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

NCT07498738 | Not Yet Recruiting

• 1 other identifier: nWMOD4- 2025-026
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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 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

Keywords

Make Care Fit; young adults; type 1 diabetes; qualitative research

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (10)

• Variety and quality of themes discussed

  1 month from enrollment to consultation

• Collaborative care plan design

  1 month from enrollment to consultation

• Fidelity of the use of the Making Care Fit tool

  1 month from enrollment to the consultation

• Unhurried conversations

  1 month from enrollment to consultation

• Perceived treatment burden, and acceptability of this burden.

  4 months from enrollment to filling out the last questionnaire

Other Outcomes (5)

• Consultation characteristics

  1 month from enrollment to consultation

• Diabetes-specific characteristics

  4 months from enrollment to last questionnaire filled out

• Consultation characteristic

  4 months from enrollment to last questionnaire

Study Arms (2)

Care as usual

OTHER

Other: Care as usual

Make Care Fit tool

EXPERIMENTAL

Behavioral: Making Care Fit tool

Interventions

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.

Care as usual

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.

Also known as: MCF tool

Make Care Fit tool

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Leiden University Medical Center: lead

Study Sites (2)

Leiden University Medical Center

Leiden, South Holland, 2333ZA, Netherlands

Location

Diabeter

Rotterdam, South Holland, 3011TA, Netherlands

Location

Related Publications (1)

• 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 Feb 5:e70246. doi: 10.1111/dme.70246. Online ahead of print.

  PMID: 41645388 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Marleen Kunneman, PhD

CONTACT

0715263967; Kunneman@lumc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: March 17, 2026
• First Posted: March 27, 2026
• Study Start: March 13, 2026
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): October 30, 2026
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

NL (2)