive course of treatment12-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. | Behavioural | Person-centred culturally sensitive course of treatment |
Primary outcome
Change in HbA1c (mmol/mol)
Time frame: Change from baseline to the end of intervention (12 months)
Assessed from blood samples in non-fasted state
13 secondary outcomes
Blood lipids (mmol/l)
Time frame: Change from baseline to the end of intervention (12 months)
Systolic blood pressure (mmHg)
Time frame: Change from baseline to the end of intervention (12 months)
Diastolic blood pressure (mmHg)
Time frame: Change from baseline to the end of intervention (12 months)
Resting heart rate (bpm)
Time frame: Change from baseline to the end of intervention (12 months)
Marker of kidney function - Creatinine (μmmol/L)
Time frame: Change from baseline to the end of intervention (12 months)
Marker of kidney function - eGFR (mL/min)
Time frame: Change from baseline to the end of intervention (12 months)
Serum sodium (mmol/L)
Time frame: Change from baseline to the end of intervention (12 months)
Serum potassium (mmol/L)
Time frame: Change from baseline to the end of intervention (12 months)
Thyroid-stimulating hormone (TSH) (mIU/L)
Time frame: Change from baseline to the end of intervention (12 months)
Marker of liver function - Alanine aminotransferase (U/L)
Time frame: Change from baseline to the end of intervention (12 months)
C-peptide
Time frame: Change from baseline to the end of intervention (12 months)
Coefficient of variation (CV) of glucose concentrations
Time frame: Change from baseline to the end of intervention (12 months)
Screening for diabetic nephropathy - Urine albumin (mg)/creatinine (g) ratio
Time frame: Change from baseline to the end of intervention (12 months)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2024.
- Derived from this study: PubMed 40471662Bjerre 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ulla Bjerre-Christensen, MD principal investigator
Steno Diabetes Center Copenhagen
Natasja B Martinsen, PhD study director
Steno Diabetes Center Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Person-centred culturally sensitive course of treatment in people with Type 2 Diabetes, run by Steno Diabetes Center Copenhagen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Natasja B Martinsen, PhD (+45 60157718, natasja.bjerre.martinsen@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in HbA1c (mmol/mol) (time frame: Change from baseline to the end of intervention (12 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06147245, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2024.