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

Study Overview

• Status: Not yet recruiting
• Conditions: Type 1 Diabetes
• Intervention / Treatment: Other: Care as usual; Behavioral: Making Care Fit tool

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marleen Kunneman, PhD; Phone Number: 0715263967; Email: Kunneman@lumc.nl

Study Locations

• Netherlands
  • South Holland
    • Leiden, South Holland, Netherlands, 2333ZA
      • Leiden University Medical Center
      • Contact: Anka van Gastel, MSc; Phone Number: +31625027266; Email: Ankavangastel@lumc.nl
      • Contact: Eelco de Koning, MD, Prof; Email: e.j.p.de_koning@lumc.nl
    • Rotterdam, South Holland, Netherlands, 3011TA
      • Diabeter
      • Contact: Anka van Gastel, MSc; Phone Number: +31625027266; Email: Ankavangastel@lumc.nl
      • Contact: Christine Fransman; Email: c.fransman@diabeter.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Care as usual	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.
Experimental: Make Care Fit tool	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 Names: MCF tool

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time 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 Measure	Measure Description	Time 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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Consultation characteristics	Encounter duration, diabetes clinic, consultation type (in-person or digital)	1 month from enrollment to consultation
Diabetes-specific characteristics	8 items (self-developed): Treatment regime, year of diagnosis, events of ketoacidosis and hypoglycaemia, HbA1c.	4 months from enrollment to last questionnaire filled out
Consultation characteristic	1 item (self-developed: Duration of patient/clinician relationship in years	4 months from enrollment to last questionnaire
Work-related characteristics	2 items (self-developed): Clinicians' years worked, clinical background	1 month from enrollment to consultation
Participant characteristics	Young adults: 7 items (self-developed): Age, gender, household situation, socioeconomic status, comorbidity, level of education13 Clinicians: 2 items (self-developed): Age, gender.	4 months from enrollment to last questionnaire

Collaborators and Investigators

• Sponsor: Leiden University Medical Center

Publications and helpful links

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

Study record dates

Study Major Dates

• Study Start (Estimated): March 13, 2026
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): October 30, 2026

Study Registration Dates

• First Submitted: March 17, 2026
• First Submitted That Met QC Criteria: March 23, 2026
• First Posted (Actual): March 27, 2026

Study Record Updates

• Last Update Posted (Actual): March 27, 2026
• Last Update Submitted That Met QC Criteria: March 23, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: young adults; type 1 diabetes; qualitative research; Make Care Fit
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Autoimmune Diseases; Immune System Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 1
• Other Study ID Numbers: nWMOD4- 2025-026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: As this is a qualitative study data from participants might be easy traced back to the individuals.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No