Menu
Not yet recruiting NCT07498738

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

No phase Interventional Type 1 Diabetes

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Making Care Fit tool, Care as usual.
Who it may be relevant to
Registry conditions: Type 1 Diabetes. Basic parameters: 18 years — 30 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Netherlands
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

Interventions

  • Behavioral 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.
  • Other 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.

Primary outcome measures

  • Observable efforts of collaboration to align care and life, with and without using the tool. [Time frame: 1 month from enrollment to the consultation]
  • Perceived and unobservable efforts to align care and life. [Time frame: 2 months from enrollment into the study to the video stimulated interview]
  • Perceived alignment of care plan and life. [Time frame: 4 months from enrollment to filling out the last questionnaire]
Secondary outcome measures (10)
  • 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]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Health services research

Study locations

Netherlands · 2 centers
  • Leiden University Medical Center — Leiden
  • Diabeter — Rotterdam

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. PMID 41645388

Identifiers

NCT: NCT07498738 · nWMOD4- 2025-026

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗