NCT07377266

The Impact of Changing to a New Child- and Family-centered Outpatient Diabetes Clinic Focusing on Early Involvement of the Child With Diabetes, Training in Calmness Around Diabetes Management, Healthy Lifestyle, and Creating Peer-to-peer Networks

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Steno Diabetes Center Copenhagen · Academic / Other
• Sex: All
• Age: 3 Years – 10 Years
• Healthy volunteers: Not accepted

Summary

The goal of StenoChild is to strengthen the treatment of children under 10 years old with diabetes through a multi-component approach. This includes play-based methods, a focus on nutrition and mental health, and peer-to-peer programs that facilitate parental support and learning. The project has both a clinical and organizational dimension, as it aims to improve diabetes care and change practices and task organization at Steno Diabetes Center Copenhagen, SDCC.

Detailed description

The investigators encourage families to engage in eating, exercising, playing, and storytelling together, leveraging children's natural inclination to learn through play. This approach allows healthcare providers (HCPs) and parents to gain insights into the child's perspective, improving communication. The hypotheses are i) improved calmness during diabetes-related tasks with potential painful procedures such as shift of insulin infusions set and sensor will ease diabetes management and reduce parental distress; ii) improved structure and calmness around meals will ease diabetes management, reflected in interaction with insulin pumps; iii) the group and play-based approach will lead to healthier lifestyle changes compared to usual care.

Conditions

• Diabetes
• Quality of Life
• Children

Interventions

Type	Name	Description
BEHAVIORAL	Group consultations and peer-to-peer learning	The intervention introduces strategies to promote structured meals, calmness, and balanced diabetes self-management using play and storytelling learning strategies. Families participate in interactive modules in small groups (\~6-8 families), covering topics like "Meal Calmness" and "Calm Mind" four times during a year (every third month). Parents learn practical techniques to reduce conflict and improve dialogue around diabetes management. Children under 7 receive play-based sessions; those 7 and older receive story-based sessions. Clinical data as well as questionnaires will be collected at each session.
OTHER	Standard Care (in control arm)	The control group receives standard care, with the intervention offered later in a waitlist design. Clinical data as well as questionnaires will be collected at baseline and again after one year.

Timeline

• Start date: 2025-04-01
• Primary completion: 2028-12-31
• Completion: 2028-12-31
• First posted: 2026-01-29
• Last updated: 2026-01-29

Locations

1 site across 1 country: Denmark