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Making Diabetes Care Fit for Young Adults Living With Type 1 Diabetes: Observations, Reflections and Expert Opinions 60

Not yet recruiting
Clinical Trial NCT07498738 is an interventional study for Type 1 Diabetes and is currently not yet recruiting. Enrollment is planned to begin on March 13, 2026 and continue until the study accrues 60 participants. Led by Leiden University Medical Center, this study is expected to complete by October 30, 2026. The latest data from ClinicalTrials.gov was last updated on March 27, 2026.
Brief 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.

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 Makin...

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Official Title

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

Conditions
Type 1 Diabetes
Publications
Scientific articles and research papers published about this clinical trial:
Other Study IDs
  • nWMOD4- 2025-026
NCT ID Number
NCT07498738
Start Date (Actual)
2026-03-13
Last Update Posted
2026-03-27
Completion Date (Estimated)
2026-10-30
Enrollment (Estimated)
60
Study Type
Interventional
PHASE
N/A
Status
Not yet recruiting
Keywords
Make Care Fit
young adults
type 1 diabetes
qualitative research
Primary Purpose
Health Services Research
Design Allocation
Non-Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
OtherCare as usual
Care as usual
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.
ExperimentalMake Care Fit tool
Making Care Fit 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.
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Observable efforts of collaboration to align care and life, with and without using the tool.
Qualitative coding of observations
1 month from enrollment to the consultation
Perceived and unobservable efforts to align care and life.
Qualitative coding
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?"
4 months from enrollment to filling out the last questionnaire
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Variety and quality of themes discussed
Quantitative coding of observations, self-developed
1 month from enrollment to consultation
Collaborative care plan design
SDMo (reported on 1-10 scale) with higher scores suggesting more collaborative behaviours
1 month from enrollment to consultation
Fidelity of the use of the Making Care Fit tool
Quantitative coding of observations, self-developed
1 month from enrollment to the consultation
Unhurried conversations
Unhurried Collaboration Assessment Tool (UCAT), 37 items to be scored on a 1-5 scale.
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.
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.
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
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.
1 month from enrollment to after the consultation
Written information by patient in making care fit tool
Qualitative coding
1 month from enrollment to having the consultation
patient involvement
OPTION12 (reported on 0-100 scale) with a higher score being more patient involvement
1 month after enrollment during the clinical consultation
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult
Minimum Age
18 Years
Eligible Sexes
All
  • 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

  • People who do not fit the participant requirements
  • People who cannot give consent themselves (who are incapacitated)
Leiden University Medical Center logoLeiden University Medical Center205 active studies to explore
Study Responsible Party
Marleen Kunneman, Principal Investigator, Principal Investigator, Leiden University Medical Center
Study Central Contact
Contact: Marleen Kunneman, PhD, 0715263967, [email protected]
2 Study Locations in 1 Countries

South Holland

Leiden University Medical Center, Leiden, South Holland, 2333ZA, Netherlands
Anka van Gastel, MSc, Contact, +31625027266, [email protected]
Eelco de Koning, MD, Prof, Contact, [email protected]
Diabeter, Rotterdam, South Holland, 3011TA, Netherlands
Anka van Gastel, MSc, Contact, +31625027266, [email protected]
Christine Fransman, Contact, [email protected]