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CUlturally Sensitive TOols for Ethnic Minorities in Diabetes Self-management Education and Support (CUSTOM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03950219
Recruitment Status : Recruiting
First Posted : May 15, 2019
Last Update Posted : October 22, 2020
Centre for Diabetes, Copenhagen municipality
Information provided by (Responsible Party):
Nana Folmann Hempler, Steno Diabetes Center Copenhagen

Brief Summary:
The CUSTOM research project represents a complex intervention. The project aim of the intervention is, through the delivery of culturally sensitive Diabetes self-management education and support, to support ethnic minorities with type 2 diabetes in making health-promoting decisions about their care and gaining insight into their goals, values and motivation to improve their daily diabetes self-management. The target group comprises ethnic minorities whose native language is Arabic, Urdu or Turkish.

Condition or disease Intervention/treatment
Diabetes Mellitus, Type 2 Other: Group course

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Study Type : Observational
Estimated Enrollment : 309 participants
Official Title: CUlturally Sensitive TOols and Methods for Ethnic Minorities (CUSTOM): Building Bridges Between Theory and Practice in Diabetes Self-management Education and Support
Actual Study Start Date : March 1, 2019
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : October 2022

Group/Cohort Intervention/treatment
Intervention, Centre for Diabetes or local setting
Group-based course in diabetes education including 6 sessions of approximately 3 hours. Sessions are constructed around themes such as; diabetes knowledge and complication, mental health, diet, physical activity, Ramadan, medicine and include practical exercises such as blood sugar measurements, walking etc.
Usual care
Usual care in 5 municipalities in the west area of Copenhagen
Other: Group course
Education and support

Primary Outcome Measures :
  1. Well-being [ Time Frame: 6 months ]

  2. diabetes self-management [ Time Frame: 6 months ]

  3. HbA1c [ Time Frame: 6 months ]
    blood sample

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Referred to rehabilitation by the GP and has type 2 diabetes

Inclusion Criteria:

  • Clinical diagnosis of type 2 diabetes
  • Ability to give written consent
  • Ability and willingness to attend and participate in a group-based education programme.
  • First language is Arabic, Turkish or Urdu.

Exclusion Criteria:

  • Physical illness that could seriously reduce their life expectancy and ability to participate in the trial
  • Mental illness that could reduce their ability to participate in the trial
  • Significant alcohol or substance misuse which could limit the participants ability to participate in the trial
  • A primary diagnosis of learning disability
  • Pregnancy, breastfeeding or plans of pregnancy during the study period

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03950219

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Contact: Nana F Hempler, PhD +45 40732591
Contact: Lone B Rasmussen, PhD +45 22857377

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Centre for Diabetes Recruiting
Copenhagen, Denmark, 1620
Contact: Charlotte Glümer, MD, PhD   
Contact: Gritt-Marie H Malling    +45 2910 6797   
Sponsors and Collaborators
Steno Diabetes Center Copenhagen
Centre for Diabetes, Copenhagen municipality
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Principal Investigator: Nana F Hempler, PhD Steno Diabetes Center Copenhagen
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Responsible Party: Nana Folmann Hempler, Team leader and senior researcher, Steno Diabetes Center Copenhagen Identifier: NCT03950219    
Other Study ID Numbers: CUSTOM
First Posted: May 15, 2019    Key Record Dates
Last Update Posted: October 22, 2020
Last Verified: October 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nana Folmann Hempler, Steno Diabetes Center Copenhagen:
Diabetes self-management
Diabetes Education
Ethnic minorities
Patient empowerment
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases