Type 1 DiabetesNCT07498738
Making Diabetes Care Fit for Young Adults Living With Type 1 Diabetes: Observations, Reflections and Expert Opinions
A study testing Making Care Fit tool and Care as usual in people with Type 1 Diabetes, run by Leiden University Medical Center at 2 sites in Netherlands.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 30 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Making Care Fit tool and Care as usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesNetherlands
- Study dates
- 13 Mar 2026to 30 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 30 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- People who do not fit the participant requirements
- People who cannot give consent themselves (who are incapacitated)
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands2 sites, 2 recruiting
- Recruiting
Leiden University Medical Center
Leiden, South Holland, 2333ZA
Anka van Gastel, MSc, +31625027266, Ankavangastel@lumc.nl
Eelco de Koning, MD, Prof, e.j.p.de_koning@lumc.nl
- Recruiting
Diabeter
Rotterdam, South Holland, 3011TA
Anka van Gastel, MSc, +31625027266, Ankavangastel@lumc.nl
Christine Fransman, c.fransman@diabeter.nl
About this study
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:
Read more
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
- Conditions
- Type 1 Diabetes
- Being tested
- Making Care Fit tool, Care as usual
- Keywords
- Make Care Fit, young adults, type 1 diabetes, qualitative research
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Making Care Fit toolBehavioural
Also called MCF tool
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.
Care as usualOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Care as usual | Other | Not described Receives: Other: Care as usual |
| Make Care Fit tool | Experimental | Not described Receives: Behavioral: Making Care Fit tool |
What is being measured
The primary outcome is the main question the study is designed to answer.
Observable efforts of collaboration to align care and life, with and without using the tool.
Qualitative coding of observations
Measured: 1 month from enrollment to the consultation
Perceived and unobservable efforts to align care and life.
Qualitative coding
Measured: 2 months from enrollment into the study to the video stimulated interview
Perceived alignment of care plan and life.
Young adults \& clinicians: Open-ended question: "why does your care plan make sense?"
Measured: 4 months from enrollment to filling out the last questionnaire
Secondary outcomes (10)
Variety and quality of themes discussed
Quantitative coding of observations, self-developed
Measured: 1 month from enrollment to consultation
Collaborative care plan design
SDMo (reported on 1-10 scale) with higher scores suggesting more collaborative behaviours
Measured: 1 month from enrollment to consultation
Fidelity of the use of the Making Care Fit tool
Quantitative coding of observations, self-developed
Measured: 1 month from enrollment to the consultation
Unhurried conversations
Unhurried Collaboration Assessment Tool (UCAT), 37 items to be scored on a 1-5 scale.
Measured: 1 month from enrollment to consultation
Perceived treatment burden, and acceptability of this burden.
Young adults: Treatment Burden Questionnaire (TBQ), 15 items to be scored on a 0-10 scale; 1 item on acceptability of burden.
Measured: 4 months from enrollment to filling out the last questionnaire
Perceived diabetes distress
Young adults: Diabetes distress scale (DDS) screening instrument, 2 items to be scored on a 1-6 scale.
Measured: 4 months from enrollment to filling out the last questionnaire
Self-reported fidelity of using the Making Care Fit tool outside of the clinical encounter
Young adults \& clinicians: 3 items about fidelity and and acceptability
Measured: 1 month from enrollment to concluding the consultation
Perceived clinical empathy
Young adults: Consultation And Relational Empathy (CARE) measure, 10 items to be scored on a 1-5 scale.
Measured: 1 month from enrollment to after the consultation
Written information by patient in making care fit tool
Qualitative coding
Measured: 1 month from enrollment to having the consultation
patient involvement
OPTION12 (reported on 0-100 scale) with a higher score being more patient involvement
Measured: 1 month after enrollment during the clinical consultation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start13 Mar 2026
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Jan 2027 (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 1 DiabetesStudies of the same condition, open and under way.
- More trials run by Leiden University Medical CenterThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This is a multi-center clinical study using a mixed methods parallel group design. Young adults with type 1 diabetes are assigned to either usual care or care supported by the finalized Making Care Fit tool (MCF tool). Clinical encounters are observed and assessed to compare collaborative efforts to align care with daily life between the two groups.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Leiden University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marleen Kunneman, Leiden University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07498738
- Sponsor's protocol ID
- nWMOD4- 2025-026
- Status last verified
- Aug 2026
- First submitted
- 17 Mar 2026
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: As this is a qualitative study data from participants might be easy traced back to the individuals.
Publications
Van Gastel A, Graner-Baars M, De Koning EJP, Montori VM, Tran VT, Dinneen SF, Mesman J, Swaak J, Aanstoot HJ, Stiggelbout AM, Kunneman M. Picture living with diabetes: A photovoice study of young adults' efforts in making diabetes care fit into their lives. Diabet Med. 2026 May;43(5):e70246. doi: 10.1111/dme.70246. Epub 2026 Feb 5.
PubMed 41645388
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Making Diabetes Care Fit for Young Adults Living With Type 1 Diabetes: Observations, Reflections and Expert Opinions
- ClinicalTrials.gov ID
- NCT07498738
- Acronym / sponsor ID
- nWMOD4- 2025-026
- Conditions
- Type 1 Diabetes
- Keywords
- Make Care Fit, young adults, type 1 diabetes, qualitative research
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Leiden University Medical CenterUniversity, hospital or other
- Study start
- 13 Mar 2026 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Jan 2027 (estimated)
- First posted
- 27 Mar 2026 (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 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
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a multi-center clinical study using a mixed methods parallel group design. Young adults with type 1 diabetes are assigned to either usual care or care supported by the finalized Making Care Fit tool (MCF tool). Clinical encounters are observed and assessed to compare collaborative efforts to align care with daily life between the two groups.
| Arm | Type | Receives |
|---|---|---|
| Care as usual | Other | Other: Care as usual |
| Make Care Fit tool | Experimental | Behavioral: Making Care Fit tool |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- People who do not fit the participant requirements
- People who cannot give consent themselves (who are incapacitated)
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 |
|---|---|---|
| Making Care Fit toolAlso: MCF toolA 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. | Behavioural | Make Care Fit tool |
| Care as usualParticipants 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. | Other | Care as usual |
Primary outcome
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
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
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?"
10 secondary outcomes
Variety and quality of themes discussed
Time frame: 1 month from enrollment to consultation
Collaborative care plan design
Time frame: 1 month from enrollment to consultation
Fidelity of the use of the Making Care Fit tool
Time frame: 1 month from enrollment to the consultation
Unhurried conversations
Time frame: 1 month from enrollment to consultation
Perceived treatment burden, and acceptability of this burden.
Time frame: 4 months from enrollment to filling out the last questionnaire
Perceived diabetes distress
Time frame: 4 months from enrollment to filling out the last questionnaire
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
Perceived clinical empathy
Time frame: 1 month from enrollment to after the consultation
Written information by patient in making care fit tool
Time frame: 1 month from enrollment to having the consultation
patient involvement
Time frame: 1 month after enrollment during the clinical consultation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
- Background: PubMed 41645388Van Gastel A, Graner-Baars M, De Koning EJP, Montori VM, Tran VT, Dinneen SF, Mesman J, Swaak J, Aanstoot HJ, Stiggelbout AM, Kunneman M. Picture living with diabetes: A photovoice study of young adults' efforts in making diabetes care fit into their lives. Diabet Med. 2026 May;43(5):e70246. doi: 10.1111/dme.70246. Epub 2026 Feb 5.
- Individual participant dataSharing planned: No. As this is a qualitative study data from participants might be easy traced back to the individuals.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Making Care Fit tool and Care as usual in people with Type 1 Diabetes, run by Leiden University Medical Center at 2 sites in Netherlands.
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 5 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marleen Kunneman, PhD (0715263967, Kunneman@lumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Observable efforts of collaboration to align care and life, with and without using the tool. (time frame: 1 month from enrollment to the consultation). The study lists 3 primary outcomes in all. 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 NCT07498738, 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 Sep 2026.