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NCT Number: NCT07498738

Making Diabetes Care Fit for Young Adults Living With Type 1 Diabetes: Observations, Reflections and Expert Opinions

The goal of this clinical study is to assess differences in collaborative efforts to make care fit between clinical encounters in usual care and those using the Making Care Fit tool among young adults with type 1 diabetes and their clinicians.

The main question it aims to answer is:

What are the differences in collaborative efforts to make care fit between clinical encounters in usual care and those using the Making Care Fit tool?

Researchers will compare clinical encounters in usual care with encounters supported by the Making Care Fit tool to examine differences in collaborative efforts to align care and daily life.

Participants will:

* Take part in an observed clinical encounter with their clinician * Participate in a post-encounter video-stimulated interview reflecting on the consultation * Complete questionnaires about their experiences of the consultation

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Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Leiden University Medical Center, Leiden, South Holland, Netherlands

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Young adults (age 18-30)
  • with ≥1 year since the diagnosis of type 1 diabetes
  • receiving ongoing treatment at participating diabetes clinics (Leiden university medical center (LUMC), Diabeter),
  • able to speak and read Dutch
  • able to provide informed consent for study participation

Exclusion criteria

  • People who do not fit the participant requirements
  • People who cannot give consent themselves (who are incapacitated)

Treatment and study plan

Making Care Fit tool

Behavioral

A web-based tool designed to help young adults with type 1 diabetes prepare for care plan design during their clinical encounter by structuring and prioritizing their experiences and efforts in making care fit.

Other names: MCF tool

Care as usual

Other

Participants receive standard diabetes care at their clinic. Clinical encounters are observed and assessed to compare collaborative efforts with those in the Making Care Fit Tool arm.

Primary outcomes

  1. Observable efforts of collaboration to align care and life, with and without using the tool.

    Time frame: 1 month from enrollment to the consultation

    Qualitative coding of observations

  2. Perceived and unobservable efforts to align care and life.

    Time frame: 2 months from enrollment into the study to the video stimulated interview

    Qualitative coding

  3. Perceived alignment of care plan and life.

    Time frame: 4 months from enrollment to filling out the last questionnaire

    Young adults & clinicians: Open-ended question: "why does your care plan make sense?"

Secondary outcomes

  1. Variety and quality of themes discussed

    Time frame: 1 month from enrollment to consultation

    Quantitative coding of observations, self-developed

  2. Collaborative care plan design

    Time frame: 1 month from enrollment to consultation

    SDMo (reported on 1-10 scale) with higher scores suggesting more collaborative behaviours

  3. Fidelity of the use of the Making Care Fit tool

    Time frame: 1 month from enrollment to the consultation

    Quantitative coding of observations, self-developed

  4. Unhurried conversations

    Time frame: 1 month from enrollment to consultation

    Unhurried Collaboration Assessment Tool (UCAT), 37 items to be scored on a 1-5 scale.

  5. Perceived treatment burden, and acceptability of this burden.

    Time frame: 4 months from enrollment to filling out the last questionnaire

    Young adults: Treatment Burden Questionnaire (TBQ), 15 items to be scored on a 0-10 scale; 1 item on acceptability of burden.

  6. Perceived diabetes distress

    Time frame: 4 months from enrollment to filling out the last questionnaire

    Young adults: Diabetes distress scale (DDS) screening instrument, 2 items to be scored on a 1-6 scale.

  7. Self-reported fidelity of using the Making Care Fit tool outside of the clinical encounter

    Time frame: 1 month from enrollment to concluding the consultation

    Young adults & clinicians: 3 items about fidelity and and acceptability

  8. Perceived clinical empathy

    Time frame: 1 month from enrollment to after the consultation

    Young adults: Consultation And Relational Empathy (CARE) measure, 10 items to be scored on a 1-5 scale.

  9. Written information by patient in making care fit tool

    Time frame: 1 month from enrollment to having the consultation

    Qualitative coding

  10. patient involvement

    Time frame: 1 month after enrollment during the clinical consultation

    OPTION12 (reported on 0-100 scale) with a higher score being more patient involvement

Other outcomes

  1. Consultation characteristics

    Time frame: 1 month from enrollment to consultation

    Encounter duration, diabetes clinic, consultation type (in-person or digital)

  2. Diabetes-specific characteristics

    Time frame: 4 months from enrollment to last questionnaire filled out

    8 items (self-developed): Treatment regime, year of diagnosis, events of ketoacidosis and hypoglycaemia, HbA1c.

  3. Consultation characteristic

    Time frame: 4 months from enrollment to last questionnaire

    1 item (self-developed: Duration of patient/clinician relationship in years

  4. Work-related characteristics

    Time frame: 1 month from enrollment to consultation

    2 items (self-developed): Clinicians' years worked, clinical background

  5. Participant characteristics

    Time frame: 4 months from enrollment to last questionnaire

    Young adults: 7 items (self-developed): Age, gender, household situation, socioeconomic status, comorbidity, level of education13

    Clinicians: 2 items (self-developed):

    Age, gender.

Study contacts

Contact information is provided by the study sponsor or research team.

Marleen Kunneman, PhD

CONTACT

[email protected]

0715263967

Sponsors and collaborators

Lead sponsor

Leiden University Medical Center

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 27, 2026
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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